Medical Devices

March 2018 510(k) Clearances

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


DEVICE: Omega VL
OV WORLD CO., LTD                 510(k) NO: K162366(Traditional)
ATTN: GEUNG-GYU  GANG             PHONE NO : 82 2 8380561 
(GASAN-DONG, FORMATEC BD)A-202,213SE DECISION MADE: 02-MAR-18
SEOUL  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist Type Blood Pressure Monitor
Xuzhou Yongkang Electronic Science510(k) NO: K162616(Traditional)
ATTN: YanLi  Li                   PHONE NO : 8686 51687 892766631 
4F Building C8,40 Jingshan Road EcSE DECISION MADE: 09-MAR-18
Xuzhou  CN 102628                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P-140-Flex Coil, Na-140-Flex Coil, C-140-Flex Coil
RAPID Biomedical GmbH             510(k) NO: K163661(Traditional)
ATTN: Christian  Zimmermann       PHONE NO : 49 9365 88260 
Kettelerstr. 3-11                 SE DECISION MADE: 21-MAR-18
Rimpar  DE 97222                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Astell UMB 220, UMB 230, UMB 240 Autoclaves/sterilizers
Astell Scientific Limited         510(k) NO: K170304(Traditional)
ATTN: Gary  Doughty               PHONE NO : 44 020 83092003 
19-21 Powerscroft Rd              SE DECISION MADE: 02-MAR-18
Sidcup  GB DA14 5DT               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Longeviti PMMA Static Cranial Implant
Longeviti Neuro Solutions, LLC    510(k) NO: K170410(Traditional)
ATTN: Kevin  Lee                  PHONE NO : 410 5271803 
303 International Circle Suite T12SE DECISION MADE: 23-MAR-18
Hunt Valley MD  21030             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Upper Arm Type Electronic Blood Pressure Monitor Series, Electronic Blood Pressure Monitor: YE650A, YE650D, YE660B, YE670A and YE670D
Jiangsu Yuyue Medical Equipment& S510(k) NO: K170605(Traditional)
ATTN: Rong  Zhong                 PHONE NO : 511 869 00827 
Yunyang Industrial Park Danyang, JSE DECISION MADE: 27-MAR-18
Danyang  CN 212300                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UF(II) Implant System
DIO Corporation                   510(k) NO: K170608(Traditional)
ATTN: Jiae  Park                  PHONE NO : 82 517 457789 
66, Centum seo-ro                 SE DECISION MADE: 30-MAR-18
Busan  KR 48058                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acculoc Total Knee System
RootLoc Co., Ltd.                 510(k) NO: K170753(Traditional)
ATTN: Jungsun  Ha                 PHONE NO : 82 2 69414341 
#1210, 68, Digital-ro 9-gil       SE DECISION MADE: 23-MAR-18
Geumcheon-gu  KR 08512            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReConnex Pre-Sutured Tendon
AlloSource                        510(k) NO: K170957(Traditional)
ATTN: Pamela  Vetter              PHONE NO : 720 8730213 
6278 S Troy Circle                SE DECISION MADE: 20-MAR-18
Centennial CO  80111              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CO Check Pro, CO Screen
MD Diagnostics Limited            510(k) NO: K171129(Traditional)
ATTN: Glen  Hillsley              PHONE NO : 44 0 1622682686 
15 Hollingworth Court, Turkey MillSE DECISION MADE: 02-MAR-18
Maidstone  GB ME14 5pp            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AW-100
Micron Corporation                510(k) NO: K171150(Traditional)
ATTN: Takashi  Terui              PHONE NO : 81 3 37550396 
2-17-7 Ikegami                    SE DECISION MADE: 08-MAR-18
Ota-ku, Tokyo  JP 146-0082        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Shenzhen Brav Electronic Technolog510(k) NO: K171214(Traditional)
ATTN: Aaron  Wan                  PHONE NO : 86 075 529781489 
4/F, Block 11, Tongfuyu IndustrialSE DECISION MADE: 02-MAR-18
Shenzhen  CN 518102               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pulse Oximeter
Hunan Accurate Bio-Medical Technol510(k) NO: K171241(Traditional)
ATTN: Zhou  Le                    PHONE NO : 86 731 89745029 
M8-613, No.8, Lutian Road, ChangshSE DECISION MADE: 27-MAR-18
Changsha  CN 410208               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARMAR / ARTIS Small Fragment and Calcaneal Plates & MBOSS / FIXION Screws, ARMAR/ ARTIS Humerus and Olecranon Plates & MBOSS/FIXION Screws, ARMAR / ARTIS Tibia and Buttress Plates & MBOSS/FIXION Screws, ARMAR / ARTIS 2.4mm Plates & MBOSS/FIXION Screws, ARMAR/ ARTISClavical Hook Plate & MBOSS/FIXION Screws, ARMAR/ ARTIS Metaphyseal Plate & MBOSS/FIXION Screws, ARMAR / ARTISCalcaneal Plate & MBOSS/FIXION Screws
Meril Healthcare Pvt. Ltd.        510(k) NO: K171320(Traditional)
ATTN: Umesh  Sharma               PHONE NO : 91 260 3052100 
First Floor, H1-H3, Meril Park, SuSE DECISION MADE: 08-MAR-18
Muktanand Marg, Chala, Vapi  IN 39510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Incontinence Treatment Device, Model LT2061
Shenzhen Dongdixin Technology Co.,510(k) NO: K171430(Traditional)
ATTN: Truman  Shen                PHONE NO : 0086 755 27652471 
No. 3 Building, XiLiBaimang XushenSE DECISION MADE: 15-MAR-18
Shenzhen  CN 518108               510(k) STATEMENT
                                                    

DEVICE: TheraBreath Dry Mouth Oral Rinse, TheraBreath Dry Mouth Lozenges
Dr. Harold Katz, LLC (dba TheraBre510(k) NO: K171542(Traditional)
ATTN: Harold  Katz                PHONE NO : 323 7628518 
5802 Willoughby Avenue            SE DECISION MADE: 16-MAR-18
Los Angeles CA  90038             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IXOS Radius Plate System
Stuckenbrock Medizintechnik GmbH  510(k) NO: K171624(Traditional)
ATTN: Fabian  Stuckenbrock        PHONE NO : 49 07461 165880 
Lessingstraße 50                  SE DECISION MADE: 29-MAR-18
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas m 511 integrated hematology analyzer
Roche Diagnostics Hematology, Inc.510(k) NO: K171655(Traditional)
ATTN: Dan  Bracco                 PHONE NO : 508 3292455 
69 Milk Street, Suite 120         SE DECISION MADE: 02-MAR-18
Westborough MA  01581             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PUMA System
Panther Orthopedics, Inc.         510(k) NO: K171703(Traditional)
ATTN: Kathryn  Stecco             PHONE NO : 408 9303332 
5279 Apennines Circle             SE DECISION MADE: 01-MAR-18
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HammerTube System
Paragon 28                        510(k) NO: K171715(Traditional)
ATTN: Frank S. Bono               PHONE NO : 888 7281888 
4B Inverness Ct. E., STE 280      SE DECISION MADE: 05-MAR-18
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Citric Complete Dry Citric Acid (45X)
Dimesol USA, LLC                  510(k) NO: K171750(Traditional)
ATTN: Marlene Van Dyke            PHONE NO : 717 9388391 
509 Fishing Creek Road            SE DECISION MADE: 06-MAR-18
Lewisberry PA  17339              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fixed Core Wire Guides
Cook Incorporated                 510(k) NO: K171764(Traditional)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 09-MAR-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR Wireless Gating System, Model WGS-100
Ivy Biomedical Systems, Inc       510(k) NO: K171778(Traditional)
ATTN: Nicole  Bush                PHONE NO : 203 4814183 
11 Business Park Drive            SE DECISION MADE: 14-MAR-18
Branford CT  06405                510(k) STATEMENT
                                                    

DEVICE: ALEVE Direct Therapy (ALEVE Direct Therapy TENS Device)
Bayer HealthCare LLC              510(k) NO: K171802(Traditional)
ATTN: Cindy R. Abraham            PHONE NO : 862 4047022 
100 Bayer Boulevard               SE DECISION MADE: 07-MAR-18
Whippany NJ  07981-0915           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TDM Plate and Screw System
TDM Co. Ltd.                      510(k) NO: K171808(Traditional)
ATTN: Babu  Periasamy             PHONE NO : 
#F105-1.101-104, Sangsan-dong, 333SE DECISION MADE: 15-MAR-18
Gwangju  KR 61008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cone Tip Ureteral Catheter, Rutner Universal Wedge Catheter
Cook Incorporated                 510(k) NO: K171810(Traditional)
ATTN: Yan  Li                     PHONE NO : 812 3353575 104987
750 Daniels Way P.O. Box 489      SE DECISION MADE: 07-MAR-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biodesign Diaphragmatic Hernia Graft
Cook Biotech Incorporated         510(k) NO: K171817(Traditional)
ATTN: Perry W. Guinn              PHONE NO : 765 4973355 
1425 Innovation Place             SE DECISION MADE: 13-MAR-18
West Lafayette IN  47906          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Transjugular Liver Access Sets
Cook Incorporated                 510(k) NO: K171820(Traditional)
ATTN: David  Lehr                 PHONE NO : 812 3392235 2309
750 Daniels Way                   SE DECISION MADE: 09-MAR-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Shoulder System
Arthrex Inc.                      510(k) NO: K171841(Traditional)
ATTN: David L. Rogers             PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 29-MAR-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOFTXIL
BISTOOL                           510(k) NO: K171851(Traditional)
ATTN: Eunhyun  Bae                PHONE NO : 82 234 467688 
9, Gwangnaru-ro 6-gil Seongdong-guSE DECISION MADE: 16-MAR-18
Seoul  KR 04796                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMSure® Enteral Feeding Syringe with ENFit Tip
Amsino International, Inc.        510(k) NO: K171857(Traditional)
ATTN: Cathy  Hong                 PHONE NO : 909 6265888 
708 Corporate Center Drive        SE DECISION MADE: 30-MAR-18
Pomona CA  91768                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anjon Bremer Halo System
Anjon Holdings, LLC               510(k) NO: K171863(Traditional)
ATTN: Tommy  Mitchell             PHONE NO : 904 7309373 
4801 Dawin Rd                     SE DECISION MADE: 19-MAR-18
Jacksonville FL  32207            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dr’s Finder NEO
Good Doctors Co.,Ltd.             510(k) NO: K171867(Traditional)
ATTN: Sungro  Joo                 PHONE NO : 82 32 4246325 
#208, B-Dong, 283 Bupyeong-Daero, SE DECISION MADE: 30-MAR-18
Incheon  KR 21315                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Double Flexible Tip Wire Guides
Cook Incorporated                 510(k) NO: K171912(Traditional)
ATTN: Jennifer  Allman            PHONE NO : 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 19-MAR-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nathanson Transcystic Bile Duct Stone Exploration Pack
