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  1. 510(k) Clearances

January 2019 510(K) Clearances

510(K) SUMMARIES OR 510(K) STATEMENTS FOR FINAL
DECISIONS RENDERED DURING THE PERIOD January 2019


DEVICE: Greenmedi Safety Filter Syringe
Sang-A Frontec Co., Ltd           510(k) NO: K173743(Traditional)
ATTN: Park  Sung-soon             PHONE NO : 82 32 4517854 
18, Namdong-daero 369beon-gil, NamSE DECISION MADE: 28-JAN-19
Incheon  KR 21629                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Disposable Ultra Reinforced Surgical Gown
Xiantao Rayxin Medical Products Co510(k) NO: K173847(Traditional)
ATTN: Liang  Zhang                PHONE NO : 86 728 2617592 
No. 258 Pengchang Road, Middle StrSE DECISION MADE: 16-JAN-19
Xiantao  CN 433018                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Safe Secure Sterilization Pouches and Rolls
Safe Secure Packing Co., Ltd.     510(k) NO: K180139(Traditional)
ATTN: Howard  Jia                 PHONE NO : 86 755 27040468 
Yaoshan Industrial Park Xiegang ToSE DECISION MADE: 03-JAN-19
Dongguan City  CN 523601          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ritter Dental Implant System
Ritter Implants GmbH & Co. KG     510(k) NO: K180183(Traditional)
ATTN: Wemer  Schmitz              PHONE NO : 49 7351 5292561 
Gruner Weg 32                     SE DECISION MADE: 24-JAN-19
Biberach  DE 88400                510(k) STATEMENT
                                                    

DEVICE: BIO-C TEMP
Angelus Industria de Produtos Odon510(k) NO: K180199(Traditional)
ATTN: Paulo Sergio Calixto de OlivPHONE NO : 55 43 21013205 
Rua Waldir Landgraf, 101          SE DECISION MADE: 04-JAN-19
Londrina  BR 86031-218            510(k) STATEMENT
                                                    

DEVICE: II-Type Intervertebral Spacer
Paonan Biotech Co., Ltd.          510(k) NO: K180228(Traditional)
ATTN: Vivi  Tsai                  PHONE NO : 886 2 26274366 
3F, No. 50, Lane 258, Rueiguang RdSE DECISION MADE: 11-JAN-19
Taipei  TW 11491                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RESCAN 700, CALLISTO eye
Carl Zeiss Meditec AG             510(k) NO: K180229(Traditional)
ATTN: Christian  Muenster         PHONE NO : 49 7364 206985 
Goeschwitzer Str. 5 1-52          SE DECISION MADE: 11-JAN-19
Jena  DE 07745                    510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NEST Interbody System
Paonan Biotech Co., Ltd.          510(k) NO: K180230(Traditional)
ATTN: Tony  Lin                   PHONE NO : 886 2 26274366 
3F, No. 50, Lane 258, Rueiguang RdSE DECISION MADE: 25-JAN-19
Taipei City  TW 11491             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VR Medical Feeding Tube and Enteral Feeding Extension Set (EFES)
VR MEDICAL TECHNOLOGY CO., LTD    510(k) NO: K180236(Traditional)
ATTN: Lee  Pan                    PHONE NO : 86 512 57200500 
No. 90 Gaoxin Rd.                 SE DECISION MADE: 18-JAN-19
Zhouzhuang  CN 215325             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Advocate Non-Contact Infrared Thermometer
BroadMaster Biotech, Corp.        510(k) NO: K180355(Traditional)
ATTN: Ke-Min  Jen                 PHONE NO : 886 3 4517600 
1F., 2F., No. 91, Xiyuan Rd., ZhonSE DECISION MADE: 10-JAN-19
Taoyuan  TW 32057                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Ear Thermometer
HeTaiDa Technology Co., Ltd.      510(k) NO: K180387(Traditional)
ATTN: Tom  Chen                   PHONE NO : 86 769 82658050 
4F, BaiShiDa High-Tech Park, XiangSE DECISION MADE: 10-JAN-19
Foshan City  CN 523820            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Dosis SAM
