Medical Devices

December 2017 510(K) Clearances

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


DEVICE: Planmed Clarity
Planmed Oy                        510(k) NO: K163328(Traditional)
ATTN: Lars  Moring                PHONE NO : 358 20 7795300 
Sorvaajankatu 7                   SE DECISION MADE: 28-DEC-17
Helsinki  FI FI-00880             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pobling MIITY 2
HABALAN MED & BEAUTY CO.,LTD      510(k) NO: K163550(Traditional)
ATTN: RAY  JEON                   PHONE NO : 82 2 8569450 
907, 219, GASANDIGITAL 1-RO, GEUMCSE DECISION MADE: 20-DEC-17
SEOUL  KR 08501                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ECG Acquisition Systems
VALES & HILLS BIOMEDICAL TECH. LTD510(k) NO: K163607(Traditional)
ATTN: Jianfang  Liu               PHONE NO : 0086 010 51665545 821
No.2 North Street Jingyuan BeijingSE DECISION MADE: 15-DEC-17
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLEX Monoclonal Mouse Anti-Human Progesterone Receptor, Clone PgR 1294, Ready-to-Use (Dako Omnis)
DAKO DENMARK A/S                  510(k) NO: K170005(Traditional)
ATTN: LASSE POST MOLLER           PHONE NO : 45 44 859500 
PRODUKTIONSVEJ 42                 SE DECISION MADE: 21-DEC-17
GLOSTRUP  DK                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLEX Monoclonal Rabbit Anti-Human Estrogen Receptor a, Clone EPI, RTU (Dako Onmis)
DAKO DENMARK A/S                  510(k) NO: K170028(Traditional)
ATTN: Lasse Post Moller           PHONE NO : 45 44 859500 
PRODUKTIONSVEJ 42                 SE DECISION MADE: 21-DEC-17
GLOSTRUP  DK 2600                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FloPump 32mL, Sterile, FloPump 32mL, Non-Sterile
INTERNATIONAL BIOPHYSICS CORPORATI510(k) NO: K170029(Traditional)
ATTN: Geoff  Marcek               PHONE NO : 
2101 E. ST. ELMO ROAD             SE DECISION MADE: 15-DEC-17
AUSTIN TX  78744                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lilium a-200E
Lilium Otsuka Co., Ltd.           510(k) NO: K170046(Traditional)
ATTN: Hiroaki  Takahashi          PHONE NO : 81 42 7043822 
4-12-6, Chiyoda, Chuo-ku          SE DECISION MADE: 07-DEC-17
Sagamihara city  JP 252-0237      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COMPACT S
DMETEC CO., LTD.                  510(k) NO: K170104(Traditional)
ATTN: Lee Seung Dae               PHONE NO : 82 70 47167195 
#402-603. Techno-Park, 193, YakdaeSE DECISION MADE: 27-DEC-17
Gyeonggi-do  KR                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEURONAUTE
BIOSERENITY                       510(k) NO: K170138(Traditional)
ATTN: Quang  TRAN                 PHONE NO : 331 5727 4271 
47 boulevard de l'Hopital         SE DECISION MADE: 26-DEC-17
Paris  FR 75013                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Osteo-P Bone Graft Substitute
Molecular Matrix, Inc.            510(k) NO: K170165(Traditional)
ATTN: Charles  Lee                PHONE NO : 916 7656196 
3410 Industrial Blvd., Suite 103  SE DECISION MADE: 29-DEC-17
West Sacramento CA  95691         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safety Blood Collection Device for Single Use
Gemtier Medical (Shanghai) Inc.   510(k) NO: K170276(Traditional)
ATTN: Lenny  Cao                  PHONE NO : 86 021 67360886 
No.18 Jianding Road, Fengjing TownSE DECISION MADE: 11-DEC-17
Shanghai  CN 201502               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable High Pressure Syringe
Union Medical Shenzhen Co., Ltd.  510(k) NO: K170279(Traditional)
ATTN: Wenguo  Zhang               PHONE NO : 86 755 88898501 
Room 603, Building 3, Fantasia MICSE DECISION MADE: 12-DEC-17
Shenzhen  CN 518062               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TAURUS PEEK Cage System
Medyssey USA, Inc.                510(k) NO: K170389(Traditional)
ATTN: Shawn  Kim                  PHONE NO : 1 847 4270200 
1550 East Higgins Road, Suite 123 SE DECISION MADE: 14-DEC-17
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S.I.N. Implant System
S.I.N. – Sistema de Implante Nacio510(k) NO: K170392(Traditional)
ATTN: Denis  Oliveira             PHONE NO : 55 11 21693000 3236
Avenida Vereador Abel Ferreira, 11SE DECISION MADE: 01-DEC-17
Sao Paulo  BR 03340-000           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex Univers Revers Apex Humeral Stems
Arthrex Inc.                      510(k) NO: K170414(Traditional)
ATTN: David L. Rogers             PHONE NO : 1 239 6435553 71924
1370 Creekside Boulevard          SE DECISION MADE: 14-DEC-17
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V10
Mediana Co., Ltd.                 510(k) NO: K170497(Traditional)
ATTN: Kim  Min-hye                PHONE NO : 82 337 425400 
132, Donghwagongdan-ro, Munmak-eupSE DECISION MADE: 15-DEC-17
Wonju-si  KR 220-801              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Altus Spine Interbody Fusion System
Altus Partners, LLC               510(k) NO: K170553(Traditional)
ATTN: Mark  Melton                PHONE NO : 901 4974193 
1340 Enterprise Drive             SE DECISION MADE: 01-DEC-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Portex Blue Line Ultra Paediatric Tracheosomy Tube
Smiths Medical ASD, Inc.          510(k) NO: K170720(Traditional)
ATTN: James  Taufen               PHONE NO : 763 3833174 
6000 Nathan Lane North            SE DECISION MADE: 07-DEC-17
Minneapolis MN  55442             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SAM CRRT Unit, SAM Cassette CRRT
Spectral Medical Inc.             510(k) NO: K170790(Abbreviated)
ATTN: Danijela  Domljanovic       PHONE NO : 416 6263233 
135 The West Mall, Unit 2         SE DECISION MADE: 13-DEC-17
Toronto  CA M9C 1C2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: wettrust D2care
Wettrust Korea Co., Ltd.          510(k) NO: K170797(Traditional)
ATTN: Sungho  Lee                 PHONE NO : 82 317 198394 
312 The Prau, 27 Jeongjail-ro, BunSE DECISION MADE: 06-DEC-17
Seongnam  KR 463-480              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Craniomaxillofacial Distraction System (CMFD)
Synthes USA Products, LLC         510(k) NO: K170818(Traditional)
ATTN: Nicholas  Fountoulakis      PHONE NO : 610 7196553 
1301 Goshen Parkway               SE DECISION MADE: 07-DEC-17
West Chester PA  19380            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Insulin Pen Needle
Jiangsu Caina Technology Co., Ltd.510(k) NO: K170846(Traditional)
ATTN: Jun  Lu                     PHONE NO : 86 510 86205183 
No.23, Huanxi Road, Zhutang Town  SE DECISION MADE: 13-DEC-17
Jiangyin  CN 214425               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vesair 0 degree Cystoscope, Vesair 30 degree Long Cystoscope, Vesair 70 degree Long Cystoscope,Vesair 30 degree Cystoscope,Vesair 70 degree Cystoscope
Solace Therapeutics, Inc.         510(k) NO: K170862(Traditional)
ATTN: Scott  Blood                PHONE NO : 508 2831200 
135 Newbury St                    SE DECISION MADE: 19-DEC-17
Framingham MA  01701              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ISP Safety Huber Needle Infusion Set
Infusion Safety Products, Inc.    510(k) NO: K170881(Traditional)
ATTN: Alan P. Reid                PHONE NO : 603 3578733 
26 Victoria Court                 SE DECISION MADE: 14-DEC-17
Keene NH  03431                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wittich Nitinol Stone Basket
Cook Incorporated                 510(k) NO: K170898(Traditional)
ATTN: Erum B. Nasir               PHONE NO : 812 3353575 102607
750 Daniels Way P.O. Box 489      SE DECISION MADE: 12-DEC-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Composite Removable Sinus Stent System
STS Medical                       510(k) NO: K170913(Traditional)
ATTN: Lena  Shlossberg            PHONE NO : 972 54 7387188 
37 Amal                           SE DECISION MADE: 15-DEC-17
Petah Tikva  IL 4951337           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: C3 Wave System
Medical Components, Inc (Dba Medco510(k) NO: K170934(Traditional)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 2285
1499 Delp Drive                   SE DECISION MADE: 06-DEC-17
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Well-Root ST
Vericom Co., Ltd.                 510(k) NO: K170950(Traditional)
ATTN: Hyoshin  Chung              PHONE NO : 82 31 4412881 
48, Toegyegongdan 1-Gil,          SE DECISION MADE: 20-DEC-17
Chuncheon-Si  KR 200-944          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CoaguChek Vantus System
Roche Diagnostics                 510(k) NO: K170960(Traditional)
ATTN: Justin  Davis               PHONE NO : 317 5216204 
9115 Hague Road                   SE DECISION MADE: 25-DEC-17
Indianapolis IN  46250            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apex Tibial Nailing System
OrthoXel                          510(k) NO: K170972(Traditional)
ATTN: Aisling  O'Sullivan         PHONE NO : 35 321 2429700 
Rubicon Center Cork Institute of TSE DECISION MADE: 20-DEC-17
Bishopstown  IE T12 Y275          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DropSafe Safety Pen Needle
HTL-Strefa S.A.                   510(k) NO: K170988(Traditional)
ATTN: Aleksandra  Prazmowska-WilanPHONE NO : 48 42 2700010 
Adamowek 7                        SE DECISION MADE: 12-DEC-17
Ozorkow  PL 95-035                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: QUANTA Flash Calprotectin Reagents, QUANTA Flash Calprotectin Calibrators, QUANTA Flash Calprotectin Controls, QUANTA Flash Calprotectin Extraction Buffer
Inova Diagnostics, Inc.           510(k) NO: K170993(Traditional)
ATTN: Roger  Albesa               PHONE NO : 858 5869900 1391
9900 Old Grove Road               SE DECISION MADE: 22-DEC-17
San Diego CA  92131-1638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Veraview X800
J.Morita USA, Inc.                510(k) NO: K171012(Traditional)
ATTN: Keisuke  Mori               PHONE NO : 949 5819600 
9 Mason                           SE DECISION MADE: 19-DEC-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PoreStar Patient Specific Implant
Anatomics Pty Ltd                 510(k) NO: K171037(Traditional)
ATTN: Joanne  Flatley             PHONE NO : 61 03 95298088 
23-27 Wellington St               SE DECISION MADE: 27-DEC-17
St Kilda  AU 3182                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ureteric Catheters, Flush Ureteric Catheters, Floppy Tip Hydro-Coated Ureteric Catheters
Coloplast Corp                    510(k) NO: K171043(Traditional)
ATTN: Cori  Ragan                 PHONE NO : 612 5975106 
1601 West River Road North        SE DECISION MADE: 21-DEC-17
Minneapolis MN  55411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Real Time Image Gating System for Proton Beam Therapy Systems
Hitachi, Ltd. Healthcare          510(k) NO: K171049(Traditional)
ATTN: Tomoyuki  Seino             PHONE NO : 81 3 62843741 
2-16-1 Higachi-Ueno, Taito-ku     SE DECISION MADE: 26-DEC-17
Tokyo  JP                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medacta Shoulder System: Threaded Glenoid Baseplate
Medacta International SA          510(k) NO: K171058(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 916 966060 
Strada Regina                     SE DECISION MADE: 13-DEC-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRSASelect II
Bio-Rad                           510(k) NO: K171061(Traditional)
ATTN: Sylvie  Fernez              PHONE NO : 33 1 47956282 
3 Boulevard Raymond Poincare      SE DECISION MADE: 28-DEC-17
92430 Marnes-la-Coquette  FR 92430510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ives MR Conditional Cup Electrode
Ives EGG Solutions                510(k) NO: K171102(Traditional)
ATTN: John  Ives                  PHONE NO : 978 3588006 
25 Storey Avenue, #118            SE DECISION MADE: 21-DEC-17
Newburyport MA  01950             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AUTOBAHN Nailing System
Globus Medical Inc.               510(k) NO: K171108(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 
2560 General Armistead Ave.       SE DECISION MADE: 29-DEC-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Praxiject 0.9% NaCl
MedXL Inc.                        510(k) NO: K171109(Traditional)
ATTN: Premala  Premanathan        PHONE NO : 1 514 6957474 
285 Av Labrosse                   SE DECISION MADE: 21-DEC-17
Pointe-Claire  CA H9R 1A3         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Prodigio Stain Powder
OperArt LLC                       510(k) NO: K171167(Traditional)
ATTN: Domenico  Cascione          PHONE NO : 310 5147056 
1551 Ocean Ave., Suite 220        SE DECISION MADE: 13-DEC-17
Santa Monica CA  90401            510(k) STATEMENT
                                                    

