Medical Devices

November 2017 510(k) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD November 2017


DEVICE: DIAZIR
ZXTGY (BEIJING) TECHNOLOGY CO., LT510(k) NO: K161652(Traditional)
ATTN: N/A  N/A                    PHONE NO : 86 106 7207928 
132 JINGCHEN RUNYE COURTYARD 7 ZONSE DECISION MADE: 28-NOV-17
BEIJING  CN 100023                510(k) STATEMENT
                                                    

DEVICE: LED Curing Light
MONITEX INDUSTRIAL CO., LTD.      510(k) NO: K161855(Traditional)
ATTN: SHU-LUNG  WANG              PHONE NO : 886 2 29993869 
6F, 70 SEC. 1 GUANG-FU ROAD, SANCHSE DECISION MADE: 27-NOV-17
NEW TAIPEI CITY  TW 241-58        510(k) STATEMENT
                                                    

DEVICE: J2A SLA Dental Implant System
KJ Meditech Co., Ltd.             510(k) NO: K161923(Traditional)
ATTN: Goong-san  Nam              PHONE NO : 82 62 9725476 
21, Cheomdan Venture-ro 40 Beon-giSE DECISION MADE: 09-NOV-17
Gwangju  KR 500-470               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTIFY Corpectomy Spacers
GLOBUS MEDICAL INC.               510(k) NO: K162315(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 GENERAL ARMISTEAD AVE.       SE DECISION MADE: 09-NOV-17
AUDUBON PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Foot Drop System (Model XFT-2001D)
SHENZHEN XFT Medical Limited      510(k) NO: K162718(Traditional)
ATTN: JIANG  XIAOYING             PHONE NO : 86 755 29888818 
RM 203, BLD1, 14JINHUI ROAD, NEW DSE DECISION MADE: 30-NOV-17
SHENZHEN  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical Neria Soft Subcutaneous Infusion Set, Medtronic Silhouette Subcutaneous Infusion Set, Medtronic Silhouette Paradigm Subcutaneous Infusion Set, Roche Accu-Chek Tender Subcutaneous Infusion Set, Asante Comfort Subcutaneous Infusion Set, Abbott Comfort Subcutaneous Infusion Set
UNOMEDICAL A/S                    510(k) NO: K162812(Traditional)
ATTN: John M. Lindskog            PHONE NO : 45 464 27810 
AAHOLMVEJ 1-3                     SE DECISION MADE: 01-NOV-17
OSTED  DK DK-4000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PixoTest Blood Glucose Monitoring System
iXensor Company Ltd.              510(k) NO: K163087(Traditional)
ATTN: JAMIE  WU                   PHONE NO : 886 2 87511335 
9F, No. 473, Sec. 2, Tiding Blvd.,SE DECISION MADE: 02-NOV-17
Taipei City  TW 114               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORCA (tm) - Operational Rescue Containment Apparatus
ISOVAC PRODUCTS, LLC              510(k) NO: K163223(Traditional)
ATTN: PETER M. JENKNER            PHONE NO : 630 6791740 
1306 ENTERPRISE DRIVE, UNIT C     SE DECISION MADE: 02-NOV-17
ROMEOVILLE IL  60446              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultrasonic scaler
NANNING VV DENTAL CO., LTD.       510(k) NO: K163414(Traditional)
ATTN: Liang  chaojun              PHONE NO : 0086 771 3391162 
4th floor,North Bld. No.1 , ZhengxSE DECISION MADE: 21-NOV-17
Nan ning  CN 530007               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitalPatch® VitalConnect Platform
VITAL CONNECT, INC.               510(k) NO: K163453(Traditional)
ATTN: KEVIN  POTGIETER            PHONE NO : 1 408 9634600 
900 E. HAMILTON AVENUE SUITE 500  SE DECISION MADE: 02-NOV-17
CAMPBELL CA  95008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intra.Ox Handheld Tissue Oximeter
VIOPTIX, INC.                     510(k) NO: K163472(Traditional)
ATTN: MARK  LONSINGER             PHONE NO : 510 2265960 
39655 EUREKA DRIVE                SE DECISION MADE: 16-NOV-17
NEWARK CA  94560                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KLS Martin Individual Patient Solutions
KLS Martin LP                     510(k) NO: K163579(Traditional)
ATTN: Jennifer  Damato            PHONE NO : 800 6251557 
11201 Saint Johns Industrial Pkwy SE DECISION MADE: 21-NOV-17
Jacksonville FL  32246            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMPIX 3D Print Cages
MEDICREA INTERNATIONAL S.A.       510(k) NO: K163595(Traditional)
ATTN: David  Ryan                 PHONE NO : 0033 4 72018787 
5389 route de Strasbourg          SE DECISION MADE: 13-NOV-17
Rillieux-la-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: External Hex Implants
SOUTHERN IMPLANTS (PTY) LTD       510(k) NO: K163634(Traditional)
ATTN: LAURANDA  BREYTENBACH       PHONE NO : 27 12 6671046 
1 ALBERT ROAD                     SE DECISION MADE: 06-NOV-17
IRENE  ZA 0062                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIRIO H3
MASMEC SPA                        510(k) NO: K163643(Traditional)
ATTN: Domenico  Marino            PHONE NO : 39 080 5856673 
Via dei Gigli 21                  SE DECISION MADE: 16-NOV-17
Modugno (BA)  IT 70026            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Terragene Bionova(R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova(R) IC10/20FR Reader Incubator
Terragene SA                      510(k) NO: K163646(Traditional)
ATTN: Maria Victoria Quiroga      PHONE NO : 54 341 4362015 
Guemes 2879                       SE DECISION MADE: 02-NOV-17
Rosario  AR 2000                  510(k) STATEMENT
                                                    