Dosis, Inc.                       510(k) NO: K180410(Traditional)
ATTN: Divya  Chhabra              PHONE NO : 650 3830186 
4388 El Camino Real, Unit 330     SE DECISION MADE: 16-JAN-19
Los Altos CA  94022               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Arm Blood Pressure Monitor
Alicn Medical (Shenzhen), Inc     510(k) NO: K180435(Traditional)
ATTN: Meisong  Fang               PHONE NO : 86 755 26501548 
4/F, B Building, Shenfubao Modern SE DECISION MADE: 03-JAN-19
Shezhen  CN 518122                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Straumann PURE Ceramic Implant System
Institut Straumann AG             510(k) NO: K180477(Traditional)
ATTN: Pierre-Yves  Calinon        PHONE NO : 41 61 9651260 
Peter Merian-Weg 12               SE DECISION MADE: 04-JAN-19
Basel  CH CH-4002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
Medentika GmbH                    510(k) NO: K180564(Traditional)
ATTN: Gerhard  Polzer             PHONE NO : 049 7229 6991216 
Hammweg 8-10                      SE DECISION MADE: 07-JAN-19
Huegelsheim  DE 76549             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Silverlon Island Wound Dressing, Silverlon Wound Pad Dressing (also known as Silverlon Burn Pad Dressing)
Argentum Medical, LLC             510(k) NO: K180570(Traditional)
ATTN: Paul  Boentges              PHONE NO : 630 2322507 
2571 Kaneville CT                 SE DECISION MADE: 14-JAN-19
Geneva IL  60134                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Park Dental Research Aligners
Park Dental Research Corporation  510(k) NO: K180648(Traditional)
ATTN: Ronald A. Bulard            PHONE NO : 800 2437372 
2401 N. Commerce St Suite E       SE DECISION MADE: 08-JAN-19
Ardmore OK  73401                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FEMON Banana Thermometer
Life Science Technology Inc.      510(k) NO: K180767(Traditional)
ATTN: Jaewoo  Jun                 PHONE NO : 82 70 86208021 
Suite B-1207, Gangseo Hangang Xi TSE DECISION MADE: 22-JAN-19
Seoul  KR 07528                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Savina 300
Dragerwerk AG & CO. KGaA          510(k) NO: K180779(Traditional)
ATTN: Dr. Bettina  Mobius         PHONE NO : 49 451 8824100 
Moislinger Allee 53-55            SE DECISION MADE: 17-JAN-19
Lubeck  DE 23558                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: microINR System
iLine Microsystems S.L.           510(k) NO: K180780(Traditional)
ATTN: Alberto  Molinero           PHONE NO : 34 688 710638 
Paseo Mikeletegi, 69. Planta 1.   SE DECISION MADE: 25-JAN-19
Donostia-San Sebastian  ES 20009  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VariLift-LX Interbody Fusion System, VariLift-C Interbody Fusion System
Wenzel Spine, Inc.                510(k) NO: K180822(Traditional)
ATTN: Beckinam  Nowatzke          PHONE NO : 512 3148271 
1130 Rutherford Lane, Suite 200   SE DECISION MADE: 28-JAN-19
Austin TX  78753                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CONTEC Oxygen Concentrator
Contec Medical System Co., Ltd.   510(k) NO: K180837(Traditional)
ATTN: Xueyong  Li                 PHONE NO : 86 355 8015490 
No. 112 Qinhuang West Street, EconSE DECISION MADE: 10-JAN-19
Qinhuangdao  CN 066004            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MediPines Gas Exchange Monitor (GEM), Accessory Mouthpiece Disposable Assembly
MediPines Corporation             510(k) NO: K180902(Traditional)
ATTN: Steve  Lee                  PHONE NO : 714 7699154 
155 N Riverview Drive             SE DECISION MADE: 11-JAN-19
Anaheim CA  92808                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Responsive Arthroscopy Suture Anchor System
