U.S. flag An official website of the United States government
  1. Home
  2. Medical Devices
  3. Products and Medical Procedures
  4. Device Approvals, Denials and Clearances
  5. 510(k) Clearances
  6. April 2018 510(K) Clearances
  1. 510(k) Clearances

April 2018 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD April 2018


DEVICE: IMACTIS CT-Navigation system
IMACTIS, SAS                      510(k) NO: K162314(Traditional)
ATTN: MADY  BATAILH               PHONE NO : 33 476 549540 
5 AVENUE DU GRAND SABLON          SE DECISION MADE: 24-APR-18
LA TRONCHE  FR 38700              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nano Varnish, Plaquit, Lightpaint on Surface
DREVE DENTAMID GMBH               510(k) NO: K162408(Traditional)
ATTN: REINER  ALTMANN             PHONE NO : 49 230 3880714 
MAX-PLANCK-STRASSE 31             SE DECISION MADE: 05-APR-18
UNNA  DE 59423                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Best Instruminal Applicator
BEST MEDICAL INTERNATIONAL, INC.  510(k) NO: K162499(Traditional)
ATTN: MANNY  SUBRAMANIAN          PHONE NO : 703 4512378 
7643 FULLERTON ROAD               SE DECISION MADE: 13-APR-18
SPRINGFIELD VA  22153             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Oniko nail brace
BEGUM SAGLIK HIZMETLERI TIBBI MALZ510(k) NO: K162525(Traditional)
ATTN: FATMA GULRU ERDOGAN         PHONE NO : 905 32 2969648 
RESIT GALIP CAD. NO: 124/10 GOP   SE DECISION MADE: 25-APR-18
CANKAYA  TR 06700                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Summit Hip System
DePuy Orthopaedics, Inc.          510(k) NO: K170339(Traditional)
ATTN: Carol S. Ming               PHONE NO : 508 9776448 
700 Orthopaedic Drive             SE DECISION MADE: 26-APR-18
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System
i-SENS, Inc.                      510(k) NO: K170463(Traditional)
ATTN: Joon Ho Jung                PHONE NO : 82 291 66191 
43,Banpo-daero 28-gil Seocho-gu   SE DECISION MADE: 13-APR-18
Seoul  KR 06646                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anchored Beacon(R) transponder, Anchored transponder, Beacon Care Package - Lung
Varian Medical Systems Inc        510(k) NO: K170570(Traditional)
ATTN: Lisa  Levine                PHONE NO : 206 7744226 
3100 Hansen Way                   SE DECISION MADE: 06-APR-18
Palo Alto CA  94304-1038          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LIGHTSonic B|UBM
Lightmed USA, Inc.                510(k) NO: K170761(Traditional)
ATTN: Katrina  Hsu                PHONE NO : 949 2189555 
1130 Calle Cordillera             SE DECISION MADE: 13-APR-18
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DTI-1 SLA IMPLANT SYSTEM
DTI Implant Sistemleri Sanayi Tica510(k) NO: K170776(Traditional)
ATTN: Fatih  Ormeci               PHONE NO : 90 533 1655480 
D1-2 No 5 Merkez Mahallesi        SE DECISION MADE: 10-APR-18
Cekmekoy  TR 34782                510(k) STATEMENT
                                                    

DEVICE: ALBUMIN, ALKALINE PHOSPHATASE (ALP)-AMP, GLUCOSE-HEXOKINASE, BA400
BioSystems S.A.                   510(k) NO: K170901(Traditional)
ATTN: Teresa Maria Cortes         PHONE NO : 34 93 3110000 3404
Costa Brava, 30.                  SE DECISION MADE: 13-APR-18
Barcelona  ES e08030              510(k) STATEMENT
                                                    

DEVICE: ACRON™ TLIF System
SpineMED Ges.m.b.H                510(k) NO: K171151(Traditional)
ATTN: Andreas  Bernegger          PHONE NO : 43 147 99281 
Twarochgasse 11                   SE DECISION MADE: 27-APR-18
Wien  AT A-1170                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piezosurgery White
Mectron S.p.a                     510(k) NO: K171326(Traditional)
ATTN: Franco  Zunino              PHONE NO : 39 018 535361 
via loreto 15                     SE DECISION MADE: 13-APR-18
Carasco  IT 16042                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Automatic Wrist Blood Pressure Monitor MD4300
Grandway Technology (Shenzhen) Lim510(k) NO: K171379(Traditional)
ATTN: Patrick  Chow               PHONE NO : 852 28516789 
Block 7, Zhu Keng Industrial Zone,SE DECISION MADE: 10-APR-18
Shenzhen  CN 518118               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OT EQUATOR
Rhein'83 SRL                      510(k) NO: K171409(Traditional)
ATTN: Claudia  Nardi              PHONE NO : 39 05 1244510 
Via E.Zago, 10/abc                SE DECISION MADE: 09-APR-18
Bologna  IT 40128                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Etherea MX
Vydence Medical Industria E Comerc510(k) NO: K171443(Traditional)
ATTN: Kathy  Maynor               PHONE NO : 352 5863113 
Rua Aldo Germano Klein, 359 Cep: 1SE DECISION MADE: 20-APR-18
Ceat - Sao Carlos/Sp Sao Paulo  BR510(k) STATEMENT
                                                    

DEVICE: Dynax clear, Dynax putty, Dynax heavy body, Dynax light, Dynax mono
Dreve Dentamid GmbH               510(k) NO: K171562(Abbreviated)
ATTN: Reiner  Altmann             PHONE NO : 49 230 3880714 
Max-Planck-StraBe 31              SE DECISION MADE: 13-APR-18
Unna  DE 59423                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cope Nephroureterostomy Stent and Amplatz Ureteral Stent Set
Cook Incorporated                 510(k) NO: K171603(Traditional)
ATTN: Erum B. Nasir               PHONE NO : 812 3353575 102607
750 Daniels Way                   SE DECISION MADE: 16-APR-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Gas Sampling Line, Coextruded, 2m/7ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 2.5m/8ft, 10/pkg, Disposable, Gas Sampling Line, Coextruded, 3m/10ft, 10/pkg, Disposable/ 100/pkg, Disposable, Gas Sampling Line, Coextruded, 6m/20ft, 5/pkg, Disposable
Vyaire Medical, Inc.              510(k) NO: K171678(Traditional)
ATTN: Leo  Sohlberg               PHONE NO : 358 108 508130 
Kuortaneenkatu 2                  SE DECISION MADE: 30-APR-18
Helsinki  FI FIN-00510            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Instrument basket, for EndoEYE
Olympus Winter & Ibe GmbH         510(k) NO: K171692(Traditional)
ATTN: Jan-Oliver  Upmeier         PHONE NO : 49 40 669662098 
Kuehnstr. 61                      SE DECISION MADE: 02-APR-18
Hamburg  DE 22045                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Instrument Kits
JJGC Industria e Comercio de Mater510(k) NO: K171713(Traditional)
ATTN: Julianne de Oliveira CapuchoPHONE NO : 55 41 21694058 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 05-APR-18
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: encevis
AIT Austrian Institute of Technolo510(k) NO: K171720(Traditional)
ATTN: Tilmann  Kluge              PHONE NO : 43 50550 4203 
Donau-City-Strabe 1               SE DECISION MADE: 19-APR-18
Vienna  AT 1220                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2 Face / Face Evolution
Heat In A Click                   510(k) NO: K171821(Traditional)
ATTN: Guy  Levi                   PHONE NO : 1 954 5189777 
1975 Tigertail Blvd Dania         SE DECISION MADE: 26-APR-18
Homestead FL  33034               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin Optimized Positioning System (OPS™) Plan
Corin USA Limited                 510(k) NO: K171847(Traditional)
ATTN: Kathy  Trier                PHONE NO : 813 7662112 
12750 Citrus Park Lane, Suite 120 SE DECISION MADE: 05-APR-18
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P50 Series Dental Operative Unit and Accessories
Pelton & Crane                    510(k) NO: K171872(Traditional)
ATTN: Frank  Ray                  PHONE NO : 704 5877227 
11727 Fruehauf Drive              SE DECISION MADE: 26-APR-18
Charlotte NC  28273               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sysmex  UF-5000 Fully Automated Urine Particle Analyzer
Sysmex America, Inc.              510(k) NO: K171883(Traditional)
ATTN: Sharita  Brooks             PHONE NO : 224 5439618 
577 Aptakisic Road                SE DECISION MADE: 23-APR-18
Lincolnshire IL  60069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Frova Intubating Introducer
Cook Incorporated                 510(k) NO: K171917(Traditional)
ATTN: Kotei  Aoki                 PHONE NO : 812 3353575 102630
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 23-APR-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wedge Microcatheter
Micro Vention, Inc.               510(k) NO: K172014(Traditional)
ATTN: Chet  Jones                 PHONE NO : 714 2478055 
1311 Valencia Avenue              SE DECISION MADE: 05-APR-18
Tustin CA  92780                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Riva Star
SDI Limited                       510(k) NO: K172047(Traditional)
ATTN: Ray  Cahill                 PHONE NO : 61 3 87277111 
3-13 Brunsdon Street              SE DECISION MADE: 11-APR-18
Bayswater  AU 3153                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Shanghai Berry Electronic Tech Co.510(k) NO: K172141(Traditional)
ATTN: Xuezhi  Yin                 PHONE NO : 86 21 58531958 
Unit C, 1st Floor, 7th Building, NSE DECISION MADE: 04-APR-18
Shanghai  CN 201112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMI 780 PET/CT System
Shanghai United Imaging Healthcare510(k) NO: K172143(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 21 67076888 6776
No.2258 Chengbei Road,Jiading DistSE DECISION MADE: 13-APR-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hysteroscopy System
Chongquin Jinshan Science & Techno510(k) NO: K172151(Traditional)
ATTN: Qing  Xu                    PHONE NO : 023 86098111 
Yubei District No. 18 Ningshang AvSE DECISION MADE: 09-APR-18
Chongqing  CN 400000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Isolette 8000 plus
Draeger Medical Sytems, Inc.      510(k) NO: K172154(Traditional)
ATTN: Gale  Winarsky              PHONE NO : 215 6602239 
3135 Quarry Road                  SE DECISION MADE: 19-APR-18
Telford PA  18969                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
StatGuard, LLC                    510(k) NO: K172155(Traditional)
ATTN: Gary  Mills                 PHONE NO : 503 5674059 
7555 Cason Lane                   SE DECISION MADE: 12-APR-18
Gladstone OR  97027               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical EPK-3000 Video Imaging System
Pentax Medical                    510(k) NO: K172156(Traditional)
ATTN: William  Goeller            PHONE NO : 800 4315880 2318
3 Paragon Drive                   SE DECISION MADE: 05-APR-18
Montvale NJ  07645                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OLYMPIC Navigated Instruments
Astura Medical                    510(k) NO: K172166(Traditional)
ATTN: Troy  Taylor                PHONE NO : 760 8148047 
3186 Lionshead Avenue Suite 100   SE DECISION MADE: 27-APR-18
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zenith Flex System
InNeuroCo, Inc.                   510(k) NO: K172167(Traditional)
ATTN: Marc  Litzenberg            PHONE NO : 954 4725988 
4635 NW 103rd Avenue              SE DECISION MADE: 19-APR-18
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DiaSpect Tm, DiaSpect Tm Cuvettes
EKF-diagnostic GmbH               510(k) NO: K172173(Traditional)
ATTN: Mick  Fenton                PHONE NO : 49 392 035110 
Ebendorfer Chaussee 3             SE DECISION MADE: 06-APR-18
Barleben  DE 39179                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Inno-Hydrowire
Suzhou Innomed Medical Device Co.,510(k) NO: K172187(Traditional)
ATTN: Jimmy  Li                   PHONE NO : 86 188 62238195 
218 Xinghu St., #B1-404           SE DECISION MADE: 11-APR-18
Suzhou  CN 215123                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica IM Folate Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K172201(Traditional)
ATTN: Darius  Daruwala            PHONE NO : 914 5242812 
511 Benedict Avenue               SE DECISION MADE: 12-APR-18
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAJA™ Ligament Correction System
Cousin Biotech S.A.S.             510(k) NO: K172206(Traditional)
ATTN: Mathilde  Collet            PHONE NO : 011 333 20144130 
8 Rue De L'abbe Bonpain           SE DECISION MADE: 10-APR-18
Wervicq-Sud  FR 59117             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIMPLANT 18
Dentsply Sirona                   510(k) NO: K172239(Traditional)
ATTN: Karl  Nittinger             PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 04-APR-18
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EUROIMMUN IFA: Crithidia luciliae (anti-dsDNA) EUROPattern
Euroimmun US, Inc.                510(k) NO: K172244(Traditional)
ATTN: Daniel  Castellanos         PHONE NO : 973 6561000 104
1 Bloomfield Avenue               SE DECISION MADE: 20-APR-18
Mountain Lakes NJ  07046          510(k) STATEMENT
                                                    