DEVICE: Rooti Rx ECG Event Recorder, Rooti Link APP Software
Rooti Labs Ltd.                   510(k) NO: K163694(Traditional)
ATTN: Sue  Chuang                 PHONE NO : 886 226 560618 
5F-1, No.17, Zhouzi St., Neihu DisSE DECISION MADE: 07-NOV-17
Taipei  TW 11493                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klockner Vega TiBase for CEREC
SOADCO S.L.                       510(k) NO: K170022(Abbreviated)
ATTN: MARIA  MITJANETA            PHONE NO : 376 800590 
AVGDA. FITER I ROSELLL, 4 BIS - LOSE DECISION MADE: 16-NOV-17
ESCALDES - ENGORDANY  AD AD-700   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Meridian PM
The Center for Craniofacial & Dent510(k) NO: K170053(Abbreviated)
ATTN: Samuel  Cress               PHONE NO : 281 5654100 
4545 Sweetwater Blvd              SE DECISION MADE: 28-NOV-17
Sugarland TX  77479               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SGS ECCOVISIONTM Pharyngometer, SGS ECCOVISIONTM Rhinometer, SGS ECCOVISIONTM Rhino/Pharyngometer
Sleep Group Solutions             510(k) NO: K170071(Traditional)
ATTN: Rani  Ben-David             PHONE NO : 305 8300327 
2035 Harding Street, Suite 200    SE DECISION MADE: 09-NOV-17
Hollywood FL  33020               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System - CM Pro PEEK Abutment
JJGC Industria e Comercio de Mater510(k) NO: K170080(Traditional)
ATTN: Julianne  Lechechem         PHONE NO : 55 41 21694058 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 02-NOV-17
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pekkton Ivory
CENDRES+METAUX SA                 510(k) NO: K170102(Traditional)
ATTN: Uli  DIERMANN               PHONE NO : 41 58 3602218 
Rue de Boujean 122                SE DECISION MADE: 13-NOV-17
Biel/Bienne  CH 2501              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex FiberTape Cerclage
ARTHREX, INC.                     510(k) NO: K170206(Traditional)
ATTN: IVETTE  GALMEZ              PHONE NO : 239 6435553 71263
1370 CREEKSIDE BOULEVARD          SE DECISION MADE: 15-NOV-17
NAPLES FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental High-speed Turbine Handpiece
GUANGDONG JINME MEDICAL TECHNOLOGY510(k) NO: K170229(Traditional)
ATTN: KRISTI  YANG                PHONE NO : 86 757 8877997 
A15, NEW LIGHT SOURCE INDUSTRIL BASE DECISION MADE: 08-NOV-17
FOSHAN  CN 528000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lucent®
Spinal Elements Inc.              510(k) NO: K170235(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071816 
3115 Melrose Dr., Suite 200       SE DECISION MADE: 29-NOV-17
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dental Low-speed Turbine Handpiece
Guangdong JINME Medical Technology510(k) NO: K170236(Traditional)
ATTN: Kristi  Yang                PHONE NO : 86 757 8877997 
A15, New Light Source Industrial BSE DECISION MADE: 21-NOV-17
Foshan  CN 528000                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medussa-PL Cage
Medyssey USA, Inc.                510(k) NO: K170341(Traditional)
ATTN: Shawn  Kim                  PHONE NO : 1 847 4270200 
1550 East Higgins Road, Suite 123 SE DECISION MADE: 02-NOV-17
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ABX MICROS ES 60 OT and ABX MICROS ES 60 CT
HORIBA ABX SAS                    510(k) NO: K170353(Traditional)
ATTN: Caroline  Ferrer            PHONE NO : 33 467 141516 
Parc Euromedecine Rue du Caducee BSE DECISION MADE: 01-NOV-17
Montpellier Cedex 4  FR 34184     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VORTEK HYDRO-COATED DOUBLE LOOP URETERAL STENTS
Coloplast Corp                    510(k) NO: K170362(Traditional)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road North        SE DECISION MADE: 15-NOV-17
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S.I.N. Dental Implant System
S.I.N. – Sistema de Implante Nacio510(k) NO: K170398(Traditional)
ATTN: Denis  Oliveira             PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 21-NOV-17
Sao Paulo  BR 03310-000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Curve Ascites Shunt
CareFusion                        510(k) NO: K170405(Traditional)
ATTN: Tamara  Brey                PHONE NO : 847 3629485 
75 North Fairway Drive            SE DECISION MADE: 02-NOV-17
Vernon Hills IL  60061            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BIOSOFT DUO DOUBLE LOOP URETERAL STENTS
Coloplast Corp                    510(k) NO: K170422(Traditional)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road north        SE DECISION MADE: 02-NOV-17
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterisheet Sterilization Wrap
Andersen Sterilizers,Inc.         510(k) NO: K170437(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 01-NOV-17
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AN87 Dosimeter
Andersen Sterilizers, Inc.        510(k) NO: K170439(Traditional)
ATTN: William K. Andersen         PHONE NO : 336 3768622 
3154 Caroline Drive               SE DECISION MADE: 01-NOV-17
Haw River NC  27258               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StatStrip Xpress Blood Glucose Monitoring System
Nova Biomedical Corporation       510(k) NO: K170464(Traditional)
ATTN: Eliza  Wang                 PHONE NO : 781 6473700 743
200 Prospect Street               SE DECISION MADE: 07-NOV-17
Waltham MA  02454                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C2 femoral stem
Limacorporate S.p.A.              510(k) NO: K170473(Traditional)
ATTN: Antonio  Soleti             PHONE NO : 390 43 2945511 
via Nazionale 52                  SE DECISION MADE: 08-NOV-17
Villanova di San Daniele  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAUSER PG II Sharps Container
Mauzer USA LLC                    510(k) NO: K170513(Traditional)
ATTN: Tatiana  Smoleeva           PHONE NO : 732 3537015 
2 Tower Center Drive, 20th floor  SE DECISION MADE: 01-NOV-17
East Brunswick NJ  08816          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merits Model R106/R136 Rehab Wheelchair
Merits Healthcare Industries (suzh510(k) NO: K170517(Traditional)
ATTN: Guangyong  Li               PHONE NO : 86 512 53510000 211
No.29, Fuzhou Road                SE DECISION MADE: 16-NOV-17
Taicang City  CN 215411           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Access AMH
Beckman Coulter, Inc.             510(k) NO: K170524(Traditional)
ATTN: Debbie  Kidder              PHONE NO : 612 4756022 
1000 Lake Hazeltine Drive         SE DECISION MADE: 13-NOV-17
Chaska MN  55318-1084             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROLIXUS TOTAL KNEE SYSTEM
OTIS Biotech Co., Ltd.            510(k) NO: K170534(Traditional)
ATTN: Sanjay  Lingot              PHONE NO : 82 313 190406 
15-118. MTV buk-ro, 193beon-gil BuSE DECISION MADE: 09-NOV-17
Siheung-si  KR 15118              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Langston dual lumen catheter
Vascular Solutions, Inc.          510(k) NO: K170544(Traditional)
ATTN: Jake  Schultz               PHONE NO : 763 6564300 
6464 Sycamore Court North         SE DECISION MADE: 17-NOV-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automatic Wrist Bluetooth Blood Pressure Monitor
Truly Instrument Ltd.             510(k) NO: K170545(Abbreviated)
ATTN: Yang  Jian-Hao              PHONE NO : 86 066 03380070 
Site 2, Truly Industry Area       SE DECISION MADE: 21-NOV-17
Shanwei  CN 516600                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True Function Adjustable Herbst Appliances
True Function Laboratory, Inc.    510(k) NO: K170578(Abbreviated)
ATTN: Frank  Madrigal             PHONE NO : 619 4661872 
7851 University Ave., #102        SE DECISION MADE: 24-NOV-17
La Mesa CA  91942                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IV Administration Sets
B. Braun Medical Inc.             510(k) NO: K170595(Traditional)
ATTN: Nancy  Skocypec             PHONE NO : 610 2660500 
901 Macon Blvd                    SE DECISION MADE: 07-NOV-17
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acrylic Herbst Appliance with Micro-Recorder
Gergen's Orthodontic Lab          510(k) NO: K170606(Traditional)
ATTN: Chris  Morrison             PHONE NO : 623 8796066 
1745 West Deer Valley Rd, Suite 11SE DECISION MADE: 16-NOV-17
Phoenix AZ  85027                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quingo Classic Power Scooter S1301, Quingo Flyte Power Scooter S551, Quingo Toura Power Scooter 5350
Advanced Vehicle Concepts Ltd.    510(k) NO: K170634(Traditional)
ATTN: Mark  Nicholls              PHONE NO : 44 1582 430889 
7 Stadium Way Cradock Road        SE DECISION MADE: 29-NOV-17
Luton  GB LU4 0JF                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Non Contact Infrared Forehead Thermometer
Intrinity Global Limited          510(k) NO: K170662(Traditional)
ATTN: Alex  Kwok                  PHONE NO : 852 352 31874 
Room 1707, 17/F, Westley Square 48SE DECISION MADE: 22-NOV-17
Hong Kong  CN 999077              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Odyssey Micro Catheter
Heraeus Medical Components, LLC   510(k) NO: K170664(Traditional)
ATTN: Margaret  Batchelder        PHONE NO : 763 2256675 
2605 Fernbrook Lane North, Suite JSE DECISION MADE: 09-NOV-17
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Wrist-Type Fully Automatic Digital Blood Pressure Monitors
Joytech Healthcare Co., Ltd.      510(k) NO: K170666(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 22-NOV-17
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PIT’Stop® implant
In2Bones SAS                      510(k) NO: K170688(Traditional)
ATTN: Morgane  Grenier            PHONE NO : 33 472 292626 
28 Chemin du Petit Bois           SE DECISION MADE: 28-NOV-17
ECULLY  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M-Vizion Femoral Revision System
Medacta International SA          510(k) NO: K170690(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 916 966060 
Strada Regina                     SE DECISION MADE: 29-NOV-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Universal Mesh
Stryker                           510(k) NO: K170725(Traditional)
ATTN: Jonathan  Schell            PHONE NO : 269 3895596 
750 Trade Centre Way-Suite 200    SE DECISION MADE: 13-NOV-17
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Tegaderm Antimicrobial Transparent Dressing, 3M Tegaderm Antimicrobial I.V. Advanced Securement Dressing
3M Company, 3M Health Care        510(k) NO: K170754(Traditional)
ATTN: Maria  Ruiz                 PHONE NO : 651 7362733 
3M Center, 2510 Conway Ave., Bldg SE DECISION MADE: 21-NOV-17
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Stainless Steel Suture, Stainless Steel Suture
Ethicon, Inc.                     510(k) NO: K170767(Special)
ATTN: Hrishikesh  Khatav          PHONE NO : 908 2182348 
P.O. Box 151 Route 22 West        SE DECISION MADE: 01-NOV-17
Somerville NJ  08876-0151         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Universal Mesh
Stryker                           510(k) NO: K170773(Traditional)
ATTN: Gregory  Gohl               PHONE NO : 269 3894319 
750 Trade Centre Way - Suite 200  SE DECISION MADE: 08-NOV-17
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AP 50/30 Insufflator with Insuflow Port
LEXION Medical LLC                510(k) NO: K170799(Traditional)
ATTN: Bernard  Horwath            PHONE NO : 651 8551447 
545 Atwater Circle                SE DECISION MADE: 14-NOV-17
St Paul MN  55103                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Retrieval Nitinol Basket V
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K170811(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 27-NOV-17
Hachioji  JP 192-8507             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InnoSpire Go
Respironics Respiratory Drug Deliv510(k) NO: K170853(Traditional)
ATTN: Filippo  Quadrelli          PHONE NO : 44 870 4231558 
Chichester Business Park, City FieSE DECISION MADE: 02-NOV-17
Chichester  GB PO20 2FT           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CMS600P2 B-Ultrasound Diagnostic System
Contec Medical Systems Co., LTD.  510(k) NO: K170856(Traditional)
ATTN: Xueyong  Li                 PHONE NO : 86 355 8015490 
No. 112 Qinhuang West Street EconoSE DECISION MADE: 17-NOV-17
Qinhuangdao  CN 066004            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dolphin/IQ and Dolphin/4D
Viasonix Ltd.                     510(k) NO: K170859(Traditional)
ATTN: Shlomi  Deler               PHONE NO : 972 9 7441692 
10 Hamelacha Street               SE DECISION MADE: 14-NOV-17
Raananna  IL 4366105              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIXIT Threaded Anchor System
S.B.M SAS Science for Bio Material510(k) NO: K170868(Traditional)
ATTN: Anne  Cospin-Latapie        PHONE NO : 0033 562 422101 
ZI du Monge                       SE DECISION MADE: 30-NOV-17
Lourdes  FR 65100                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surecan Safety II Needle, Surecan Safety II Needle, Surecan Safety II Needle with Caresite Luer Access Device and Y site
B. Braun Medical Inc.             510(k) NO: K170897(Traditional)
ATTN: Angela J. Caravella         PHONE NO : 610 5962966 
901 Marcon Blvd.                  SE DECISION MADE: 03-NOV-17
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DASH 6 NRFit Lock Syringe + Accessories, DASH 6 NRFit Slip Syringe + Accessories, DASH 6 NRFit Plastic LOR Syringe + Accessories
INTERVENE Group Ltd               510(k) NO: K170900(Traditional)
ATTN: Homer  Trieu                PHONE NO : 440 1895 347568 
Russell Building, Brunel Science PSE DECISION MADE: 09-NOV-17
Uxbridge  GB UB8 3PQ              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TXM Support Catheter
Texas Medical Technologies, Inc.  510(k) NO: K170914(Traditional)
ATTN: Ed  Anderson                PHONE NO : 323 2510970 
2118 Wilshire Blvd. #682          SE DECISION MADE: 21-NOV-17
Santa Monica CA  90403            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TXM Hydrophilic Guidewire
Texas Medical Technologies, Inc.  510(k) NO: K170915(Traditional)
ATTN: Aaron  Chiu                 PHONE NO : 915 7744321 
9005 Montana Ave., Suite. A       SE DECISION MADE: 21-NOV-17
El Paso TX  79925                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portable Nebulizer
MicroBase Technology Corporation  510(k) NO: K170916(Traditional)
ATTN: Molly  Hsieh                PHONE NO : 11 886 33767555 
No.756, Jiadong Road              SE DECISION MADE: 28-NOV-17
Bade District, Taoyuan City  TW 33510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CXI TriForce Peripheral Crossing Set
Cook Incorporated                 510(k) NO: K170931(Special)
ATTN: Sarah  Reeves               PHONE NO : 812 3353575 175024
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 13-NOV-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Skan-C Mobile C-Arm X-Ray System - 230V Variant, Skan-C Mobile C-Arm X-Ray System - 110V Variant
Skanray Technologies Private Limit510(k) NO: K170946(Traditional)
ATTN: Mahadevan  J.               PHONE NO : 91 821 2415559 
Plot 15-17 Hebbal Industrial Area SE DECISION MADE: 24-NOV-17
Mysore  IN 570016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIXI Medical Microdeep Depth Electrode
DIXI Medical                      510(k) NO: K170959(Traditional)
ATTN: Lucie  Petegnief            PHONE NO : 33 3 81889890 
2A route de Pouligney             SE DECISION MADE: 24-NOV-17
Chaudefontaine  FR                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fingertip Pulse Oximeter
Shenzhen Jumper Medical Equipment 510(k) NO: K170965(Special)
ATTN: Yang  Gang                  PHONE NO : 86 0755 26696279 
Jumper Building, No.71-4, Xintian SE DECISION MADE: 03-NOV-17
Baoan District, Shenzhen  CN 51810510(k) STATEMENT
                                                    

DEVICE: NIOX VERO
Circassia AB                      510(k) NO: K170983(Traditional)
ATTN: Susanne  Parks              PHONE NO : 
Hanselligatan 13                  SE DECISION MADE: 22-NOV-17
Uppsala  SE se-754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hintermann Series H2 Total Ankle System
Dt MedTech LLC                    510(k) NO: K171004(Traditional)
ATTN: Shawn T Huxel               PHONE NO : 908 8965893 
110 West Road Suite 227           SE DECISION MADE: 07-NOV-17
Towson MD  21024                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mytens Model: BW-TSX
Bewell Connect Corp.              510(k) NO: K171026(Traditional)
ATTN: Jacob  Chen                 PHONE NO : 1 617 5762005 
Suite 410, 185 Alewife Brook ParkwSE DECISION MADE: 01-NOV-17
Cambridge MA  02138               510(k) STATEMENT
                                                    