DEVICE: PERIO-FLOW nozzle
E.M.S. Electro Medical Systems S.A510(k) NO: K171174(Traditional)
ATTN: Suzanne  Fassio-Hardy       PHONE NO : 41 22 9944771 
31 CH. de la Vuarpilliere         SE DECISION MADE: 18-DEC-17
Nyon  CH ch-1260                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IR Type Implant System
Biotem Co., Ltd.                  510(k) NO: K171185(Traditional)
ATTN: Hong Koo Yeo                PHONE NO : 82 708 2204934 
57, Sasang-ro , 401 beon-gil SasanSE DECISION MADE: 01-DEC-17
Busan  KR                         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cerebrotech CMS-5000
Cerebrotech Medical Systems       510(k) NO: K171186(Traditional)
ATTN: Dawnel  Scott               PHONE NO : 510 5016571 
1048 Serpentine Lane Suite 301    SE DECISION MADE: 08-DEC-17
Pleasanton CA  94566              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Certa Catheter
Ferrosan Medical Devices SP. Z O.O510(k) NO: K171193(Traditional)
ATTN: Elzbieta  Porebska-GuillemanPHONE NO : 48 91 4283400 
Koksowa 3                         SE DECISION MADE: 18-DEC-17
Szczecin  PL 70-031               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NeuViz 16 Essence Multi-slice CT Scanner System
Neusoft Medical Systems Co., Ltd. 510(k) NO: K171198(Traditional)
ATTN: Shao  Xiancheng             PHONE NO : 86 248 3660645 
No. 16, Shiji Road Hunnan IndustriSE DECISION MADE: 07-DEC-17
Shenyang  CN 110179               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X-PSI Knee System
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K171269(Traditional)
ATTN: Guylaine  Roy               PHONE NO : 514 8614074 231
75 Queen Street Suite 3300        SE DECISION MADE: 28-DEC-17
Montreal  CA h3c 2n6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polyform Synthetic Mesh
Boston Scientific Corporation     510(k) NO: K171271(Special)
ATTN: Michelle  Berry             PHONE NO : 508 6834344 
100 Boston Scientific Way         SE DECISION MADE: 15-DEC-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Micropuncture Introducer Set, Micropuncture Introducer Set with Push-Plus Design, Micropuncture Introducer Set with Silhouette Transitionless Design,  Micropuncture Introducer Set with Silhouette Transitionless Design and Push-Plus Design
Cook Incorporated                 510(k) NO: K171275(Special)
ATTN: Daniel J. Corbin            PHONE NO : 812 3353575 104018
750 Daniels Way                   SE DECISION MADE: 20-DEC-17
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cystoscope 4.0mm autoclavable 0° WL 302mm; Hysteroscope 4.0mm autoclavable 0° WL 302mm; Cysto-Urethroscope Sheath 19 Fr.; Bridge for 17-25 Fr. Cysto-Urethroscope Sheath
Henke-Sass, Wolf GmbH             510(k) NO: K171336(Traditional)
ATTN: Anna  Reifschneider         PHONE NO : 49 7462 9466147 
Keltenstrasse 1                   SE DECISION MADE: 07-DEC-17
Tuttlingen  DE 78532              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZFluence
Radformation, Inc.                510(k) NO: K171352(Traditional)
ATTN: Kurt  Sysock                PHONE NO : 844 7233675 
335 Madison Avenue 16th Floor     SE DECISION MADE: 01-DEC-17
New York NY  10017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Adhesive Electrodes
ShenZhen Quality Medical Technolog510(k) NO: K171381(Traditional)
ATTN: Grace  Zhao                 PHONE NO : 86 755 29016583 
5/F, Plant C3, No.1, Nuclear PowerSE DECISION MADE: 13-DEC-17
Shenzhen  CN                      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROCCIA® MultiLIF
Silony Medical GmbH               510(k) NO: K171434(Traditional)
ATTN: Bircan  Yilmaz              PHONE NO : 49 711 78252540 
Leinfelder Strasse 60             SE DECISION MADE: 21-DEC-17
Leinfelden-Echterdingen  DE 70771 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OxyPure Color Silicone Hydrogel Soft Contact Lenses
Visco Vision Inc                  510(k) NO: K171447(Traditional)
ATTN: Evan  Huang                 PHONE NO : 886 3 3596868 
No. 1, Xingye St., Guishan Dist., SE DECISION MADE: 05-DEC-17
Taoyuan City  TW 33341            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NoCoding1 Plus Blood Glucose Monitoring System, VeraSens Blood Glucose Monitoring System
i-SENS, Inc.                      510(k) NO: K171480(Special)
ATTN: Joon Ho Jung                PHONE NO : 82 2 9100453 
43, Banpo-daero 82-gil, Seocho-gu SE DECISION MADE: 13-DEC-17
Seoul  KR 06646                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ArchFlo CT Midline
Medcomp (dba Medical Components, I510(k) NO: K171483(Traditional)
ATTN: Courtney  Nix               PHONE NO : 215 2564201 
1499 Delp Drive                   SE DECISION MADE: 15-DEC-17
Harleysville PA  19438            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lunderquist Extra Stiff Wire Guide
William Cook Europe ApS           510(k) NO: K171513(Traditional)
ATTN: Henriette Stordal ChristiansPHONE NO : 0045 56 868756 
Sandet 6                          SE DECISION MADE: 07-DEC-17
Bjaeverskov  DK 4632              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Deltaven XiV Max, Deltaven XiV Max FF
Delta Med SpA                     510(k) NO: K171530(Traditional)
ATTN: Raschi  Olga                PHONE NO : 39 037 5785915 
Via Guido Rossa N 20              SE DECISION MADE: 21-DEC-17
Viadana  IT 46019                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xpert Xpress Flu, Xpert Nasopharyngeal Sample Collection Kit, Xpert Nasal Sample Collection Kit, GeneXpert Xpress II, GeneXpert Xpress IV
Cepheid                           510(k) NO: K171552(Dual Track)
ATTN: Yi-Ping  Lin                PHONE NO : 408 4006838 
904 Caribbean Drive               SE DECISION MADE: 19-DEC-17
Sunnyvale CA  94089-1189          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: W&H Assistina Twin
W & H Dentalwerk Buermoos GmbH    510(k) NO: K171553(Traditional)
ATTN: Mag. Anja  Lindner          PHONE NO : 0043 6274 6236397 
Ignaz-Glaser-StraBe 53            SE DECISION MADE: 08-DEC-17
Buermoos  AT 5111                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fusion Cytology Brush, CytoMax II Double Lumen Cytology Brush
Wilson-Cook Medical, Inc.         510(k) NO: K171573(Traditional)
ATTN: Sierra  Lowe                PHONE NO : 336 7440157 396506
4900 Bethania Station Road        SE DECISION MADE: 29-DEC-17
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neuro Omega System
Alpha Omega Engineering Ltd,      510(k) NO: K171581(Traditional)
ATTN: Maysana  Mousa              PHONE NO : 972 4 6563327 
Nazareth Industrial Park, Mount PrSE DECISION MADE: 22-DEC-17
Nazareth  IL 1612102              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: B. Braun Tear-Away Introducer Needle
B. Braun Medical Inc.             510(k) NO: K171584(Traditional)
ATTN: Kimberly  Smith             PHONE NO : 610 5962326 
901 Marcon Blvd.                  SE DECISION MADE: 22-DEC-17
Allentown PA  18109               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Double Lumen Ovum Aspiration Needles
William A. Cook Australia Pty Ltd 510(k) NO: K171611(Special)
ATTN: Gordana  Pozvek             PHONE NO : 61 7 38411188 
95 Brandl Street                  SE DECISION MADE: 15-DEC-17
Eight Mile Plains  AU 4113        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Guide SCENERGY
Clear Guide Medical               510(k) NO: K171677(Traditional)
ATTN: Jack  Kent                  PHONE NO : 410 9297720 
3600 Clipper Mill Road, Suite 400 SE DECISION MADE: 08-DEC-17
Baltimore MD  21211               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fixtemp C&B
Dreve Dentamid GmbH               510(k) NO: K171729(Traditional)
ATTN: Reiner  Altmann             PHONE NO : 49 230 3880714 
Max-Planck-StraBe 31              SE DECISION MADE: 13-DEC-17
Unna  DE 59423                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Micro Touch Denta Glove Nitrile Hydrasoft Patient Examination Gloves
Ansell Healthcare Products LLC    510(k) NO: K171737(Traditional)
ATTN: Robert  Mahler              PHONE NO : 732___ 3452174 
111 Wood Avenue South, Suite 210  SE DECISION MADE: 29-DEC-17
Iselin NJ  08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vitrification Kit and Thawing Kit
Kitazato Corporation              510(k) NO: K171748(Traditional)
ATTN: Futoshi  Inoue              PHONE NO : 81 545 662202 
81 Nakajima                       SE DECISION MADE: 14-DEC-17
Fuji  JP 416-0907                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay
Siemens Healthcare Diagnostics Inc510(k) NO: K171771(Traditional)
ATTN: Alan  Haley                 PHONE NO : 302 6319883 
500 GBC Drive                     SE DECISION MADE: 04-DEC-17
Newark DE  19714-6101             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann n!ce Glass Ceramic A14 Blocks
Institut Straumann AG             510(k) NO: K171773(Traditional)
ATTN: Shokoufeh  Khodabandeh      PHONE NO : 41 61 9651225 
Peter Merian Weg 12               SE DECISION MADE: 01-DEC-17
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: eVox System
Evoke Neuroscience, Inc.          510(k) NO: K171781(Traditional)
ATTN: David  Hagedorn             PHONE NO : 917 2616096 
200 Valencia Dr. Suite 109        SE DECISION MADE: 13-DEC-17
Jacksonville NC  28546            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G Surgical OCT Spinal System
G Surgical LLC                    510(k) NO: K171834(Traditional)
ATTN: Donald  Grafton             PHONE NO : 512 4944749 
9433 Bee Cave Road Building 3, SuiSE DECISION MADE: 19-DEC-17
Austin TX  78733                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FORTIFY and FORTIFY Integrated Corpectomy Spacers, XPand Corpectomy Spacers, NIKO Corpectomy Spacers, SUSTAIN Spacers, COALITION Spacers, PATRIOT Lumbar Spacers, PATRIOT Cervical Spacers, ALTERA Spacers, RISE Spacers, CALIBER Spacers, ELSA Spacers, LATIS Spacers, MONUMENT Spacers, InterContinental Plate-Spacer, MAGNIFY Spacers, INDEPENDENCE Spacers
Globus Medical Inc.               510(k) NO: K171848(Traditional)
ATTN: Lori  Burns                 PHONE NO : 610 9301800 2950
2560 General Armistead Ave.       SE DECISION MADE: 21-DEC-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sidus Stem-Free Shoulder
Zimmer GmbH                       510(k) NO: K171858(Traditional)
ATTN: Roberto  Tommasini          PHONE NO : 41 588 548264 
Sulzer Allee 8                    SE DECISION MADE: 18-DEC-17
Winterthur  CH 8404               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sentrant Introducer Sheath with Hydrophilic Coating
Medtronic Vascular, Inc.          510(k) NO: K171866(Special)
ATTN: Wee Wen Leow                PHONE NO : 707 5917703 
3576 Unocal Place                 SE DECISION MADE: 20-DEC-17
Santa Rosa CA  95403              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLM-1ER, SLM-2ER, SLM-3ER
Chongqing Kanghua Ruiming S&T Co.,510(k) NO: K171877(Traditional)
ATTN: Xi  You                     PHONE NO : 86 23 63227333 
No.5, Road1, Tongjiaxi Industrial SE DECISION MADE: 21-DEC-17
Chongqing  CN 400070              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reusable Blood Pressure Cuff
Suzhou Minhua Medical Apparatus Su510(k) NO: K171889(Traditional)
ATTN: Yang  Qidong                PHONE NO : 86 21 59840221 
You Yi Industrial Park, Songlin ToSE DECISION MADE: 19-DEC-17
Suzhou  CN 215222                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HAL for Medical Use (Lower Limb Type)
CYBERDYNE Inc.                    510(k) NO: K171909(Traditional)
ATTN: Yohei  Suzuki               PHONE NO : 81 29 8698453 
2-2-1 Gakuen-Minami               SE DECISION MADE: 17-DEC-17
Tsukuba  JP 305-0818              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Med-Hot Thermal Imaging Systems
Med-Hot Thermal Imaging Inc.      510(k) NO: K171928(Traditional)
ATTN: Carol  Chandler             PHONE NO : 863 6461599 
5120 S. Florida Ave. Suite 301    SE DECISION MADE: 08-DEC-17
Lakeland FL  33813                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alevicyn SG Antimicrobial Gel
Sonoma Pharmaceuticals, Inc.      510(k) NO: K171935(Traditional)
ATTN: Brian W. Martin             PHONE NO : 707 2830550 
1129 N. McDowell Boulevard        SE DECISION MADE: 01-DEC-17
Petaluma CA  94954                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sterile Endoscope Biopsy Sampling Needle
Changzhou Detain Medical Devices C510(k) NO: K171956(Traditional)
ATTN: Zhengrong  Ding             PHONE NO : 86 519 69805285 
No.47, North Qingyang Rd, TianningSE DECISION MADE: 12-DEC-17
Changzhou  CN 213017              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sofia Strep A+ FIA, Sofia 2 Analyzer
Quidel Corporation                510(k) NO: K171976(Dual Track)
ATTN: Edward C. Brehm             PHONE NO : 1 858 5521100 21015
12544 High Bluff Drive, Suite 200 SE DECISION MADE: 21-DEC-17
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ARIX Humerus System
Jeil Medical Corporation          510(k) NO: K172008(Traditional)
ATTN: Sejin  Ryu                  PHONE NO : 82 2 8503583 
702.703.704.705.706.804.805.807.81SE DECISION MADE: 01-DEC-17
Seoul  KR 152-728                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cascadia Interbody System
K2M, Inc.                         510(k) NO: K172009(Traditional)
ATTN: Nancy  Giezen               PHONE NO : 571 9192000 
600 Hope Parkway SE               SE DECISION MADE: 14-DEC-17
Leesburg VA  20175                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gel-e Bandage
gel-e, Inc. (formerly Remedium Tec510(k) NO: K172010(Traditional)
ATTN: Matthew  Dowling            PHONE NO : 1 301 4053585 
387 Technology Dr., Ste 3110B     SE DECISION MADE: 07-DEC-17
College Park MD  20742            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arthrex DynaNite Nitinol Staple
Arthrex Inc.                      510(k) NO: K172052(Traditional)
ATTN: Rebecca R. Homan            PHONE NO : 239 6435553 73429
1370 Creekside Boulevard          SE DECISION MADE: 13-DEC-17
Naples FL  34108-1945             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InnoSight Diagnostic Ultrasound System
Qisda Corporation                 510(k) NO: K172056(Traditional)
ATTN: Johnson  Sheu               PHONE NO : 886 3359 5000 3822
No.157, Shanying Rd., Gueishan DisSE DECISION MADE: 13-DEC-17
Taoyuan City  TW 333              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PhotoFix Decellularized Bovine Pericardium
CryoLife, Inc.                    510(k) NO: K172085(Traditional)
ATTN: Heather  Emerick            PHONE NO : 770 4193355 4502
1655 Roberts Blvd. NW             SE DECISION MADE: 04-DEC-17
Kennesaw GA  30144                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital Blood Pressure Monitor Models: B01, B02, B05 & B06T
Shenzhen Jamr Medical Technology C510(k) NO: K172171(Traditional)
ATTN: Li  Xue                     PHONE NO : 86 0755 85292057 
2nd Floor, A-building, No.2 GuiyuaSE DECISION MADE: 21-DEC-17
Shenzhen  CN 518110               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical PT Interbody Spacer System
Tyber Medical LLC                 510(k) NO: K172185(Traditional)
ATTN: Mark F. Schenk              PHONE NO : 610 8490645 
83 South Commerce Way,            SE DECISION MADE: 21-DEC-17
Bethlehem PA  18017               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Flexor Ureteral Access Sheath and Flexor Parallel Rapid Release Ureteral Access Sheath
Cook Incorporated                 510(k) NO: K172217(Traditional)
ATTN: Andrew  Breidenbach         PHONE NO : 812 3392235 104901
750 Daniels Way                   SE DECISION MADE: 13-DEC-17
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 8ch Flex Suite
Shenzhen RF Tech Co., Ltd.        510(k) NO: K172222(Traditional)
ATTN: Ke  Xi                      PHONE NO : 086 755 26641989 
2-F, Bld4, Juhui Industrial Park, SE DECISION MADE: 08-DEC-17
Shenzhen  CN 518132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: pioli IOL Delivery System
AST Products, Inc.                510(k) NO: K172228(Traditional)
ATTN: William  Lee                PHONE NO : 978 6674500 
9 Linnell Circle                  SE DECISION MADE: 15-DEC-17
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CAREline Airless Hemodialysis Blood Tubing Sets
Fresenius Medical Care Renal Thera510(k) NO: K172238(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 14-DEC-17
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftolozane/tazobactam (0.25/4 - 16/4 ug/mL)
Beckman Coulter, Inc              510(k) NO: K172255(Traditional)
ATTN: Shannon  Popson             PHONE NO : 916 3743330 
1584 Enterprise Blvd              SE DECISION MADE: 01-DEC-17
West Sacramento CA  95691         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)
True Diagnostics, Inc             510(k) NO: K172257(Traditional)
ATTN: Jerry  Lee                  PHONE NO : 
2782 Loker Ave West               SE DECISION MADE: 22-DEC-17
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: gammaCore-2
eletroCore, LLC                   510(k) NO: K172270(Traditional)
ATTN: Mike  Romaniw               PHONE NO : 973 2900097 
150 Allen Road, Suite 201         SE DECISION MADE: 07-DEC-17
Basking Ridge NJ  07920           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Xario 200 Diagnostic Ultrasound System V6.0
Toshiba Medical Systems Corporatio510(k) NO: K172276(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 12-DEC-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Automated Blood Coagulation Analyzer CS-2500
Siemens Healthcare Diagnostic Prod510(k) NO: K172286(Traditional)
ATTN: Nils  Neumann               PHONE NO : 49 6421 397133 
Emil-von Behring Strasse 76       SE DECISION MADE: 18-DEC-17
Marburg  DE 35041                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InMode PLUS System
InMode MD Ltd.                    510(k) NO: K172302(Traditional)
ATTN: Amit  Goren                 PHONE NO : 972 4 9097470 
Tabor Building Shaar Yokneam      SE DECISION MADE: 08-DEC-17
Yoqneam Illit  IL 2069200         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BioFlux Device
Biotricity Inc.                   510(k) NO: K172311(Third Party - Traditional)
ATTN: Spencer  LaDow              PHONE NO : 416 2144216 
275 Shoreline Drive, Suite 150    SE DECISION MADE: 15-DEC-17
Redwood City CA  94065            510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Shepard, Insemi-Cath, and Soft-Pass Coaxial - Cook Intrauterine Insemination Catheters
Cook Incorporated                 510(k) NO: K172321(Special)
ATTN: Naomi  Funkhouser           PHONE NO : 812 3353575 104371
750 Daniels Way P.O. Box 489      SE DECISION MADE: 21-DEC-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Blustone Synergy Silica System
Blustone Synergy                  510(k) NO: K172330(Traditional)
ATTN: Lisa  Peterson              PHONE NO : 512 5070746 
5520 Ventana Ct.                  SE DECISION MADE: 21-DEC-17
Pueblo CO  81005                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MicroScan Dried Gram Negative MIC/Combo Panels with Ceftazidime/Avibactam (0.25/4 - 64/4 ug/mL)
Beckman Coulter, Inc.             510(k) NO: K172337(Traditional)
ATTN: Teresa S. Wong              PHONE NO : 916 3742432 
1584 Enterprise Blvd.             SE DECISION MADE: 15-DEC-17
West Sacramento CA  95691         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: InFill® Interbody Fusion Device
Pinnacle Spine Group, LLC         510(k) NO: K172349(Traditional)
ATTN: Zach  Sowell                PHONE NO : 214 4661428 
2921 Canton St.                   SE DECISION MADE: 14-DEC-17
Dallas TX  75226                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AxSOS 3 Ti
Stryker GmbH                      510(k) NO: K172350(Traditional)
ATTN: Kemine  Hale                PHONE NO : 41 32 6416935 
Bohnackerweg 1                    SE DECISION MADE: 15-DEC-17
Selzach  CH 2545                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Powder Free Vinyl Exam Glove, Clear/Yellow
EVER GROWTH (VIETNAM) CO., LTD    510(k) NO: K172357(Abbreviated)
ATTN: Che-Min  Lee                PHONE NO : 84 127 3926920 
Long Khanh Industrial Zone, Binh LSE DECISION MADE: 29-DEC-17
Long Khanh Township  VN 810000    510(k) STATEMENT
                                                    