DEVICE: EUROIMMUN IFA: Crithidia luciliae sensitive (anti-dsDNA) EUROPattern
Euroimmun US, Inc.                510(k) NO: K172252(Traditional)
ATTN: Daniel  Castellanos         PHONE NO : 973 6561000 104
1 Bloomfield Avenue               SE DECISION MADE: 20-APR-18
Mountain Lakes NJ  07046          510(k) STATEMENT
                                                    

DEVICE: Novasight Hybrid System
Conavi Medical Inc.               510(k) NO: K172258(Traditional)
ATTN: Sam  Mostafavi              PHONE NO : 416 4830100 
293 Lesmill Road                  SE DECISION MADE: 27-APR-18
Toronto  CA M3B2V1                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion OMNI Sphincterotome
Wilson-Cook Medical, Inc./ Cook En510(k) NO: K172288(Traditional)
ATTN: Sierra  Lowe                PHONE NO : 336 7440154 396506
4900 Bethania Station Road        SE DECISION MADE: 17-APR-18
Winston Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperSlyde Personal Lubricant
ICM Pharma Pte Ltd                510(k) NO: K172306(Traditional)
ATTN: Dennis  Fortich             PHONE NO : 65 62 965411 
26 Kallang Place #05-17           SE DECISION MADE: 19-APR-18
Singapore  SG 339157              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rotarex S Catheter Set – 6F x 110 cm, Rotarex S Catheter Set – 6F x 135 cm, Rotarex S Catheter Set – 8F x 85 cm, Rotarex S Catheter Set – 8F x 110 cm, Drive System,  Replacement Control Unit (with cord), Replacement Motor (with cord), Replacement Footswitch,  Replacement Power Cord, Replacement 0.018” Guidewire 220 cm with 4 cm angled tip,  Replacement 0.018” Guidewire 270 cm with 4 cm angled tip, Replacement 0.018” Guidewire 320 cm with 4 cm angled tip, Replacement 0.018” Guidewire 220 cm with 4 cm angled tip (5 pack), Replacement 0.018” Guidewire/270 cm with 4 cm angled tip (5 pack), Replacement 0.018” Guidewire 320 cm with 4 cm angled tip (5 pack), Replacement Collecting Bag, 2000 ml,  Replacement Sterile drape for motor or footswitch
Straub Medical AG                 510(k) NO: K172315(Traditional)
ATTN: Amy  Ehlenfeldt             PHONE NO : 41 81 7200460 
Straubstrasse 12                  SE DECISION MADE: 12-APR-18
Wangs  CH ch 7323                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Status Engine
Isansys Lifecare Ltd              510(k) NO: K172329(Traditional)
ATTN: Julian  Jones               PHONE NO : 44 1235 436225 
8C Park Square Milton Park, AbingdSE DECISION MADE: 23-APR-18
Oxford  GB OX14 4RR               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panoramic Oxygen Mask (POM)
Pom Medical, LLC                  510(k) NO: K172365(Traditional)
ATTN: Jeff  Voss                  PHONE NO : 855 7660202 
1230 Madera Rd., Suite 5, Box 101 SE DECISION MADE: 19-APR-18
Simi Valley CA  92065             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bipolar Micro-Coagulation Forceps
Gunter Bissinger Medizintechnik Gm510(k) NO: K172368(Traditional)
ATTN: Matthias  Bissinger         PHONE NO : 49 7641 914330 
Hans-Theisen-Str. 1               SE DECISION MADE: 05-APR-18
Teningen  DE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GC Fuji Direct
GC America Inc.                   510(k) NO: K172382(Traditional)
ATTN: Mark  Heiss                 PHONE NO : 708 5970900 
3737 W. 127th Street              SE DECISION MADE: 02-APR-18
Alsip IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advisor HD Grid Mapping Catheter, Sensor Enabled
St. Jude Medical, Inc.            510(k) NO: K172393(Traditional)
ATTN: Jennifer  Ruether           PHONE NO : 651 7565400 
5050 Nathan Lane N                SE DECISION MADE: 23-APR-18
Plymouth MN  55442                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EnSite Velocity Cardiac Mapping System v5.2
St. Jude Medical                  510(k) NO: K172396(Traditional)
ATTN: Melissa  Frank              PHONE NO : 1 651 7562954 
One St. Jude Medical Drive        SE DECISION MADE: 23-APR-18
St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Synermed Opiate Enzyme Immunoassay
Infrared Laboratory Systems, LLC (510(k) NO: K172416(Traditional)
ATTN: Julie  Paschal              PHONE NO : 317 8961565 
17408 Tiller Court, Suite 1900    SE DECISION MADE: 19-APR-18
Westfield IN  40674               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AViTA Radar Thermo NT16 Series IR Thermometer
Avita Corporation                 510(k) NO: K172427(Traditional)
ATTN: Steven  Jhou                PHONE NO : 886 2 85121568 
9F, No.78, Sec. 1, Kwang-Fu Road.,SE DECISION MADE: 19-APR-18
New Taipei City  TW 24158         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADHEAR System
MED-EL Elektromedizinische Geraete510(k) NO: K172460(Traditional)
ATTN: Elizabeth  Gfoeller         PHONE NO : 43 577 885614 
Fuerstenweg 77a                   SE DECISION MADE: 27-APR-18
Innsbruck  AT 6020                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XD880A Ultrasonic Osteotomy Surgical System
Morley Research Consortium        510(k) NO: K172464(Traditional)
ATTN: Suzan  Davis                PHONE NO : 1 508 2715016 
Four Concourse Parkway Suite 215  SE DECISION MADE: 24-APR-18
Atlanta GA  30328                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSchemaView RAPID
iSchemaView, Inc.                 510(k) NO: K172477(Traditional)
ATTN: Jim  Rosa                   PHONE NO : 650 3889767 
201 Marshall Street, Ste. 101     SE DECISION MADE: 19-APR-18
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TENS device-EmeTerm, CinvStop
WAT Medical Technology (Ningbo) Co510(k) NO: K172478(Traditional)
ATTN: Rodney  Zhang               PHONE NO : 86 574 65060811 
Room703-711, No.2 North Taoyuan RoSE DECISION MADE: 19-APR-18
Ningbo  CN 315600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reform® POCT System
Precision Spine, Inc.             510(k) NO: K172495(Traditional)
ATTN: Michael C. Dawson           PHONE NO : 601 4204244 
2050 Executive Drive              SE DECISION MADE: 11-APR-18
Pearl MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hickman TriFusion Catheter
C.R. Bard, Inc                    510(k) NO: K172511(Traditional)
ATTN: Mona  Shahrebani            PHONE NO : 801 5225967 
605 North 5600 West               SE DECISION MADE: 20-APR-18
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Balloon Catheter and Balloon Ureteral Dilator Set
Cook Incorporated                 510(k) NO: K172588(Traditional)
ATTN: Carly  Powell               PHONE NO : 812 3392235 104913
750 Daniels Way                   SE DECISION MADE: 19-APR-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Coventry Topical Anesthetic Mist Spray HAZMAT FREE, Coventry Topical Anesthetic Stream Spray HAZMAT FREE
ITW Contamination Control Electron510(k) NO: K172598(Traditional)
ATTN: Steve  Cook                 PHONE NO : 770 4244888 
8125 Cobb Center Drive            SE DECISION MADE: 19-APR-18
Kennesaw GA  30152                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: THUNDERBEAT 5 mm, 20 cm, Front-actuated Grip Type S, THUNDERBEAT 5 mm, 35 cm, Front-actuated Grip Type S,  THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S
Olympus Medical Systems Corp.     510(k) NO: K172610(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 17-APR-18
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kisses Plus Implant System
ACHIMHAI Medical Corporation      510(k) NO: K172630(Traditional)
ATTN: Ji Ho  Jung                 PHONE NO : 82 70 42964318 
28, Namyang-ro, 930beon-gil, NamyaSE DECISION MADE: 03-APR-18
Hwaseong-si  KR 18255             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INFINITY Total Ankle System
Wright Medical Technology, Inc.   510(k) NO: K172633(Traditional)
ATTN: Tara  Conrad                PHONE NO : 901 8674367 
1023 Cherry Road                  SE DECISION MADE: 26-APR-18
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: High-Flo Silver Polyethylene Catheter
Cook Incorporated                 510(k) NO: K172635(Traditional)
ATTN: Jessica  Swafford           PHONE NO : 812 3353575 104260
750 Daniels Way                   SE DECISION MADE: 03-APR-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VitaMESH Macroporous PP Surgical Mesh
Proxy Biomedical Ltd.             510(k) NO: K172636(Traditional)
ATTN: Adrienne  Tierney           PHONE NO : 353 091896934 
Coilleach, Spiddal                SE DECISION MADE: 30-APR-18
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Agile Nail
Orthofix Srl                      510(k) NO: K172699(Traditional)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via delle Nazioni 9               SE DECISION MADE: 23-APR-18
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRACOE silcosoft Tracheostomy Tube
TRACOE medical GmbH               510(k) NO: K172720(Traditional)
ATTN: Eva  Schaeffer              PHONE NO : 49 61 3691690 
Reichelsheimer Str. 1/3           SE DECISION MADE: 27-APR-18
Nieder-Olm  DE 55268              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EVIS EXERA III BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F, Single Use Biopsy Forceps FB-433D
Olympus Medical Systems Corp.     510(k) NO: K172726(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 30-APR-18
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hemoclip
Hangzhou AGS MedTech CO., Ltd     510(k) NO: K172727(Traditional)
ATTN: Chunqi  Han                 PHONE NO : 86 571 87671223 
Building 6, Kangxin Road No.597 QiSE DECISION MADE: 16-APR-18
Hangzhou  CN 311106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WR19 System
Zeto, Inc.                        510(k) NO: K172735(Traditional)
ATTN: Aswin  Gunasekar            PHONE NO : 512 7892891 
2336 Park Ave                     SE DECISION MADE: 17-APR-18
Santa Clara CA  95050             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HYALURONIC ACID TOPICAL WOUND CREAM
VIRCHOW BIOTECH PVT LTD           510(k) NO: K172747(Traditional)
ATTN: Bruce  Gibbins              PHONE NO : 001 503 7817565 
5903 SE Milwaukie Ave             SE DECISION MADE: 27-APR-18
Portland OR  97202                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Keymill
Mycone Dental Supply Company, Inc.510(k) NO: K172764(Traditional)
ATTN: Priscilla  Herpai           PHONE NO : 856 6634700 
480 S Democrat Road               SE DECISION MADE: 27-APR-18
Gibbstown NJ  08027               510(k) STATEMENT
                                                    