Responsive Arthroscopy LLC        510(k) NO: K180951(Traditional)
ATTN: Doug  Kohrs                 PHONE NO : 858 7201847 
701 N. 3rd Street, Suite 202      SE DECISION MADE: 03-JAN-19
Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Maxcon Two Gallon Chemotherapy Container
Ningbo Maxcon Medical Technology C510(k) NO: K180983(Traditional)
ATTN: Yang  Song                  PHONE NO : 008 657 455 011910
No.30 Dongbei Road/No.228 Dong XinSE DECISION MADE: 03-JAN-19
Ningbo  CN 315157                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Maxcon Sharps Container
Ningbo Maxcon Medical Technology C510(k) NO: K180984(Traditional)
ATTN: Yang  Song                  PHONE NO : 008 657 455 011910
No.30 Dongbei Road/No.228 Dong XinSE DECISION MADE: 03-JAN-19
Ningbo  CN 315157                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free White, Blue Sterilized Nitrile Copolymer Surgical Gloves Tested  for Use with Chemotherapy Drugs
Smart Glove Corporation Sdn.Bhd.  510(k) NO: K181047(Traditional)
ATTN: Khon Pu Foo                 PHONE NO : 603 32916100 
Lot 6487, Batu 5 3/4, Sementa, JalSE DECISION MADE: 09-JAN-19
Klang  MY 42100                   510(k) STATEMENT
                                                    

DEVICE: Neo Cage System TM
Neo Medical S.A.                  510(k) NO: K181048(Traditional)
ATTN: Jonas  Larsson              PHONE NO : 41 225483880 
Route de Lausanne 157 A           SE DECISION MADE: 29-JAN-19
Villette  CH 1096                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Care Orchestrator
Respironics Inc.                  510(k) NO: K181053(Traditional)
ATTN: Ankitha  Rao                PHONE NO : 724 3877442 
1001 Murry Ridge Lane             SE DECISION MADE: 04-JAN-19
Murrysville PA  15668             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed CS Diagnostic Electrophysiology Catheter
Stryker Sustainability Solutions  510(k) NO: K181056(Traditional)
ATTN: Mia  McCorkel               PHONE NO : 480 3431855 
1810 W. Drake Drive               SE DECISION MADE: 24-JAN-19
Tempe AZ  85283                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIRA RFA Electrosurgical Device
Innoblative Designs, Inc.         510(k) NO: K181071(Traditional)
ATTN: Tyler  Wanke                PHONE NO : 920 4507529 
4660 Ravenswood Avenue            SE DECISION MADE: 16-JAN-19
Chicago IL  60640                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Responsive Arthroscopy Wedge Push-In Suture Anchors
Responsive Arthroscopy LLC        510(k) NO: K181076(Traditional)
ATTN: Doug  Kohrs                 PHONE NO : 858 7201847 
701 N. 3rd Street, Suite 202      SE DECISION MADE: 18-JAN-19
Minneapolis MN  55401             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Video Colonoscopes (EC Family)
PENTAX of America, Inc.           510(k) NO: K181084(Traditional)
ATTN: James W. Monroe             PHONE NO : 201 5712300 2129
3 Paragon Drive                   SE DECISION MADE: 18-JAN-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cortical Fixation Systems
Cousin Biotech S.A.S.             510(k) NO: K181086(Traditional)
ATTN: Mathilde  Collet            PHONE NO : 011 33 320144130 
8 Rue De L'abbe Bonpain           SE DECISION MADE: 09-JAN-19
Wervicq-Sud  FR 59117             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Avenue P Cage System
Zimmer Biomet Spine, Inc.         510(k) NO: K181096(Traditional)
ATTN: Alex  Pawlowski             PHONE NO : 303 5331062 
10225 Westmoor Drive              SE DECISION MADE: 15-JAN-19
Westminster CO  80021             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cook Cystostomy Catheter Set