DEVICE: Climax Personal Lubricant
WSM Investment LLC, dba Topco Sale510(k) NO: K171044(Traditional)
ATTN: Adrian  Mendoza             PHONE NO : 805 8429159 
3990 Suite B Heritage Oak Court   SE DECISION MADE: 21-NOV-17
Simi Valley CA  93063             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geistlich Fibro-Gide
Geistlich Pharma AG               510(k) NO: K171050(Traditional)
ATTN: Marco  Steiner              PHONE NO : 011 4141 4926764 
Bahnhofstrasse 40                 SE DECISION MADE: 09-NOV-17
Wolhusen  CH 6110                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew, Inc. REDAPT Augments
Smith & Nephew, Inc.              510(k) NO: K171073(Traditional)
ATTN: Kim  Phan                   PHONE NO : 901 8003175 
7135 Goodlett Farms Parkway       SE DECISION MADE: 21-NOV-17
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX ADVANCE KNOTLESS Anchor
Medos International SARL          510(k) NO: K171114(Traditional)
ATTN: Julie  Vafides              PHONE NO : 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 27-NOV-17
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo Root Monitoring System and Accessories
Masimo Corporation                510(k) NO: K171121(Traditional)
ATTN: Marguerite  Thomlinson      PHONE NO : 949 2977683 
52 Discovery                      SE DECISION MADE: 17-NOV-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MHC Standard and NRFit Tip Syringes
Mazza Healthcare, LLC.            510(k) NO: K171131(Traditional)
ATTN: Michael A. Mazza            PHONE NO : 847 2823441 
2101 Waukegan Road Suite 208      SE DECISION MADE: 08-NOV-17
Bannockburn IL  60015             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIA Pregnancy Test
LIA Diagnostics                   510(k) NO: K171136(Traditional)
ATTN: Anna  Couturier             PHONE NO : 717 7997795 
1015 Chestnut St Suite 1401       SE DECISION MADE: 20-NOV-17
Philadelphia PA  19107            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Angle Handpiece, Surgical Straight Handpiece
Nakanishi Inc.                    510(k) NO: K171155(Traditional)
ATTN: Kimihiko  Satoh             PHONE NO : 81 028 9643380 
700 Shimonhinata                  SE DECISION MADE: 21-NOV-17
Kanuma-shi  JP 322-8666           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Electrosurgical knife
Olympus Medical Systems Corp.     510(k) NO: K171158(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 17-NOV-17
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TOKUYAMA UNIVERSAL BOND
Tokuyama Dental Corporation       510(k) NO: K171226(Traditional)
ATTN: Fumia  Takahashi            PHONE NO : 81 3 38352261 
38-9 Taitou 1-chome, Taitou-ku    SE DECISION MADE: 28-NOV-17
Tokyo  JP 110-0016                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LeEject 2 Dental Syringe and Needle System
Advanced Technology and Capital, I510(k) NO: K171254(Traditional)
ATTN: Alexander  Lee              PHONE NO : 202 8035202 
5 Sylvan Ave.                     SE DECISION MADE: 16-NOV-17
Englewood Cliffs NJ  07632        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIGITAL RADIOGRAPHY CXDI-410C WIRELESS
Canon, Inc                        510(k) NO: K171270(Traditional)
ATTN: SHINJI  MORI                PHONE NO : 81 3 37582111 
9-1, Imaikami-cho, Nakahara-ku    SE DECISION MADE: 17-NOV-17
Kawasaki  JP                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Collision Check
Radformation, Inc.                510(k) NO: K171350(Traditional)
ATTN: Kurt  Sysock                PHONE NO : 844 7233675 
335 Madison Avenue 16th Floor     SE DECISION MADE: 29-NOV-17
New York NY  10017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Knee Systems
Arthrex Inc.                      510(k) NO: K171365(Traditional)
ATTN: David L. Rogers             PHONE NO : 1 239 6435553 71924_
1370 Creekside Boulevard          SE DECISION MADE: 07-NOV-17
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IMAGEnet 6 Ophthalmic Data System
Topcon Corporation                510(k) NO: K171370(Traditional)
ATTN: James  Lorkowski            PHONE NO : 201 5995187 
75-1 Hasunuma-Cho, Itabashi-Ku    SE DECISION MADE: 01-NOV-17
Tokyo  JP 174-8580                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DynaNail TTC Fusion System
MedShape, Inc.                    510(k) NO: K171376(Traditional)
ATTN: Courtney  Kline             PHONE NO : 678 2353316 
1575 Northside Drive, Suite 440   SE DECISION MADE: 02-NOV-17
Atlanta GA  30318                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Planmeca Romexis
Planmeca Oy                       510(k) NO: K171385(Traditional)
ATTN: Lars  Moring                PHONE NO : 358 207 795500 
Asentajankatu 6                   SE DECISION MADE: 14-NOV-17
Helsinki  FI 00880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ulrichINJECT CT motion
ulrich GmbH & Co. KG              510(k) NO: K171392(Traditional)
ATTN: Sven  Erdmann               PHONE NO : 49 731 96541714 
Buchbrunnenweg 12                 SE DECISION MADE: 09-NOV-17
Ulm  DE 89081                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelDesign, DTX Studio Design
Nobel Biocare AB                  510(k) NO: K171466(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
Vastra Hamngatan 1                SE DECISION MADE: 29-NOV-17
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioZorb Marker GOLD / LP Marker GOLD
Focal Therapeutics                510(k) NO: K171467(Traditional)
ATTN: George  Hermann             PHONE NO : 408 9627010 
1010 Stewart Drive                SE DECISION MADE: 09-NOV-17
Sunnyvale CA  94085               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compressyn™ Staple
Dallen Medical, Inc.              510(k) NO: K171473(Traditional)
ATTN: Al  Memmolo                 PHONE NO : 949 2180030 
1046 Calle Recodo, Suite G        SE DECISION MADE: 07-NOV-17
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEPHROCHECK Test System
Astute Medical, Inc.              510(k) NO: K171482(Traditional)
ATTN: Karin  Hughes               PHONE NO : 858 5007044 
3550 General Atomics Ct., BuildingSE DECISION MADE: 16-NOV-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PSLT for PASCAL Streamline
Topcon Medical Laser Systems, Inc.510(k) NO: K171488(Traditional)
ATTN: Sweta  Srivastava           PHONE NO : 408 2358200 
606 Enterprise Ct.                SE DECISION MADE: 27-NOV-17
Livermore CA  94550               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: B7 2C Occlusion Balloon
Spiration, Inc.                   510(k) NO: K171492(Traditional)
ATTN: Cheryl  Frederick           PHONE NO : 425 6365470 
6675 185th Avenue N.E.            SE DECISION MADE: 20-NOV-17
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgicalPreview
Endo Vantage, LLC                 510(k) NO: K171534(Traditional)
ATTN: Robert S. Green             PHONE NO : 520 4441433 
1475 N Scottsdale Road, Suite 200 SE DECISION MADE: 08-NOV-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renovis Surgical Hip Replacement System
Renovis Surgical Technologies     510(k) NO: K171543(Traditional)
ATTN: Anthony  DeBenedictis       PHONE NO : 909 5572360 
1901 W. Lugonia                   SE DECISION MADE: 16-NOV-17
Redlands CA  92374                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NexSite HD, Hemodialysis Step Tip Catheter (60cm)
Marvao Medical Devices, Ltd.      510(k) NO: K171571(Special)
ATTN: Christopher  Davey          PHONE NO : 353 0 91759301 
GMIT Innovation in Business CentreSE DECISION MADE: 30-NOV-17
Galway  IE                        510(k) STATEMENT
                                                    

DEVICE: Infrared thermometer
Shenzhen Aeon Technology Co.,Ltd. 510(k) NO: K171578(Traditional)
ATTN: Applicant  Wendy            PHONE NO : 86 755 86182120 
East 5/F, Block 15 Industrial ZoneSE DECISION MADE: 30-NOV-17
Shenzhen  CN 51800                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monitor B125, Monitor B105
GE MEDICAL SYSTEMS (CHINA) CO., LT510(k) NO: K171580(Traditional)
ATTN: Sun  YanLi                  PHONE NO : 86 510 85278232 
No. 19 Changjiang road National HiSE DECISION MADE: 01-NOV-17
WuXi  CN 214028                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEON Endoscopic Stapler
Lexington Medical Inc.            510(k) NO: K171589(Traditional)
ATTN: Donna  Gasper               PHONE NO : 617 2099817 
11 Executive Park Dr.             SE DECISION MADE: 17-NOV-17
Billerica MA  01862               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MC3 QuickFlow Dual Lumen Catheter
MC3 Incorporated                  510(k) NO: K171610(Traditional)
ATTN: Martha  Rumford             PHONE NO : 734 9959089 
2555 Bishop Circle West           SE DECISION MADE: 16-NOV-17
Dexter MI  48130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Symetrex Long Term Hemodialysis Catheter
Medcomp (DBA Medical Components, I510(k) NO: K171618(Traditional)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 
1499 Delp Drive                   SE DECISION MADE: 16-NOV-17
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alere Afinion HbA1c and ACR on Afinion 2 analyzer
Abbott Rapid Diagnostics          510(k) NO: K171650(Special)
ATTN: Monica  Vallestad           PHONE NO : 47 240 56000 
9975 Summers Ridge Road           SE DECISION MADE: 21-NOV-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hermes Medical Imaging Suite v5.7
Hermes Medical Solutions AB       510(k) NO: K171681(Traditional)
ATTN: Joakim  Arwidson            PHONE NO : 46 8 190325 
Skeppsbron 44                     SE DECISION MADE: 21-NOV-17
Stockholm  SE 11130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: s-Clean TiN Coating Abutments
Dentis Co., Ltd.                  510(k) NO: K171694(Traditional)
ATTN: Sun Chul Shin               PHONE NO : 82 53 5822804 
99, Seongseoseo-ro, Dalseo-gu     SE DECISION MADE: 29-NOV-17
Daegu  KR 42718                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hybrid3D
Hermes Medical Solutions AB       510(k) NO: K171719(Traditional)
ATTN: Joakim  Arwidson            PHONE NO : 46 81 90325 
Skeppsbron 44                     SE DECISION MADE: 21-NOV-17
Stockholm  SE 11130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geri Embryo Incubator and Geri Dish
Genea Biomedx Pty Ltd             510(k) NO: K171736(Traditional)
ATTN: Kea  Dent                   PHONE NO : 61 284 847677 
Level 2, 321 Kent Street          SE DECISION MADE: 15-NOV-17
Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: N Latex FLC kappa assay, N Latex FLC Lambda assay, N FLC Standard SL, N FLC Control SL1 & SL2
Siemens Healthcare Diagnostics Pro510(k) NO: K171742(Traditional)
ATTN: Christine  Perkins          PHONE NO : 302 6318811 
Emil-von-Behring-Str. 76          SE DECISION MADE: 17-NOV-17
Marburg  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Pink Polychloroprene Copolymer Examination Gloves, Powder Free Black Polychloroprene Copolymer Examination Gloves
Smart Glove Corporation Sdn.Bhd   510(k) NO: K171743(Traditional)
ATTN: Khon Pu Foo                 PHONE NO : 603 329 16100 
Lot 6487, Batu 5 3/4, Sementa, JalSE DECISION MADE: 17-NOV-17
Klang  MY 42100                   510(k) STATEMENT
                                                    