DEVICE: ZOOM
Zetta Medical Technologies, LLC.  510(k) NO: K172768(Traditional)
ATTN: Main M. Ghazal              PHONE NO : 847 5509990 
1313 Ensell Road                  SE DECISION MADE: 24-APR-18
Lake Zurich IL  60047             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuroCap
Memory MD INC                     510(k) NO: K172866(Traditional)
ATTN: Abdus-Salaam  Muwwakkil     PHONE NO : 1 215 3416373 
205 E 42nd Street, 14th Floor     SE DECISION MADE: 27-APR-18
New York NY  10017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astral 100/150
ResMed Ltd                        510(k) NO: K172875(Traditional)
ATTN: Peter  Jennings             PHONE NO : 61 2 88841000 
1 Elizabeth Macarthur Drive       SE DECISION MADE: 26-APR-18
Bella Vista  AU 2153              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K172880(Traditional)
ATTN: Gerhard  Frick              PHONE NO : 41 717 277059 
Espenstrasse 139                  SE DECISION MADE: 18-APR-18
Widnau  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XinBo Electrode (Model: Neck Therapy Pro - I, Neck Therapy Pro - II, Neck Therapy Pro - III, Neck Therapy Pro - IV)
Guangzhou Xinbo Electronic Co., Lt510(k) NO: K172887(Traditional)
ATTN: Sammy  Li                   PHONE NO : 86 020 66393598 
2nd Building, Juntuo Industry ParkSE DECISION MADE: 19-APR-18
Guangzhou  CN 511400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EV-804 OTC Pain Relief TENS
Everyway Medical Instruments Co., 510(k) NO: K172919(Traditional)
ATTN: Paul  Hung                  PHONE NO : 886 2 26620038 
3Fl., No. 5, Lane 155, Sec. 3, PeiSE DECISION MADE: 19-APR-18
New Taipei City  TW 22203         510(k) STATEMENT
                                                    

DEVICE: Nitrile Examination Powder Free Glove, White, Black, Orange, Nitrile Examination Powder Free Gloves Tested For Use With Chemotherapy Drugs, Blue
Top Glove Sdn. Bhd.               510(k) NO: K172923(Traditional)
ATTN: Noor Akilah  Binti Saidin   PHONE NO : 03 3392 1992 
Lot 4968, Jalan Teratai, Batu 6 OfSE DECISION MADE: 26-APR-18
Klang  MY 41050                   510(k) STATEMENT
                                                    

DEVICE: mCare Powder-free Blue Nitrile Examination Gloves
Mercator Medical (Thailand) LTD.  510(k) NO: K172930(Traditional)
ATTN: Dariusz Jan Krezymon        PHONE NO : 66 74 584222 
88/2 Moo 12 Tambon Kampaengphet   SE DECISION MADE: 13-APR-18
Amphur Rattaphum  TH              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HALF DOME Posterior Lumbar Interbody System
Astura Medical                    510(k) NO: K172947(Special)
ATTN: Thomas  Purcell             PHONE NO : 760 8148047 
3186 Lionshead Ave, Suite 100     SE DECISION MADE: 18-APR-18
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LungVision Tool
Body Vision Medical Ltd.          510(k) NO: K172955(Traditional)
ATTN: Dorian  Averbuch            PHONE NO : 646 8637848 
34 SOKOLOV ST.                    SE DECISION MADE: 26-APR-18
Ramat Hasharon  IL                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medicant Mucosal Atomizer
Medica Holdings, LLC              510(k) NO: K172956(Traditional)
ATTN: George  Reed                PHONE NO : 503 2271900 
5200 Meadows Rd Ste 150           SE DECISION MADE: 06-APR-18
Lake Oswego OR  97035             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Master-Frank N95 Particulate Respirator
Master & Frank Enterprise Co., Ltd510(k) NO: K172963(Traditional)
ATTN: Shuge  Zhao                 PHONE NO : 86 769 83361381 
Banhu Industrial District         SE DECISION MADE: 04-APR-18
Dong Duan  CN 523000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mercury® Spinal System
Spinal Elements Inc.              510(k) NO: K172967(Traditional)
ATTN: Julie  Lamothe              PHONE NO : 760 6071816 
3115 Melrose Dr., Suite 200       SE DECISION MADE: 10-APR-18
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uWS-MI
Shanghai United Imaging Healthcare510(k) NO: K172998(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 021670 768886776 
NO.2258 Chengbei Road             SE DECISION MADE: 05-APR-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Algidex Ag Silver Alginate Wound  Dressing
DeRoyal Industries, Inc.          510(k) NO: K173072(Traditional)
ATTN: Sarah  Bennett              PHONE NO : 865 3626112 
200 DeBusk Lane                   SE DECISION MADE: 04-APR-18
Powell TN  37849                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ICONIX XBraid TT with Needles, NanoTack TT Suture Anchor
Stryker                           510(k) NO: K173074(Special)
ATTN: Jacob  Scheenstra           PHONE NO : 303 3577618 
5670 Greenwood Plaza Blvd. Suite 2SE DECISION MADE: 04-APR-18
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4
Philips Medical Systems Nederland 510(k) NO: K173079(Abbreviated)
ATTN: Jan  van de Kerkhot         PHONE NO : 31 613 3011542 
Veenpluis 4-6                     SE DECISION MADE: 04-APR-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pivet and Soft-Pass Embryo Transfer Catheter Sets
Cook Incorporated                 510(k) NO: K173103(Traditional)
ATTN: Naomi  Funkhouser           PHONE NO : 812 3353575 104371
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 13-APR-18
Bloomington IN  47402-0489        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phasix ST Mesh
C. R. Bard Inc                    510(k) NO: K173143(Traditional)
ATTN: Tony  John                  PHONE NO : 401 8258692 
100 Crossings Boulevard           SE DECISION MADE: 25-APR-18
Warwick RI  02886                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNITY Sacroiliac Joint Fixation System
Huvexel Co., Ltd                  510(k) NO: K173201(Traditional)
ATTN: Sung  Hee-Lee               PHONE NO : 82 31 7763690 
101-105 Megacenter, SK Technopark,SE DECISION MADE: 26-APR-18
Seongnam-si  KR 124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIC invent Dental Implant Systems
SIC invent AG                     510(k) NO: K173207(Abbreviated)
ATTN: Cretia Arlene McNett        PHONE NO : 41 061 2613966 
Birmannsgasse 3                   SE DECISION MADE: 05-APR-18
Basel  CH ch-4055                 510(k) STATEMENT
                                                    