DEVICE: Arthrosurface Bone Screws
Arthrosurface, Inc.               510(k) NO: K172383(Traditional)
ATTN: Dawn J. wilson              PHONE NO : 508 5203003 
28 Forge Parkway                  SE DECISION MADE: 22-DEC-17
Franklin MA  02038                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VPOD ITPR
Advanced Circulatory System, a who510(k) NO: K172388(Traditional)
ATTN: Anja  Metzger               PHONE NO : 651 2261626 
ZOLL 1905 County Rd C West        SE DECISION MADE: 22-DEC-17
Roseville MN  55113               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SNIPER STAPLE SYSTEM, NON-STERILE
Trilliant Surgical                510(k) NO: K172405(Traditional)
ATTN: Jon  Olson                  PHONE NO : 800 4952919 
6721 Portwest Drive               SE DECISION MADE: 11-DEC-17
Houston TX  77024                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Velofix™ TLIF Cage
U&i Corporation                   510(k) NO: K172419(Traditional)
ATTN: Jee-Ae  Bang                PHONE NO : 82 31 8606846 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 04-DEC-17
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OrthoPediatrics Wrist Fusion Plate
OrthoPediatrics, Inc.             510(k) NO: K172425(Traditional)
ATTN: Adam  Cargill               PHONE NO : 574 2686379 
2850 Frontier Drive               SE DECISION MADE: 06-DEC-17
Warsaw IN  46582                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SporView Rapid Read Biological Indicator
Crosstex/SPSmedical, A Division of510(k) NO: K172432(Traditional)
ATTN: Megan  Skaar                PHONE NO : 800 7221529 
6789 West Henrietta Road          SE DECISION MADE: 12-DEC-17
Rush NY  14543                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RoyalGuard Surgical Gown, i600, Breathable
GRI Medical & electrical Technolog510(k) NO: K172445(Traditional)
ATTN: Martin D. Paugh             PHONE NO : 86 135 11359722 
1805 Honggao rd., Xiuzhou IndustrySE DECISION MADE: 08-DEC-17
Jiaxing  CN 314031                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Riptide Aspiration System
Micro Therapeutics, Inc., d/b/a ev510(k) NO: K172448(Traditional)
ATTN: Ryan  Kenney                PHONE NO : 949 2975489 
9775 Toledo Way                   SE DECISION MADE: 21-DEC-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Idys™ TLIF 3DTi Cages
CLARIANCE, SAS                    510(k) NO: K172465(Traditional)
ATTN: Pascal  Rokegem             PHONE NO : 33 03 21161215 
18 rue Robespierre                SE DECISION MADE: 15-DEC-17
Beaurains  FR 62217               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OMNI ARC Anteverted Neck Hip Stem
OMNIlife science                  510(k) NO: K172467(Traditional)
ATTN: Christina  Rovaldi          PHONE NO : 774 2261857 
480 Paramount Drive               SE DECISION MADE: 21-DEC-17
Raynham MA  02767                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 091 Long Sheath, 70 cm, 091 Long Sheath, 80 cm, 091 Long Sheath, 90 cm
InNeuroCo, Inc                    510(k) NO: K172468(Traditional)
ATTN: Marc  Litzenberg            PHONE NO : 954 4725988 
4635 NW 103rd Avenue              SE DECISION MADE: 06-DEC-17
Sunrise FL  33351                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LifeStyles® SKYN® Intimate Moments Personal Lubricant
SXWELL USA LLC                    510(k) NO: K172473(Traditional)
ATTN: Robert  Mahler              PHONE NO : 732 3452174 
111 Wood Avenue South, Suite 210  SE DECISION MADE: 15-DEC-17
Iselin NJ  08830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity 20 HP Biological Indicator
Steris Corporation                510(k) NO: K172474(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 1 440 3927437 
5960 Heisley Road                 SE DECISION MADE: 29-DEC-17
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: The Nellcor pulse oximetry monitor interface cable
Covidien                          510(k) NO: K172482(Traditional)
ATTN: Mia M. Ware                 PHONE NO : 303 3052750 
6135 Gunbarrel Avenue             SE DECISION MADE: 15-DEC-17
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROTEUS PTA Balloon Catheter with Embolic Capture Feature
Angioslide, Ltd.                  510(k) NO: K172494(Special)
ATTN: Eran  Vickus                PHONE NO : 972 4 7904600 
4 Ha'Omanut Street, Poleg IndustriSE DECISION MADE: 15-DEC-17
Netanya  IL 4250438               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MR Conditional Cup Electrode, MR Conditional Webb Electrode
Rhythmlink International, LLC     510(k) NO: K172503(Traditional)
ATTN: Daniel  McCoy               PHONE NO : 803 2521222 
1140 First Street South           SE DECISION MADE: 01-DEC-17
Columbia SC  29209                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS C1 Narrow Platform Conical Connection Implant System, MIS C1 Wide Platform Conical Connection Abutments
MIS Implants Technologies Ltd.    510(k) NO: K172505(Traditional)
ATTN: Arbel  Shezaf               PHONE NO : 972 4 9016800 
P.O. Box 7, Bar Lev Industrial ParSE DECISION MADE: 28-DEC-17
Bar Lev Industrial Park  IL 201560510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SOZO
ImpediMed Limited                 510(k) NO: K172507(Traditional)
ATTN: Catherine  Kingsford        PHONE NO : 61 7 38603703 
Unit 1 50 Parker Court            SE DECISION MADE: 22-DEC-17
Pinkenba  AU 4008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vivaer ARC Stylus
Aerin Medical, Inc.               510(k) NO: K172529(Traditional)
ATTN: Shannon  Scott              PHONE NO : 512 2219956 
232 E. Caribbean Drive            SE DECISION MADE: 05-DEC-17
Sunnyvale CA  94089               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BEAUTIFIL Flow Plus X
Shofu Dental Corporation          510(k) NO: K172530(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 
1225 Stone Drive                  SE DECISION MADE: 06-DEC-17
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: PREMIUM ONE Implant Systems
Sweden & Martina S.p.A            510(k) NO: K172560(Traditional)
ATTN: Alessia  Pezzato            PHONE NO : 39 049 9124300 
via Veneto,  10                   SE DECISION MADE: 21-DEC-17
Due Carrare  IT 35020             510(k) STATEMENT
                                                    