Cook Incorporated                 510(k) NO: K181097(Traditional)
ATTN: Danlu  Chen                 PHONE NO : 812 3353575 104851
750 Daniels Way, P.0. Box 489     SE DECISION MADE: 18-JAN-19
Bloomington IN  47402             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bright Guard
Koncept Innovators, LLC.          510(k) NO: K181099(Traditional)
ATTN: Sylvan  Newby               PHONE NO : 843 9454031 
1619 Executive Ave                SE DECISION MADE: 18-JAN-19
Myrtle Beach SC  29577            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Powder Free Nitrile Patient Examination Gloves, Blue Color
JiangSu DongXin Medical Technology510(k) NO: K181106(Traditional)
ATTN: Deng  Yujie                 PHONE NO : 
LongJin Road, The Economic DevelopSE DECISION MADE: 16-JAN-19
Suqian  CN 223800                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reliance Lumbar IBF System
Reliance Medical Systems          510(k) NO: K181118(Traditional)
ATTN: Bret M Berry                PHONE NO : 801 2953280 
545 West 500 South Suite 100      SE DECISION MADE: 09-JAN-19
Bountiful UT  84010               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Reprocessed Visions PV .035 Digital IVUS Catheter
Innovative Health, LLC            510(k) NO: K181126(Traditional)
ATTN: Amanda  Babcock             PHONE NO : 480 5255911 
1435 North Hayden Road, Suite 100 SE DECISION MADE: 18-JAN-19
Scottsdale AZ  85257              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EndoRotor Console, EndoRotor Catheters, EndoRotor Specimen Trap, EndoRotor Filter Set, EndoRotor Foot Control
Interscope, Inc.                  510(k) NO: K181127(Traditional)
ATTN: Jeffery  Ryan               PHONE NO : 1 877 4207299 
100 Main Street, Suite 108        SE DECISION MADE: 03-JAN-19
Whitinsville MA  01588            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: STRONG Dental Handpieces
Saeshin Precision Co., Ltd.       510(k) NO: K181129(Traditional)
ATTN: Choi  Jong Woo              PHONE NO : 82 53 5872345 
52, Secheon-ro 1-gil, Dasa-eup, DaSE DECISION MADE: 31-JAN-19
Daegu  KR 42921                   510(k) STATEMENT
                                                    

DEVICE: Immunalysis SEFRIA PCP Oral Fluid Enzyme Immunoassay
Immunalysis Corporation           510(k) NO: K181135(Traditional)
ATTN: Wenying (Jessica)  Zhu      PHONE NO : 909 4820480 
829 Towne Center Drive            SE DECISION MADE: 24-JAN-19
Pomona CA  91767                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OSSIO™ Pin Product Family
Ossio Ltd.                        510(k) NO: K181180(Traditional)
ATTN: Taly  Lindner               PHONE NO : 972 4 9986600 
8 HaTochen St.                    SE DECISION MADE: 10-JAN-19
Caesarea  IL 3088900              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pinehurst Anterior Cervical Plate System
Signature Orthopaedics Pty Ltd.   510(k) NO: K181190(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 17-JAN-19
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: RENASYS Y-Connector; RENASYS TOUCH
Smith & Nephew Medical Limited    510(k) NO: K181204(Traditional)
ATTN: Sam  Greenhalgh             PHONE NO : 44 1482673436 
101 Hessle Road                   SE DECISION MADE: 10-JAN-19
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Infrared Thermometer
Shenzhen Finicare Co., Ltd.       510(k) NO: K181215(Traditional)
ATTN: Chao  Li                    PHONE NO : 86 755 23013503 
Room201, A Building NO. 1 Qianwan SE DECISION MADE: 02-JAN-19
Shenzhen  CN 518052               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: G3A 40 Bone Cement