DEVICE: Straumann Screw Retained Abutments
Straumann USA, LLC (on behalf of I510(k) NO: K171757(Traditional)
ATTN: Chanrasmey  White           PHONE NO : 978 7472614 
60 Minuteman Road                 SE DECISION MADE: 27-NOV-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann PURE Ceramic Implants
Straumann USA, LLC (on behalf of I510(k) NO: K171769(Traditional)
ATTN: Chanrasmey  White           PHONE NO : 978 7472614 
60 Minuteman Road                 SE DECISION MADE: 14-NOV-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Halo XP Diagnostic Electrophysiology Catheter
Innovative Health, LLC.           510(k) NO: K171788(Traditional)
ATTN: Amy  Stoklas-Oakes          PHONE NO : 480 5255972 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 03-NOV-17
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HIVOX OTC Electrical Stimulator
Hivox Biotek Inc.                 510(k) NO: K171803(Traditional)
ATTN: Linda  Lin                  PHONE NO : 886 285 112668 
5F., No. 123, Xingde Rd. Sanchong SE DECISION MADE: 29-NOV-17
New Taipei City  TW 24158         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Registrado Scan
VOCO GmbH                         510(k) NO: K171815(Traditional)
ATTN: M. Th.  Plaumann            PHONE NO : 49 4721 7190 
Anton-Flettner-Str. 1-3           SE DECISION MADE: 15-NOV-17
Cuxhaven  DE 27472                510(k) STATEMENT
                                                    

DEVICE: Kardia Band System
AliveCor, Inc                     510(k) NO: K171816(Traditional)
ATTN: Prabhu  Raghavan            PHONE NO : 
444 Castro Street, Suite 600      SE DECISION MADE: 16-NOV-17
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geistlich Wound Matrix
Geistlich Pharma AG               510(k) NO: K171842(Traditional)
ATTN: Jan van der Ploeg           PHONE NO : 41 41 4926928 
Bahnhofstrasse 40                 SE DECISION MADE: 03-NOV-17
Wolhusen  CH CH-6110              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips CT Big Bore
Philips Medical Systems (Cleveland510(k) NO: K171850(Traditional)
ATTN: Michael  Chilbert           PHONE NO : 1 440 4833284 
595 Miner Road                    SE DECISION MADE: 09-NOV-17
Cleveland OH  44143               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A1AT Genotyping Test
Progenika Biopharma S.A., a Grifol510(k) NO: K171868(Traditional)
ATTN: Diego  Tejedor              PHONE NO : 34 944 064525 
Ibaizabal bidea, Edificio 504, ParSE DECISION MADE: 11-NOV-17
Derio  ES 48160                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Glove, Blue Colored, Non Sterile, Tested for Use with Chemotherapy Drugs
Zhonghong Pulin Medical Products C510(k) NO: K171873(Traditional)
ATTN: Jinge  Li                   PHONE NO : 86 315 4165760 
Pachigang Industrial Park, LuannanSE DECISION MADE: 15-NOV-17
Tangshan  CN 063502               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: I-Portal Portable Assessment System - Nystagmograph (I-PAS)
Neuro Kinetics, Inc               510(k) NO: K171884(Traditional)
ATTN: Brian  Sullivan             PHONE NO : 412 9636649 
128 Gamma Dr                      SE DECISION MADE: 22-NOV-17
Blawnox PA  15238                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OverStitch SX Endoscopic Suturing System (ESS)
Apollo Endosurgery Inc            510(k) NO: K171886(Traditional)
ATTN: Maritza  Ward               PHONE NO : 512 2795114 
1120 S. Capital of Texas Hwy. Ste SE DECISION MADE: 15-NOV-17
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMEC Series Patient Monitors (including uMEC6, uMEC7, uMEC10, uMEC12, uMEC15, uMEC15S)
Shenzhen Mindray Bio-Medical Elect510(k) NO: K171901(Traditional)
ATTN: Yanhong  Bai                PHONE NO : 86 755 81885635 
Mindray Building, Keji 12th Road SSE DECISION MADE: 15-NOV-17
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nexstim Navigated Brain Therapy (NBT) System 2
Nexstim Plc                       510(k) NO: K171902(Traditional)
ATTN: Rainer  Harjunpaa           PHONE NO : 011 358 927271710 
Elimaenkatu 9b                    SE DECISION MADE: 10-NOV-17
Helsinki  FI 00510                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline ReNewal Reprocessed Synthes External Fixation Systems
Surgical Instrument Service and Sa510(k) NO: K171911(Traditional)
ATTN: Stephanie Boyle Mays        PHONE NO : 541 9233310 
(dba Medline ReNewal) 1500 NE HemlSE DECISION MADE: 09-NOV-17
Redmond OR  97756                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Birmingham Hip (BH) Dual Mobility Insert
Smith & Nephew, Inc.              510(k) NO: K171934(Traditional)
ATTN: Mike  Scott                 PHONE NO : 901 3991633 
7135 Goodlett Farms Parkway       SE DECISION MADE: 30-NOV-17
Cordova TN  38016                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compower CPR Mask With Oxygen Port, Compower CPR Mask Without Oxygen Port, Compower Infant CPR Mask, Compower Non-Rebreathing Valve (22mm/15mmOD), Non-Rebreathing Valve (22mm/18.5mm)
Xiamen Compower Medical Tech. Co. 510(k) NO: K171961(Traditional)
ATTN: Lifen  Chen                 PHONE NO : 
Unit 301, No.16 Xianghong Road, XiSE DECISION MADE: 17-NOV-17
Xiamen  CN 361101                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alivio Ventricular Catheter and Flusher System (Alivio System)
Alcyone Lifesciences. Inc.        510(k) NO: K172006(Traditional)
ATTN: PJ  Anand                   PHONE NO : 1 978 7091946 
250 Jackson Street Mill No. 5, UniSE DECISION MADE: 09-NOV-17
Lowell MA  01852                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CamX Triton HD Proxi Head
Duerr Dental AG                   510(k) NO: K172007(Traditional)
ATTN: Oliver  Lange               PHONE NO : 49 714 27050 
Hopfigheimer Strasse 17           SE DECISION MADE: 22-NOV-17
Bietigheim-Bissingen  DE D-74321  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Brisbane ALIF Device, Gladstone ALIF Device
Signature Orthopaedics Pty Ltd.   510(k) NO: K172019(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 294 285181 
7 Sirius Road                     SE DECISION MADE: 29-NOV-17
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arlington PLIF/TLIF Cage
Signature Orthopaedics Pty Ltd.   510(k) NO: K172020(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 294 285181 
7 Sirius Road                     SE DECISION MADE: 29-NOV-17
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Devon 51
Devon Medical Products (Jiangsu) L510(k) NO: K172030(Traditional)
ATTN: Julian  Chu                 PHONE NO : 86 513 51080988 
East Half of 1-2f, Appt D2, 1, QinSE DECISION MADE: 27-NOV-17
Nantong  CN 226017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Modulift Vertebral Body Replacement (VBR) System
Aesculap Implants Systems, Inc.   510(k) NO: K172032(Traditional)
ATTN: Lisa  Boyle                 PHONE NO : 610 9849274 
3773 Corporate Parkway            SE DECISION MADE: 20-NOV-17
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aespire 7100, Aespire 7900, Aespire View, Avance, Avance CS2, Aisys, Aisys CS2
Datex-Ohmeda, Inc.                510(k) NO: K172045(Traditional)
ATTN: Trishia  Mercier            PHONE NO : 608 7093260 
3030 Ohmeda Drive, PO Box 7550    SE DECISION MADE: 03-NOV-17
Madison WI  53707-7550            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Follicle Aspiration Set, Reduced Single Lumen
Vitrolife Sweden AB               510(k) NO: K172050(Traditional)
ATTN: Anja  Bengtzelius           PHONE NO : 46 31 7218000 
Gustaf Werners gata 2             SE DECISION MADE: 21-NOV-17
Vastra Frolunda  SE SE-42132      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Materialise Glenoid Positioning System
Materialise NV                    510(k) NO: K172054(Traditional)
ATTN: Oliver  Clemens             PHONE NO : 32 16 396280 
Technologielaan 15                SE DECISION MADE: 03-NOV-17
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Capio SLIM Suture Capturing Device
Boston Scientific Corporation     510(k) NO: K172060(Traditional)
ATTN: Rachel  Nankervis           PHONE NO : 508 6834755 
100 Boston Scientific Way         SE DECISION MADE: 03-NOV-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: One Mum Pumpset
Ardo medical AG                   510(k) NO: K172067(Special)
ATTN: Roger  Dubach               PHONE NO : 41 041 7547070 
Gewerbestrasse 19                 SE DECISION MADE: 29-NOV-17
Unterageri  CH 6314               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Idys™ ALIF System
CLARIANCE SAS                     510(k) NO: K172083(Traditional)
ATTN: Pascal  Rokegem             PHONE NO : 33 03 21161215 
18 rue Robespierre                SE DECISION MADE: 08-NOV-17
Beaurains  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vevazz LED
Vevazz, LLC                       510(k) NO: K172111(Traditional)
ATTN: Jamie  Fettig               PHONE NO : 773 6654005 
3839 McKinney Ave. #251           SE DECISION MADE: 22-NOV-17
Dallas TX  75204                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Televere Podiatry Digital Imaging System
Televere Systems                  510(k) NO: K172124(Traditional)
ATTN: Randell  Quaal              PHONE NO : 800 3859593 
1160 Cavalier Rd                  SE DECISION MADE: 09-NOV-17
Arnold MD  21012                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EsoFLIP® ES-310 Balloon Catheter
Crospon Ltd.                      510(k) NO: K172128(Traditional)
ATTN: John  O’Dea                 PHONE NO : 11 353 91519882 
Galway Business Park Dangan       SE DECISION MADE: 22-NOV-17
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Resorbable Mesh Device
SeaSpine Orthopedics Corporation  510(k) NO: K172130(Traditional)
ATTN: Jenny  Fam                  PHONE NO : 949 4473616 
2 Goodyear                        SE DECISION MADE: 16-NOV-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoolSculpting System
ZELTIQ Aesthetics                 510(k) NO: K172144(Traditional)
ATTN: Ewald  Riechert             PHONE NO : 925 5682977 
4410 Rosewood Road                SE DECISION MADE: 01-NOV-17
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Femoral Recon Nail System
Synthes (USA) Products, LLC       510(k) NO: K172157(Traditional)
ATTN: Alexander  Zwahlen          PHONE NO : 41 32 7204104 
1301 Goshen Parkway               SE DECISION MADE: 14-NOV-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parkell Universal Adhesive
Parkell, Inc.                     510(k) NO: K172176(Traditional)
ATTN: David  Mott                 PHONE NO : 631 3891545 
300 Executive Drive               SE DECISION MADE: 21-NOV-17
Edgewood NY  11717                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Insulia Diabetes Management Companion
Voluntis S.A.                     510(k) NO: K172177(Traditional)
ATTN: Kevin  Howard               PHONE NO : 33 141 383920 
22 Quai Gallieni                  SE DECISION MADE: 07-NOV-17
Suresnes  FR 92150                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Minimally Invasive Bunion Plating System
Trilliant Surgical, LTD           510(k) NO: K172178(Traditional)
ATTN: Jonathan  Olson             PHONE NO : 713 3886055 
6721 Portwest Drive, Suite 160    SE DECISION MADE: 16-NOV-17
Houston TX  77024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIM – Y90 Dosimetry
MIM Software Inc.                 510(k) NO: K172218(Traditional)
ATTN: Lynn  Hanigan               PHONE NO : 216 4550600 
25800 Science Park Drive - Suite 1SE DECISION MADE: 21-NOV-17
Cleveland OH  44122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SleepRight ProRx Custom Dental Guard
Splintek, Inc.                    510(k) NO: K172223(Traditional)
ATTN: Samantha  Schroeder         PHONE NO : 816 5312008 
15555 West 108th Street           SE DECISION MADE: 17-NOV-17
Lenexa KS  66219                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atlantis Abutment for MIS Implant
Dentsply Sirona                   510(k) NO: K172225(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 30-NOV-17
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MX40 Release B.07
Philips Medical Systems           510(k) NO: K172226(Traditional)
ATTN: Theresa  Poole              PHONE NO : 978 6597621 
3000 Minuteman Road               SE DECISION MADE: 09-NOV-17
Andover MA  01810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GC85A
Samsung Electronics Co.,Ltd.      510(k) NO: K172229(Traditional)
ATTN: Jaesang  NOH                PHONE NO : 82 31 2001764 
129, Samsung-Ro, Yeongtong-Gu     SE DECISION MADE: 22-NOV-17
Suwon-Si  KR 16677                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyece OTC EMS System, Model EM35
Tyece Ltd.                        510(k) NO: K172241(Traditional)
ATTN: Parshid  Falahati           PHONE NO : 852 2 3497456 
Unit 801, Block A, Po Lung Centre,SE DECISION MADE: 20-NOV-17
Kowloon  HK                       510(k) STATEMENT
                                                    