DEVICE: Disposable Circular Stapler
Changzhou Kangdi Medical Stapler C510(k) NO: K172561(Special)
ATTN: Eve  Zhou                   PHONE NO : 86 519 85162780 
No.16 Kunlun Road, XinBei Zone    SE DECISION MADE: 05-DEC-17
Changzhou City  CN 213022         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advantage/Advantage Fit Delivery Device, Lynx Delivery Device, Obtryx Delivery Device (Curved & Halo), Obtryx II Delivery Device (Curved & Halo), Solyx SIS Delivery Device
Boston Scientific Corporation     510(k) NO: K172565(Traditional)
ATTN: Anand  Patel                PHONE NO : 508 6835320 
100 Boston Scientific Way         SE DECISION MADE: 20-DEC-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ReBOSSIS85
Orthorebirth Co., Ltd.            510(k) NO: K172573(Traditional)
ATTN: Yasutoshi  Nishikawa        PHONE NO : 81 455 323650 
3-17-43 Chigasaki Higashi         SE DECISION MADE: 15-DEC-17
Tsuzuki-ku Yokohama  JP 224-0033  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Equipment Pouch
WickiMed(Huizhou)Medical Equipment510(k) NO: K172578(Traditional)
ATTN: Haobin  Li                  PHONE NO : 86 075 23860807 
Tang Jiao Xing Wang Street, Lilin SE DECISION MADE: 07-DEC-17
Huizhou  CN 516000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Proficient® Posterior Cervical Spine System
Spine Wave, Inc.                  510(k) NO: K172594(Traditional)
ATTN: Amy  Noccioli               PHONE NO : 203 9449494 
3 Enterprise Drive Suite 210      SE DECISION MADE: 15-DEC-17
Shelton CT  06484                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYSTEMS INTEGRATION ENDOALPHA MEDICAL CONTROL UNIT FOR ENDOSURGERY UCES-4 Software Version 1
OLYMPUS MEDICAL SYSTEMS CORP.     510(k) NO: K172618(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 05-DEC-17
Hachioji-shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive Navigation Instruments
NuVasive, Incorporated            510(k) NO: K172623(Traditional)
ATTN: Manthan J. Damani           PHONE NO : 858 4582272 
7475 Lusk Blvd.                   SE DECISION MADE: 21-DEC-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panther Fusion AdV/hMPV/RV Assay
Hologic, Inc.                     510(k) NO: K172629(Traditional)
ATTN: Anila K Tarte               PHONE NO : 858 4108055 
10210 Genetic Center Drive        SE DECISION MADE: 04-DEC-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iLux Instrument, iLux Disposable
Tear Film Innovations, Inc.       510(k) NO: K172645(Traditional)
ATTN: John  Slate                 PHONE NO : 844 4589776 
12625 High Bluff Drive, Suite 107 SE DECISION MADE: 26-DEC-17
San Diego CA  92130               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FMP Extended Liners
Encore Medical, L.P.              510(k) NO: K172651(Traditional)
ATTN: Teffany  Hutto              PHONE NO : 512 8346255 
9800 Metric Blvd.                 SE DECISION MADE: 13-DEC-17
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CrossBow Fascial Closure System, CrossBow Fascial Closure System with Adaptor
SutureEase, Inc.                  510(k) NO: K172666(Traditional)
ATTN: Scott  Heneveld             PHONE NO : 408 4597595 
1735 N First Street, Suite 300    SE DECISION MADE: 01-DEC-17
San Jose CA  95112                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® Modulus-C Interbody System
NuVasive, Incorporated            510(k) NO: K172676(Traditional)
ATTN: Marysa E. Loustalot         PHONE NO : 858 3204515 
7475 Lusk Boulevard               SE DECISION MADE: 14-DEC-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advantage Plus Pass-Thru
Medivators Inc.                   510(k) NO: K172677(Traditional)
ATTN: Megan  Skaar                PHONE NO : 763 5533369 
14605 28th Avenue North           SE DECISION MADE: 19-DEC-17
Minneapolis MN  55447             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Align Radial Head System
Skeletal Dynamics, LLC            510(k) NO: K172688(Special)
ATTN: Ana M. Escagedo             PHONE NO : 305 5967585 
8905 SW 87 Avenue, Suite 201      SE DECISION MADE: 22-DEC-17
Miami FL  33176                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
Tangible Science LLC              510(k) NO: K172692(Traditional)
ATTN: Vic  McCray                 PHONE NO : 650 2411045 
173 Jefferson Drive               SE DECISION MADE: 13-DEC-17
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GammaPod - Model A
Xcision Medical Systems, LLC      510(k) NO: K172706(Traditional)
ATTN: Daniel R. Plonski           PHONE NO : 443 6817468 
9176 Red Branch Road, Suite O     SE DECISION MADE: 22-DEC-17
Columbia MD  21045                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Renamel Microfill
Cosmedent, Inc                    510(k) NO: K172707(Traditional)
ATTN: Mary  Nowak                 PHONE NO : 312 6449586 
401 N. Michigan Ave, Suite 2500   SE DECISION MADE: 05-DEC-17
Chicago IL  60611                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Lumipulse G B•R•A•H•M•S PCT Immunoreaction Cartridges, Lumipulse G B•R•A•H•M•S PCT Calibrators set
Fujirebio Diagnostics, Inc.       510(k) NO: K172713(Traditional)
ATTN: Stacey  Dolan               PHONE NO : 610 2403843 
201 Great Valley Parkway          SE DECISION MADE: 10-DEC-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LipiVage
Genesis Biosystems, Inc.          510(k) NO: K172714(Traditional)
ATTN: Jim  Lafferty               PHONE NO : 972 3157888 102
1500 Eagle Court                  SE DECISION MADE: 08-DEC-17
Lewisville TX  75057              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anti-Borrelia burgdorferi US EUROLINE-WB (IgM)
EUROIMMUN US, Inc.                510(k) NO: K172722(Traditional)
ATTN: Michael A. Locke            PHONE NO : 973 6561000 105
1 Bloomfield Ave.                 SE DECISION MADE: 10-DEC-17
Mountain Lakes NJ  07046          510(k) STATEMENT
                                                    