G21 S.r.l                         510(k) NO: K181282(Traditional)
ATTN: Filippo  Foroni             PHONE NO : 39 053530312 
Via Sandro Petrini, 8             SE DECISION MADE: 09-JAN-19
San Possidonio  IT 41039          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Bodycad Unicompartmental Knee System
Bodycad Laboratories Inc.         510(k) NO: K181302(Abbreviated)
ATTN: Marc  Chaunet               PHONE NO : 418 5271388 
2035, rue du Haut-Bord            SE DECISION MADE: 17-JAN-19
Quebec City  CA G1N 4R7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Nexel Total Elbow, Connrad/Morrey Total Elbow
Zimmer Inc                        510(k) NO: K181307(Traditional)
ATTN: Patricia Sandborn Beres     PHONE NO : 574 2676639 
P.O. Box 708                      SE DECISION MADE: 28-JAN-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Imboki Knee Instrument System
Signature Orthopaedics Pty Ltd.   510(k) NO: K181338(Traditional)
ATTN: Declan  Brazil              PHONE NO : 61 2 94285181 
7 Sirius Road                     SE DECISION MADE: 17-JAN-19
Lane Cove  AU 2066                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PROSTEP MICA Screw System
Wright Medical Technology, Inc.   510(k) NO: K181377(Special)
ATTN: Val  Myles                  PHONE NO : 901 2905162 
1023 Cherry Road                  SE DECISION MADE: 11-JAN-19
Memphis TN  38117                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pre-Formed Penile Silicone Block
International Medical Devices, Inc510(k) NO: K181387(Traditional)
ATTN: James  Elist                PHONE NO : 310 6522600 
717 North Maple Drive             SE DECISION MADE: 23-JAN-19
Beverly Hills CA  90210           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CLARUS
Carl Zeiss Meditec, Inc.          510(k) NO: K181444(Traditional)
ATTN: Saurabh  Jamkhindikar       PHONE NO : 925 5574696 
5160 Hacienda Drive               SE DECISION MADE: 10-JAN-19
Dublin CA  94568                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: URETERO-RENO VIDEOSCOPE OLYMPUS URF-V3/V3R, URETERO-RENO FIBERSCOPE OLYMPUS URF-P7/P7R
Olympus Medical Systems Corp.     510(k) NO: K181451(Traditional)
ATTN: Toshiyuki  Nakajima         PHONE NO : 81 42 6422694 
2951 Ishikawa-cho                 SE DECISION MADE: 16-JAN-19
Hachioji-Shi  JP 192-8507         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Rapid-i™ Kit
Vitrolife Sweden AB               510(k) NO: K181461(Traditional)
ATTN: Nina  Arvidsson             PHONE NO : 46 31 7218000 
Gustaf Werners gata 2             SE DECISION MADE: 04-JAN-19
Vastra Frolunda  SE 421 32        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Estremo Citieffe Nailing System
CITIEFFE S.r.L.                   510(k) NO: K181540(Traditional)
ATTN: Stefano  Pullega            PHONE NO : 0039 051 721850 
Via Armaroli, 21                  SE DECISION MADE: 16-JAN-19
Calderara di Reno  IT 40012       510(k) STATEMENT
                                                    

DEVICE: Cortex CAD/CAM Abutments
Cortex Dental Implants Industries 510(k) NO: K181580(Traditional)
ATTN: Ronit  Polack               PHONE NO : 972 4 9873970 105
Shlomi Industrial Estate          SE DECISION MADE: 29-JAN-19
Shlomi  IL 22832                  510(k) STATEMENT
                                                    

DEVICE: DC-70/DC-70T/DC-70 Pro/DC-70 Exp/DC-75/DC-78/DC-70S Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K181637(Traditional)
ATTN: Zhang  Wei                  PHONE NO : 86 755 81885655 
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 09-JAN-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AeroChamber Plus* Flow-Vu* Anti-Static Valved Holding Chamber (VHC)