Cook Incorporated                 510(k) NO: K171915(Traditional)
ATTN: Colin  Jacob                PHONE NO : 812 3353575 104965
450 Daniels Way, P.O. Box 489     SE DECISION MADE: 01-MAR-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microlife Upper Arm Automatic Digital Blood Pressure Monitor
Microlife Intellectual Property Gm510(k) NO: K171937(Traditional)
ATTN: Gerhard  Frick              PHONE NO : 4 171 7277059 
Espenstrasse 139                  SE DECISION MADE: 16-MAR-18
Widnau  CH 9443                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ALVUE Balloon Dilation System
Globus Medical, Inc.              510(k) NO: K171939(Traditional)
ATTN: Lori  Burns                 PHONE NO : 610 9301800 2950
2560 General Armistead Ave. ValleySE DECISION MADE: 07-MAR-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dimesol Tubing Sets for Hemodialysis
Dimesol, Inc.                     510(k) NO: K171952(Traditional)
ATTN: Stephen P. Callaghan        PHONE NO : 717 9388391 
509 Fishing Creek Road            SE DECISION MADE: 30-MAR-18
Lewisberry PA  17339              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mpact® 3D Metal™ Implants and Augments 3D Metal™
Medacta International SA          510(k) NO: K171966(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 27-MAR-18
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Web II Memory Extraction Basket or Memory II Double Lumen Extraction Basket, Memory 5 Fr. Soft Wire Baskets or Memory Helical Stone Extractor, Memory Eight Wire Baskets or Memory Hard Wire Baskets, Fusion Wire Guided Extraction Basket, Non-Lithotripsy Extraction Basket
Wilson-Cook Medical, Inc.         510(k) NO: K171969(Traditional)
ATTN: Ashley  Howard              PHONE NO : 1 336 7440157 6174
4900 Bethania Station Road        SE DECISION MADE: 28-MAR-18
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Captura® Disposable Hot Biopsy Forceps
Wilson-Cook Medical, Inc.         510(k) NO: K171973(Traditional)
ATTN: Ashley  Howard              PHONE NO : 336 7440157 6174
4900 Bethania Station Road        SE DECISION MADE: 21-MAR-18
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DROPLET PEN NEEDLE
HTL-STREFA S.A.                   510(k) NO: K171982(Traditional)
ATTN: Aleksandra  Prazmowska-WilanPHONE NO : 48 42 2700010 
Adamowek 7                        SE DECISION MADE: 21-MAR-18
Ozorkow  PL 95-035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Performer Guiding Sheath
Cook Incorporated                 510(k) NO: K171988(Traditional)
ATTN: Reuben G. Lidster           PHONE NO : 812 3353575 104866
750 Daniels Way P.O. Box 489      SE DECISION MADE: 30-MAR-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Classic ERCP Catheter and Huibregtse-Katon ERCP Catheter and Huibregtse-Katon Angled, Glo-Tip ERCP Catheter, Glo-Tip II Double Lumen ERCP Catheter & w/ Radiopaque Bands, Fusion ERCP Catheter with DomeTip and Fusion OMNI ERCP Catheter with DomeTip, Haber RAMP Catheter, Soehendra Universal Catheter
Wilson-Cook Medical Inc.          510(k) NO: K171989(Traditional)
ATTN: Ashley  Howard              PHONE NO : 336 7440157 6174
4900 Bethania Station Road        SE DECISION MADE: 20-MAR-18
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mandril Wire Guide
Cook Incorporated                 510(k) NO: K171997(Traditional)
ATTN: Jennifer  Allman            PHONE NO : 1 812 3353575 104280
750 Daniels Way                   SE DECISION MADE: 30-MAR-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: star RF Electrode, VIV A RF Electrode
STARmed Co., Ltd.                 510(k) NO: K172012(Traditional)
ATTN: Jun-Young  Jung             PHONE NO : 82 70 46738657 
B-dong, 4F, 158, Haneulmaeul-ro, ISE DECISION MADE: 14-MAR-18
Gyeonggi-do  KR 10355             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Black Silicone Filiform Double Pigtail Stent Set
Cook Incorporated                 510(k) NO: K172017(Traditional)
ATTN: Karthik  Pillai             PHONE NO : 812 3353575 104929
750 Daniels Way P.O. Box 489      SE DECISION MADE: 26-MAR-18
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EKOS ultrasound EVD Device, EVD Control Unit
BTG International, Inc.           510(k) NO: K172035(Traditional)
ATTN: Brit  Baird                 PHONE NO : 425 4153114 
11911 North Creek Pkwy S          SE DECISION MADE: 24-MAR-18
Bothell WA  98011                 510(k) STATEMENT
                                                    

DEVICE: Zimmon Pancreatic Stents/Stent sets, Geenen Pancreatic Stents/Stent Sets, Pushing Catheter and Guiding Catheter, Johlin Pancreatic Wedge Stent and Introducer Set
Cook Ireland Ltd.                 510(k) NO: K172057(Traditional)
ATTN: Orla  Gunning               PHONE NO : 011 353 61334440 2895
O' Halloran Road, National TechnolSE DECISION MADE: 09-MAR-18
Limerick  IE                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AllergiEnd ST-9 Multiple Skin Test Applicator, AllergiEnd ST-9 Multiple Well Test Tray
MedScience Science Research Group,510(k) NO: K172062(Traditional)
ATTN: Marvin  Smollar             PHONE NO : 561 4990411 
16469 Bridlewood Circle           SE DECISION MADE: 05-MAR-18
Delray Beach FL  33445            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo  Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo  Capiox  NX19 Oxygenator (west orientation)
Terumo Cardiovascular Systems Corp510(k) NO: K172071(Traditional)
ATTN: Garry A. Courtney           PHONE NO : 800 2623304 7486
125 Blue Ball Road                SE DECISION MADE: 29-MAR-18
Elkton MD  21921                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmuLisa Enhanced RNA POL III Antibody ELISA
IMMCO Diagnostics, Inc.           510(k) NO: K172078(Traditional)
ATTN: Kevin  Lawson               PHONE NO : 716 4915245 
60 Pineview Dr.                   SE DECISION MADE: 30-MAR-18
Buffalo NY  14228                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flowtron DVT5 Small Calf Garment
Getinge (Suzhou) Co., Ltd.        510(k) NO: K172103(Traditional)
ATTN: Daisy  Qin                  PHONE NO : 86 512 69561698 
No. 158 Fangzhou Road             SE DECISION MADE: 02-MAR-18
Suzhou  CN 2015024                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Navigated Instrument System
Orthofix Inc.                     510(k) NO: K172115(Special)
ATTN: Jacki  Koch                 PHONE NO : 214 9372100 
3451 Plano Parkway                SE DECISION MADE: 08-MAR-18
Lewisville TX  75056              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uCT Computed Tomography X-ray System
Shanghai United Imaging Healthcare510(k) NO: K172135(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 2167 0768886776 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 02-MAR-18
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anchorage Bone Plating System
Stryker GmbH                      510(k) NO: K172148(Traditional)
ATTN: Jackie  Perri               PHONE NO : 732 7705616 
325 Corporate Drive               SE DECISION MADE: 19-MAR-18
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WillCeph
HDX WILL CORP.                    510(k) NO: K172168(Traditional)
ATTN: Myoung-Joon  Lee            PHONE NO : 82 43 7107318 
#105, 106, 201, 202, 203, 204, 38,SE DECISION MADE: 21-MAR-18
Cheongju-si  KR 28161             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoreHip® System
Aesculap Implants Systems, LLC    510(k) NO: K172235(Traditional)
ATTN: Paul  Amudala               PHONE NO : 610 9849147 
3773 Corporate Parkway            SE DECISION MADE: 28-MAR-18
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OLYMPUS URF-V2/V2R
Olympus Medical Systems Corp.     510(k) NO: K172246(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 30-MAR-18
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SoftVue
Delphinus Medical Technologies    510(k) NO: K172256(Traditional)
ATTN: Francis X. Dobscha          PHONE NO : 248 5229508 
45525 Grand River Avenue          SE DECISION MADE: 02-MAR-18
Novi MI  48374                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OTW Takeru PTCA Balloon Dilatation Catheter
Kaneka Corporation                510(k) NO: K172264(Special)
ATTN: Toshihiko  Motomine         PHONE NO : 81 3 55748023 
1-12-32, Akasaka, Minato-ku       SE DECISION MADE: 19-MAR-18
Tokyo  JP 107-6028                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dynarex Three-Way Stopcock
Dynarex Corporation               510(k) NO: K172266(Traditional)
ATTN: Pablo  Martinez             PHONE NO : 845 3986616 
10 Glenshaw Street                SE DECISION MADE: 14-MAR-18
Orangeburg NY  10962              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IRENE Thoracolumbar Fixation System
Tianjin Zhengtian Medical Instrume510(k) NO: K172267(Traditional)
ATTN: Ou  Changli                 PHONE NO : 86 10 822929 
No. 318, Jingyi Road, Airport EconSE DECISION MADE: 06-MAR-18
Tianjin  CN 300308                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTRESS™ Radiopaque Bone Cement (FORTRESS™ and FORTRESS-Plus™), CREO® Fenestrated Screw System, REVLOK® Fenestrated Screw System
Globus Medical, Inc.              510(k) NO: K172269(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 27-MAR-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OLYMPUS URF-P6/P6R
Olympus Medical Systems Corp.     510(k) NO: K172298(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 29-MAR-18
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eego amplifiers
eemagine Medical Imaging Solutions510(k) NO: K172312(Traditional)
ATTN: Frank  Zanow                PHONE NO : 49 30 29048404 
Gubenerstr. 47, Fabrik D-10243    SE DECISION MADE: 30-MAR-18
Berlin  DE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Atellica IM Total hCG (ThCG)
Siemens Healthcare Diagnostics Inc510(k) NO: K172322(Traditional)
ATTN: Anoop  Joy                  PHONE NO : 914 5242273 
511 Benedict Avenue               SE DECISION MADE: 29-MAR-18
Tarrytown NY  10591               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Type I, Type II, Type III, Type IV
Lepu Medical Technology (Beijing) 510(k) NO: K172331(Traditional)
ATTN: Xiangdan  Jin               PHONE NO : 86 10 80123510 
No. 37 Chaoqian Road              SE DECISION MADE: 02-MAR-18
Beijing  CN 102200                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bleep DreamPort
snapCPAP                          510(k) NO: K172335(Traditional)