DEVICE: VITEK 2 AST-GN Amikacin (<=1 ->=64 ug/mL)
bioMerieux, Inc.                  510(k) NO: K172731(Traditional)
ATTN: Esther  Hernandez           PHONE NO : 314 7318841 
595 Anglum Road                   SE DECISION MADE: 08-DEC-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: E-CUBE 8
ALPINION MEDICAL SYSTEMS Co., Ltd.510(k) NO: K172732(Traditional)
ATTN: Boyeon  CHO                 PHONE NO : 82 70 74652104 
1FL and 6FL, Verdi Tower, 72, DigiSE DECISION MADE: 14-DEC-17
Seoul  KR 08393                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Single Use Electrosurgical Snare SD-400
Olympus Medical Systems Corp.     510(k) NO: K172734(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 07-DEC-17
Hachioji  JP 192-8507             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MESIRE - Balloon Sinus Dilatation System
M/s. Meril Life Sciences Private L510(k) NO: K172737(Traditional)
ATTN: Umesh  Sharma               PHONE NO : 91 0260 3052100 
Survey No. 135/139, Bilakhia HouseSE DECISION MADE: 12-DEC-17
Chala, Vapi  IN 396191            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Natus VikingQuest
Natus Neurology Incorporated      510(k) NO: K172743(Special)
ATTN: Shane T. Sawall             PHONE NO : 608 8298673 
3150 Pleasant View Road           SE DECISION MADE: 19-DEC-17
Middleteon WI  53562              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Varian cage
Medyssey USA, Inc.                510(k) NO: K172756(Traditional)
ATTN: Shawn  Kim                  PHONE NO : 847 4270200 
1550 E. Higgins Road, Suite 123   SE DECISION MADE: 08-DEC-17
Elk Grove Village IL  60007       510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONQUEST FN
Smith & Nephew                    510(k) NO: K172785(Special)
ATTN: Allison  Chan               PHONE NO : 901 3991098 
1450 E Brooks Road                SE DECISION MADE: 22-DEC-17
Memphis TN  38116                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MDS Plating System
Miami Device Solutions, LLC       510(k) NO: K172786(Traditional)
ATTN: Michelle  Montesino         PHONE NO : 786 4221400 106
7620 NW 25th Street, Unit 3       SE DECISION MADE: 08-DEC-17
Miami FL  33122                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LightWalker Laser System Family
Fotona d.o.o.                     510(k) NO: K172819(Traditional)
ATTN: Marko  Berdajs              PHONE NO : 386 1 5009299 
Stegne 7                          SE DECISION MADE: 01-DEC-17
Ljubljana  SI                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cellvizio 100 Series System with Confocal Miniprobes
Mauna Kea Technologies            510(k) NO: K172844(Traditional)
ATTN: Veronique  Dentan           PHONE NO : 33 1 70080994 
9 Rue d'Enghien                   SE DECISION MADE: 15-DEC-17
Paris  FR 75010                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MEVION S250i Proton Beam Radiation Therapy Device
Mevion Medical Systems            510(k) NO: K172848(Traditional)
ATTN: Thomas H. Faris             PHONE NO : 978 5401500 
300 Foster St.                    SE DECISION MADE: 27-DEC-17
Littleton MA  01460               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NobelPerfect Abutments
Nobel Biocare AB                  510(k) NO: K172854(Traditional)
ATTN: Charlemagne  Chua           PHONE NO : 714 2824800 7830
BOX 5190, SE-402 26, Vastra HamngaSE DECISION MADE: 14-DEC-17
Goteborg  SE SE-411 17            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Digital thermometer(with disposable thermometer cover)
Hangzhou Hua'an medical&health ins510(k) NO: K172861(Special)
ATTN: Ahneo  Yang                 PHONE NO : 86 571 88734065 
Building 2, 1# Fuzhu Nan RD, WuchaSE DECISION MADE: 19-DEC-17
Hangzhou  CN 310023               510(k) STATEMENT
                                                    