Trudell Medical International     510(k) NO: K181649(Traditional)
ATTN: Marianne  Tanton            PHONE NO : 519 4557060 
725 Third Street                  SE DECISION MADE: 11-JAN-19
London  CA N5V 5G4                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Raycell MK1
Best Theratronics Limited         510(k) NO: K181737(Traditional)
ATTN: Mojgan  Soleimani           PHONE NO : 613 5912100 
413 March Road                    SE DECISION MADE: 02-JAN-19
Ottawa  CA k2k 0e4                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Quantum Blood and IV Fluid Infusion Warmer
Life Warmer, Inc.                 510(k) NO: K181775(Traditional)
ATTN: John  Pettini               PHONE NO : 888 6896277 
840 F. Avenue Suite 104           SE DECISION MADE: 28-JAN-19
Plano TX  75074                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: UV Phototherapy
Xuzhou Kernel Medical Equipment Co510(k) NO: K181805(Traditional)
ATTN: Jing  Wang                  PHONE NO : 86 516 87732208 
Kernel Mansion, Economic DevelopmeSE DECISION MADE: 11-JAN-19
Xuzhou  CN 221004                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polaris RF Ablation System
Baylis Medical Company Inc.       510(k) NO: K181864(Traditional)
ATTN: May  Tsai                   PHONE NO : 1 905 6024875 
2775 Matheson Blvd. East          SE DECISION MADE: 02-JAN-19
Mississauga  CA L4W 4P7           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AMD Anti-Fog Solution
Advanced Medical Design Co., Ltd  510(k) NO: K181887(Traditional)
ATTN: Silvia  Yeh                 PHONE NO : 886 222 902627 508
4-5F, No 29, Wuquan 5th Rd., Wugu SE DECISION MADE: 22-JAN-19
New Taipei City  TW 24888         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T-PLUS
Wintecare SA                      510(k) NO: K181893(Traditional)
ATTN: Claudio  Freti              PHONE NO : 41 091 2255229 
Via Livio 12                      SE DECISION MADE: 29-JAN-19
Chiasso  CH 6830                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kurin PIV Blood Collection Set with High Pressure
Kurin, Inc                        510(k) NO: K181895(Traditional)
ATTN: Bob  Rogers                 PHONE NO : 760 6126090 
10840 Thornmint Road, Suite 111   SE DECISION MADE: 18-JAN-19
San Diego CA  92127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTA2.3 MATERIALS
NuSmile, LTD.                     510(k) NO: K181917(Traditional)
ATTN: Alafiz  Prasla              PHONE NO : 713 8610033 559
3315 W 12th Street                SE DECISION MADE: 11-JAN-19
Houston TX  77008                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Masimo MightySat Rx Fingertip Pulse Oximeter
Masimo Corporation                510(k) NO: K181956(Traditional)
ATTN: Kelly  Nguyen               PHONE NO : 949 2977919 
52 Discovery                      SE DECISION MADE: 23-JAN-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AQrate Robotic Assistance System
Globus Medical Inc.               510(k) NO: K182000(Traditional)
ATTN: Kelly J. Baker              PHONE NO : 610 9301800 1670
2560 General Armistead Avenue     SE DECISION MADE: 29-JAN-19
Audubon PA  19403                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProgenaMatrix
Cell Constructs I, LLC            510(k) NO: K182010(Traditional)
ATTN: Elizabeth  O'Keeffe         PHONE NO : 770 6272547 
7828 Hickory Flat Highway Suite 12SE DECISION MADE: 17-JAN-19
Woodstock GA  30188               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ClearUP Sinus Pain Relief
Tivic Health Systems Inc.         510(k) NO: K182025(Traditional)
ATTN: Nina  Peled                 PHONE NO : 650 4540322 