ATTN: Stuart  Heatherington       PHONE NO : 919 6197170 
143 Harrison Pond Dr.             SE DECISION MADE: 30-MAR-18
Pittsboro NC  37312               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OssBuilder System
Osstem Implant Co., Ltd..         510(k) NO: K172354(Traditional)
ATTN: Jungmin  Yoo                PHONE NO : 82 51 8502575 
66-16, Bansong-ro 513beon-gil, HaeSE DECISION MADE: 26-MAR-18
Busan  KR 612-070                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist Pulse Oximeter
Beijing Choice Electronic Technolo510(k) NO: K172366(Traditional)
ATTN: Lei  Chen                   PHONE NO : 86 10 88798300 6020
No.9 Shuangyuan road, Badachu Hi-tSE DECISION MADE: 16-MAR-18
Beijing  CN 100041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex UNIVERS REVERS COATED BASEPLATE
Arthrex, Inc.                     510(k) NO: K172371(Traditional)
ATTN: Courtney  Smith             PHONE NO : 1 239 6435553 71720
1370 Creekside Boulevard          SE DECISION MADE: 22-MAR-18
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digitimer DS7AP Constant Current Stimulator
Digitimer Ltd.                    510(k) NO: K172381(Traditional)
ATTN: John  Smale                 PHONE NO : 44 01707 328347 
37 Hydeway                        SE DECISION MADE: 06-MAR-18
Welwyn Garden City  GB            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cardiovascular Analzyer
PhysioWave, Inc.                  510(k) NO: K172431(Traditional)
ATTN: Laurent  Giovangrandi       PHONE NO : 408 6380008 
1700 Wyatt Drive Suite 2          SE DECISION MADE: 14-MAR-18
Santa Clara CA  95054             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA BRAIN (v3.0.0.5)
MEDTECH S.A.                      510(k) NO: K172444(Traditional)
ATTN: Elise  Lagacherie           PHONE NO : 33 46 7107740 
ZAC Eureka - 900 Rue Du Mas De VerSE DECISION MADE: 28-MAR-18
Montpellier  FR 34000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AESKUSLIDES ANCA Ethanol, AESKUSLIDES ANCA Formalin
Aesku.Diagnostics GmbH & Co. KG   510(k) NO: K172461(Traditional)
ATTN: Sandra  Reuter              PHONE NO : 49 6734 96220 
Mikro-Forum-Ring 2                SE DECISION MADE: 23-MAR-18
Wendelsheim  DE 55234             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Footmotion HammerToe
Newclip Technics                  510(k) NO: K172485(Traditional)
ATTN: Gaelle  Lussori             PHONE NO : 33 2 28213712 
PA de la Lande Saint Martin - 45 rSE DECISION MADE: 02-MAR-18
Haute-Goulaine  FR 44 115         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SUPERCATH 5 (26G)
TOGO Medikit Co., Ltd.            510(k) NO: K172496(Traditional)
ATTN: Daisuke  Nagamizu           PHONE NO : 11 81 982538000 
17148-6 Aza Kamekawa Oaza Hichiya SE DECISION MADE: 23-MAR-18
Hyuga City  JP 883-0062           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Technoweb Surgical Mask
YTS GLOBAL INC.                   510(k) NO: K172500(Traditional)
ATTN: Eddie  Nguyen               PHONE NO : 703 3408178 
7406 ALBAN STATION CT STE A 108   SE DECISION MADE: 01-MAR-18
SPRINGFIELD VA  22150             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgiQuest AIRSEAL iFS System
ConMed Corporation                510(k) NO: K172516(Traditional)
ATTN: Lisa  Anderson              PHONE NO : 203 7992400 202
488 Wheelers Farms Road           SE DECISION MADE: 16-MAR-18
Milford CT  06461                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Spectra Optia Apheresis System
Terumo BCT, Inc.                  510(k) NO: K172590(Traditional)
ATTN: Nicholas  Wong              PHONE NO : 303 2392384 
10811 W. Collins Avenue           SE DECISION MADE: 02-MAR-18
Lakewood CO  80215                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XCelliStem Wound Powder
StemSys                           510(k) NO: K172593(Traditional)
ATTN: Clay  Fette                 PHONE NO : 561 3249507 
10871 NW 52nd St, Ste 4           SE DECISION MADE: 16-MAR-18
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Next Generation iBOT
DEKA Research & Development Corp  510(k) NO: K172601(Traditional)
ATTN: Roger  Leroux               PHONE NO : 603 6695139 
340 Commercial St.                SE DECISION MADE: 02-MAR-18
Manchester NH  03101              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Universal Cylinder Applicator Family, Universal Segmented Cylinder Applicator Set, Universal Stump Applicator Set, Universal Cervix Probe Sets, odd lengths and even lengths, Universal Titanium Cervix Probe Sets, odd lengths and even lengths
Varian Medical Systems, Inc       510(k) NO: K172611(Special)
ATTN: Peter J. Coronado           PHONE NO : 650 4246320 
911 Hansen Way                    SE DECISION MADE: 21-MAR-18
Palo Alto CA  94304               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: David Home Pregnancy Test Cassette, David Professional Pregnancy Test Cassette
Runbio BioTech Co.,Ltd            510(k) NO: K172627(Traditional)
ATTN: Chandler  Chen              PHONE NO : 86 186 88026317 
Rongsheng Technology Garden, ShantSE DECISION MADE: 28-MAR-18
Shantou  CN 515063                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Drive DeVilbiss iGo 2 Portable Oxygen Concentrator
DeVilbiss Healthcare, LLC         510(k) NO: K172648(Traditional)
ATTN: Betty  Miller               PHONE NO : 814 4437602 
100 DeVilbiss Drive               SE DECISION MADE: 23-MAR-18
Somerset PA  15501                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cytology Brush
Micro-Tech (Nanjing) CO., Ltd.    510(k) NO: K172663(Traditional)
ATTN: Becky  Li                   PHONE NO : 86 25 58646378 
NO. 10 Gaoke Third Road           SE DECISION MADE: 05-MAR-18
Nanjing  CN 210032                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dario LC Blood Glucose Monitoring System
LabStyle Innovation, Ltd.         510(k) NO: K172723(Traditional)
ATTN: Erez  Raphael               PHONE NO : 972 52 5522685 
9 Halamish Street, North IndustriaSE DECISION MADE: 23-MAR-18
Caesarea  IL 3890000              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rotatable Snares, Non-Rotatable Snares
Zhejiang Chuangxiang Medical Techn510(k) NO: K172758(Traditional)
ATTN: Lucius  Long                PHONE NO : 8657 189167 0888187 
301B, No.22, XinYan Road          SE DECISION MADE: 07-MAR-18
Hanzhou  CN 311100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REST EAZY Appliance
Insert Molding Solutions, Inc.    510(k) NO: K172760(Traditional)
ATTN: Paul  Hendrixson            PHONE NO : 678 9655334 
4325 Settingdown Circle, Suite 103SE DECISION MADE: 26-MAR-18
Cumming GA  30028                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Hemoclip
Zhejiang Chuangxiang Medical Techn510(k) NO: K172762(Traditional)
ATTN: Lucius  Long                PHONE NO : 865718 916708 88187 
301B, No.22, XinYan Road          SE DECISION MADE: 20-MAR-18
Hanzhou  CN 311100                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Shenzhen Jumper Medical Equipment 510(k) NO: K172795(Traditional)
ATTN: Rambo  Yang                 PHONE NO : 86 755 26696279 
D Building, No. 71, Xintian Road, SE DECISION MADE: 14-MAR-18
Shenzhen  CN 518102               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Positional Sleep Assessment System (PoSAS) software
Advanced Brain Monitoring         510(k) NO: K172799(Traditional)
ATTN: Daniela  Soll               PHONE NO : 760 7200099 6006
2237 Faraday Ave, Suite 100       SE DECISION MADE: 09-MAR-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PORT-X IV
GENORAY Co., Ltd.                 510(k) NO: K172810(Traditional)
ATTN: Ji-Yeon  Choi               PHONE NO : 82 31 6273953 
512, 560, Dunchon-daero, Jungwon-gSE DECISION MADE: 07-MAR-18
Seongnam  KR 13230                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LMT-3000
Lameditech Co., Ltd.              510(k) NO: K172818(Traditional)
ATTN: Jong Seuk Choi              PHONE NO : 82 70 42081082 
#1002, ACE High End Tower 6th     SE DECISION MADE: 07-MAR-18
234, Beotkkot-ro, Geumcheon-gu  KR510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Microscope Navigation Software
Brainlab AG                       510(k) NO: K172820(Traditional)
ATTN: Alexander  Schwiersch       PHONE NO : 49 89 9915680 
Olof-Palme-Str. 9                 SE DECISION MADE: 01-MAR-18
Munich  DE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TwitchView System
Blink Device Corporation          510(k) NO: K172843(Traditional)
ATTN: Justin  Hulvershorn         PHONE NO : 206 2953372 
1530 Westlake Ave N Suite 600     SE DECISION MADE: 29-MAR-18
Seattle WA  98109                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DePuy Synthes Femoral Neck System
DePuy Synthes                     510(k) NO: K172872(Traditional)
ATTN: Ana Sala Roca               PHONE NO : 41 32 7204573 
Luzernstrasse 21                  SE DECISION MADE: 05-MAR-18
Zuchwil  CH 4528                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Dongguan HCS Electronics Co., Ltd 510(k) NO: K172891(Traditional)
ATTN: Angel  You                  PHONE NO : 86 769 82553442 
Floor 4, Building 1, No.1 Longtan SE DECISION MADE: 16-MAR-18
Dongguan  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neuro Assessment System NAS-1000
HeadSense Medical Inc.            510(k) NO: K172892(Traditional)
ATTN: Richard A. Lotti            PHONE NO : 234 6783888 
520 S. Main St. Suite 2457        SE DECISION MADE: 08-MAR-18
Akron OH  44311                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FUJIFILM Endoscope Models EG-760R, EG-760Z, EC-760R-V/L and EC-760ZP-V/L, and FUJIFILM Water Tank Model WT-603
Fujifilm Corporation              510(k) NO: K172916(Traditional)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 01-MAR-18
Ashigarakami-Gun Kanagawa  JP 258-510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portable X-ray System
Rolence Enterprise Inc.           510(k) NO: K172928(Traditional)
ATTN: Sterling  Cheng             PHONE NO : 886 3 4631999 
18-3 Lane 231 Pu Chung Rd., ChunglSE DECISION MADE: 16-MAR-18
Taoyuan  TW 32083                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wrist Type Automatic Blood Pressure Monitor
Shenzhen Jiacom Technology Co., Lt510(k) NO: K172972(Traditional)
ATTN: Luo  Tianfeng               PHONE NO : 86 755 29015600 
No. A6 Building, Silicon Valley PoSE DECISION MADE: 02-MAR-18
Shenzhen  CN 518109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nipro Syringe