DEVICE: Infinix-i, INFX-8000V, V7.0
Toshiba Medical Systems Corporatio510(k) NO: K172863(Traditional)
ATTN: Paul  Biggins               PHONE NO : 714 6697808 
1385 Shimoishigami                SE DECISION MADE: 14-DEC-17
Otawara-shi  JP 324-8550          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PowerDot PD-01M
Smartmissimo Technologies Pte Ltd 510(k) NO: K172876(Special)
ATTN: Alexey  Pisarev             PHONE NO : 65 83 216256 
#28-01, SGX Centre II, 4 Shenton WSE DECISION MADE: 04-DEC-17
Singapore  SG 068807              510(k) STATEMENT
                                                    

DEVICE: Breakaway Screw System
Paragon 28                        510(k) NO: K172886(Special)
ATTN: Eric  Lintula               PHONE NO : 888 7281888 
4B Inverness Ct. E Ste 280        SE DECISION MADE: 20-DEC-17
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EIT Cellular Titanium® Cervical Cages, EIT Cellular Titanium® PLIF Cages, EIT Cellular Titanium® TLIF Cages, EIT Cellular Titanium® ALIF Cages
EIT Emerging Implant Technologies 510(k) NO: K172888(Traditional)
ATTN: Barbara  Wirth              PHONE NO : 49 7461 1716904 
Eisenbahnstrasse 84               SE DECISION MADE: 15-DEC-17
Wurmlingen  DE 78573              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SafeSept Needle Free Transseptal Guidewire
Pressure Products Medical Device M510(k) NO: K172893(Traditional)
ATTN: Andrew  Armour              PHONE NO : 610 5432324 
1 School Street                   SE DECISION MADE: 21-DEC-17
Morton PA  19070                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: IntelliVue Capnography Extension, IntelliVue Microstream Extension
Philips Medizin Systeme Boeblingen510(k) NO: K172904(Traditional)
ATTN: Markus  Stacha              PHONE NO : 49 7031 4632840 
Hewlett-Packard-Str.-2            SE DECISION MADE: 26-DEC-17
Boeblingen  DE 71034              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Q-Switched Nd:YAG Laser System
AMI Inc.                          510(k) NO: K172908(Traditional)
ATTN: Hae Youn Lee                PHONE NO : 82 2 3281 9091
RM 1412, SJ Techno Ville, 287 BeotSE DECISION MADE: 07-DEC-17
Seoul  KR 08511                   510(k) STATEMENT
                                                    

DEVICE: MicroScan Dried Gram-Negative MIC/Combo Panels with Ciprofloxacin-S (0.004 – 8 µg/mL)
Beckman Coulter Inc.              510(k) NO: K172912(Traditional)
ATTN: Shannon  Popson             PHONE NO : 916 3721900 
2040 Enterprise Bldv              SE DECISION MADE: 07-DEC-17
West Sacramento CA  95691         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DEXIS Titanium, KaVo IXS HD (Size 1, Size 2)
KaVo Dental Technologies, LLC     510(k) NO: K172918(Traditional)
ATTN: Frank  Ray                  PHONE NO : 704 5877227 
11727 Fruehauf Drive              SE DECISION MADE: 18-DEC-17
Charlotte NC  28273               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MMPC-4127F1
Barco N.V.                        510(k) NO: K172922(Traditional)
ATTN: Lieven  De Wandel           PHONE NO : 32 5 6233459 
President Kennedypark 35          SE DECISION MADE: 21-DEC-17
Kortrijk  BE 8500                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Vu cPOD, Zuma-C, Complete Cervical
SeaSpine Orthopedics Corporation  510(k) NO: K172926(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 21-DEC-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DUS-6000 Digital Ultrasonic Diagnostic Imaging System
Advanced Instrumentations, Inc.   510(k) NO: K172931(Abbreviated)
ATTN: Jorge  Millan               PHONE NO : 305 4776331 
6800 NW 77th Ct                   SE DECISION MADE: 01-DEC-17
Miami FL  33166                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: True Flow Valvuloplasty Perfusion Catheter
C. R. Bard, Inc.                  510(k) NO: K172932(Traditional)
ATTN: Aaron  Conovaloff           PHONE NO : 480 3506012 
1625 West 3rd Street              SE DECISION MADE: 13-DEC-17
Tempe AZ  85281                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VITEK 2 AST-GN Ceftazidime/Avibactam <=0.12 – >=16 µg/mL
bioMerieux, Inc.                  510(k) NO: K172944(Traditional)
ATTN: Cherece L. Jones            PHONE NO : 314 7318684 
595 Anglum Rd.                    SE DECISION MADE: 19-DEC-17
Hazelwood MO  63042               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: easyEndoTM Linear Cutting Stapler and Loading Units for Single Use, easyEndoTM Universal Linear Cutting Stapler and Loading Units for Single Use
Ezisurg Medical Co., Ltd.         510(k) NO: K172960(Traditional)
ATTN: Sheng  Tian                 PHONE NO : 86 21 50456176 
Rm. 103, Bldg.2, No.1690 Cailun RoSE DECISION MADE: 21-DEC-17
Shanghai  CN 201203               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CMS-2000 Central Monitoring System
Advanced Instumentations, Inc.    510(k) NO: K172966(Traditional)
ATTN: Jorge  Millan               PHONE NO : 305 4776331 
6800 NW 77th. Ct.                 SE DECISION MADE: 08-DEC-17
Miami FL  33166                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Life Spine Foot and Ankle Plating System
Life Spine Inc.                   510(k) NO: K172973(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 21-DEC-17
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SurgeoBite
Surgovations LLC                  510(k) NO: K172978(Traditional)
ATTN: Chris  Menard               PHONE NO : 478 2541707 
110 Fairway Run                   SE DECISION MADE: 22-DEC-17
Forsyth GA  31029                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SuperGrow 272, Ultimate 272
Super Grow Lasers                 510(k) NO: K172982(Traditional)
ATTN: Jeff  Stanifer              PHONE NO : 713 5516320 
1903 Commonwealth Street #16      SE DECISION MADE: 19-DEC-17
Houston TX  77006                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zmachine Synergy
Consolidated Research of Richmond,510(k) NO: K172986(Traditional)
ATTN: Richard  Kaplan             PHONE NO : 216 2892331 
26250 Euclid Avenue, Suite 709    SE DECISION MADE: 19-DEC-17
Cleveland OH  44132               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Electric Breast Pump
Joytech Healthcare Co., Ltd.      510(k) NO: K172989(Traditional)
ATTN: Ren  Yunhua                 PHONE NO : 86 571 81957767 
No.365, Wuzhou Road, Yuhang EconomSE DECISION MADE: 20-DEC-17
Hangzhou  CN 311100               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P20 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp.           510(k) NO: K172993(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f yizhe buSE DECISION MADE: 05-DEC-17
shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Apogee 2100 Digital Color Doppler Ultrasound Imaging System Apogee 2300 Digital Color Doppler Ultrasound Imaging System
Shantou Institute of Ultrasonic In510(k) NO: K173000(Traditional)
ATTN: Flower  Cai                 PHONE NO : 86 754 88250150 
77 Jinsha Road                    SE DECISION MADE: 07-DEC-17
Shantou  CN 515041                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2940 nm Er:Yag Laser Handpiece
Quanta System S.p.A.              510(k) NO: K173002(Traditional)
ATTN: Francesco  Dell’Antonio     PHONE NO : 39 0331 376797 
Via Acquedotto, 109               SE DECISION MADE: 13-DEC-17
Samarate  IT 21017                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SCS 17-01
Anika Therapeutics, Inc.          510(k) NO: K173008(Traditional)
ATTN: Steven  Chartier            PHONE NO : 781 4579000 
32 Wiggins Avenue                 SE DECISION MADE: 26-DEC-17
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WishBone K-Wire System
WishBone Medical, Inc.            510(k) NO: K173013(Traditional)
ATTN: Gary  Barnett               PHONE NO : 574 3064006 
2150 North Pointe Drive           SE DECISION MADE: 14-DEC-17
Warsaw IN  46582                  510(k) STATEMENT
                                                    