DEVICE: CardiMax Electrocardiograph
Fukuda Denshi USA, Inc.           510(k) NO: K173226(Traditional)
ATTN: Doug  Blakely               PHONE NO : 210 2404521 
17725-C NE 65th St.               SE DECISION MADE: 16-APR-18
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polychloroprene Powder Free Sterile Surgical Gloves, White, Tested for Use with Chemotherapy
Pt. Medisafe Technologies         510(k) NO: K173258(Traditional)
ATTN: Deepak  Bang                PHONE NO : 62 61 30007134 
J1 Batang Kuis, Gg Tambak Rejo PasSE DECISION MADE: 20-APR-18
Medan  ID 20362                   510(k) STATEMENT
                                                    

DEVICE: Finessis Intense Polyisoprene Surgical Glove
Lucenxia Prescience Ag            510(k) NO: K173304(Special)
ATTN: Robert  Hill                PHONE NO : 41 417 689126 
Rathausstrasse 7                  SE DECISION MADE: 30-APR-18
Baar  CH 6341                     510(k) STATEMENT
                                                    

DEVICE: DiLumen C2; DiLumen Tool Mount
Lumendi, LLC                      510(k) NO: K173317(Traditional)
ATTN: Dennis  Daniels             PHONE NO : 203 4632669 
253 Post Road West                SE DECISION MADE: 17-APR-18
Westport CT  06880                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: StimuQuik 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 9cm (3.5”) Peripheral Nerve Block Needle, StimuQuik 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik Echo 21G x 15cm (6”) Peripheral Nerve Block Needle, StimuQuik 21G x 2.5cm (1”) Peripheral Nerve Block Needle
Teleflex Medical                  510(k) NO: K173321(Traditional)
ATTN: Kristen  Bisanz             PHONE NO : 919 4334932 
3015 Carrington Mill Blvd.        SE DECISION MADE: 25-APR-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GORE ENFORM Biomaterial
W.L. Gore & Associates, Inc.      510(k) NO: K173333(Traditional)
ATTN: Barbara L Smith             PHONE NO : 410 5068189 
1505 N. Fourth Street             SE DECISION MADE: 05-APR-18
Flagstaff AZ  86004               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intuitive Surgical EndoWrist Vessel Sealer Extend
Intuitive Surgical, Inc.          510(k) NO: K173337(Traditional)
ATTN: Crystal  Ong                PHONE NO : 408 5238636 
1266 Kifer Road                   SE DECISION MADE: 26-APR-18
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DSM Biomedical Calcium Phosphate Cement
Kensey Nash Corporation dba DSM Bi510(k) NO: K173362(Traditional)
ATTN: Susan  Pileggi              PHONE NO : 484 7132173 
735 Pennsylvania Drive            SE DECISION MADE: 03-APR-18
Exton PA  19431                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VisuMax Femtosecond Laser
Carl Zeiss Meditec, Inc.          510(k) NO: K173371(Traditional)
ATTN: Todd  Otani                 PHONE NO : 925 5574513 
5160 Hacienda Drive               SE DECISION MADE: 13-APR-18
Dublin CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BLUselect, non-fenestrated, BLUselect, non-fenestrated, cont, BLUselect, fenestrated, BLUselect Suctionaid, BLUpere Dilation Trachestomy Kit, without tube
Smiths Medical ADS, Inc.          510(k) NO: K173384(Traditional)
ATTN: Donna M. Semlak             PHONE NO : 763 3833076 
6000 Nathan Lane North            SE DECISION MADE: 10-APR-18
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Finessis Zero Flexylon Powder Free Sterile White Surgical Glove Tested for use with Chemotherapy Drugs
Lucenxia Prescience AG            510(k) NO: K173386(Traditional)
ATTN: Robert  Hill                PHONE NO : 41 417 689126 
Rathausstrasse 7                  SE DECISION MADE: 09-APR-18
Baar  CH 6341                     510(k) STATEMENT
                                                    