Nipro Medical Corporation         510(k) NO: K173029(Traditional)
ATTN: Jessica  Oswald-McLeod      PHONE NO : 786 5676343 
3150 NW 107th Ave.                SE DECISION MADE: 30-MAR-18
Miami FL  33172                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Knee Joint Replacement Prostheses MR Labeling
Zimmer, Inc.                      510(k) NO: K173057(Traditional)
ATTN: Jason  Heckaman             PHONE NO : 574 3718313 
P.O. Box 708                      SE DECISION MADE: 29-MAR-18
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZyMot ICSI Sperm Separation Device, ZyMot Multi Sperm Separation Device (850µl, 3ml)
DxNow, Inc.                       510(k) NO: K173075(Abbreviated)
ATTN: William T. Sharp            PHONE NO : 240 4549893 
401 Professional Drive, Suite 130 SE DECISION MADE: 08-MAR-18
Gaithersburg MD  20879-3429       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder-free Clear Vinyl Patient Examination Gloves
Yongsheng Medical Products Co., Lt510(k) NO: K173078(Traditional)
ATTN: Jason  Wei                  PHONE NO : 86 189 54428069 
No.277, Yangtianshan Road         SE DECISION MADE: 09-MAR-18
Qingzhou  CN 255000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arco™-SA Lumbar Cage System
NeuroStructures, Inc.             510(k) NO: K173082(Traditional)
ATTN: Kathleen  Wong              PHONE NO : 949 3704497 
16 Technology Drive Suite 165     SE DECISION MADE: 29-MAR-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endoscopic Cap, Check-Flo Adapter, Side-arm Adapter, Tuohy-Borst Adapter
Cook Incorporated                 510(k) NO: K173105(Traditional)
ATTN: Samuel  Engelman            PHONE NO : 812 3392235 104340
750 Daniels Way                   SE DECISION MADE: 22-MAR-18
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: primeMidline Catheters
PFM Medical, Inc.                 510(k) NO: K173114(Traditional)
ATTN: Jessica  Jho                PHONE NO : 760 7588749 
1916 Palomar Oaks Way Suite 150   SE DECISION MADE: 07-MAR-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CCM Abutment System
InnoBioSurg Co., Ltd.             510(k) NO: K173120(Traditional)
ATTN: Bo-reum  Yoo                PHONE NO : 82 42 9332879 
44-19, Techno 10-ro, Yuseong-gu   SE DECISION MADE: 16-MAR-18
Daejeon  KR 34027                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alamo® C
Alliance Partners, LLC            510(k) NO: K173128(Traditional)
ATTN: Kristiina  Gilkey           PHONE NO : 1 210 3142525 
14206 Northbrook Dr.              SE DECISION MADE: 22-MAR-18
San Antonio TX  78232             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SENTIO MMG Pedicle Access Needles
Medos International SARL          510(k) NO: K173134(Traditional)
ATTN: Sheree  Geller              PHONE NO : 508 8283291 
Chemin-Blanc 38                   SE DECISION MADE: 22-MAR-18
Le Locle  CH 2400                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mega Plus Spine System
BK MEDITECH Co., Ltd.             510(k) NO: K173180(Traditional)
ATTN: Byoungjun  Park             PHONE NO : 82 313 529135 
58, Eunhaengnamu-ro, Yanggam-myeonSE DECISION MADE: 15-MAR-18
Hwaseong-si  KR                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ExSpiron 1Xi
Respiratory Motion Inc.           510(k) NO: K173181(Traditional)
ATTN: Susan  Hamann               PHONE NO : 781 7951595 
411 Waverly Oaks Road, Building 1,SE DECISION MADE: 16-MAR-18
Waltham MA  02452                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Athena GTX Device Management Suite (ADMS) Software
Athena GTX                        510(k) NO: K173203(Traditional)
ATTN: Sean  Mahoney               PHONE NO : 515 2883360 103
5900 NW 86th Street, Suite 300    SE DECISION MADE: 14-MAR-18
Johnston IA  50131                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NES Reprocessed RF Stylet (RFS)
Northeast Scientific, Inc. (NES)  510(k) NO: K173214(Traditional)
ATTN: Matthew  Farley             PHONE NO : 203 7562111 
2142 Thomaston Avenue             SE DECISION MADE: 27-MAR-18
Waterbury CT  06704               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ologen Collagen Matrix
Aeon Astron Europe B.V.           510(k) NO: K173223(Special)
ATTN: Horng Ji Lai                PHONE NO : 31 71 3322280 
J.H. Oortweg 19                   SE DECISION MADE: 02-MAR-18
Leiden  NL 2333 CH                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Preview Digital Pregnancy Test
Guangzhou Wondfo Biotech Co., Ltd.510(k) NO: K173229(Traditional)
ATTN: Bin  Chen                   PHONE NO : 86 20 32296069 
No.8 Lizhishan Road, Science City SE DECISION MADE: 12-MAR-18
Guangzhou  CN 510641              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Moisyn Dry Mouth Oral Rinse, Moisyn Dry Mouth Oral Mist, Moisyn Free Dry Mouth Oral Rinse, Moisyn Free Dry Mouth Oral Mist
Syendgen, Inc.                    510(k) NO: K173237(Traditional)
ATTN: Shenda  Baker               PHONE NO : 909 4476858 
1420 N. Claremont Blvd. Suite 105DSE DECISION MADE: 19-MAR-18
Claremont CA  91711               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MED-TAB
PLUM Medical Solutions GmbH       510(k) NO: K173241(Traditional)
ATTN: Arpad  Bischof              PHONE NO : 49 381 49658280 
Lange StraBe 16                   SE DECISION MADE: 23-MAR-18
Rostock  DE 18055                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD HORIZON™ Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K173249(Traditional)
ATTN: Ankit K. Shah               PHONE NO : 901 3963133 
1800 Pyramid Pl                   SE DECISION MADE: 08-MAR-18
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: System 1 endo Liquid Chemical Sterilant Processing System
Steris Corporation                510(k) NO: K173256(Traditional)
ATTN: Marcia L Benedict           PHONE NO : 440 3927063 
5976 Heisley Rd                   SE DECISION MADE: 02-MAR-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter
Innovative Health, Llc.           510(k) NO: K173262(Traditional)
ATTN: Amy  Stoklas-Oakes          PHONE NO : 480 5256006 
1435 North Hayden Road Suite 100  SE DECISION MADE: 06-MAR-18
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LigaSure Exact Dissector, Nano-coated
Covidien                          510(k) NO: K173281(Traditional)
ATTN: Celso  Duran                PHONE NO : 303 5306445 
5920 Longbow Drive                SE DECISION MADE: 02-MAR-18
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SmartTouch
Adherium (NZ) Ltd                 510(k) NO: K173310(Traditional)
ATTN: Chris  Mander               PHONE NO : 64 9 3072771 
Level 2, 204 Quay Street          SE DECISION MADE: 26-MAR-18
Auckland  NZ 1010                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProBx Software
Harmonus Inc.                     510(k) NO: K173312(Traditional)
ATTN: Nicole  Mauro               PHONE NO : 617 7022271 
110 Canal St 3rd Floor            SE DECISION MADE: 02-MAR-18
Lowell MA  01852                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AnastoClip GC Closure System
LeMaitre Vascular, Inc.           510(k) NO: K173323(Traditional)
ATTN: Xiang  Zhang                PHONE NO : 781 4251729 
63 Second Ave.                    SE DECISION MADE: 08-MAR-18
Burlington MA  01803              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS CONNECT Conical Connection Abutment
MIS Implants Technologies LTD.    510(k) NO: K173326(Traditional)
ATTN: Noa  Ofer                   PHONE NO : 972 4 9016829 
P.O. Box 7 Bar Lev Industrial ParkSE DECISION MADE: 16-MAR-18
Bar Lev Industrial Park  IL 201560510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LENSAR Laser System - fs 3D (LLS-fs 3D)
Lensar, Inc.                      510(k) NO: K173346(Traditional)
ATTN: Keith  Peck                 PHONE NO : 888 5756412 
2800 Discovery Drive Suite 100    SE DECISION MADE: 02-MAR-18
Orlando FL  32826                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ingenia Elition S and Ingenia Elition X R5.4
Philips Medical Systems Nederland 510(k) NO: K173356(Abbreviated)
ATTN: Jan van de  Kerkhof         PHONE NO : 31 613 300542 
Veenpluis 4-6                     SE DECISION MADE: 06-MAR-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARTAS System
Restoration Robotics, Inc.        510(k) NO: K173358(Traditional)
ATTN: Raymond  Lee                PHONE NO : 408 8836760 
128 Baytech Drive                 SE DECISION MADE: 16-MAR-18
San Jose CA  95134                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann Variobase for Crown AS
Institut Straumann AG             510(k) NO: K173379(Traditional)
ATTN: Gordon  Dodds               PHONE NO : 49 89 309075291 
Lochhamer Schlag 6                SE DECISION MADE: 30-MAR-18
Graefelfing  DE 82166             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech Equinoxe Stemless Shoulder
Exactech Inc                      510(k) NO: K173388(Traditional)
ATTN: Thomas  McNamara            PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 09-MAR-18
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mammomat Revelation
Siemens Medical Solutions, Inc.   510(k) NO: K173408(Traditional)
ATTN: Denise  Adams               PHONE NO : 610 4486139 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 21-MAR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SRT-100+
Sensus Healthcare, Inc.           510(k) NO: K173425(Traditional)
ATTN: Nicolas  Soro               PHONE NO : 561 9225808 
851 Broken Sound Parkway NW Suite SE DECISION MADE: 23-MAR-18
Boca Raton FL  33487              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PREVENA PLUS Incision Management System, PREVENA PLUS DUO Incision Management System
KCI USA, INC.                     510(k) NO: K173426(Traditional)
ATTN: Margaret  Marsh             PHONE NO : 210 2556481 
6203 Farinon Drive                SE DECISION MADE: 09-MAR-18
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY Chemical Indicator for S40 Sterilant
STERIS Corporation                510(k) NO: K173428(Traditional)
ATTN: Marcia L. Benedict          PHONE NO : 440 3927063 
5976 Heisley Rd                   SE DECISION MADE: 02-MAR-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Attest Super Rapid Readout Biological Indicator 1492V, 3M Attest Auto-reader 490, 3M Attest Auto-reader 490H
3M Company                        510(k) NO: K173437(Traditional)
ATTN: Hilary B. Hovde             PHONE NO : 651 7360364 