DEVICE: Kindguard Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)
Anhui Kindguard Medical Supplies T510(k) NO: K173017(Traditional)
ATTN: Chen  Wei                   PHONE NO : 
Intersection of Yulan Road and ChaSE DECISION MADE: 15-DEC-17
Suzhou  CN 234300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CuRAS Nd:YAG Laser
Ilooda Co., Ltd.                  510(k) NO: K173038(Traditional)
ATTN: Yun-Jung  HA                PHONE NO : 720 9625412 
120, Jangan-ro 458 Beon-gil JanganSE DECISION MADE: 01-DEC-17
Suwon-Si Gyeonggido  KR 16200     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Holycon Synthetic Absorbable Sutures
Nantong Holycon Medical Devices Co510(k) NO: K173043(Traditional)
ATTN: Feng  Lu                    PHONE NO : 86 513 80979102 
No.66, Zhongyang Road, Economic TeSE DECISION MADE: 14-DEC-17
Nantong  CN 226009                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: P10 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp.           510(k) NO: K173058(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f Yizhe buSE DECISION MADE: 01-DEC-17
Shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AltiVate Anatomic to Reverse Conversion Module
Encore Medical, L.P.              510(k) NO: K173073(Traditional)
ATTN: Teffany  Hutto              PHONE NO : 512 8346255 
9800 Metric Blvd                  SE DECISION MADE: 26-DEC-17
Austin TX  78758                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UroLift System (UL400 and UL500)
NeoTract, Inc.                    510(k) NO: K173087(Traditional)
ATTN: Louis-Pierre  Marcoux       PHONE NO : 925 2018861 
4473 Willow Road, Suite 100       SE DECISION MADE: 28-DEC-17
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Boundary Anterior Lumbar Buttress Plate
Nvision Biomedical Technologies, L510(k) NO: K173091(Traditional)
ATTN: Diana L. Langham            PHONE NO : 210 5453713 
1350 N Loop 1604 E, Suite 103     SE DECISION MADE: 06-DEC-17
San Antonio TX  78232             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Cervical IBF System
Reliance Medical Systems, LLC     510(k) NO: K173102(Special)
ATTN: Bret M. Berry               PHONE NO : 801 2953280 
545 West 500 South Suite 100      SE DECISION MADE: 29-DEC-17
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: COALITION® and COALITION® TPS, COALITION MIS® and COALITION MIS® TPS, COALITION AGX® and COALITION AGX® TPS
Globus Medical Inc.               510(k) NO: K173115(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Ave.       SE DECISION MADE: 20-DEC-17
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NuVasive® VersaTie™ System
NuVasive, Inc.                    510(k) NO: K173117(Traditional)
ATTN: Marysa  Loustalot           PHONE NO : 858 3204549 
7475 Lusk Blvd                    SE DECISION MADE: 07-DEC-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PEEK Biosolution
Merz Dental GmbH                  510(k) NO: K173124(Traditional)
ATTN: Claudia  Bobrowski          PHONE NO : 011 43 81403411 
Eetzweg 20                        SE DECISION MADE: 18-DEC-17
Lutjenburg  DE D-24321            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 STRATOSPHERE™ Expandable Corpectomy System
Medtronic Sofamor Danek           510(k) NO: K173125(Traditional)
ATTN: Kanesha  Hines              PHONE NO : 901 3992670 
1800 Pyramid Place                SE DECISION MADE: 20-DEC-17
Memphis TX  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arisstos™ Spinal System
Ingenium Spine                    510(k) NO: K173126(Traditional)
ATTN: David  Brumfield            PHONE NO : 888 6847861 
3145 E. Chandler Blvd. #110       SE DECISION MADE: 05-DEC-17
Phoenix AZ  85048                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRECICE System
NuVasive Specialized Orthopedics, 510(k) NO: K173129(Special)
ATTN: Lance  Justice              PHONE NO : 949 5446540 
101 Enterprise, Suite 100         SE DECISION MADE: 01-DEC-17
Aliso Viejo CA  92656             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reform® Midline Cortical Screw System
Precision Spine, Inc.             510(k) NO: K173130(Traditional)
ATTN: Michael C. Dawson           PHONE NO : 601 4204244 
2050 Executive Drive              SE DECISION MADE: 19-DEC-17
Pearl MS  39208                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rexious Spinal Fixation System
Huvexel Co., Ltd                  510(k) NO: K173131(Special)
ATTN: Sung  Hee-Lee               PHONE NO : 82 31 7763690 
101-105 Megacenter, SK Technopark,SE DECISION MADE: 08-DEC-17
Seongnam-si  KR 13207             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Nitrile Powder Free Examination Glove Tested for Use with Chemotherapy Drugs (Pink)
Hartalega Sdn. Bhd.               510(k) NO: K173137(Traditional)
ATTN: Kuan Kam Hon                PHONE NO : 603 62 771733 
Dataran Sd Pju 9                  SE DECISION MADE: 12-DEC-17
Bandar Sri Damansara  MY 52200    510(k) STATEMENT
                                                    

DEVICE: ACIF
coLigne, AG                       510(k) NO: K173148(Traditional)
ATTN: Robert  Lange               PHONE NO : 41 43 3438000 
Utoquai 43                        SE DECISION MADE: 01-DEC-17
Zurich  CH CH 8008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vertera Spine™ Coalesce™ Thoracolumbar Interbody Fusion System
NuVasive, Incorporated            510(k) NO: K173153(Traditional)
ATTN: Michelle  Cheung            PHONE NO : 858 9093360 
7475 Lusk Blvd.                   SE DECISION MADE: 06-DEC-17
San Diego CA  92121               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProLift® Expandable System
Life Spine Inc.                   510(k) NO: K173182(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 20-DEC-17
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Meropenem/Vaborbactam in the Dilution Range of 0.008/8 - 18/8 ug/mL
Thermo Fisher Scientific          510(k) NO: K173209(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909322 4117
1 Thermo Fisher Way               SE DECISION MADE: 01-DEC-17
Oakwood Village OH  440146        510(k) STATEMENT
                                                    