750 Menlo Ave #200                SE DECISION MADE: 02-JAN-19
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MiniCollect K2E K2EDTA Tubes
Greiner Bio-One NA Inc.           510(k) NO: K182078(Traditional)
ATTN: Manfred  Abel               PHONE NO : 704 2617823 
4238 Capital Drive                SE DECISION MADE: 25-JAN-19
Monroe NC  28110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZOLL ECG Analysis Software
ZOLL Manufacturing Corporation    510(k) NO: K182093(Traditional)
ATTN: Zachary  Nelson             PHONE NO : 412 9683333 14814
121 Gamma Drive                   SE DECISION MADE: 28-JAN-19
Pittsburgh PA  15238              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DL Self-adhesive Electrode
Shaoxing DL Healthcare Co., Ltd.  510(k) NO: K182111(Traditional)
ATTN: Zhao  Qingya                PHONE NO : 86 575 82181757 
Jiulin Land, Baiguan Street, ShangSE DECISION MADE: 17-JAN-19
Shaoxing  CN 312300               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FlareHawk Interbody Fusion System
Integrity Implants Inc            510(k) NO: K182114(Traditional)
ATTN: Lauren  Kamer               PHONE NO : 561 5293861 
850 Parkway Street                SE DECISION MADE: 07-JAN-19
Jupiter FL  33477                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Maxpower Relief
Omron Healthcare, Inc.            510(k) NO: K182120(Traditional)
ATTN: Renee  Thornborough         PHONE NO : 847 2475626 
1925 West Field Court             SE DECISION MADE: 10-JAN-19
Lake Forest IL  60045             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: S-Line
BIO CETEC CO., LTD.               510(k) NO: K182193(Traditional)
ATTN: Hee See JIN                 PHONE NO : 82 2 7042876 
RM 1001-1002 New T Castle, 108, GaSE DECISION MADE: 22-JAN-19
Seoul  KR 08506                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Panoura X-ERA PF/NF/MF
The Yoshida Dental Mfg. Co., Ltd. 510(k) NO: K182198(Traditional)
ATTN: Hidenori  Watanabe          PHONE NO : 81 3 36312165 
1-3-6, Kotobashi                  SE DECISION MADE: 31-JAN-19
Sumida-ku  JP 130-8516            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: NFC-700 non-mydriatic auto fundus camera
Crystalvue Medical Corporation    510(k) NO: K182199(Traditional)
ATTN: Oliver  Lin                 PHONE NO : 88 63 3607711 
No.116, Ln.956, Zhongshan Rd., TaoSE DECISION MADE: 02-JAN-19
Taoyuan  TW 33072                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SLEEPAPP
Comfort Acrylics, Inc.            510(k) NO: K182202(Abbreviated)
ATTN: Richard W. Moore            PHONE NO : 360 8349218 
2103 NE 272nd Ave.                SE DECISION MADE: 11-JAN-19
Camas WA  98607                   510(k) STATEMENT
                                                    

DEVICE: TiWAVE-L Porous Titanium Lumbar Cage
Kalitec Medical, LLC              510(k) NO: K182210(Traditional)
ATTN: Scott  Winn                 PHONE NO : 407 5452063 
617 E. South Street, Suite 500    SE DECISION MADE: 07-JAN-19
Orlando FL  32801                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aurora Surgiscope System
Rebound Therapeutics Corporation  510(k) NO: K182211(Traditional)
ATTN: Jane  Metcalf               PHONE NO : 949 3058111 
13900 Alton Parkway               SE DECISION MADE: 18-JAN-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Geo Staple System
Gramercy Extremity Orthopedics, LL510(k) NO: K182212(Traditional)
ATTN: Michael P. Simpson          PHONE NO : 972 8244624 
1239 N. Glenville Dr              SE DECISION MADE: 11-JAN-19
Richardson TX  75081              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Esprit Nova
Neurozone MSH Incorporated        510(k) NO: K182227(Traditional)