3M Center, Building 275-5w-06     SE DECISION MADE: 19-MAR-18
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bloom2 Programmable Electrophysiology Stimulator
Fischer Medical                   510(k) NO: K173439(Traditional)
ATTN: Wes  Rogers                 PHONE NO : 303 2428078 
3990 Youngfield Street            SE DECISION MADE: 29-MAR-18
Wheat Ridge CO  80033             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carriere SLX 3D Clear
Ortho Organizers, Inc.            510(k) NO: K173440(Traditional)
ATTN: Colleen  Boswell            PHONE NO : 760 4488730 
1822 Aston Avenue                 SE DECISION MADE: 08-MAR-18
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V.A.C.VIA 7 Day Therapy System Kit, V.A.C.VIA Therapy Starter Kit, V.A.C.VIA Negative Pressure Wound Therapy Unit
KCI USA, Inc.                     510(k) NO: K173447(Traditional)
ATTN: Melanie  Avila              PHONE NO : 
6203 Farinon Drive                SE DECISION MADE: 02-MAR-18
San Antonio TX  78249             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ingenia Elition S and Ingenia Elition X
Philips Medical Systems Nederland 510(k) NO: K173451(Abbreviated)
ATTN: Jan van de  Kerkhof         PHONE NO : 31 613 300542 
Veenpluis 4-6                     SE DECISION MADE: 20-MAR-18
Best  NL 5684PC                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Valeo® C+CSC with Lumen Interbody Fusion Device
Amedica Corp.                     510(k) NO: K173453(Traditional)
ATTN: Jason  Parberry             PHONE NO : 801 8393562 
1885 W 2100 S                     SE DECISION MADE: 05-MAR-18
Salt Lake City UT  84119          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Olympus Small Intestinal Capsule Endoscope System
Olympus Medical Systems Corp.     510(k) NO: K173459(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 13-MAR-18
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Concentrix MX-AC High-Speed Handpiece
DentalEZ, Inc.                    510(k) NO: K173465(Traditional)
ATTN: Dan  Laskowitz              PHONE NO : 717 2911161 
1816 Colonial Village Lane        SE DECISION MADE: 28-MAR-18
Lancaster PA  17601               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Amsco Evolution Medium Steam Sterilizer
STERIS Corporation                510(k) NO: K173481(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Rd                   SE DECISION MADE: 09-MAR-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CELERITY 20 HP Challenge Pack
STERIS Corporation                510(k) NO: K173488(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5976 Heisley Rd                   SE DECISION MADE: 01-MAR-18
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GYN-Pump PH304
W.O.M. World of Medicine GmbH     510(k) NO: K173489(Traditional)
ATTN: Soeren  Markworth           PHONE NO : 0049 30 39981594 
Salzufer 8                        SE DECISION MADE: 28-MAR-18
Berlin  DE 10587                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoSteady G Bone Cement
G21 s.r.l.                        510(k) NO: K173494(Traditional)
ATTN: Filippo  Foroni             PHONE NO : 39 05 3530312 
Via Sandro Petrini, 8             SE DECISION MADE: 06-MAR-18
San Possidonio  IT 841039         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exeter V40 Femoral Stem Hip System, Orthinox V40 Femoral Heads
Stryker Orthopaedics              510(k) NO: K173499(Traditional)
ATTN: Kirsten  Lehmuller          PHONE NO : 201 8315903 
325 Corporate Drive               SE DECISION MADE: 19-MAR-18
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NMF004A
GC America Inc.                   510(k) NO: K173500(Traditional)
ATTN: Mark  Heiss                 PHONE NO : 708 5970900 
3737 W. 127th Street              SE DECISION MADE: 08-MAR-18
Alsip IL  60803                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RADspeed fit
SHIMADZU corporation              510(k) NO: K173517(Traditional)
ATTN: Toshio  Kadowaki            PHONE NO : 81 75 8231305 
1 Nishinokyo-Kuwabaracho Nakagyo-kSE DECISION MADE: 30-MAR-18
Kyoto  JP 604-8511                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter
Poiesis Medical, LLC              510(k) NO: K173533(Traditional)
ATTN: Greg  Wiita                 PHONE NO : 561 8427560 
1095 Jupiter Park Drive Suite 10  SE DECISION MADE: 29-MAR-18
Jupiter FL  33458                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Phoenix Wound Matrix
Nanofiber Solutions, Inc.         510(k) NO: K173544(Traditional)
ATTN: Ronald L. Bracken           PHONE NO : 770 5977656 
4389 Weaver Court North           SE DECISION MADE: 02-MAR-18
Hilliard OH  43026                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merit Pursue Microcatheter
Merit Medical Systems, Inc.       510(k) NO: K173548(Traditional)
ATTN: Niloufar  Samimi            PHONE NO : 801 2084583 
1600 West Merit Parkway           SE DECISION MADE: 30-MAR-18
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Element System with IBT Electrodes
Infinite Biomedical Technologies, 510(k) NO: K173571(Traditional)
ATTN: Rahul  Kaliki               PHONE NO : 443 4517175 
1101 E 33rd Street Suite E305     SE DECISION MADE: 21-MAR-18
Baltimore MD  21218               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Exactech® Novation® and AcuMatch® E-HXL Acetabular Liners
Exactech, Inc.                    510(k) NO: K173583(Traditional)
ATTN: Shing Jen Tai               PHONE NO : 352 3771140 
2320 NW 66th Court                SE DECISION MADE: 12-MAR-18
Gainesville FL  32653             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Diagnostic Module, Quantum Diagnostic Module - No Gas
Spectrum Medical Ltd              510(k) NO: K173591(Traditional)
ATTN: Mark  Drain                 PHONE NO : 44 0 1242650120 
Harrier 4, Meteor Business Park, CSE DECISION MADE: 28-MAR-18
Gloucester  GB GL2 9QL            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iQMR
Medic Vision - Imaging Solutions L510(k) NO: K173605(Traditional)
ATTN: Eyal  Aharon                PHONE NO : 972 73 7262226 
3 Hayozma Street                  SE DECISION MADE: 08-MAR-18
Tirat Carmel  IL 3903203          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMATOM Edge Plus
Siemens Medical Solutions USA, Inc510(k) NO: K173607(Traditional)
ATTN: Alaine  Medio               PHONE NO : 865 2182703 
40 Liberty Boulevard              SE DECISION MADE: 21-MAR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo Application Software
Siemens Medical Solutions, USA Inc510(k) NO: K173611(Traditional)
ATTN: Patricia D. Jones           PHONE NO : 610 4486474 
40 Liberty Boulevard 65-1A        SE DECISION MADE: 16-MAR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Vida with Compressed Sensing GRASP-VIBE
Siemens Medical Solutions USA, Inc510(k) NO: K173617(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
65 Valley Stream Parkway Mailcode SE DECISION MADE: 30-MAR-18
Malvern PA  19533                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mimics inPrint
Materialise NV                    510(k) NO: K173619(Traditional)
ATTN: Oliver  Clemens             PHONE NO : 32 16 396280 
Technologielaan 15                SE DECISION MADE: 21-MAR-18
Leuven  BE 3001                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORIGIO® Handling™ without phenol red (Cat. No. 8310), ORIGIO® Handling™ with phenol red (Cat. No. 8311)
Origio a/s                        510(k) NO: K173624(Traditional)
ATTN: Tove  Kjaer                 PHONE NO : 45 4 6790220 
Knardrupvej 2                     SE DECISION MADE: 02-MAR-18
Malov  DK 2760                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Clinical Extensions
Siemens Medical Solutions USA, Inc510(k) NO: K173625(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd.                  SE DECISION MADE: 08-MAR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Acclarent ENT Navigation System
Acclarent, Inc                    510(k) NO: K173628(Special)
ATTN: James Patrick Garvey        PHONE NO : 1 949 7898505 
1525-B O’Brien Drive              SE DECISION MADE: 10-MAR-18
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOMATOM Force, SOMATOM Definition Flash, SOMATOM Drive, SOMATOM Definition Edge, SOMATOM Definition AS Open, SOMATOM Deinition AS/AS+, SOMATOM Confidence
Siemens Medical Solutions USA, Inc510(k) NO: K173630(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 4486477 
40 Liberty Blvd.                  SE DECISION MADE: 30-MAR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: syngo.CT Coronary Analysis; syngo.CT Vascular Analysis
Siemens Medical Solutions USA, Inc510(k) NO: K173637(Traditional)
ATTN: Kimberly  Mangum            PHONE NO : 610 448 6477
40 Liberty Blvd.                  SE DECISION MADE: 30-MAR-18
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LenSx Laser System
Alcon Laboratories, Inc.          510(k) NO: K173660(Traditional)
ATTN: James  Arganda              PHONE NO : 949 5057038 
20511 Lake Forest Dr              SE DECISION MADE: 27-MAR-18
Lake Forest CA  92630             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sapphire II PRO
OrbusNeich Medical Trading Inc.   510(k) NO: K173680(Traditional)
ATTN: John  Pazienza              PHONE NO : 954 7300711 
5363 NW 35th Avenue               SE DECISION MADE: 01-MAR-18
Fort Lauderdale FL  33309         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: L300 Go System
Bioness, Inc.                     510(k) NO: K173682(Traditional)
ATTN: Mercedes  Bayani            PHONE NO : 661 3626690 
25103 Rye Canyon Loop             SE DECISION MADE: 09-MAR-18
Valencia CA  91355                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Grass TWin
Natus Medical Incorporated DBA Exc510(k) NO: K173690(Special)
ATTN: Shane  Sawall               PHONE NO : 608 8298673 
2568 Bristol Circle               SE DECISION MADE: 09-MAR-18
Oakville  CA L6H 5S1              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STERIZONE VP4 Sterilizer
TSO3, Inc.                        510(k) NO: K173694(Traditional)
ATTN: Alexandre  Jokci            PHONE NO : 418 6510003 
2505, Rue Dalton                  SE DECISION MADE: 13-MAR-18
Quebec  CA G1P 3S5                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ImmunoCAP Tryptase, ImmunoCAP Tryptase Calibrators, ImmunoCAP Tryptase Curve Control, ImmunoCAP Tryptase Conjugate 50, ImmunoCAP Tryptase Calibrator Strip, ImmunoCAP Tryptase Curve Control Strip