DEVICE: hipEOS
oneFIT Medical                    510(k) NO: K173390(Traditional)
ATTN: Camille  Vernay             PHONE NO : 33 3 81252427 
18 Rue Alain Savary               SE DECISION MADE: 27-APR-18
Besancon  FR 25000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress Strep A
Cepheid                           510(k) NO: K173398(Dual Track)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 26-APR-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENZA-A Titanium ALIF
Camber Spine Technologies         510(k) NO: K173432(Traditional)
ATTN: Damian  Heinz               PHONE NO : 484 4204286 
418 E. Lancaster Ave.             SE DECISION MADE: 18-APR-18
Wayne PA  19087                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MySpine Pedicle Screw Placement Guides – MC and Drill Pilot Instruments
Medacta International SA          510(k) NO: K173472(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 19-APR-18
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LigaPASS
Medicrea International S.A.       510(k) NO: K173506(Traditional)
ATTN: David  Ryan                 PHONE NO : 33 4 72018787 
5389 route de Strasbourg-Vancia   SE DECISION MADE: 03-APR-18
Rillieux-la-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Admiral Xtreme
Medtronic Vascular                510(k) NO: K173515(Third Party - Traditional)
ATTN: Maddalena  Pinsi            PHONE NO : 39 06 9068307 
3576 Unoacal Place                SE DECISION MADE: 12-APR-18
Santa Rosa CA  95403              510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: 3M Attest Super Rapid Readout Steam Challenge Pack, 3M Attest Super Rapid 5 Steam-Plus Chaallenge Pack, 3M Attest Auto-reader, 3M Attest Auto-reader
3M Company                        510(k) NO: K173519(Traditional)
ATTN: Hilary B. Hovde             PHONE NO : 651 7360364 
3M Center, Building 275-5W-06     SE DECISION MADE: 23-APR-18
St Paul MN  55144                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoGro
OsteoNovus, Inc.                  510(k) NO: K173525(Traditional)
ATTN: Brian M. Schlossberg        PHONE NO : 419 5305940 
1510 North Westwood Avenue, Suite SE DECISION MADE: 06-APR-18
Toledo OH  43606                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SENTIO MMG Gen 2
Medos International, SARL         510(k) NO: K173526(Traditional)
ATTN: Karen  Sylvia               PHONE NO : 508 9773804 
Chemin-Blanc 38                   SE DECISION MADE: 05-APR-18
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VAMP Venous/Arterial Blood Management Protection System
Edwards Lifesciences, LLC         510(k) NO: K173586(Traditional)
ATTN: Ye Seul Kim                 PHONE NO : 949 2502445 
One Edwards Way                   SE DECISION MADE: 05-APR-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Scenium VE20 Software
Siemens Medical Solutions USA, Inc510(k) NO: K173597(Special)
ATTN: Veronica  Padharia          PHONE NO : 630 8775761 
810 Innovation Drive              SE DECISION MADE: 04-APR-18
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Vu a•POD Prime NanoMetalene Intervertebral Body Fusion Device, SeaSpine Vu a•POD Prime Intervertebral Body Fusion Device
SeaSpine Orthopedics Corporation  510(k) NO: K173606(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 13-APR-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Penumbra Coil 400, Ruby Coil System, POD System
Penumbra, Inc.                    510(k) NO: K173614(Traditional)
ATTN: Aditi  Kolla                PHONE NO : 510 9952010 
One Penumbra Place                SE DECISION MADE: 17-APR-18
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Universal Select Sterilization Tray System
Paragon Medical                   510(k) NO: K173615(Third Party - Traditional)
ATTN: Rebecca  Walker             PHONE NO : 574 5942140 10384
8 Matchett Drive                  SE DECISION MADE: 18-APR-18
Pierceton IN  46562               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SOMATOM go.Up, SOMATOM go.Now, SOMATOM go.Top, SOMATOM go.All, Scan&GO
Siemens Medical Solutions USA, Inc510(k) NO: K173632(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd.                  SE DECISION MADE: 13-APR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax
Siemens Medical Solutions, Inc    510(k) NO: K173639(Traditional)
ATTN: Denise  Adams               PHONE NO : 610 4486139 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 02-APR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wingman 35 Crossing Catheter
ReFlow Medical, Inc.              510(k) NO: K173661(Traditional)
ATTN: Rebecca K Pine              PHONE NO : 760 8095178 
1003 Calle Sombra                 SE DECISION MADE: 18-APR-18
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K-D Balance
King-Devick Technologies, Inc.    510(k) NO: K173669(Traditional)
ATTN: Lori  Grover                PHONE NO : 630 3594383 
Two Mid America Plaza Suite 110   SE DECISION MADE: 02-APR-18
Oakbrook Terrace IL  60181        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Guardia Access Embryo Transfer Catheter Sets and Sydney IVF® Transfer Catheter
Cook Incorporated                 510(k) NO: K173686(Traditional)
ATTN: Naomi  Funkhouser           PHONE NO : 812 3353575 104371
750 Daniels Way P.O. Box 489      SE DECISION MADE: 11-APR-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: D-Actor 200 Vibration Massage System
Storz Medical AG                  510(k) NO: K173692(Traditional)
ATTN: Pavel  Novak                PHONE NO : 41 0 716774513 
Lohstampfestrasse 8               SE DECISION MADE: 13-APR-18
Tägerwilen  CH CH-8274            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Pump by Babyation
Babyation, LLC                    510(k) NO: K173699(Traditional)
ATTN: Jared  Miller               PHONE NO : 844 7447867 
911 Washington Ave Suite 427      SE DECISION MADE: 04-APR-18
St. Louis MO  63101               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AlertWatch:OB
AlertWatch, Inc.                  510(k) NO: K173715(Traditional)
ATTN: Justin  Adams               PHONE NO : 734 9988344 
1600 Huron Parkway, Bldg. 520, SteSE DECISION MADE: 23-APR-18
Ann Arbor MI  48109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmunoCAP Specific IgE, ImmunoCAP Allergen f447, Allergen Component rAra h 6, Peanut
Phadia AB                         510(k) NO: K173726(Traditional)
ATTN: Ulf  Karlberg               PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 16-APR-18
Uppsala  SE 75137                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VACUETTE EVOPROTECT Safety Blood Collection / Infusion Set
Greiner Bio-One NA Inc            510(k) NO: K173757(Traditional)
ATTN: Manfred  Abel               PHONE NO : 704 2617823 
4238 Capital Drive                SE DECISION MADE: 19-APR-18
Monroe NC  28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: A. L. P. S. Clavicle Plating System
Biomet Inc.                       510(k) NO: K173767(Traditional)
ATTN: Dhaval  Saraiya             PHONE NO : 305 2696386 
56 East Bell Drive                SE DECISION MADE: 06-APR-18
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clench Compression Staple
F & A Foundation LLC d.b.a. Reign 510(k) NO: K173775(Traditional)
ATTN: Daniel  Lanois              PHONE NO : 918 3029546 
6303 E 102nd Street Suite 200     SE DECISION MADE: 06-APR-18
Tulsa OK  74137                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UNiD Patient Specific 3D printed cage
Medicrea International S.A.       510(k) NO: K173782(Traditional)
ATTN: David  Ryan                 PHONE NO : 0033 472 018787 
5389 route de Strasbourg-Vancia   SE DECISION MADE: 25-APR-18
Rillieux-La-Pape  FR 69140        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NM/CT 850, NM/CT 860
GE Healthcare                     510(k) NO: K173816(Traditional)
ATTN: George  Mashour             PHONE NO : 972 4 8563666 
4 Hayozma Street                  SE DECISION MADE: 17-APR-18
Tirat Hacarmel  IL 30200          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: da Vinci Xi Surgical System, da Vinci X Surgical System
Intuitive Surgical, Inc           510(k) NO: K173842(Traditional)
ATTN: Brandon  Hansen             PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 23-APR-18
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sharpsite AC Rigid Endsocope
Medtronic Xomed Inc.              510(k) NO: K173855(Traditional)
ATTN: Shravan  Chawla             PHONE NO : 904 2797577 
6743 Southpoint Drive North       SE DECISION MADE: 20-APR-18
Jacksonville FL  32216            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HEALIX ADVANCE Anchor with DYNACORD Suture
Medos International SARL          510(k) NO: K173859(Traditional)
ATTN: Tatyana  Tatyana Korsunsky  PHONE NO : 
Chemin-Blanc 38, Case Postale     SE DECISION MADE: 11-APR-18
Le Locle  CH CH 2400              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System
Volcano Corporation               510(k) NO: K173860(Traditional)
ATTN: Nora  York                  PHONE NO : 858 7641286 
3721 Valley Centre Dr Ste 500     SE DECISION MADE: 11-APR-18
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: trophon2
Nanosonics Limited                510(k) NO: K173865(Traditional)
ATTN: Ruth  Cremin                PHONE NO : 612 80 631600 
14 Mars Road                      SE DECISION MADE: 24-APR-18
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Axis Anterior Cervical Plate System
Axis Orthopaedics                 510(k) NO: K173867(Traditional)
ATTN: Craig  Wilcox               PHONE NO : 907 2023111 
34355 Poppy Wood St.              SE DECISION MADE: 05-APR-18
Soldotna AK  99669                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corin TriFit CF Hip Stem
Corin USA Limited                 510(k) NO: K173880(Traditional)
ATTN: Rachel  King                PHONE NO : 813 9774469 
12750 Citrus Park Lane            SE DECISION MADE: 11-APR-18
Tampa FL  33625                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine Binary Lumbar Plate System
Genesys Spine                     510(k) NO: K173885(Traditional)
ATTN: Brian J. Bergeron           PHONE NO : 512 3817071 
1250 South Capital of Texas HighwaSE DECISION MADE: 03-APR-18
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Cautery Electrode (PTFE)
Medline Industries, Inc.          510(k) NO: K173889(Traditional)
ATTN: Matt  Clausen               PHONE NO : 847 6434785 
Three Lakes Drive                 SE DECISION MADE: 09-APR-18
Northfield IL  60093              510(k) STATEMENT
                                                    