DEVICE: Altus Spine Cervical Interbody Fusion System
Altus Partners, LLC               510(k) NO: K172253(Traditional)
ATTN: Mark  Melton                PHONE NO : 610 3554156 
1340 Enterprise Drive             SE DECISION MADE: 21-NOV-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omni Foot Plating System
Extremity Medical, LLC.           510(k) NO: K172260(Traditional)
ATTN: Brian  Smekal               PHONE NO : 973 5888980 
300 Interpace Parkway Suite 410   SE DECISION MADE: 06-NOV-17
Parsippany NJ  07054              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phlebo Press DVT Model
Mego Afek AC Ltd.                 510(k) NO: K172277(Traditional)
ATTN: Reuven  Yunger              PHONE NO : 972 77 9084276 
Kibbutz Afek                      SE DECISION MADE: 03-NOV-17
Kibbutz Afek  IL 3004200          510(k) STATEMENT
                                                    

DEVICE: Firlit-Kluge Urethral Stent, Koyle Diaper Stent, Zaontz Urethral Stent
Cook Incorporated                 510(k) NO: K172278(Traditional)
ATTN: Samuel  Engelman            PHONE NO : 812 3392235 104340
750 Daniels Way                   SE DECISION MADE: 22-NOV-17
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SALUS - Hygiene Instrument Reprocessing Container
SciCan Ltd.                       510(k) NO: K172292(Abbreviated)
ATTN: Teresa  Boyce               PHONE NO : 416 4451600 
1440 Don Mills Road               SE DECISION MADE: 24-NOV-17
Toronto  CA M3B 3P9               510(k) STATEMENT
                                                    

DEVICE: CoLink View Plating System
In2Bones USA, LLC                 510(k) NO: K172300(Traditional)
ATTN: Rebecca  Wahl               PHONE NO : 
6060 Poplar Ave, Suite 380        SE DECISION MADE: 27-NOV-17
Memphis TN  38119                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mako Partial Knee Application
MAKO Surgical Corp.               510(k) NO: K172301(Special)
ATTN: Andrea Dwyer Steiner        PHONE NO : 954 6280735 
2555 Davie Rd                     SE DECISION MADE: 02-NOV-17
Fort Lauderdale FL  33317         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoform Silver Dermal Template
Aroa Biosurgery                   510(k) NO: K172318(Traditional)
ATTN: Tina  O'Brien               PHONE NO : 64 09 8693035 
2 Kingsford Smith Place           SE DECISION MADE: 17-NOV-17
Airport Oaks  NZ 2022             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOVEREIGN™ Spinal System
Medtronic Sofamor Danek           510(k) NO: K172328(Traditional)
ATTN: Kanesha  Hines              PHONE NO : 901 3992670 
1800 Pyramid Place                SE DECISION MADE: 02-NOV-17
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medax Biopsy Systems II (MEDONE, MEDCUT, MEDEM, MEDBONE, MEDLOCK)
MEDAX S.R.L. UNIPERSONALE         510(k) NO: K172344(Traditional)
ATTN: Stefano  Cavalieri          PHONE NO : 39 0535 1813915 
Via R. Piva 1/A                   SE DECISION MADE: 13-NOV-17
Poggio Rusco  IT 46025            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GMK Hinge, GMK Revision
Medacta International SA          510(k) NO: K172347(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 01-NOV-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEKA SMARTXIDE TOUCH
EL.EN Electronic Engineering Spa  510(k) NO: K172362(Traditional)
ATTN: Paolo  Peruzzi              PHONE NO : 39 055 8826807 
Via Baldanzese 17                 SE DECISION MADE: 17-NOV-17
Calenzano  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEKA SMARTXIDE ULTRASPEED
EL.EN. Electronic Engineering Spa 510(k) NO: K172363(Traditional)
ATTN: Paolo  Peruzzi              PHONE NO : 39 055 8826807 
via Baldanzese 17                 SE DECISION MADE: 17-NOV-17
Calenzano  IT 50041               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Compound W Nitro-Freeze
Medtech Products Inc.             510(k) NO: K172373(Traditional)
ATTN: Jean  Boyko                 PHONE NO : 914 5246894 
660 White Plains Rd Suite 250     SE DECISION MADE: 02-NOV-17
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lateral Spinal Truss System (LSTS) Interbody Fusion Device
4Web, Inc.                        510(k) NO: K172392(Traditional)
ATTN: Jessee  Hunt                PHONE NO : 800 2857090 
2801 Network Blvd. Suite 620      SE DECISION MADE: 07-NOV-17
Frisco TX  75034                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DENTCA DENTURE Teeth
DENTCA, INC.                      510(k) NO: K172398(Traditional)
ATTN: Jason  Lee                  PHONE NO : 1 424 5588726 
357 Van Ness Way, Suite 250       SE DECISION MADE: 22-NOV-17
Torrance CA  90501                510(k) STATEMENT
                                                    

DEVICE: Duracetal
The Myerson Company Limited       510(k) NO: K172407(Traditional)
ATTN: Cindy  Buchoon-Legendre     PHONE NO : 868 6231007 46
3 Trinity Avenue                  SE DECISION MADE: 02-NOV-17
Laventille  TT                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velofix™ SA Cervical Cage
U&I Corporation                   510(k) NO: K172424(Traditional)
ATTN: Jee-Ae  Bang                PHONE NO : 82 31 8606846 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 22-NOV-17
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONSTRUX® Mini PTC Spacer System, FORZA® PTC Spacer System, PILLAR® SA PTC Spacer System
Orthofix Inc.                     510(k) NO: K172437(Special)
ATTN: Natalia  Volosen            PHONE NO : 214 9372145 
3451 Plano Parkway                SE DECISION MADE: 02-NOV-17
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EPIC Extremity Fracture Plate System
EPIC Extremity, LLC               510(k) NO: K172441(Traditional)
ATTN: Dan  Schwartzbauer          PHONE NO : 724 7794747 
120 Marguerite Dr, Ste 301        SE DECISION MADE: 06-NOV-17
Cranberry Twp PA  16066           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim and Tested for Use with Chemotherapy Drugs (Blue)
Hartalega NGC SDN. BHD.           510(k) NO: K172442(Traditional)
ATTN: Kuan Mun Leong              PHONE NO : 603 62771733 
No. 1, Persiaran Tanjung Kawasan PSE DECISION MADE: 06-NOV-17
Sepang  MY 43900                  510(k) STATEMENT
                                                    