Phadia AB                         510(k) NO: K173704(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 02-MAR-18
Uppsala  SE 75137                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K173713(Traditional)
ATTN: Ji Yea Lee                  PHONE NO : 82 2 21941594 
42, Teheran-ro 108-gil            SE DECISION MADE: 08-MAR-18
Seoul  KR 06176                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EMPOWR Universal Tibial Baseplate
Encore Medical, L.P.              510(k) NO: K173723(Traditional)
ATTN: Teffany  Hutto              PHONE NO : 512 8346255 
9800 Metric Blvd                  SE DECISION MADE: 05-MAR-18
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor
Ambu A/S                          510(k) NO: K173727(Traditional)
ATTN: Maja  Brons                 PHONE NO : 45 72 252000 
Baltorpbakken 13                  SE DECISION MADE: 28-MAR-18
Ballerup  DK 2750                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAGE Vitrification Kit (ART-8025 and ART-8026) / SAGE Vitrification Warming Kit (ART-8030 and ART-8031)
CooperSurgical, Inc               510(k) NO: K173731(Traditional)
ATTN: Tove  Kjaer                 PHONE NO : 454 6790220 
95 Corporate Dr.                  SE DECISION MADE: 02-MAR-18
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RocaJJ Soft Stents
Promepla SAM                      510(k) NO: K173734(Traditional)
ATTN: Alexandre  Bareille         PHONE NO : 377 9798 4244 
9 Avenue Albert II                SE DECISION MADE: 12-MAR-18
Monaco  MC 98000                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed DePuy Mitek Ablation Wand
ReNovo, Inc.                      510(k) NO: K173740(Traditional)
ATTN: Mark K. Wells               PHONE NO : 1 541 4228880 
340 SW Columbia St.               SE DECISION MADE: 19-MAR-18
Bend OR  97702                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed ArthoCare Ablation Wand
ReNovo, Inc.                      510(k) NO: K173741(Traditional)
ATTN: Mark K. Wells               PHONE NO : 541 4228880 
340 SW Columbia St.               SE DECISION MADE: 05-MAR-18
Bend OR  97702                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SI Screw System
Zavation Medical Products, LLC    510(k) NO: K173752(Traditional)
ATTN: James M. Phillips           PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 16-MAR-18
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Monarch Endoscopy Platform (Monarch Platform)
Auris Surgical Robotics, Inc.     510(k) NO: K173760(Traditional)
ATTN: Joy  Sacmar                 PHONE NO : 408 3063537 
125 Shoreway Road Suite D         SE DECISION MADE: 22-MAR-18
San Carlos CA  94070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DMAX Coloring Liquid; Chang's Liquid; Confident Coloring Liquid; CAMeleon Coloring Liquid
DMAX CO., LTD.                    510(k) NO: K173769(Traditional)
ATTN: Hyeon Seok Cho              PHONE NO : 
37-26, Dasa-ro 71-gil, Dasa-eup, DSE DECISION MADE: 08-MAR-18
Daegu  KR 42907                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BreathID Hp System
Exalenz Bioscience Ltd.           510(k) NO: K173772(Traditional)
ATTN: Raffi  Werner               PHONE NO : 972 8 9737521 
4 Ha'Maayan st.                   SE DECISION MADE: 08-MAR-18
Modiin  IL 7177872                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BreathID Hp Lab System
Exalenz Bioscience Ltd.           510(k) NO: K173777(Traditional)
ATTN: Raffi  Werner               PHONE NO : 972 8 9737521 
4 Ha'Maayan st.                   SE DECISION MADE: 08-MAR-18
Modiin  IL 7177872                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: REXMONO, PDREX
SM ENG CO., LTD                   510(k) NO: K173779(Traditional)
ATTN: Soon-Gu  Lee                PHONE NO : 82 51 3058016 
46, Nakdong-daero 1302beon-gil    SE DECISION MADE: 12-MAR-18
Sasang-gu  KR 46910               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Custom Clear Aligner System
Derby Dental Laboratory           510(k) NO: K173785(Traditional)
ATTN: Reed  Nunnally              PHONE NO : 800 7456718 
3332 Gilmore Industrial Blvd      SE DECISION MADE: 13-MAR-18
Louisville KY  40213              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Corkscrew FT
Arthrex Inc.                      510(k) NO: K173788(Special)
ATTN: David L Rogers              PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 01-MAR-18
Napes FL  34108-1945              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Leksell Gamma Knife Perfexion, Leksell Gamma Knife Icon
Elekta Instrument AB              510(k) NO: K173789(Traditional)
ATTN: Alf  Laurell                PHONE NO : 011 468 58725400 
Kungstensgatan 18                 SE DECISION MADE: 30-MAR-18
Stockholm  SE 10393               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EliA PR3s Immunoassay; EliA MPOs Immunoassay; EliA GBM Immunoassay
Phadia AB                         510(k) NO: K173792(Traditional)
ATTN: Carina  Magnusson           PHONE NO : 46 18 165000 
Rapsgatan 7P                      SE DECISION MADE: 13-MAR-18
Uppsala  SE SE 754 50             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMIStem-H Proximal Coating, AMIStem-P and AMIStem-P Collared
Medacta International SA          510(k) NO: K173794(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 14-MAR-18
Castel San Pietro  CH Ch-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Parietex Surgical Mesh (modified into Parietex Hydrophilic 2D, 3D, Anatomical Mesh), Parietex Composite Mesh (PCO and PCO-OS references), Parietex Optimized Composite Mesh (PCO-X, PCO-FX and PCO-OSX references)
Sofradim Production               510(k) NO: K173796(Traditional)
ATTN: Benjamin  Rochette          PHONE NO : 33 4 74089000 
116 avenue du Formans             SE DECISION MADE: 09-MAR-18
Trevoux  FR 01600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Simplexa HSV 1 & 2 Direct, Simplexa HSV 1 & 2 Positive Control Pack
DiaSorin Molecular LLC            510(k) NO: K173798(Traditional)
ATTN: Sharon  Young               PHONE NO : 562 2406680 
11331 Valley View Street          SE DECISION MADE: 14-MAR-18
Cypress CA  90630                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NaviCross 0.018"
Terumo Corporation                510(k) NO: K173799(Traditional)
ATTN: Yuko  Watanabe              PHONE NO : 732 3024900 4120
44-1, 2-Chome, Hatagaya           SE DECISION MADE: 29-MAR-18
Shibuya-Ku,  JP 151-0072          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorPath GRX System
Corindus, Inc.                    510(k) NO: K173806(Traditional)
ATTN: Robert  Lavado              PHONE NO : 508 6533335 211
309 Waverley Oaks Road            SE DECISION MADE: 01-MAR-18
Waltham MA  02452                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TRIWAY Tibiotalocalcaneal (TTC) Arthrodesis System
In2Bones SAS                      510(k) NO: K173811(Traditional)
ATTN: Morgane  Grenier            PHONE NO : 33 4 72292626 
28 chemin du Petit Bois           SE DECISION MADE: 15-MAR-18
Ecully  FR 69130                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalyst CSR 3 Peg Glenoids
Catalyst OrthoScience, Inc        510(k) NO: K173812(Traditional)
ATTN: Dale  Davison               PHONE NO : 239 3259976 102
14710 Tamiami Trail North, Suite 1SE DECISION MADE: 09-MAR-18
Naples FL  34110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tissue of Origin Test Kit-FFPE
Cancer Genetics, Inc.             510(k) NO: K173839(Special)
ATTN: Janet  Graff                PHONE NO : 323 2243900 
1640 Marengo Street 6th Floor     SE DECISION MADE: 15-MAR-18
Los Angeles CA  90033             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert CT/NG
Cepheid                           510(k) NO: K173840(Traditional)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 16-MAR-18
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AXS Catalyst Distal Access Catheter 058 x 115cm; AXS Catalyst Distal Access Catheter 058 x 132cm; AXS Catalyst Distal Access Catheter 060 x 132cm
Stryker                           510(k) NO: K173841(Traditional)
ATTN: Angelica  Beckmann          PHONE NO : 510 4132900 
47900 Bayside Parkway             SE DECISION MADE: 18-MAR-18
Fremont CA  94538                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DermaScalp Laser Cap
DermaScalp LLC                    510(k) NO: K173846(Traditional)
ATTN: John  Carullo               PHONE NO : 214 6830724 
190 E. Stacy Rd Suite 306-291     SE DECISION MADE: 21-MAR-18
Allen TX  75002                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD BACTEC Peds Plus/F Culture Vials Soybean-Casein Digest Broth with Resins in a Plastic Vial
Becton Dickinson and Company      510(k) NO: K173873(Traditional)
ATTN: Ashanti  Brown              PHONE NO : 410 3164766 
7 Loveton Circle MC:694           SE DECISION MADE: 16-MAR-18
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiniMed Mio Advance infusion set
Unomedical A/S                    510(k) NO: K173879(Traditional)
ATTN: Heidi Bjerre Lovkvist       PHONE NO : 45 2177 5394 
Aaholmvej 1-3                     SE DECISION MADE: 05-MAR-18
Osted  DK DK-4320                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CPRmeter 2 CPR Feedback Device
Laerdal Medical AS                510(k) NO: K173886(Traditional)
ATTN: Mari  Kaada                 PHONE NO : 47 51 511700 
Tanke Svilandsgate 30             SE DECISION MADE: 23-MAR-18
Stavanger  NO 2007                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: cobas CT/NG for use on cobas 6800/8800 systems
Roche Molecular Systems, Inc.     510(k) NO: K173887(Traditional)
ATTN: Nobuko  Nakajima            PHONE NO : 925 7308215 
4300 Hacienda Drive               SE DECISION MADE: 21-MAR-18
Pleasanton CA  94588-2722         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Granada Medium
Hardy Diagnostics                 510(k) NO: K173903(Traditional)
ATTN: Rianna  Malherbe            PHONE NO : 805 3462766 5714
1430 West McCoy Lane              SE DECISION MADE: 22-MAR-18
Santa Maria CA  93455             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CATS Tonometer Prism
CATS Tonometer, LLC               510(k) NO: K173904(Traditional)
ATTN: Sean J. McCafferty          PHONE NO : 520 9754550 
1517 N. Wilmot, Suite 143         SE DECISION MADE: 09-MAR-18
Tucson AZ  85712                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Test of Variables of Attention (T.O.V.A.)