DEVICE: Microcyn Antimicrobial Hydrogel
Sonoma Pharmaceuticals, Inc.      510(k) NO: K173896(Traditional)
ATTN: Brian  Martin               PHONE NO : 707 5597181 
1129 N. McDowell Blvd.            SE DECISION MADE: 02-APR-18
Petaluma CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.via MI Workflows
Siemens Medical Solutions USA, Inc510(k) NO: K173897(Special)
ATTN: Veronica  Padharia          PHONE NO : 630 8775761 
810 Innovation Drive              SE DECISION MADE: 05-APR-18
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Univers Revers Modular Glenoid System
Arthrex Inc.                      510(k) NO: K173900(Traditional)
ATTN: Courtney  Smith             PHONE NO : 1 239 6435553 71720
1370 Creekside Boulevard          SE DECISION MADE: 20-APR-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neodent Implant System – GM Line
JJGC Industria e Comercio de Mater510(k) NO: K173902(Traditional)
ATTN: Julianne de Oliveira CapuchoPHONE NO : 55 41 21691000 
Av. Juscelino Kubitschek de OliveiSE DECISION MADE: 20-APR-18
Curitiba  BR 81270-200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reza Band, Reflux Band
Somna Therapeutics, L.L.C.        510(k) NO: K173934(Traditional)
ATTN: James S. Miller             PHONE NO : 262 3455553 
W175 N11081 StoneWood Dr.         SE DECISION MADE: 13-APR-18
Germantown WI  53022              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mediant Anterior Cervical Plating System
Intelligent Implant Systems, LLC  510(k) NO: K173935(Traditional)
ATTN: Michael  Nutt               PHONE NO : 704 4241009 
3300 International Airport Dr; STESE DECISION MADE: 16-APR-18
Charlotte NC  28208               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens
Visco Vision Inc                  510(k) NO: K173958(Traditional)
ATTN: Evan  Huang                 PHONE NO : 886 3 3596868 
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 03-APR-18
Taoyuan  TW 33341                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viamo c100 TUS-VC100 Diagnostic Ultrasound System
Toshiba Medical Systems Corporatio510(k) NO: K173962(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 20-APR-18
Otawara-Shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OVOMotion Shoulder Arthroplasty System
Arthrosurface, Inc.               510(k) NO: K173964(Traditional)
ATTN: Dawn J. Wilson              PHONE NO : 508 5203003 
28 Forge Parkway                  SE DECISION MADE: 18-APR-18
Franklin MA  02038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rampart One Lumbar Interbody Fusion Device
Spineology Inc.                   510(k) NO: K180002(Traditional)
ATTN: Jacqueline A. Hauge         PHONE NO : 651 2568500 
7800 3rd Street N., Suite 600     SE DECISION MADE: 25-APR-18
St. Paul MN  55128                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter
Creagh Medical, Ltd.              510(k) NO: K180007(Traditional)
ATTN: Shane  Costello             PHONE NO : 353 90 9646300 
IDA Business Park                 SE DECISION MADE: 19-APR-18
Ballinasloe  IE H53 K8P4          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)
Medtronic, Inc.                   510(k) NO: K180030(Traditional)
ATTN: Nancy  Cameron              PHONE NO : 763 5262355 
8200 Coral Sea St. NE             SE DECISION MADE: 24-APR-18
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 8mm Monopolar Curved Scissors
Intuitive Surgical, Inc           510(k) NO: K180033(Traditional)
ATTN: Gayle  Perry                PHONE NO : 408 5232100 
1266 Kifer Road                   SE DECISION MADE: 06-APR-18
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Beacon EUS Access System
Covidien llc                      510(k) NO: K180037(Traditional)
ATTN: Rachel  Silva               PHONE NO : 408 3287359 
15 Hampshire Street               SE DECISION MADE: 26-APR-18
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HDR MRI Lumen Marker
C4 Imaging LLC                    510(k) NO: K180069(Traditional)
ATTN: Andrew  Bright              PHONE NO : 609 9335895 
196 West Ashland Street           SE DECISION MADE: 27-APR-18
Doylestown PA  18901              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Px PEEK IBF System, Px HA PEEK IBF System, TxHA PEEK IBF System
Innovasis, Inc.                   510(k) NO: K180078(Traditional)
ATTN: Marshall  McCarty           PHONE NO : 801 2612236 
614 East 3900 South               SE DECISION MADE: 17-APR-18
Salt Lake City UT  84107          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FIBERGRAFT BG Matrix Bone Graft Substitute
Prosidyan, Inc                    510(k) NO: K180080(Traditional)
ATTN: Charanpreet S Bagga         PHONE NO : 908 5173666 
30 Technology Drive               SE DECISION MADE: 06-APR-18
Warren NJ  07059                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RAILWAY Sheathless Access System
Cordis Corporation                510(k) NO: K180081(Traditional)
ATTN: Michelle Ragozzino Rodgers  PHONE NO : 408 2733444 
1820 McCarthy Boulevard           SE DECISION MADE: 18-APR-18
Milpitas CA  95035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silicone Personal Lubricant, ALL-IN-ONE
United Consortium                 510(k) NO: K180083(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 09-APR-18
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrapLiner catheter
Vascular Solutions, Inc.          510(k) NO: K180088(Special)
ATTN: Beka  Vite                  PHONE NO : 763 6575732 
6464 Sycamore Court North         SE DECISION MADE: 04-APR-18
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medacta Shoulder System Short Humeral Diaphysis
Medacta International SA          510(k) NO: K180089(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 05-APR-18
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cure™ Lumbar Plate System
Meditech Spine, LLC               510(k) NO: K180090(Special)
ATTN: Bruce  Dunaway              PHONE NO : 678 9745287 
1447 Peachtree St NE Suite 440    SE DECISION MADE: 23-APR-18
Atlanta GA  30309                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GDT-1000 System
AcuVu Inc.                        510(k) NO: K180096(Traditional)
ATTN: Sam  Mostafavi              PHONE NO : 605 6706972 
1749 Broadway Street              SE DECISION MADE: 16-APR-18
Redwood City CA  94063            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Embozene Color-Advanced Microspheres
Boston Scientific                 510(k) NO: K180102(Traditional)
ATTN: Heidi  Shearer              PHONE NO : 763 2550056 
3 Scimed Place                    SE DECISION MADE: 19-APR-18
Maple Grove MN  55311             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rafugen DBM
Cellumed Co., Ltd.                510(k) NO: K180121(Traditional)
ATTN: JooWoong (Albert)  Jang     PHONE NO : 82 2 21040475 
#402, 130 Digital-ro Geumcheon-gu SE DECISION MADE: 11-APR-18
Seoul  KR 153782                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerLook Density Assessment Software
iCAD, Inc                         510(k) NO: K180125(Traditional)
ATTN: John  DeLucia               PHONE NO : 603 3091945 
98 Spitbrook Road Suite 100       SE DECISION MADE: 05-APR-18
Nashua NH  03062                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOZO
ImpediMed Limited                 510(k) NO: K180126(Traditional)
ATTN: Catherine  Kingsford        PHONE NO : 61 7 38603703 
Unit 1 50 Parker Court            SE DECISION MADE: 16-APR-18
Pinkenba  AU 4008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProFlex Laser Fibers
InnovaQuartz LLC                  510(k) NO: K180140(Traditional)
ATTN: Stephen E Griffin           PHONE NO : 623 4341895 
23030 North 15th Ave              SE DECISION MADE: 20-APR-18
Phoenix AZ  85027-1315            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: KARL STORZ ICG Imaging System
KARL STORZ Endoscopy America, Inc.510(k) NO: K180146(Traditional)
ATTN: Winkie  Wong                PHONE NO : 424 2188379 
2151 E. Grand Avenue              SE DECISION MADE: 17-APR-18
El Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QiF Blood and Fluid Warmer
Quality In Flow Ltd.              510(k) NO: K180154(Special)
ATTN: Neta  Sherman               PHONE NO : 972 54 6600146 
Kibutz Einat POB 29               SE DECISION MADE: 27-APR-18
Kibutz Einat  IL 4880500          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viz CTP
Viz.ai, Inc.                      510(k) NO: K180161(Traditional)
ATTN: Gregory  Ramina             PHONE NO : 239 8983105 
855 El Camino Real Suit 13A-252   SE DECISION MADE: 20-APR-18
Palo Alto CA  94301               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ESG-300, APU-300, Pressure Reducer, MAPC Probes
Olympus Winter & Ibe GmbH         510(k) NO: K180200(Traditional)
ATTN: Jan-Oliver  Upmeier         PHONE NO : 49 40 669662098 
Kuehnstr. 61                      SE DECISION MADE: 26-APR-18
Hamburg  DE                       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: neuromate Gen III
Renishaw Mayfield Sarl            510(k) NO: K180206(Traditional)
ATTN: Stephane  Vinot             PHONE NO : 011 33 437238900 
31, Rue Ampere                    SE DECISION MADE: 24-APR-18
Chassieu  FR 69680                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Endoscopic Trocar
Fengh Medical Co., Ltd.           510(k) NO: K180208(Traditional)
ATTN: Jun  Zhou                   PHONE NO : 86 15 906171661 
D3 No. 6 Dongsheng West Road, JianSE DECISION MADE: 09-APR-18
Jiangyin  CN 214437               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CREO® Stabilization System
Globus Medical Inc.               510(k) NO: K180210(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 02-APR-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JO H2O Flavored Personal Lubricants
United Consortium                 510(k) NO: K180219(Traditional)
ATTN: Stephanie  Morris           PHONE NO : 661 2951700 
29000 N. Hancock Pkwy.            SE DECISION MADE: 20-APR-18
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reaxon Plus
Medovent GmbH                     510(k) NO: K180222(Traditional)
ATTN: Peter  Meier                PHONE NO : 496 131 617690 
Friedrich-Koenig-Str. 3           SE DECISION MADE: 24-APR-18
Mainz  DE 55129                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GSI Viewer with GSI Fat Option
GE Medical Systems SCS            510(k) NO: K180225(Traditional)
ATTN: Peter  Uhlir                PHONE NO : 00 36 14793318 
283 rue de la Miniere             SE DECISION MADE: 24-APR-18
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Eviva Stereotactic Guided Breast Biopsy System
Hologic, Inc                      510(k) NO: K180233(Traditional)
ATTN: Brenda M Geary              PHONE NO : 508 2638819 
250 Campus Drive                  SE DECISION MADE: 10-APR-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infinity-Lock Button System
Xiros Ltd                         510(k) NO: K180243(Traditional)
ATTN: Stephen  Seed               PHONE NO : 44 113 2387200 
Springfield House, Whitehouse LaneSE DECISION MADE: 03-APR-18
Leeds  GB LS17 7UE                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
Crown Porcelain Dental Technology 510(k) NO: K180252(Traditional)
ATTN: Chu Lien  Fan               PHONE NO : 886 2 27324911 11
5F.-1, No. 189, Sec 2, Keelung Rd.SE DECISION MADE: 24-APR-18
Taipei City  CN 110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InCore® Lapidus System
Nextremity Solutions, Inc.        510(k) NO: K180257(Traditional)
ATTN: Greg  Denham                PHONE NO : 732 3837901 
210 North Buffalo Street          SE DECISION MADE: 25-APR-18
Warsaw IN  46580                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NAVIO™ Surgical System (NAVIO system)
Blue Belt Technologies, Inc.      510(k) NO: K180271(Special)
ATTN: Corrine  Herlinger          PHONE NO : 763 4524950 
2905 Northwest Blvd. Ste. 40      SE DECISION MADE: 06-APR-18
Plymouth MN  55441                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Smith & Nephew SURESHOT Distal Targeting System V4.0 Targeter
Smith & Nephew, Inc.              510(k) NO: K180277(Special)
ATTN: Allison  Chan               PHONE NO : 901 3991098 
1450 Brooks Road                  SE DECISION MADE: 24-APR-18
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUVUE OASYS (senofilcon A) with Photochromic Additive
Johnson & Johnson Vision Care, Inc510(k) NO: K180299(Traditional)
ATTN: Victoria  Brennand          PHONE NO : 904 4433160 
7500 Centurion Parkway, Suite 100 SE DECISION MADE: 10-APR-18
Jacksonville FL  32256            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXIS 5.5 Lumbar Pedicle Screw System
Axis Orthopaedics                 510(k) NO: K180301(Traditional)
ATTN: Craig  Wilcox               PHONE NO : 907 2023111 
34355 Poppy Wood                  SE DECISION MADE: 10-APR-18
Soldotna AK  99669                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geri Embryo Incubator and Geri Dish
Genea Biomedx Pty Ltd             510(k) NO: K180304(Special)
ATTN: Kea  Dent                   PHONE NO : 61 2 84847677 
Level 2, 321 Kent Street          SE DECISION MADE: 20-APR-18
Sydney  AU 2000                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hychloderm Wound and Skin Care (Rx) and Hychloderm Wound and Skin Care (OTC)
Aquilabs US LLC                   510(k) NO: K180305(Traditional)
ATTN: Juan  Salcedo               PHONE NO : 305 8852255 
9205 NW 101st St.                 SE DECISION MADE: 13-APR-18
Medley FL  33178                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mazor X
Mazor Robotics Ltd.               510(k) NO: K180307(Special)
ATTN: Shiran  Conforti            PHONE NO : 972 4 6187100 
5 Shacham St. North Industrial ParSE DECISION MADE: 30-APR-18
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PET Digital Gating
GE Medical Systems, LLC           510(k) NO: K180318(Traditional)
ATTN: Lee  Bush                   PHONE NO : 262 5482848 
3000 N. Grandview Blvd.           SE DECISION MADE: 11-APR-18
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: dpl IIa Panel
LED Technologies, Inc.            510(k) NO: K180320(Traditional)
ATTN: Lloyd  Nelson               PHONE NO : 303 6460543 117
6000 Greenwood Plaza Blvd., Suite SE DECISION MADE: 03-APR-18
Greenwood Village CO  80111       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
Visco Vision Inc.                 510(k) NO: K180322(Traditional)
ATTN: Evan  Huang                 PHONE NO : 866 3 3596868 
No. 1, Xingye St. Guishan Dist.   SE DECISION MADE: 20-APR-18
Taoyuan City  TW 33341            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patriot Spinal Fixation System
Valorus Spine                     510(k) NO: K180324(Traditional)
ATTN: Leah  Fero                  PHONE NO : 858 2459798 
822 Hartz Way, Suite 230          SE DECISION MADE: 06-APR-18
Danville CA  94526                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClotTriever Thrombectomy System
Inari Medical                     510(k) NO: K180329(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 09-APR-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.MR Applications
Siemens Medical Solutions USA, Inc510(k) NO: K180336(Traditional)
ATTN: Cordell L Fields            PHONE NO : 610 4486469 
40 Liberty Boulevard Mailcode 65-1SE DECISION MADE: 19-APR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS), Azithromycin 0.016 - 256 µg/mL
Liofilchem s. r. l.               510(k) NO: K180339(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 04-APR-18
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: SYSTEM 1E Liquid Chemical Sterilant Processing System
Steris Corporations               510(k) NO: K180342(Special)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 04-APR-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TheraCal DC
Bisco, Inc.                       510(k) NO: K180344(Special)
ATTN: Ryan  Hobson                PHONE NO : 847 5346000 
1100 West Irving Park Road        SE DECISION MADE: 05-APR-18
Schaumburg IL  60193              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AssureTech Panel Dip Tests, AssureTech Quick Cup Tests
Assure Tech (Hangzhou) Co., Ltd.  510(k) NO: K180349(Traditional)
ATTN: Shisheng  Ling              PHONE NO : 86 571 88868960 
No. 10, Xiyuansan Rd., Westlake EcSE DECISION MADE: 05-APR-18
Hangzhou  CN 310030               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diode laser hair removal device
Zhengzhou PZ Laser Slim Technology510(k) NO: K180353(Traditional)
ATTN: Zhou  Hongwei               PHONE NO : 86 187 36013788 
Fl 2th, jia Tu zhi ye IntersectionSE DECISION MADE: 17-APR-18
High-tech Development Zone, Zhengz510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aurora Evacuator
Rebound Therapeutics              510(k) NO: K180372(Traditional)
ATTN: Jeffrey J. Valko            PHONE NO : 949 3058111 
13900 Alton Parkway, Suite 120    SE DECISION MADE: 09-APR-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: K2M Patient Specific Rods
K2M, Inc.                         510(k) NO: K180376(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 05-APR-18
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optomed Aurora Camera with Aurora Retinal Module and Aurora Anterior Module
Optomed Oy                        510(k) NO: K180378(Traditional)
ATTN: Jyri  Leskela               PHONE NO : 358 20 7413380 
Yrttipellontie 1                  SE DECISION MADE: 05-APR-18
Oulu  FI 90230                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RayStation 7
RaySearch Laboratories AB (publ)  510(k) NO: K180379(Traditional)
ATTN: David  Hedfors              PHONE NO : 46 722 366110 
Sveavagen 44                      SE DECISION MADE: 25-APR-18
Stockholm  SE 111 34              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total1, DAILIES Total1 Multifocal
Alcon Laboratories, Inc.          510(k) NO: K180398(Traditional)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 10-APR-18
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: U60 Diagnostic Ultrasound System
Edan Instruments, Inc.            510(k) NO: K180408(Special)
ATTN: Crystal  Cai                PHONE NO : 86 755 26858736 
#15 Jinhui Road, Jinsha Community,SE DECISION MADE: 13-APR-18
Shenzhen  CN 518122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System
Cardiovascular Systems Inc.       510(k) NO: K180416(Traditional)
ATTN: Susan  Wolf                 PHONE NO : 651 2024149 
1225 Old Highway 8 NW             SE DECISION MADE: 17-APR-18
Saint Paul MN  55112              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ENNOVATE®
Aesculap Implant Systems, LLC     510(k) NO: K180433(Traditional)
ATTN: Melanie  Burkert            PHONE NO : 800 2581946 
3773 Corporate Parkway            SE DECISION MADE: 26-APR-18
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed LigaSure Impact without Nano-coating Large Jaw, Open Sealer/Divider
Stryker Sustainability Solutions  510(k) NO: K180451(Traditional)
ATTN: Scott  English              PHONE NO : 480 7635333 
1810 W Drake Drive                SE DECISION MADE: 20-APR-18
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FOCUS Pedicle Screw System
Nvision Biomedical Technologies, L510(k) NO: K180458(Traditional)
ATTN: Diana  Langham              PHONE NO : 210 5453713 
1350 N Loop 1604 E, Suite 103     SE DECISION MADE: 17-APR-18
San Antonio TX  78232             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed LigaSure Maryland Jaw Sealer/Divider
Stryker Sustainability Solutions  510(k) NO: K180499(Traditional)
ATTN: Scott  English              PHONE NO : 480 7635333 
1810 W Drake Drive                SE DECISION MADE: 23-APR-18
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE STRYDE System
NuVasive Specialized Orthopedics, 510(k) NO: K180503(Special)
ATTN: Lance  Justice              PHONE NO : 949 5446540 
101 Enterprise, Suite 100         SE DECISION MADE: 03-APR-18
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERITON NM
Spectrum Dynamics Medical Ltd.    510(k) NO: K180514(Traditional)
ATTN: Igor  Naroditsky            PHONE NO : 972 54 4384386 
22 Bareket St.                    SE DECISION MADE: 25-APR-18
North Industrial Park  IL 3088900 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Imager II Urology Torque Catheter
Boston Scientific Corporation     510(k) NO: K180530(Special)
ATTN: Daniel  FitzDaniel          PHONE NO : 508 6834156 
100 Boston Scientific Way         SE DECISION MADE: 10-APR-18
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherers; 3F Single Lumen and 4F Dual Lumen PowerPICC Provena Catherters with SOLO Valve Technology
C.R. Bard, Inc (Bard has joined BD510(k) NO: K180548(Special)
ATTN: Bryan  Stone                PHONE NO : 801 5225876 
605 North 5600 West               SE DECISION MADE: 26-APR-18
Salt Lake City UT  84116          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZED Link
Zed Technologies                  510(k) NO: K180549(Traditional)
ATTN: Ronald  Li                  PHONE NO : 61 13000 662980 
12 Yarra Street, Office 105       SE DECISION MADE: 12-APR-18
South Yarra  AU vic 3141          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MobileX Portable X-ray System
Denterprise International, Inc.   510(k) NO: K180561(Traditional)
ATTN: Claude  Berthoin            PHONE NO : 877 5093180 
100 E. Granada Blvd., Suite 219   SE DECISION MADE: 04-APR-18
Ormond Beach FL  32176            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.plaza
Siemens Healthcare GmbH           510(k) NO: K180563(Third Party - Traditional)
ATTN: Vijay  Ramadas              PHONE NO : 49 172 4324369 
Henkestrasse 127                  SE DECISION MADE: 25-APR-18
Erlangen  DE 91502                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Unite Connect for Clinical Systems
Ascom Sweden AB                   510(k) NO: K180566(Special)
ATTN: Ivan  Liljegren             PHONE NO : 011 46 31559311 
Grimbodalen 2                     SE DECISION MADE: 03-APR-18
Goteborg  SE se-402 76            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C3 Wave System
Medical Components, Inc. (dba Medc510(k) NO: K180567(Special)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 2285
1499 Delp Drive                   SE DECISION MADE: 12-APR-18
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GammaPod
Xcision Medical Systems, LLC      510(k) NO: K180571(Special)
ATTN: Daniel R. Plonski           PHONE NO : 443 6817468 
9176 Red Branch Road              SE DECISION MADE: 04-APR-18
Columbia MD  21045                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solar Storm, Solar Wave, Sunco, and ESB (Avalon, Galaxy, Grande, Oasis, Elite and Leisure Select)
LPI, Inc.                         510(k) NO: K180576(Traditional)
ATTN: Christopher  Steadman       PHONE NO : 423 3492920 
506 Twin Oaks Drive               SE DECISION MADE: 19-APR-18
Johnson City TN  37601            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Viveve RF System, Secure
Viveve Inc.                       510(k) NO: K180584(Special)
ATTN: Suzon  Lommel               PHONE NO : 408 6454979 
345 Inverness Dr S, Building B, SuSE DECISION MADE: 06-APR-18
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Varian Head Frame
Varian Medical Systems, Inc.      510(k) NO: K180586(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
3100 Hansen Way                   SE DECISION MADE: 02-APR-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FAST1™ Intraosseous Infusion System; FASTResponder™ Sternal Intraosseous Device
Teleflex Medical                  510(k) NO: K180588(Traditional)
ATTN: Ying  Zhao                  PHONE NO : 919 3613941 
3015 Carrington Mill Blvd.        SE DECISION MADE: 17-APR-18
Morrisville NC  27560             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DR 800 with MUSICA Dynamic
Agfa HealthCare N.V.              510(k) NO: K180589(Traditional)
ATTN: Wim  Govaerts               PHONE NO : 32 3 4446246 
Septestraat 27                    SE DECISION MADE: 05-APR-18
Mortsel  BE b-2640                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SciMoCa
Radialogica LLC                   510(k) NO: K180595(Traditional)
ATTN: Debra  Vigil                PHONE NO : 800 5159132 
511 N. 511 N. Garrison Avenue     SE DECISION MADE: 04-APR-18
Saint Louis MO  63103             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO
Lumenis Ltd.                      510(k) NO: K180597(Special)
ATTN: Amaya  De Levie             PHONE NO : 972 4 9599119 
6 Hakidma Street P O Box 240      SE DECISION MADE: 03-APR-18
Yokneam  IL 2069204               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited    510(k) NO: K180614(Special)
ATTN: Lavinia  Tompkins           PHONE NO : 44 1482 225181 
101 Hessle Road                   SE DECISION MADE: 06-APR-18
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OPTIMUM GP (roflufocon D, roflurocon E) Daily Wear Contact Lens, HEXA100 (hexafocon A) Daily Wear Contact Lens
Contamac Ltd.                     510(k) NO: K180616(Traditional)
ATTN: Rob  McGregor               PHONE NO : 44 1799 542000 
Carlton House Shire Hall          SE DECISION MADE: 25-APR-18
Saffron Walden  GB CB11 3AU       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited    510(k) NO: K180618(Special)
ATTN: Lavinia  Tompkins           PHONE NO : 44 1482 225181 
101 Hessle Road                   SE DECISION MADE: 20-APR-18
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PTFE SURGICAL SUTURE
OMNIA SPA                         510(k) NO: K180630(Special)
ATTN: Roberto  Cerioli            PHONE NO : 0039 0524 527453 
Via F. Delnevo, 190               SE DECISION MADE: 06-APR-18
Fidenza  IT 43036                 510(k) STATEMENT
                                                    