DEVICE: SPIRA-C Open Matrix Cervical Interbody
Camber Spine Technologies         510(k) NO: K172446(Traditional)
ATTN: Michael  Black              PHONE NO : 855 8999869 
418 E. Lancaster Avenue           SE DECISION MADE: 07-NOV-17
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dr.MUSIC 3s
SmartMedicalDevice Co., Ltd.      510(k) NO: K172451(Traditional)
ATTN: Dong-Min  Lee               PHONE NO : 82 70 75252104 
32-19, Gobong-ro, Ilsandong-gu    SE DECISION MADE: 17-NOV-17
Goyang-si  KR 10364               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WATCHDOG Hemostasis Valve Kit
Boston Scientific Corporation     510(k) NO: K172453(Traditional)
ATTN: Lori  Berends               PHONE NO : 1 763 4941528 
Three Scimed Place                SE DECISION MADE: 09-NOV-17
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemoDraw Plus Closed Blood Sampling System with LogiCal Transducer Kit, HemoDraw Plus Closed Blood Sampling System with Transtar Transducer Kit
Smiths Medical ASD, Inc.          510(k) NO: K172458(Traditional)
ATTN: Mikael  Evans               PHONE NO : 763 3833047 
6000 Nathan Lane North            SE DECISION MADE: 09-NOV-17
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthAlign Plus System
OrthAlign, Inc.                   510(k) NO: K172462(Traditional)
ATTN: David  Vancelette           PHONE NO : 949 7152424 
120 Columbia, Suite 500           SE DECISION MADE: 22-NOV-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TiLock Modular Spinal System
Genesys Spine                     510(k) NO: K172469(Traditional)
ATTN: Brian J. Bergeron           PHONE NO : 512 3817071 
1250 Capital of Texas of Highway SSE DECISION MADE: 30-NOV-17
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Micro-MEC 1.8% Glutaraldehyde Monitor Strip
STERIS Corporation                510(k) NO: K172472(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 17-NOV-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ICONN Square 2.5MM Suture Anchor
ICONN Orthopedics, LLC            510(k) NO: K172491(Traditional)
ATTN: Whitt  Israel               PHONE NO : 205 9132068 
400 Union Hill Drive, Suite 150   SE DECISION MADE: 29-NOV-17
Birmingham AL  35209              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive AttraX Scaffold
NuVasive, Incorporated            510(k) NO: K172497(Traditional)
ATTN: Marysa E. Loustalot         PHONE NO : 858 9093360 
7475 Lusk Blvd.                   SE DECISION MADE: 24-NOV-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trak Plus Male Fertility Testing System
Sandstone Diagnostics, Inc.       510(k) NO: K172514(Traditional)
ATTN: Ulrich  Schaff              PHONE NO : 925 3157246 
6111 Southfront Road, Suite J     SE DECISION MADE: 17-NOV-17
Livermore CA  94551               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Non Sterile Powder Free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Central Medicare Sdn. Bhd.        510(k) NO: K172525(Traditional)
ATTN: Arivalagan  Subramaniam     PHONE NO : 60 56 290000 
PT 2609 - 2620, BT 8, Jalan ChangkSE DECISION MADE: 13-NOV-17
Teluk Intan  MY 36000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph mMR with mMR Angio Transfer Option
Siemens Medical Solutions USA, Inc510(k) NO: K172531(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
51 Valley Stream Parkway          SE DECISION MADE: 14-NOV-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bipolar applicator "CELON ProCurve V"
Olympus Winter & Ibe GmbH         510(k) NO: K172535(Traditional)
ATTN: Jan-Oliver  Upmeier         PHONE NO : 49 40 669662098 
Kuehnstrasse 61                   SE DECISION MADE: 16-NOV-17
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Linear Stapler, Disposable Linear Cutter
Changzhou Kangdi Medical Stapler C510(k) NO: K172538(Special)
ATTN: Eve  Zhou                   PHONE NO : 86 519 85162780 
No.16 Kunlun Road, XinBei Zone    SE DECISION MADE: 30-NOV-17
Changzhou City  CN 213022         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CereTom Elite
NeuroLogica Corporation, a Subsidi510(k) NO: K172539(Traditional)
ATTN: Ninad  Gujar                PHONE NO : 978 5648503 
14 Electronics Avenue             SE DECISION MADE: 22-NOV-17
Danvers MA  01923                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OEC Elite
GE OEC Medical Systems, Inc.      510(k) NO: K172550(Traditional)
ATTN: Rachel  Schandel            PHONE NO : 385 2377519 
384 Wright Brothers Drive         SE DECISION MADE: 16-NOV-17
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gunther Tulip Vena Cava Filter Set for Femoral Vein Approach, Gunther Tulip Vena Cava Filter Set for Jugular Vein Approach, Gunther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
William Cook Europe ApS           510(k) NO: K172557(Traditional)
ATTN: Henriette Stordal ChristiansPHONE NO : 0045 5686 8756 
Sandet 6                          SE DECISION MADE: 20-NOV-17
Bjaeverskov  DK 4632              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenePOC CDiff
GenePOC Inc.                      510(k) NO: K172569(Traditional)
ATTN: Guy  Sevigny                PHONE NO : 1 418 6503535 
360 rue Franquet                  SE DECISION MADE: 22-NOV-17
Quebec  CA G1P 4N3                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioHorizons Tapered Short Implants
BioHorizons Implant Systems, Inc. 510(k) NO: K172576(Traditional)
ATTN: Michael  Davis              PHONE NO : 205 9677880 
2300 Riverchase Center            SE DECISION MADE: 22-NOV-17
Birmingham AL  35244              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENSEAL X1 Tissue Sealer, Straight Jaw, 25 cm Shaft Length, ENSEAL X1 Tissue Sealer, Straight Jaw, 37 cm Shaft Length, ENSEAL X1 Tissue Sealer, Curved Jaw, 25 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 37 cm Shaft Length,ENSEAL X1 Tissue Sealer, Curved Jaw, 45 cm Shaft Length
Ethicon Endo-Surgery, LLC         510(k) NO: K172580(Traditional)
ATTN: Carmen  Ortiz               PHONE NO : 787 2726500 
475 Calle C                       SE DECISION MADE: 20-NOV-17
Guaynabo PR  00969                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Günther Tulip Vena Cava Filter Set for Femoral Vein Approach, Günther Tulip Vena Cava Filter Set for Femoral and Jugular Vein Approach
William Cook Europe ApS           510(k) NO: K172584(Traditional)
ATTN: Henriette Stordal ChristiansPHONE NO : 0045 5686 8756 
Sandet 6                          SE DECISION MADE: 20-NOV-17
Bjaeverskov  DK 4632              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fixed Patient Leads ECG Cable (Model 3153)
Boston Scientific Corporation     510(k) NO: K172591(Special)
ATTN: Elizabeth A. Lisowski       PHONE NO : 651 5825131 
4100 Hamline Avenue North         SE DECISION MADE: 03-NOV-17
St. Paul MN  55112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cerafix Dura Substitute
Acera Surgical, Inc.              510(k) NO: K172603(Traditional)
ATTN: Matthew  MacEwan            PHONE NO : 1 844 8792237 
10880 Baur Blvd.                  SE DECISION MADE: 27-NOV-17
St. Louis MO  63132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XW-100 Automated Hematology  Analyzer for CLIA Waived Use
Sysmex America, Inc.              510(k) NO: K172604(Dual Track)
ATTN: Michelle  Abraham           PHONE NO : 224 5439639 
577 Aptakisic Road                SE DECISION MADE: 06-NOV-17
Lincolnshire IL  60069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CSMC Cardiac Suite
Cedars-Sinai Medical Center       510(k) NO: K172609(Special)
ATTN: Geoff  Pollard              PHONE NO : 310 4234663 
8700 Beverly Blvd                 SE DECISION MADE: 03-NOV-17
Los Angeles CA  90048             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SyndesMetrics Syndesmosis Repair System
Mortise Medical LLC               510(k) NO: K172620(Traditional)
ATTN: Robert  Hoy                 PHONE NO : 614 4486358 
124 South 600 West Suite 100      SE DECISION MADE: 08-NOV-17
Logan UT  84321                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microcyn Antimicrobial Skin and Wound Cleanser
Sonoma Pharmaceuticals            510(k) NO: K172622(Traditional)
ATTN: Brian W. Martin             PHONE NO : 707 2830550 
1129 N. McDowell Boulevard        SE DECISION MADE: 21-NOV-17
Petaluma CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Triathlon® X3® UHMWPE Tibial Inserts and Patellar Components
Howmedica Osteonics Corp aka Stryk510(k) NO: K172634(Traditional)
ATTN: Shahrir  Alam               PHONE NO : 201 8316223 
325 Corporate Dr.                 SE DECISION MADE: 16-NOV-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HeRO Graft
Merit Medical Systems, Inc.       510(k) NO: K172637(Traditional)
ATTN: Susan  Christensen          PHONE NO : 801 2084789 
1600 West Merit Parkway           SE DECISION MADE: 30-NOV-17
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PALLAS 308/311 Solid-State UV Laser System
Laseroptek Co.Ltd                 510(k) NO: K172639(Third Party - Traditional)
ATTN: Hong  Chu                   PHONE NO : 82 31 80235150 
#203 & #204 Hyundai 1 Valley 31 GaSE DECISION MADE: 03-NOV-17
Gyeonggido  KP                    510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Orange Non Sterile Powder Free Nitrile Examination Gloves
Central Medicare Sdn. Bhd.        510(k) NO: K172642(Traditional)
ATTN: Arivalagan  Subramaniam     PHONE NO : 60 562 90000 
PT 2609 - 2620, BT 8, Jalan ChangkSE DECISION MADE: 28-NOV-17
Teluk Intan  MY 36000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sandshark Injectable Anchor Kit, Injectroducer Handle, Loading Rod with Anchor, Loading Base
Stimwave Technologies Incorporated510(k) NO: K172644(Traditional)
ATTN: Elizabeth  Greene           PHONE NO : 1 800 9655134 
1310 Park Central Boulevard South SE DECISION MADE: 03-NOV-17
Pompano Beach FL  33064           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor
Heidelberg Engineering GmbH       510(k) NO: K172649(Special)
ATTN: Gerhard  Zinser             PHONE NO : 49 6221 64630 
Max-Jarecki-Strasse 8             SE DECISION MADE: 01-NOV-17
Heidelberg  DE 69115              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Materialise PKA Guide System
Materialise NV                    510(k) NO: K172650(Traditional)
ATTN: Oliver  Clemens             PHONE NO : 32 16 396280 
Technologielaan 15                SE DECISION MADE: 20-NOV-17
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Duravess bovine pericardial vascular patch
Edwards Lifesciences, LLC         510(k) NO: K172660(Traditional)
ATTN: Christine  Chun             PHONE NO : 949 2502773 
One Edwards Way                   SE DECISION MADE: 17-NOV-17
Irvine CA  92614                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire Cervical Implant System
Sapphire Medical Group            510(k) NO: K172674(Special)
ATTN: Anthony  Ruggiero           PHONE NO : 949 9398502 
32565 B Golden Lantern #113       SE DECISION MADE: 02-NOV-17
Dana Point CA  92629              510(k) STATEMENT
                                                    

DEVICE: THERMOPLASTIC ELASTOMER EXAMINATION (TPE) GLOVE
Shen Wei USA Inc.                 510(k) NO: K172678(Traditional)
ATTN: Cheryl  Reep                PHONE NO : 510 4298692 
33278 Central Ave. Suite 102      SE DECISION MADE: 24-NOV-17
Union City CA  94587              510(k) STATEMENT
                                                    