The TOVA Company                  510(k) NO: K173915(Traditional)
ATTN: Chris  Holder               PHONE NO : 360 6612899 
2828 SW Corbett Ave Suite 128     SE DECISION MADE: 22-MAR-18
Portland OR  97201                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HX Device
Human Extension Ltd.              510(k) NO: K173919(Traditional)
ATTN: Dalit  Doron                PHONE NO : 972 9 7669569 
45 Hamada Street Poleg Industrial SE DECISION MADE: 20-MAR-18
Netanya  IL 4250574               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C-PTFETM Surgical Suture
CP Medical Inc.                   510(k) NO: K173922(Traditional)
ATTN: John  Hartigan              PHONE NO : 678 7102016 
1775 Corporate Dr. Suite 150      SE DECISION MADE: 26-MAR-18
Norcross GA  30093                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PYTHON Plate Trial Instruments
Treace Medical Concepts, Inc.     510(k) NO: K173930(Special)
ATTN: Rachel  Osbeck              PHONE NO : 904 3735940 1304
203 Fort Wade Rd. Suite 150       SE DECISION MADE: 19-MAR-18
Ponte Vedra FL  32081             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantib Brain
Quantib BV                        510(k) NO: K173939(Traditional)
ATTN: Floor van Leeuwen           PHONE NO : 31 108 411749 
Westblaak 106                     SE DECISION MADE: 09-MAR-18
Rotterdam  NL 3012 KM             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blue Non Sterile powder free Nitrile Examination Gloves Tested for Use with Chemotherapy Drugs
Central Medicare Sdn. Bhd.        510(k) NO: K173942(Traditional)
ATTN: Arivalagan  Subramaniam     PHONE NO : 6 05 6290000 
PT 2609-2620, BT 8, Jalan ChangkatSE DECISION MADE: 05-MAR-18
Teluk Intan  MY 36000             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Specular Microscope CEM-530
Nidek Co., Ltd.                   510(k) NO: K173980(Traditional)
ATTN: Yoneji  Mizuno              PHONE NO : 81 533 678901 
34-14 Maehama, Hiroishi-cho       SE DECISION MADE: 14-MAR-18
Gamagori  JP 443-0038             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Philips Incisive CT
Philips Healthcare (Suzhou) Co., L510(k) NO: K180015(Traditional)
ATTN: Gordon  Shu                 PHONE NO : 86 512 67336804 
No.258, ZhongYuan Road, Suzhou IndSE DECISION MADE: 20-MAR-18
Suzhou  CN 215024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Home Use IPL Beauty Device
Shenzhen Mismon Technology Co., Lt510(k) NO: K180016(Traditional)
ATTN: Vicky  Yang                 PHONE NO : 86 755 66816307 
2nd Floor, A2 Building, Zhengfeng SE DECISION MADE: 20-MAR-18
Shenzhen  CN 518000               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WIRION
Gardia Medical Ltd.               510(k) NO: K180023(Traditional)
ATTN: Vardit  Segal               PHONE NO : 972 4 6277166 
HaEshel 2                         SE DECISION MADE: 21-MAR-18
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIROLaser Blue
Dentsply Sirona                   510(k) NO: K180044(Traditional)
ATTN: Karl J Nittinger            PHONE NO : 717 8494424 
221 West Philadelphia Street SuiteSE DECISION MADE: 08-MAR-18
York PA  17401                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UriSwab-Urine Collection, Transport and Preservation System
Copan Italia S.p.A.               510(k) NO: K180052(Traditional)
ATTN: Elisabetta  Zanella         PHONE NO : 39 030 2687290 
Via F. Perotti 10                 SE DECISION MADE: 23-MAR-18
Brescia  IT 25125                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Genesys Spine AIS-C Cervical Anchored Interbody System
Genesys Spine                     510(k) NO: K180056(Traditional)
ATTN: Benjamin V. Keller          PHONE NO : 512 3817093 
1250 Capital of Texas Highway SoutSE DECISION MADE: 28-MAR-18
Austin TX  78746                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VORTEK URETERAL DOUBLE LOOP STENT
Coloplast Corp                    510(k) NO: K180057(Traditional)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road North        SE DECISION MADE: 09-MAR-18
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UltraCor Twirl Breast Tissue Marker
Bard Peripheral Vascular, Inc.    510(k) NO: K180061(Traditional)
ATTN: Meghan  McKelvey            PHONE NO : 480 3506067 
1625 W. 3rd Street                SE DECISION MADE: 09-MAR-18
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OCM-G1 Attachment
The Anspach Effort, Inc.          510(k) NO: K180063(Special)
ATTN: Tamara J West               PHONE NO : 561 4943712 
4500 Riverside Drive              SE DECISION MADE: 27-MAR-18
Palm Beach Gardens FL  33410      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Diazyme Lipoprotein (a) Assay
Diazyme Laboratories, Inc.        510(k) NO: K180074(Traditional)
ATTN: Abhijit  Datta              PHONE NO : 858 4554762 
12889 Gregg Court                 SE DECISION MADE: 22-MAR-18
Poway CA  92130                   510(k) STATEMENT
                                                    

DEVICE: Gyrus ACMI – EZDilate 3-Stage Balloon Dilatation Catheter
Gyrus ACMI, Inc.                  510(k) NO: K180086(Traditional)
ATTN: Mary Anne Patella           PHONE NO : 508 8042690 
136 Turnpike Rd.                  SE DECISION MADE: 08-MAR-18
Southborough MA  01772            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Intellitorq
Gauthier Biomedical, Inc.         510(k) NO: K180092(Traditional)
ATTN: Austin  Braganza            PHONE NO : 262 5460010 
2221 Washington St.               SE DECISION MADE: 08-MAR-18
Grafton WI  53024                 510(k) STATEMENT
                                                    

DEVICE: Trojan Chain Reaction Natural Rubber Latex Condom with Sensate Lubricant
Church & Dwight Co., Inc          510(k) NO: K180104(Traditional)
ATTN: Joelle  Reinson             PHONE NO : 609 8061671 
500 Charles Ewing Blvd.           SE DECISION MADE: 14-MAR-18
Ewing NJ  08628                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Indigo Aspiration System - Penumbra Engine Pump, Indigo Aspiration System - Penumbra Engine Pump Canister
Penumbra, Inc.                    510(k) NO: K180105(Special)
ATTN: Richard  Kimura             PHONE NO : 510 9952034 
One Penumbra Place                SE DECISION MADE: 08-MAR-18
Alameda CA  94502                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ThinkQA
DOSIsoft                          510(k) NO: K180106(Traditional)
ATTN: Marc  Uszynski              PHONE NO : 33 1 41242626 
45/47, Avenue Carnot              SE DECISION MADE: 13-MAR-18
Cachan  FR 94230                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STARband, STARlight, St. Louis Band
Orthomerica Products, Inc         510(k) NO: K180109(Special)
ATTN: David C. Kerr               PHONE NO : 407 2906592 
6333 North Orange Blossom Trail   SE DECISION MADE: 01-MAR-18
Orlando FL  32810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AEON Retrieval Bag
Lexington Medical Inc.            510(k) NO: K180114(Traditional)
ATTN: Donna  Gasper               PHONE NO : 617 2099817 
11 Executive Park Drive           SE DECISION MADE: 27-MAR-18
Billerica MA  01862               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Imbio Segmentation Editing Tool software
Imbio, LLC                        510(k) NO: K180129(Traditional)
ATTN: Vipul  Goel                 PHONE NO : 612 5207360 
807 Broadway St NE, #350          SE DECISION MADE: 16-MAR-18
Minneapolis MN  55413             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: THD Anopress with THD SensyProbe
THD SpA                           510(k) NO: K180135(Traditional)
ATTN: Maurizio  Pantaleoni        PHONE NO : 39 0522 634311 
Via dell'Industria 1              SE DECISION MADE: 08-MAR-18
Correggio  IT 42015               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ATS Thermal Imaging Probe, ATS Patient Interface Unit
Securus Medical Group, Inc.       510(k) NO: K180148(Special)
ATTN: William J. Gorman           PHONE NO : 978 3170836 
100 Cummings Center, Suite 215F   SE DECISION MADE: 21-MAR-18
Beverly MA  01915                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sonicision Reusable Generator, Sonicision Reusable Battery Pack, Sonicision Curved Jaw Dissectors (multiple lengths), Sonicision Battery Charger, Sonicision Battery Insertion Guide
Covidien, llc                     510(k) NO: K180149(Traditional)
ATTN: Nancy  Sauer                PHONE NO : 303 5816791 
5920 Longbow Drive                SE DECISION MADE: 26-MAR-18
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-spine Cortical Bone Screw System
X-spine Systems, Inc.             510(k) NO: K180153(Traditional)
ATTN: Charlene  Brumbaugh         PHONE NO : 406 3880480 1128
664 Cruiser Lane                  SE DECISION MADE: 15-MAR-18
Belgrade MT  59714                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SP-Fix® Spinous Process Fixation Plate, RELIEVE® Laminoplasty Fixation System
Globus Medical Inc.               510(k) NO: K180156(Traditional)
ATTN: Lori  Burns                 PHONE NO : 610 9301800 295
2560 General Armistead Ave.       SE DECISION MADE: 07-MAR-18
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Klassic® Knee System
Total Joint Orthopedics, Inc.     510(k) NO: K180159(Traditional)
ATTN: Chris  Weaber               PHONE NO : 801 4866070 
1567 E. Stratford Avenue          SE DECISION MADE: 09-MAR-18
Salt Lake City UT  84106          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Habib EndoHPB
EMcision Ltd.                     510(k) NO: K180165(Traditional)
ATTN: Francois  Poulin            PHONE NO : 
DuCane Road                       SE DECISION MADE: 20-MAR-18
London  GB W12 0HS                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PillCam Patency System
Given Imaging Ltd.                510(k) NO: K180171(Traditional)
ATTN: Hilla  Debby                PHONE NO : 972 4 9097774 
2 Hacarmet St. New Industrial ParkSE DECISION MADE: 08-MAR-18
Yoqneam  IL 20692                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG
Paragon Vision Sciences           510(k) NO: K180172(Traditional)
ATTN: Rich  Jefferies             PHONE NO : 480 5077660 
974 E Impala Ave                  SE DECISION MADE: 16-MAR-18
Mesa AZ  85204                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Emprint Ablation Visualization Application
Covidien, LLC                     510(k) NO: K180192(Traditional)
ATTN: Patti L. Arndt              PHONE NO : 303 5816668 
5920 Longbow Dr.                  SE DECISION MADE: 21-MAR-18
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SherpaPak Cardiac Transport System and SherpaPak Kidney Transport System
Paragonix Technologies, Inc.      510(k) NO: K180194(Traditional)
ATTN: Leo  Basta                  PHONE NO : 617 8177790 
d/o Vaughn & Asociates 639 GraniteSE DECISION MADE: 30-MAR-18
Braintree MA  021184              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Frigitronics adapter
Phakos                            510(k) NO: K180195(Traditional)
ATTN: Olivier  Aumaitre           PHONE NO : 88 149887400 
62 Rue Kléber                     SE DECISION MADE: 16-MAR-18
Montreuil  FR 93100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: On Call Express Mobile Blood Glucose Monitoring System
ACON Laboratories, Inc.           510(k) NO: K180196(Special)
ATTN: Qiyi  Xie                   PHONE NO : 858 8758011 
10125 Mesa Rim Road               SE DECISION MADE: 07-MAR-18
San Diego CA  92126               510(k) STATEMENT
                                                    

DEVICE: NuVasive® VuePoint® II OCT System
NuVasive, Incorporated            510(k) NO: K180198(Traditional)
ATTN: Michelle  Cheung            PHONE NO : 858 9093360 
7475 Lusk Boulevard               SE DECISION MADE: 15-MAR-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freezpoint
Bovie Medical Corp.               510(k) NO: K180211(Traditional)
ATTN: Sam  Niedbala               PHONE NO : 855 3552796 
5115 Ulmerton Road                SE DECISION MADE: 21-MAR-18
Clearwater FL  33760              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELEMENT-TL
Elemenic Co., Ltd.                510(k) NO: K180224(Traditional)
ATTN: Jo Won Ju                   PHONE NO : 82 32 6135007 
3rd, 34 , Gyeongin-ro 3beon-gil   SE DECISION MADE: 15-MAR-18
Bucheon-si  KR 14731              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polaris Spinal Growth System
Zimmer Biomet Spine, Inc.         510(k) NO: K180227(Traditional)
ATTN: Anthony Michael Maahs       PHONE NO : 303 4658923 
10225 Westmoor Drive              SE DECISION MADE: 15-MAR-18
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SICAT Endo
SICAT GmbH & Co. KG               510(k) NO: K180262(Traditional)