DEVICE: ExactVu High Resolution Micro-Ultrasound System
Exact Imaging Inc.                510(k) NO: K180636(Third Party - Traditional)
ATTN: Randy  AuCoin               PHONE NO : 905 4150030 
7676 Woodbine Avenue, Unit 15     SE DECISION MADE: 30-APR-18
Markham  CA L3R 2N2               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: leva Pelvic Floor Trainer
Renovia Inc.                      510(k) NO: K180637(Traditional)
ATTN: Gina  Prochillo-Cawston     PHONE NO : 866 7358424 1024
263 Summer St., 5th Floor         SE DECISION MADE: 04-APR-18
Boston MA  02210                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Uroview FD II
Pausch Medical GmbH               510(k) NO: K180651(Traditional)
ATTN: Christian  Stoian           PHONE NO : 49 0 913199920 
Graf-Zeppelin-StraBe 1            SE DECISION MADE: 12-APR-18
Erlangen  DE d-91056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 48CH Head Coil
GE Healthcare Coils (USA Instrumen510(k) NO: K180666(Special)
ATTN: Veronica A. Meridith        PHONE NO : 330 9955708 
1515 Danner Drive                 SE DECISION MADE: 12-APR-18
Aurora OH  44202                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartGrid
Carestream Health, Inc.           510(k) NO: K180667(Special)
ATTN: Diane  Koetter              PHONE NO : 585 6276505 
150 Verona Street                 SE DECISION MADE: 13-APR-18
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal
Alcon Laboratories, Inc.          510(k) NO: K180669(Traditional)
ATTN: Sherri  Lakota              PHONE NO : 817 6155472 
6201 South Freeway                SE DECISION MADE: 27-APR-18
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surefire Spark Infusion System
Surefire Medical, Inc.            510(k) NO: K180677(Third Party - Traditional)
ATTN: Lynne  Aronson              PHONE NO : 720 3059877 
6272 W. 91st Ave                  SE DECISION MADE: 03-APR-18
Westminster CO  80031             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CoaguChek XS Plus System
Roche Diagnostics                 510(k) NO: K180684(Special)
ATTN: Bin  Sun                    PHONE NO : 317 5213107 
9115 Hague Road                   SE DECISION MADE: 19-APR-18
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Padlock Clip defect closure device; Padlock Clip Pro-Select defect closure device
STERIS Corporation                510(k) NO: K180689(Special)
ATTN: Tony  Piotrkowski           PHONE NO : 440 3927437 
5976 Heisley Road                 SE DECISION MADE: 12-APR-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoaguChek XS Pro System
Roche Diagnostics                 510(k) NO: K180693(Special)
ATTN: Angie  Clements             PHONE NO : 317 5217338 
9115 Hague Road                   SE DECISION MADE: 19-APR-18
Indianapolis IN  46250            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: K180694(Special)
ATTN: Travis  Pittman             PHONE NO : 719 4472470 
9965 Federal Drive                SE DECISION MADE: 05-APR-18
Colorado Springs CO  80921        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medline Green Ambidextrous Powder-Free Nitrile Examination Gloves with Colloidal Oatmeal (Tested for use with Chemotherapy Drugs)
Medline Industries, Inc.          510(k) NO: K180696(Traditional)
ATTN: Pauline  Maralit            PHONE NO : 847 9492283 
Three Lakes Drive                 SE DECISION MADE: 30-APR-18
Northfield IL  60093              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voyant Open Fusion Device
Applied Medical Resources Corporat510(k) NO: K180699(Special)
ATTN: Patricia  Villarreal        PHONE NO : 949 7136235 
22872 Avenida Empresa             SE DECISION MADE: 13-APR-18
Rancho Santa Margarita CA  92688  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SonoSite iViz Ultrasound System
FUJIFILM SonoSite, Inc.           510(k) NO: K180704(Third Party - Abbreviated)
ATTN: Sudipta  Chakrabarti        PHONE NO : 425 9511371 
21919 30th Drive SE               SE DECISION MADE: 13-APR-18
Bothell WA  98021                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: PreludeSYNC DISTAL Radial Compression System
Merit Medical Systems, Inc        510(k) NO: K180723(Special)
ATTN: Susan  Christensen          PHONE NO : 801 2084789 
1600 West Merit Parkway           SE DECISION MADE: 17-APR-18
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ultramatrix EUS Balloon
United States Endoscopy Group, Inc510(k) NO: K180731(Special)
ATTN: Coletta  Cohara             PHONE NO : 440 3586251 
5976 Heisley Road                 SE DECISION MADE: 19-APR-18
Mentor OH  44060                  510(k) STATEMENT
                                                    