DEVICE: LiverMultiScan
Perspectum Diagnostics Ltd        510(k) NO: K172685(Traditional)
ATTN: Jaco  Jacobs                PHONE NO : 44 186 5655329 
23-38 Hythe Bridge Street         SE DECISION MADE: 21-NOV-17
Oxford  GB OX1 2ET                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Turbo-Power (2.0mm) Laser Atherectomy Catheters, Turbo-Power (2.3mm) Laser Atherectomy Catheters
Spectranetics, Inc.               510(k) NO: K172687(Traditional)
ATTN: Stephanie  Byrum            PHONE NO : 719 4472671 
9965 Federal Drive                SE DECISION MADE: 27-NOV-17
Colorado Springs CO  80921        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DESCRIBE PFD Patch
Merz North America, Inc.          510(k) NO: K172689(Traditional)
ATTN: Misty  D’Ottavio            PHONE NO : 925 5828000 
6501 Six Forks Road               SE DECISION MADE: 29-NOV-17
Raleigh NC  27615                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIR Anterior Array, AIR Posterior Array
GE Healthcare Coils (USA Instrumen510(k) NO: K172695(Traditional)
ATTN: Mary A. Mayka               PHONE NO : 262 5273148 
1515 Danner Drive                 SE DECISION MADE: 22-NOV-17
Aurora OH  44202                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OEC One
GE HUALUN MEDICAL SYSTEMS CO., LTD510(k) NO: K172700(Traditional)
ATTN: Lifeng  Wang                PHONE NO : 86 10 57083145 
No1 YongChang North Road Beijing ESE DECISION MADE: 09-NOV-17
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Snap Electrode
Embla Systems                     510(k) NO: K172703(Abbreviated)
ATTN: Sanjay  Mehta               PHONE NO : 905 2875055 
1 Hines Road, Suite 202           SE DECISION MADE: 13-NOV-17
Kanata  CA K2K 3C7                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Comet-PLUS
Natus Medical Incorporated DBA Exc510(k) NO: K172711(Special)
ATTN: Sanjay  Mehta               PHONE NO : 905 2875055 
2568 Bristol Circle               SE DECISION MADE: 03-NOV-17
Oakville  CA L6H 5S1              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gentleheel Micro-Preemie, gentleheel Preemie, gentleheel Newborn, gentleheel Toddler
GRI Medical & Electronic Technolog510(k) NO: K172712(Traditional)
ATTN: Marty D. Paugh              PHONE NO : 86 135 11359722 
XiuZhou Industry Zone, 1805 HonggaSE DECISION MADE: 06-NOV-17
JiaXing  CN 314031                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RadiForce RX560, RX560-AR
EIZO Corporation                  510(k) NO: K172738(Traditional)
ATTN: Hiroaki  Hashimoto          PHONE NO : 81 76 2742468 
153 Shimokashiwano                SE DECISION MADE: 08-NOV-17
Hakusan  JP 924-8566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Valleylab FX8 Electrosurgical Platform
Covidien llc                      510(k) NO: K172757(Traditional)
ATTN: Sharon  McDermott           PHONE NO : 303 5816789 
5920 Longbow Drive                SE DECISION MADE: 02-NOV-17
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smart External Drain (SED) System
Aqueduct Critical Care, Inc.      510(k) NO: K172759(Traditional)
ATTN: Thomas  Clement             PHONE NO : 425 9851571 
11822 North Creek Parkway North SuSE DECISION MADE: 14-NOV-17
Bothell WA  98011                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: New Century All-Ceramic Dental Zirconia Blocks (Un-Shaded & Pre-Shaded)
Shanghai New Century Dental Materi510(k) NO: K172761(Traditional)
ATTN: Charles  Shen               PHONE NO : 86 21 59954240 
No.461 Tanghang Village, Huating TSE DECISION MADE: 17-NOV-17
Shanghai  CN 201816               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Trabecular Metal Reverse Shoulder System, Mini Glenoid
Zimmer, Inc.                      510(k) NO: K172767(Traditional)
ATTN: Ehab  Esmail                PHONE NO : 574 3719492 
345 East Main Street              SE DECISION MADE: 30-NOV-17
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CryOmega Flexx
CryoConcepts LP                   510(k) NO: K172769(Traditional)
ATTN: R Sam  Niedbala             PHONE NO : 855 3552796 
205 Webster Street                SE DECISION MADE: 30-NOV-17
Bethlehem PA  18015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Epic Pro 940
Biolase, Inc                      510(k) NO: K172771(Traditional)
ATTN: Alicia  Mszyca              PHONE NO : 949 2268471 
4 Cromwell                        SE DECISION MADE: 29-NOV-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ER-REBOA Catheter
Prytime Medical Devices, Inc.     510(k) NO: K172790(Traditional)
ATTN: Brian  Young                PHONE NO : 210 3400116 
229 North Main Street             SE DECISION MADE: 08-NOV-17
Boerne TX  78006                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Suction Irrigation Set
WickiMed (Huizhou) Medical Equipme510(k) NO: K172794(Traditional)
ATTN: Haobin  Li                  PHONE NO : 0086 0752 3860807 
Tang Jiao Xing Wang Street LiLin TSE DECISION MADE: 29-NOV-17
Huizhou  CN 516000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Azurion series R1.2
Philips Medical Systems Nederland 510(k) NO: K172822(Special)
ATTN: Jeanette  Becker            PHONE NO : 31 6 21823383 
Veenpluis 4-6                     SE DECISION MADE: 22-NOV-17
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intellijoint HIP System (Cart), Intellijoint HIP System (Portable), Intellijoint HIP Instrument Tray
Intellijoint Surgical Inc.        510(k) NO: K172849(Special)
ATTN: Brandon  Gingrich           PHONE NO : 1 519 3423178 
60 Bathurst Drive Unit 6          SE DECISION MADE: 16-NOV-17
Waterloo  CA N2V 2A9              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SterilContainer with PrimeLine Pro Lid
Aesculap, Inc.                    510(k) NO: K172850(Special)
ATTN: Lisa  Boyle                 PHONE NO : 1 800 2581946 
3773 Corporate Parkway            SE DECISION MADE: 17-NOV-17
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microcyn Plus Antimicrobial Wound Care Solution
Sonoma Pharmaceuticals, Inc.      510(k) NO: K172851(Traditional)
ATTN: Brian  Martin               PHONE NO : 707 5597181 
1129 N. McDowell Boulevard        SE DECISION MADE: 15-NOV-17
Petaluma CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed LigaSure Blunt Tip Laparoscopic Sealer/Divider
Stryker Sustainability Solutions  510(k) NO: K172856(Traditional)
ATTN: Scott  English              PHONE NO : 480 7635333 
1810 W Drake Drive                SE DECISION MADE: 16-NOV-17
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder
Prosomnous Sleep Technologies     510(k) NO: K172859(Traditional)
ATTN: David  Kuhns                PHONE NO : 925 8038643 
5860 W. Las Positas Blvd., Suite 2SE DECISION MADE: 22-NOV-17
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vantage Titan 3T, MRT-3010/A7, M-Power GX
Toshiba Medical Systems Corporatio510(k) NO: K172878(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 7305000 
1385 Shimoishigami                SE DECISION MADE: 17-NOV-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL D-Dimer HS 500
Instrumentation Laboratory Co.    510(k) NO: K172903(Special)
ATTN: Shajunath  Nirupama         PHONE NO : 781 8614083 
180 Hartwell Road                 SE DECISION MADE: 22-NOV-17
Bedford MA  01730-4207            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Self-Punching ICONIX
Stryker                           510(k) NO: K172921(Traditional)
ATTN: Katie  Farraro              PHONE NO : 408 7542285 
5900 Optical Ct.                  SE DECISION MADE: 20-NOV-17
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GentleCath Intermittent Urinary Catheter
ConvaTec Limited                  510(k) NO: K172924(Traditional)
ATTN: Hannah  Sharp               PHONE NO : 44 0 1244854145 
ConvaTec Limited (GDC) First AvenuSE DECISION MADE: 21-NOV-17
Deeside  GB CH5 2NU               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Contact Lens Case, Model: A-1, B-1
P L Overseas Limited              510(k) NO: K172925(Traditional)
ATTN: Maggie  Li                  PHONE NO : 86 138 28882233 
Rm. A 4/F Alexandra Indl. Bldg. BlSE DECISION MADE: 30-NOV-17
Cheung Sha Wan  HK                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Destiknee™ Total Knee System
Meril Healthcare Pvt. Ltd.        510(k) NO: K172936(Traditional)
ATTN: Bhavik  Gondaliya           PHONE NO : 91 968 7604713 
Survey No. 135/2/B & 174/2, H1-H3,SE DECISION MADE: 30-NOV-17
Vapi  IN 396191                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® Growth Rod Conversion Set
NuVasive, Incorporated            510(k) NO: K172979(Traditional)
ATTN: Olga  Lewis                 PHONE NO : 858 3205488 
7475 Lusk Boulevard               SE DECISION MADE: 06-NOV-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balance Biosurface, Affinity Pixie Oxygenator with Cortiva BioActive Surface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Cortiva BioActive Surface
Medtronic, Inc.                   510(k) NO: K172984(Traditional)
ATTN: Lisa  Stone                 PHONE NO : 763 5149866 
8200 Coral Sea Street NE          SE DECISION MADE: 20-NOV-17
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Destination Carotid Guiding Sheath, Destination Peripheral Guiding Sheath, Destination Renal Guiding Sheath
Terumo Medical Corporation        510(k) NO: K172995(Traditional)
ATTN: Liang  Lu                   PHONE NO : 410 3927321 
950 Elkton Blvd                   SE DECISION MADE: 21-NOV-17
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U50 Diagnostic Ultrasound System
Edan Instruments, Inc.            510(k) NO: K173003(Special)
ATTN: Alice  Yang                 PHONE NO : 86 755 28340011 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 15-NOV-17
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cefaly Dual
CEFALY Technology                 510(k) NO: K173006(Traditional)
ATTN: Jean-Yves  Mignolet         PHONE NO : 32 4 3676722 
Rue Louis Plescia, 34             SE DECISION MADE: 28-NOV-17
Seraing  BE 4102                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NCompass Nitinol Stone Extractors
Cook Incorporated                 510(k) NO: K173009(Traditional)
ATTN: Colin  Jacob                PHONE NO : 812 3353575 104965
750 Daniels Way P.O. Box 489      SE DECISION MADE: 07-NOV-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kindguard Powder Free Vinyl Patient Examination Gloves, Light Yellow Color
Anhui Kindguard Medical Supplies T510(k) NO: K173016(Traditional)
ATTN: Chen  Wei                   PHONE NO : 
Intersection of Yulan Road and ChaSE DECISION MADE: 15-NOV-17
Suzhou  CN 234300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MDR17 Mobile Direct Radiographic System
Del Medical, Inc.                 510(k) NO: K173018(Abbreviated)
ATTN: Tony  Bavuso                PHONE NO : 847 2887021 
241 Covington Dr.                 SE DECISION MADE: 20-NOV-17
Bloomingdale IL  60108            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Symbia T16, Symbia Intevo 16 and Symbia Intevo Bold
Siemens Medical Solutions USA, Inc510(k) NO: K173023(Traditional)
ATTN: Tabitha  Estes              PHONE NO : 865 2182421 
2501 N. Barrington Road           SE DECISION MADE: 17-NOV-17
Hoffman Estates IL  60192         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vertera Spine Cohere Cervical Interbody Fusion Device
NuVasive, Incorporated            510(k) NO: K173030(Traditional)
ATTN: Michelle  Cheung            PHONE NO : 858 9093360 
7475 Lusk Blvd.                   SE DECISION MADE: 21-NOV-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FibroScan® Family of Products (Models: 502 Touch, 530 Compact, and 430 Mini+)
Echosens                          510(k) NO: K173034(Traditional)
ATTN: Karine  Bonenfant           PHONE NO : 33 1 44827856 
30 Place d'Italie                 SE DECISION MADE: 14-NOV-17
Paris  FR 75013                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Visual-ICE MRI Cryoblation Console, Visual-ICE MRI Junction Box Assembly, Visual-ICE MRI Mobile Connection Panel
Galil Medical Inc.                510(k) NO: K173037(Traditional)
ATTN: Lynne  Davies               PHONE NO : 651 2875098 
4364 Round Lake Road              SE DECISION MADE: 21-NOV-17
Arden Hills MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable Blood Pressure Cuff, Disposable Blood Pressure Cuff
Ningbo Albert Novosino Co.,Ltd.   510(k) NO: K173044(Traditional)
ATTN: Ningbo  Albert Novosino     PHONE NO : 
No.1 Xinheng 3 Road Cicheng Town JSE DECISION MADE: 20-NOV-17
Ningbo  CN 315036                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Orthofix MJ-FLEX THE NEW METAIZEAU NAIL
Orthofix Srl                      510(k) NO: K173051(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via Delle Nazioni 9               SE DECISION MADE: 16-NOV-17
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Performer Introducer
COOK Incorporated                 510(k) NO: K173068(Traditional)
ATTN: Reuben G. Lidster           PHONE NO : 812 3353575 104866
750 Daniels Way P.O. Box 489      SE DECISION MADE: 17-NOV-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
Visioneering Technologies, Inc.   510(k) NO: K173086(Traditional)
ATTN: Stephen  Snowdy             PHONE NO : 844 8845367 102
10745 Westside Way Suite 200      SE DECISION MADE: 07-NOV-17
Alpharetta GA  30009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bausch + Lomb Boston Original Cleaner, Bausch + Lomb Boston Original Conditioning Solutions
Bausch & Lomb Incorporated        510(k) NO: K173089(Traditional)
ATTN: Melissa  Thomas             PHONE NO : 585 3386045 
1400 North Goodman Street         SE DECISION MADE: 27-NOV-17
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fortis and Hana Anterior Cervical Plate System
Huvexel Co., Ltd                  510(k) NO: K173099(Traditional)
ATTN: Sung  Hee-Lee               PHONE NO : 82 31 7763690 
101-105 Megacenter, SK Technopark,SE DECISION MADE: 30-NOV-17
Seongnam-si  KR 13207             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LAP-iX Suction Irrigation
Sejong Medical Co., Ltd.          510(k) NO: K173111(Traditional)
ATTN: Yoojung  Choi               PHONE NO : 
11, Sinchon 2-ro                  SE DECISION MADE: 28-NOV-17
Paju-si  KR 10880                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LAP-iX
Sejong Medical Co., Ltd.          510(k) NO: K173112(Traditional)
ATTN: Yoojung  Choi               PHONE NO : 82 31 9458191 
11, Sinchon 2-ro                  SE DECISION MADE: 21-NOV-17
Paju-si  KR 10880                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ankle Fusion Plating System
In2Bones SAS                      510(k) NO: K173121(Traditional)
ATTN: Morgane  Grenier            PHONE NO : 33 4 72292626 
28 Chemin du Petit Bois           SE DECISION MADE: 28-NOV-17
Ecully  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariAx 2 System
Stryker GmbH                      510(k) NO: K173135(Traditional)
ATTN: Paul  Nelson                PHONE NO : 201 8315691 
 325 Corporate Drive              SE DECISION MADE: 27-NOV-17
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Menicon Progent Protein Remover for Rigid Gas Permeable Contact Lenses
Menicon Co., Ltd.                 510(k) NO: K173136(Traditional)
ATTN: Kenichi  Tanaka             PHONE NO : 81 52 9351676 
21-19, Aoi 3, Naka-ku             SE DECISION MADE: 16-NOV-17
Nagoya  JP 460-0006               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANTHEM Fracture System
Globus Medical Inc.               510(k) NO: K173166(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 13-NOV-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid Family
SharpLight Technologies Ltd.      510(k) NO: K173169(Special)
ATTN: Ilan  Sharon                PHONE NO : 972 3 9611969 
33 Lazarov St.                    SE DECISION MADE: 20-NOV-17
Rishon Le Zion  IL 7565435        510(k) STATEMENT
                                                    