ATTN: Manfred  Breuer             PHONE NO : 49 228 85469782 
Brunnenallee 6                    SE DECISION MADE: 12-MAR-18
Bonn  DE 53177                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COMPACT TOUCH Ophthalmic Ultrasound System
Quantel Medical                   510(k) NO: K180265(Third Party - Traditional)
ATTN: Maureen  O'Connell          PHONE NO : 978 2071245 
11 rue Bois Joli, CS40015         SE DECISION MADE: 02-MAR-18
Cournon D'Auvergne-Cedex  FR 63808510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Ventix Link Knotless Anchor with Inserter
Cayenne Medical, Inc              510(k) NO: K180274(Traditional)
ATTN: Shima  Hashemian            PHONE NO : 480 4582196 
16597 N 92nd Street               SE DECISION MADE: 21-MAR-18
Scottsdale AZ  85260              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prelude
MedCom GmbH                       510(k) NO: K180308(Traditional)
ATTN: Johannes  Messow            PHONE NO : 49 6151 9514720 
Dolivostrasse 11                  SE DECISION MADE: 27-MAR-18
Darmstadt  DE 64293               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DISKOM
Biopsybell s.r.l.                 510(k) NO: K180315(Traditional)
ATTN: Tiziana  Bellini            PHONE NO : 39 535 27850 
Via A. Manuzio n.24               SE DECISION MADE: 26-MAR-18
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution
Bausch and Lomb Incorporated      510(k) NO: K180319(Traditional)
ATTN: Melissa  Thomas             PHONE NO : 585 3386045 
1400 North Goodman Street         SE DECISION MADE: 27-MAR-18
Rochester NY  14609               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aesculap Optilene Nonabsorbable Suture
Aesculap, Inc.                    510(k) NO: K180321(Special)
ATTN: Kathy A. Racosky            PHONE NO : 610 9849291 
3773 Corporate Parkway            SE DECISION MADE: 07-MAR-18
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrea Software Package; VSTP-001A
Canon Medical Systems Corporation 510(k) NO: K180323(Traditional)
ATTN: Paul  Biggins               PHONE NO : 81 287 266478 
1385 Shimoishigami                SE DECISION MADE: 30-MAR-18
Otawara  JP 324-8550              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: icobrain
icometrix                         510(k) NO: K180326(Special)
ATTN: Dirk  Smeets                PHONE NO : 32 16 369000 
Kolonel Begaultlaan 1b /12        SE DECISION MADE: 08-MAR-18
Leuven  BE 3012                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS)- Linezolid 0.016 - 256ug/mL
Liofilchem s. r. l.               510(k) NO: K180330(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 15-MAR-18
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: LEGION Knee System
Smith & Nephew, Inc.              510(k) NO: K180334(Special)
ATTN: Michael  Scott              PHONE NO : 901 3991633 
1450 Brooks Rd.                   SE DECISION MADE: 05-MAR-18
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accutension Smartphone Auscultatory Blood
Shanghai Hulu Devices Co., Ltd    510(k) NO: K180335(Third Party - Traditional)
ATTN: Jungeng  Zhao               PHONE NO : 86 186 21892190 
No. 509 Caobao Road, Room 101-2 BlSE DECISION MADE: 08-MAR-18
Shanghai  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Dornier Medilas H Solvo 35 Laser
Dornier MedTech America           510(k) NO: K180350(Special)
ATTN: John  Hoffer                PHONE NO : 770 5146163 
1155 Roberts Blvd                 SE DECISION MADE: 07-MAR-18
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson S8/ Voluson S10/ Voluson S10 Expert
GE Healthcare                     510(k) NO: K180374(Special)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 13-MAR-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AIRO Computed Tomography (CT) X-ray System
Mobius Imaging, LLC               510(k) NO: K180393(Traditional)
ATTN: Norma  LeMay                PHONE NO : 978 3919644 
2 Shaker Road                     SE DECISION MADE: 15-MAR-18
Shirley MA  01464                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BrightMatter Plan 1.6.0
Synaptive Medical Inc.            510(k) NO: K180394(Traditional)
ATTN: Maham  Ansari               PHONE NO : 647 2433122 
555 Richmond Street West, Suite 80SE DECISION MADE: 09-MAR-18
Toronto  CA M5V 3B1               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: miraDry System
Miramar Labs, Inc.                510(k) NO: K180396(Special)
ATTN: Cynthia  Kada               PHONE NO : 408 9408700 
2790 Walsh Avenue                 SE DECISION MADE: 15-MAR-18
Santa Clara CA  95051             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Clarity Ultra Self-Ligating Brackets and Adhesive Coated Appliance System
3M Health Care                    510(k) NO: K180404(Third Party - Traditional)
ATTN: Lam  Duong                  PHONE NO : 651 7335945 
2510 Conway Avenue                SE DECISION MADE: 16-MAR-18
St. Paul MN  55144-1000           510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: FUJIFILM Endoscope Models EC-600HL and EC-600LS
FUJIFILM Corporation              510(k) NO: K180405(Special)
ATTN: Randy  Vader                PHONE NO : 360 3566821 
798 Miyanodai Kaisei-Machi        SE DECISION MADE: 15-MAR-18
Ashigarakami-Gun  JP 258-8538     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ellipse Ydun
Ellipse A/S                       510(k) NO: K180406(Special)
ATTN: Ole  Kofod                  PHONE NO : 45 4517 6863 
Agern Alle 11                     SE DECISION MADE: 15-MAR-18
Horsholm  DK DK-2970              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEMO 4D
Sorin Group Italia S.r.l.         510(k) NO: K180411(Special)
ATTN: Mauro  Ercolani             PHONE NO : 39 0161 487412 
Via Crescentino sn                SE DECISION MADE: 16-MAR-18
Saluggia  IT 13040                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Natus NeuroWorks
Natus Medical Incorporated DBA Exc510(k) NO: K180421(Special)
ATTN: Shane  Sawall               PHONE NO : 608 8298673 
2568 Bristol Circle               SE DECISION MADE: 14-MAR-18
Oakville  CA L6H 5SI              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Empower H65
quanta system spa                 510(k) NO: K180423(Special)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 376797 
via Acquedotto 109                SE DECISION MADE: 15-MAR-18
Samarate (Va)  IT 21017           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Empower H35
Quanta System Spa                 510(k) NO: K180426(Special)
ATTN: Francesco  Dell'Antonio     PHONE NO : 39 0331 376797 
Via Acquedotto, 109               SE DECISION MADE: 16-MAR-18
Samarate  IT 21017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advincula Delineator Uterine Manipulator
CooperSurgical, Inc.              510(k) NO: K180429(Special)
ATTN: Roaida  Johnson             PHONE NO : 203 6015200 3325
95 Corporate Dr                   SE DECISION MADE: 14-MAR-18
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cortina [MAX] Lumbar Cage System
NeuroStructures, Inc.             510(k) NO: K180431(Traditional)
ATTN: Kathleen  Wong              PHONE NO : 949 3704497 
16 Technology Drive, Suite 165    SE DECISION MADE: 22-MAR-18
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit
BD                                510(k) NO: K180438(Special)
ATTN: Brad  Spring                PHONE NO : 410 3164206 
10865 Road to the Cure            SE DECISION MADE: 20-MAR-18
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tumark Vision
SOMATEX Medical Technologies GmbH 510(k) NO: K180443(Special)
ATTN: Burkhard  Jakob             PHONE NO : 4930 319 822500 
Rheinstr. 7d                      SE DECISION MADE: 22-MAR-18
Teltow  DE 14513                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hollow Fiber Oxygenator; INSPIRE 8F M Hollow Fiber Oxygenator with Integrated Arterial Filter
Sorin Group Italia S.r.l          510(k) NO: K180448(Special)
ATTN: Luigi  Vecchi               PHONE NO : 011 39 053529811 
86, Via Statale 12 Nord           SE DECISION MADE: 15-MAR-18
Mirandola  IT 41037               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Corvocet Biopsy System
Merit Medical Systems, Inc.       510(k) NO: K180450(Special)
ATTN: Angela  Brady               PHONE NO : 801 3164818 
1600 W Merit Parkway              SE DECISION MADE: 12-MAR-18
South Jordan UT  84095            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bio-Medicus Adult Cannulae and Introducer
Medtronic Inc                     510(k) NO: K180453(Special)
ATTN: Huda  Yusuf                 PHONE NO : 763 5149521 
8200 Coral Street NE              SE DECISION MADE: 22-MAR-18
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bio-Medicus Adult Cannulae Kit
Medtronic Inc.                    510(k) NO: K180456(Special)
ATTN: Huda  Yusuf                 PHONE NO : 763 5149805 
8200 Coral Street NE              SE DECISION MADE: 22-MAR-18
Mounds View MN  55112             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANYVIEW DR SERIES FPD Fluoroscopic Mobile C-arm ANYVIEW-240DR, ANYVIEW-320DR, ANYVIEW-500DR
ECOTRON Co., Ltd                  510(k) NO: K180473(Traditional)
ATTN: Sang  Bond Lee              PHONE NO : 82 2 20253760 
Rm 504, Hanshin IT Tower II, 47, DSE DECISION MADE: 23-MAR-18
Seoul  KR 153-712                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CapLOX II® / TowerLOX® MIS Pedicle Screw System
Captiva Spine, Inc.               510(k) NO: K180475(Traditional)
ATTN: Jackie  Ferro               PHONE NO : 877 7725571 
967 N. Alternate A1A, Suite 1     SE DECISION MADE: 19-MAR-18
Jupiter FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HemosIL Factor XII Deficient Plasma
Instrumentation Laboratory Co.    510(k) NO: K180486(Special)
ATTN: Carol  Marble               PHONE NO : 781 8614467 
180 Hartwell Road                 SE DECISION MADE: 22-MAR-18
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Mission Lipid Panel Monitoring System
ACON Laboratories, Inc.           510(k) NO: K180504(Special)
ATTN: Qiyi  Xie                   PHONE NO : 858 8758011 
10125 Mesa Rim Road               SE DECISION MADE: 28-MAR-18
San Diego CA  92121               510(k) STATEMENT
                                                    

DEVICE: CorPath GRX System
Corindus, Inc.                    510(k) NO: K180517(Special)
ATTN: Robert  Lavado              PHONE NO : 508 6533335 211
309 Waverley Oaks Road            SE DECISION MADE: 29-MAR-18
Waltham MA  02452                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NovoStitch Pro Meniscal Repair System
Ceterix Orthopaedics, Inc.        510(k) NO: K180531(Special)
ATTN: Tarhan  Kayihan             PHONE NO : 650 3963478 
6500 Kaiser Drive, Suite 120      SE DECISION MADE: 29-MAR-18
Fremont CA  94555                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Voluson P6 and Voluson P8
GE Healthcare                     510(k) NO: K180535(Special)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 29-MAR-18
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zavation Buttress Plate System
Zavation Medical Products LLC     510(k) NO: K180537(Traditional)
ATTN: Matt  Jones                 PHONE NO : 601 9191119 
220 Lakeland Parkway              SE DECISION MADE: 27-MAR-18
Flowood MS  39232                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gammaCore Sapphire
electroCore, LLC                  510(k) NO: K180538(Special)
ATTN: Mike  Romaniw               PHONE NO : 973 2900097 
150 Allen Road, Suite 201         SE DECISION MADE: 30-MAR-18
Basking Ridge NJ  07920           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PressureWire X
St. Jude Medical (now part of Abbo510(k) NO: K180558(Special)
ATTN: Josh  Johnson               PHONE NO : 651 7563767 
One St. Jude Medical Drive        SE DECISION MADE: 28-MAR-18
St. Paul MN  55117                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ezee Retrieval
Genicon, Inc                      510(k) NO: K180579(Special)
ATTN: Katlyn  Kachman             PHONE NO : 407 6574851 
6869 Stapoint Court Suite 114     SE DECISION MADE: 19-MAR-18
Winter Park FL  32792             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G-scan Brio
Esaote S.p.A                      510(k) NO: K180592(Special)
ATTN: Massimo  Polignano          PHONE NO : 39 055 4229402 
Via Enrico Melen 77               SE DECISION MADE: 30-MAR-18
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    


              TOTAL 510(k)s THIS PERIOD   295                                     
              TOTAL WITH SUMMARIES        287                                     
              TOTAL WITH STATEMENTS         8
                                       

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