DEVICE: Stablyx CMC Arthroplasty Implant System
Skeletal Dynamics, LLC            510(k) NO: K180744(Special)
ATTN: Ana M. Escagedo             PHONE NO : 305 5967585 
8905 SW 87 Avenue, Suite 201      SE DECISION MADE: 11-APR-18
Miami FL  33176                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: World Knee System
Signature Orthopaedics Pty Ltd.   510(k) NO: K180750(Special)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 20-APR-18
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafetyFix EasyOut System
SafetyFix Medical Technologies, In510(k) NO: K180753(Special)
ATTN: Michael  Horwitz            PHONE NO : 314 9830303 
8637 Delmar Blvd                  SE DECISION MADE: 20-APR-18
St. Louis MO  63124               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Televere Podiatry X-Ray System HF
Televere Systems, Inc.            510(k) NO: K180765(Traditional)
ATTN: Randell  Quaal              PHONE NO : 800 3859593 
                                  SE DECISION MADE: 20-APR-18
Arnold MD  21012                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aria
GE Medical Systems Ultrasound & Pr510(k) NO: K180782(Traditional)
ATTN: Nicole  Landreville         PHONE NO : 289 2082365 
3030 Ohmeda Drive                 SE DECISION MADE: 20-APR-18
Madison WI  53718                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: JUDO 1 Guidewire, JUDO 3 Guidewire, JUDO 6 Guidewire
Boston Scientific                 510(k) NO: K180795(Special)
ATTN: Nikki M. Ibis               PHONE NO : 763 4942381 
Three Scimed Place                SE DECISION MADE: 12-APR-18
Maple Grove MN  55311-1566        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genistrong
Genicon, Inc                      510(k) NO: K180836(Special)
ATTN: Katlyn  Kachman             PHONE NO : 407 6574851 
6869 Stapoint Court Suite 114     SE DECISION MADE: 18-APR-18
Winter Park FL  32792             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERTEX™ Reconstruction System
Medtronic Sofamor Danek USA, Inc  510(k) NO: K180851(Special)
ATTN: Ankit K Shah                PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 18-APR-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic Model 53401 External Pulse Generator (EPG)
Medtronic, Inc.                   510(k) NO: K180873(Special)
ATTN: Brenna  Loufek              PHONE NO : 763 5262365 
8200 Coral Sea Street NE          SE DECISION MADE: 19-APR-18
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aesculap Slim Clip Applier
Aesculap, Inc.                    510(k) NO: K180914(Traditional)
ATTN: Paul  Amudala               PHONE NO : 1800 2581946 
3773 Corporate Parkway            SE DECISION MADE: 17-APR-18
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    


         TOTAL 510(k)s THIS PERIOD   262                                     
         TOTAL WITH SUMMARIES        246                                     
         TOTAL WITH STATEMENTS        16