DEVICE: Solana GBS Assay
Quidel Corporation                510(k) NO: K173250(Traditional)
ATTN: Ronald H. Lollar            PHONE NO : 740 5893373 
2005 East State Street, Suite 100 SE DECISION MADE: 21-DEC-17
Athens OH  45701                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LumiCoil Platinum Fiducial Marker
Boston Scientific Corporation     510(k) NO: K173251(Traditional)
ATTN: Lindsay  Forys              PHONE NO : 508 6836317 
100 Boston Scientific Way         SE DECISION MADE: 19-DEC-17
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SeaSpine Spacer System (NanoMetalene)- Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Spacer System -Hollywood, Hollywood VI, Ventura, Pacifica; SeaSpine Vu e·POD System
SeaSpine Orthopedics Corporation  510(k) NO: K173260(Traditional)
ATTN: Gina  Flores                PHONE NO : 760 2165136 
5770 Armada Drive                 SE DECISION MADE: 04-DEC-17
Carlsbad CA  92008                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Octane aspiration system
Vascular Solutions Inc.           510(k) NO: K173266(Traditional)
ATTN: Becky  Astrup               PHONE NO : 763 7622601 
6464 Sycamore Court North         SE DECISION MADE: 01-DEC-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MasterLoc Stem: Lateralized Plus
Medacta International SA          510(k) NO: K173267(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 07-DEC-17
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cannulated Screw Internal Fixation System
Life Spine Inc.                   510(k) NO: K173286(Traditional)
ATTN: Randy  Lewis                PHONE NO : 847 8846117 
13951 S Quality Drive             SE DECISION MADE: 14-DEC-17
Huntley IL  60142                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Elite HV Radial
Galt Medical Corp.                510(k) NO: K173287(Traditional)
ATTN: David  Derrick              PHONE NO : 972 2715177 
2220 Merritt Drive                SE DECISION MADE: 21-DEC-17
Garland TX  75087                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Liofilchem MIC Test Strip (MTS), Meropenem/vaborbactam 0.016/8 - 256/8 µg/mL
Liofilchem s. r. l.               510(k) NO: K173307(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 19-DEC-17
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: OMNI Surgical System
Sight Sciences, Inc.              510(k) NO: K173332(Traditional)
ATTN: Anne-Marie  Ripley          PHONE NO : 661 6458546 
3000 Sand Hill Road Building 3, SuSE DECISION MADE: 21-DEC-17
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Operio
Toul Meditech AB                  510(k) NO: K173349(Traditional)
ATTN: Tomas  Hansson              PHONE NO : 46 21 135000 
Tunbytorpsgatan 31                SE DECISION MADE: 20-DEC-17
Vasteras  SE 72137                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD Nexiva Diffusics Closed IV Catheter Systems
Becton Dickinson Infusion Therapy 510(k) NO: K173354(Third Party - Traditional)
ATTN: Henry  Boland               PHONE NO : 801 5652300 
9450 South State Street           SE DECISION MADE: 15-DEC-17
Sandy UT  84070                   510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: DC-30/DC-32/DC-28/DC-26/DC-25 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Meidcal Elect510(k) NO: K173369(Traditional)
ATTN: Jean  Lei                   PHONE NO : 86 0755 81885082 
Mindray Building, Keji 12th Road SSE DECISION MADE: 13-DEC-17
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TSV BellaTek Encode Healing Abutments
Biomet 3i                         510(k) NO: K173374(Traditional)
ATTN: Nichole  O’Neil             PHONE NO : 1 561 7766700 
4555 Riverside Drive              SE DECISION MADE: 13-DEC-17
Palm Beach Gardens FL  33410      510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Anterior Cervical Plate System
Evolution Spine, LLC              510(k) NO: K173375(Traditional)
ATTN: Douglas  Davis              PHONE NO : 469 6086582 
2300 N. Haskell                   SE DECISION MADE: 21-DEC-17
Dallas TX  75204                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pure-Vu System
Motus GI Medical Technologies Ltd.510(k) NO: K173392(Special)
ATTN: Hagit  Ephrath              PHONE NO : 1 561 3059029 
22 Keren Ha'yesod St.             SE DECISION MADE: 12-DEC-17
Tirat Carmel  IL 3902638          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GEM Premier 5000
Instrumentation Laboratory Co.    510(k) NO: K173403(Traditional)
ATTN: Carol  Marble               PHONE NO : 781 8614467 
180 Hartwell Road                 SE DECISION MADE: 29-DEC-17
Bedford MA  01730                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Radiomics App v1.0
Microsoft Corp.                   510(k) NO: K173420(Traditional)
ATTN: Ivan  Tarapov               PHONE NO : 425 5907761 
1 Microsoft Way                   SE DECISION MADE: 27-DEC-17
Redmond WA  98052                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 2MP Color LCD Monitor CL-S200, 3MP Color LCD Monitor CL-S300
JVC KENWOOD Corporation           510(k) NO: K173434(Traditional)
ATTN: Masafumi  Yugami            PHONE NO : 81 258 246611 
3-12, Moriya-cho, Kanagawa-ku     SE DECISION MADE: 14-DEC-17
Yokohama  JP 221-0022             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Neurosoft TMS (also CloudTMS)
TeleEMG, LLC                      510(k) NO: K173441(Special)
ATTN: Joe F. Jabre                PHONE NO : 617 8403253 
27 Arlington Rd., Building 2, UnitSE DECISION MADE: 13-DEC-17
Woburn MA  01801                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ORTHOFIX CHIMAERA Hip Fracture System - Trochanteric Nailing System
Orthofix Srl                      510(k) NO: K173458(Special)
ATTN: Gianluca  Ricadona          PHONE NO : 39 045 6719000 
Via Delle Nazioni 9               SE DECISION MADE: 07-DEC-17
Bussolengo  IT 37012              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Pain Relieve Device Model: LT5018C
Shenzhen Dongdixin Technology Co.,510(k) NO: K173462(Special)
ATTN: Siping  Yuan                PHONE NO : 0086 755 27652471 
No. 3 Building Xilibaimang XushengSE DECISION MADE: 08-DEC-17
Shenzhen  CN 51808                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advanced Diffusion Analysis (ADA) application
Philips Medical Systems Nederland 510(k) NO: K173467(Traditional)
ATTN: Yoram  Levy                 PHONE NO : 1 800 7229377 
Veenpluis 4-6 5684 PC Best        SE DECISION MADE: 12-DEC-17
Best Noord-Brabant  NL 5684 PC    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClotTriever Thrombectomy System, ClotTriever Catheter, ClotTriever Sheath
Inari Medical                     510(k) NO: K173470(Special)
ATTN: Eben  Gordon                PHONE NO : 949 6008433 
9272 Jeronimo Rd., Suite 124      SE DECISION MADE: 04-DEC-17
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merge PACS
Merge Healthcare Incorporated     510(k) NO: K173475(Traditional)
ATTN: Carol  Nakagawa             PHONE NO : 905 3648027 
900 Walnut Ridge Drive            SE DECISION MADE: 08-DEC-17
Hartland WI  53029                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Crystalsert Lens Delivery System
Bausch & Lomb, Inc                510(k) NO: K173480(Special)
ATTN: Gary  Rauvola               PHONE NO : 636 2263402 
3365 Tree Ct. Industrial Blvd.    SE DECISION MADE: 11-DEC-17
St. Louis MO  63122               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CorticaLINK Spinal Fusion Platform
LinkSPINE Inc                     510(k) NO: K173484(Special)
ATTN: Nickolas  Kriska            PHONE NO : 410 7725465 
5950 Symphony Woods Road, Suite 62SE DECISION MADE: 11-DEC-17
Columbia MD  21044                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRDx BCR-ABL Test, MRDx BCR-ABL Test Software
MolecularMD Corporation           510(k) NO: K173492(Traditional)
ATTN: Kevin  Hawkins              PHONE NO : 877 4594979 
1341 SW Custer Drive              SE DECISION MADE: 22-DEC-17
Portland OR  97219                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Alere Scarborough, Inc.           510(k) NO: K173502(Special)
ATTN: Benjamin  Crystal           PHONE NO : 207 7305820 
10 Southgate Road                 SE DECISION MADE: 13-DEC-17
Scarborough ME  04074             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ANAX 5.5™ Spinal System
U&I Corporation                   510(k) NO: K173524(Special)
ATTN: Jee Ae Bang                 PHONE NO : 82 31 8606846 
20, Sandan-ro 76beon-gil(Rd)      SE DECISION MADE: 13-DEC-17
Uijeongbu-si  KR 11781            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Raider Guidewire
Vascular Solutions, Inc.          510(k) NO: K173532(Third Party - Traditional)
ATTN: Beka  Vite                  PHONE NO : 763 6575732 
6464 Sycamore Court North         SE DECISION MADE: 15-DEC-17
Minneapolis MN  55369             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: T2Candida 1.1 Panel
T2 Biosystems, Inc.               510(k) NO: K173536(Special)
ATTN: Anne Marie Whalen           PHONE NO : 781 7614647 
101 Hartwell Avenue               SE DECISION MADE: 12-DEC-17
Lexington MA  02421               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Care Cleaning & Disinfecting Solution, AOCup Lens Case with AODisc
Alcon Laboratories, Inc.          510(k) NO: K173538(Special)
ATTN: Katryna  Warren             PHONE NO : 817 6155076 
6201 South Freeway                SE DECISION MADE: 04-DEC-17
Fort Worth TX  76134-2099         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Akros FibuLink™ Syndesmosis Repair Kit
Akros Medical                     510(k) NO: K173550(Special)
ATTN: Charles  Horrell            PHONE NO : 248 2595535 
3503 Pleasant Green Rd            SE DECISION MADE: 14-DEC-17
Durham NC  27705                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: LOGIQ E10
GE Healthcare                     510(k) NO: K173555(Traditional)
ATTN: Bryan  Behn                 PHONE NO : 262 2475502 
9900 Innovation Drive             SE DECISION MADE: 20-DEC-17
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Biograph mCT Family of PET/CT Systems
Siemens Medical Solutions USA, Inc510(k) NO: K173578(Special)
ATTN: Tabitha  Estes              PHONE NO : 865 2182421 
810 Innovation Drive              SE DECISION MADE: 20-DEC-17
Knoxville TN  37932               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Amira
Siemens Medical Solutions USA, Inc510(k) NO: K173600(Special)
ATTN: Martin  Rajchel             PHONE NO : 610 4486545 
40 Liberty Boulevard Mail Code 65-SE DECISION MADE: 19-DEC-17
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optima XR646 HD
GE Hualun Medical Systems Co., Ltd510(k) NO: K173612(Special)
ATTN: Kenny  Ma                   PHONE NO : 0086 10 57388715 
No.1 Yong Chang North Road, EconomSE DECISION MADE: 11-DEC-17
Beijing  CN 100176                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ACUSON AcuNav Volume Intracardiac Echocardiography Catheter
Siemens Medical Solutions USA, Inc510(k) NO: K173618(Special)
ATTN: HyunJung  Lee               PHONE NO : 425 2815061 
685 East Middlefield Road         SE DECISION MADE: 19-DEC-17
Mountain View CA  94043           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advocate PTA Catheter
Merit Medical Systems Inc.        510(k) NO: K173621(Traditional)
ATTN: Mark  Mullaney              PHONE NO : 353 91 703700 3061
Parkmore Business Park West       SE DECISION MADE: 13-DEC-17
Galway  IE                        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FS Ergo
PaloDEx Group Oy                  510(k) NO: K173646(Traditional)
ATTN: Anni  Lundholm              PHONE NO : 358 10 2702000 
Nahkelantie 160                   SE DECISION MADE: 19-DEC-17
Tuusula  FI 04300                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Piccolo Composite Nailing System
CarboFix Orthopedics Ltd.         510(k) NO: K173652(Special)
ATTN: Yael  Rubin                 PHONE NO : 972 9 9511511 
11 Ha'hoshlim St.                 SE DECISION MADE: 28-DEC-17
Herzeliya  IL 4672411             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: speX Support Catheter
ReFlow Medical, Inc.              510(k) NO: K173662(Special)
ATTN: Rebecca K Pine              PHONE NO : 760 2905178 
1003 Calle Sombra                 SE DECISION MADE: 20-DEC-17
San Clemente CA  92673            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medtronic O-arm O2 Imaging System
Medtronic Inc.                    510(k) NO: K173664(Special)
ATTN: Dean  Honkonen              PHONE NO : 978 6986065 
300 Foster St                     SE DECISION MADE: 29-DEC-17
Littleton MA  01460               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Peel-Away Introducer Set
Cook Incorporated                 510(k) NO: K173685(Special)
ATTN: Colin  Jacob                PHONE NO : 812 3353575 104965
750 Daniels Way P.O. Box 489      SE DECISION MADE: 20-DEC-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Strange Bile Duct Stone Exploration Set
Cook Incorporated                 510(k) NO: K173687(Traditional)
ATTN: Colin  Jacob                PHONE NO : 812 3353575 104965
750 Daniels Way, P.O. Box 489     SE DECISION MADE: 15-DEC-17
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TBL-ABI System
LD Technology LLC                 510(k) NO: K173696(Special)
ATTN: Albert  Maarek              PHONE NO : 305 3799900 
100 N. Biscayne Blvd Suite 502    SE DECISION MADE: 19-DEC-17
Miami FL  33132                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    


         TOTAL 510(k)s THIS PERIOD   255                                     
         TOTAL WITH SUMMARIES        243                                     
         TOTAL WITH STATEMENTS        12
                                      

Page Last Updated: 03/22/2018
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