DEVICE: FilmArray RP2/RP2plus Control Panel
Maine Molecular Quality Controls, 510(k) NO: K173171(Traditional)
ATTN: Joan  Gordon                PHONE NO : 207 8851072 
23 Mill Brook Road                SE DECISION MADE: 24-NOV-17
Saco ME  04072                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Paramount Anterior Cervical Cage System
Spine Wave, Inc.                  510(k) NO: K173175(Special)
ATTN: Yvonne  Riley-Poku          PHONE NO : 203 9449494 
3 Enterprise Drive Suite 210      SE DECISION MADE: 01-NOV-17
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CEDIA Heroin Metabolite (6-AM) Assay
Microgenics Corporation           510(k) NO: K173183(Traditional)
ATTN: Minoti  Patel               PHONE NO : 510 9795000 
46500 Kato Road                   SE DECISION MADE: 22-NOV-17
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MobileDiagnost M50
Philips India Limited             510(k) NO: K173187(Traditional)
ATTN: Nidhi  Bathwal              PHONE NO : 91 206 6357814 
Plot No. B-79, MIDC, Phase II, ChaSE DECISION MADE: 16-NOV-17
Pune  IN 410501                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CereLink ICP Sensor Basic Kit, CereLink ICP Sensor Metal Skull Bolt Kit, CereLink ICP Sensor Plastic Skull Bolt Kit, CereLink ICP Sensor Ventricular Catheter Kit
Codman & Shurtleff, Inc           510(k) NO: K173192(Special)
ATTN: Megan  Palumbo              PHONE NO : 508 8283571 
325 Paramount Drive               SE DECISION MADE: 08-NOV-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: myMerlin(TM) Mobile Application Model APP1001
St. Jude Medical                  510(k) NO: K173232(Special)
ATTN: Jennifer  Dunham            PHONE NO : 818 3626822 
15900 Valley View Ct.             SE DECISION MADE: 02-NOV-17
Sylmar CA  91342                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReliefBand 1.5
ReliefBand Technologies           510(k) NO: K173233(Traditional)
ATTN: Dave  Hartman               PHONE NO : 215 2728587 
220 Gibraltar Rd Ste 270          SE DECISION MADE: 30-NOV-17
Horsham PA  19044                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Planning Software version 1.1
Ortho Kinematics, Inc             510(k) NO: K173247(Special)
ATTN: Adam  Dietz                 PHONE NO : 512 3345490 
110 Wild Basin Road, Suite 250    SE DECISION MADE: 08-NOV-17
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraVision 2 Diagnostic Ultrasound System
WinProbe Corporation              510(k) NO: K173265(Third Party - Abbreviated)
ATTN: Guy  Scott                  PHONE NO : 561 6264055 
11770 US Highway 1 suite 302E     SE DECISION MADE: 07-NOV-17
Palm Beach Gardens FL  33408      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Aesculap Slim Clip Applier Forceps
Aesculap, Inc.                    510(k) NO: K173271(Special)
ATTN: Paul  Amudala               PHONE NO : 800 2581946 
3773 Corporate Parkway            SE DECISION MADE: 10-NOV-17
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aquarius 8600 1417WCI; Aquarius 8600 1717WCI
Imaging Dynamics Company Ltd.     510(k) NO: K173273(Special)
ATTN: Nicole  Wherry              PHONE NO : 403 2519939 
Suite 130, 3510-29th Street NE    SE DECISION MADE: 09-NOV-17
Calgary  CA T1Y 7E5               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)
Boston Scientific Corporation     510(k) NO: K173284(Special)
ATTN: Mugdha  Dongre              PHONE NO : 510 6242111 
47215 Lakeview Boulevard          SE DECISION MADE: 16-NOV-17
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beacon Tip Torcon NB Advantage Catheter, Slip-Cath Beacon Tip Catheter and Shuttle Select Slip-Cath Catheter, Beacon Tip Centimeter Sizing Catheter, Beacon Tip Cava Vessel Sizing Catheter, Beacon Tip White Vessel Sizing Catheter
Cook Incorporated                 510(k) NO: K173289(Special)
ATTN: David E. Chadwick           PHONE NO : 812 3353575 102330
750 Daniels Way                   SE DECISION MADE: 15-NOV-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DuoFLEX Coil Suite
MR Instruments, Inc               510(k) NO: K173290(Third Party - Traditional)
ATTN: Leon  Ricord                PHONE NO : 952 2298812 
5610 Rowland Road, Suite 145      SE DECISION MADE: 28-NOV-17
Minnetonka MN  55343              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: NeuroBlate System
Monteris Medical,                 510(k) NO: K173305(Special)
ATTN: David H. Mueller            PHONE NO : 763 2534710 
14755 27th Avenue North Suite C   SE DECISION MADE: 17-NOV-17
Plymouth MN  55447                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LessRay System
NuVasive, Incorporated            510(k) NO: K173314(Traditional)
ATTN: Manthan J. Damani           PHONE NO : 858 4582272 
7475 Lusk Blvd.                   SE DECISION MADE: 16-NOV-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KaVo NOMAD Pro 2 Handheld X-ray System
Aribex                            510(k) NO: K173319(Special)
ATTN: Erika  Martin               PHONE NO : 704 5877241 
11727 Fruehauf Drive              SE DECISION MADE: 16-NOV-17
Charlotte NC  28273               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: jFit Surgical Planner
JointVue LLC                      510(k) NO: K173329(Third Party - Traditional)
ATTN: Mohamed R. Mahfouz          PHONE NO : 877 7256920 101
2099 Thunderhead Rd., Suite 104   SE DECISION MADE: 15-NOV-17
Knoxville TN  37922               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: JOURNEY II XR Knee Instruments
Smith & Nephew, Inc.              510(k) NO: K173331(Special)
ATTN: Shereen  Bienz              PHONE NO : 901 8003161 
1450 E. Brooks Road               SE DECISION MADE: 16-NOV-17
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivid E80, Vivid E90, Vivid E95
GE Medical Systems                510(k) NO: K173341(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 6766120 
Ultrasound and Primary Care DiagnoSE DECISION MADE: 02-NOV-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gastric Sizing Balloon Catheter
Cook Incorporated                 510(k) NO: K173355(Special)
ATTN: Colin  Jacobs               PHONE NO : 812 3353575 104965
750 Daniels Way P.O. Box 489      SE DECISION MADE: 17-NOV-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bausch + Lomb Boston Scleral Lens Case
Bausch & Lomb Incorporated        510(k) NO: K173365(Traditional)
ATTN: Nancy  Fehrman              PHONE NO : 585 3385310 
1400 North Goodman Street         SE DECISION MADE: 17-NOV-17
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExactechGPS Total Shoulder Application
Blue Ortho                        510(k) NO: K173372(Special)
ATTN: Anthony  Boyer              PHONE NO : 33 0 4583525 
6 Allee de Bethleem               SE DECISION MADE: 24-NOV-17
Gieres  FR 38610                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3.0T 16ch Breast Coil
NeoCoil, LLC                      510(k) NO: K173377(Traditional)
ATTN: Michael  Leigh              PHONE NO : 262 5226127 
N27 W23910 A Paul Rd.             SE DECISION MADE: 28-NOV-17
Pewaukee WI  53072                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo®.via protoNeo (Version VA20)
Siemens Healthcare GmbH           510(k) NO: K173378(Third Party - Traditional)
ATTN: Abhineet  Johri             PHONE NO : 484 6808723 
Henkestrasse 127                  SE DECISION MADE: 20-NOV-17
Erlangen  DE 91052                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Graft Delivery, DePuy Synthes
Micromedics, Inc. (d/b/a Nordson M510(k) NO: K173385(Special)
ATTN: Kristi  Brezinka            PHONE NO : 651 4052183 
1270 Eagan Industrial Road, Suite SE DECISION MADE: 30-NOV-17
St. Paul MN  55121                510(k) STATEMENT
                                                    

DEVICE: Endophys Pressure Sensing Sheath Kit- 8F
Endophys Holdings, LLC            510(k) NO: K173399(Third Party - Traditional)
ATTN: Phillip  Purdy              PHONE NO : 214 8010578 
1601 Elm Street Suite 3500        SE DECISION MADE: 30-NOV-17
Dallas TX  75201                  510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: n!ce for Planmill
Institut Straumann AG             510(k) NO: K173410(Special)
ATTN: Shokoufeh  Khodabandeh      PHONE NO : 41 61 9651260 
Peter Merian-Weg 12               SE DECISION MADE: 14-NOV-17
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR Wire Guide Wire Straight, MR Wire Guide Wire Angled
Nano4Imaging GmbH                 510(k) NO: K173423(Special)
ATTN: Christoph R. Manegold       PHONE NO : 49 241 56528261 
Pauwelsstrasse 17                 SE DECISION MADE: 17-NOV-17
Aachen  DE 52074                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Contour 24
Quality Electrodynamics, LLC      510(k) NO: K173446(Traditional)
ATTN: Eric  Yeh                   PHONE NO : 440 4842940 
6655 Beta Drive Suite 100         SE DECISION MADE: 17-NOV-17
Mayfield Village OH  44143        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solanas® Posterior Stabilization System
Alphatec Spine, Inc               510(k) NO: K173522(Special)
ATTN: Natalia  Shirina            PHONE NO : 760 4946740 
5818 El Camino Real               SE DECISION MADE: 30-NOV-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    


      TOTAL 510(k)s THIS PERIOD   299                                     
      TOTAL WITH SUMMARIES        282                                     
      TOTAL WITH STATEMENTS        17
                                      

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