ATTN: Daniel Ramirez Rodriguez    PHONE NO : 1 289 2389696 
17 Lantern Lane                   SE DECISION MADE: 17-JAN-19
Dundas  CA L9H 6N9                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MIS LOCKiT Abutments System, OT-Equators and Ball Attachments
MIS Implants Technologies Ltd.    510(k) NO: K182228(Traditional)
ATTN: Arbel  Shezaf               PHONE NO : 972 4 9016800 
P.O. Box 7, Bar Lev Industrial ParSE DECISION MADE: 28-JAN-19
Bar Lev Industrial Park  IL 201560510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tyber Medical PT Interbody Spacer
Tyber Medical LLC                 510(k) NO: K182284(Traditional)
ATTN: Mark F. Schenk              PHONE NO : 610 8490645 
83 South Commerce Way, Suite 310  SE DECISION MADE: 18-JAN-19
Bethlehem PA  18017               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surveyor S2
Mortara Instrument Inc            510(k) NO: K182297(Traditional)
ATTN: Marco  Manduchi             PHONE NO : 414 3541600 
7865 North 86th Street            SE DECISION MADE: 24-JAN-19
Milwaukee WI  53224               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Stryker Facial iD Plating System
Stryker                           510(k) NO: K182305(Traditional)
ATTN: Zainab  Amini               PHONE NO : 269 3898349 
750 Trade Centre Way - Suite 200  SE DECISION MADE: 07-JAN-19
Portage MI  49002                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Small Bone Phantom® Intramedullary Nail System; TTC Phantom® Intramedullary Nail System
Paragon 28, Inc                   510(k) NO: K182307(Traditional)
ATTN: Eric  Lintula               PHONE NO : 888 7281888 
4B Inverness Ct. E, Ste 280       SE DECISION MADE: 14-JAN-19
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zyppah Anti-Snoring Device
Always More Marketing             510(k) NO: K182312(Traditional)
ATTN: Jonathan  Greenburg         PHONE NO : 818 4144817 
24981 Palmilla Drive              SE DECISION MADE: 24-JAN-19
Calabasas CA  91302               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PICO 7Y Single Use Negative Pressure Wound Therapy System
Smith & Nephew Medical Limited    510(k) NO: K182323(Traditional)
ATTN: Shruthi  Bhat               PHONE NO : 44 1482 225181 
101 Hessle Road                   SE DECISION MADE: 18-JAN-19
Hull  GB HU3 2BN                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Patient Cables and Leadwires , Disposable ECG Leadwires
Orantech Inc.                     510(k) NO: K182327(Traditional)
ATTN: Hsin  Xiong                 PHONE NO : 86 755 23699939 
Zone#A, 4F, 1st Bld, 7th IndustriaSE DECISION MADE: 30-JAN-19
Shenzhen  CN 518106               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BTL-703
BTL Industries, Inc.              510(k) NO: K182363(Traditional)
ATTN: David  Chmel                PHONE NO : 1 866 2851656 
362 Elm Street                    SE DECISION MADE: 24-JAN-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DIASAFEplusUS
Fresenius Medical Care Renal Thera510(k) NO: K182367(Traditional)
ATTN: Denise  Oppermann           PHONE NO : 781 6994479 
920 Winter Street                 SE DECISION MADE: 10-JAN-19
Waltham MA  02451                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sysmex XN-L Automated Hematology Analyzer
Sysmex America, Inc.              510(k) NO: K182389(Traditional)
ATTN: Sharita  Brooks             PHONE NO : 224 5439618 
577 Aptakisic Road.               SE DECISION MADE: 25-JAN-19
Lincolnshire IL  60069            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Applied Tissue Technologies PWD™ Platform Wound Dressing
Applied Tissue Technologies LLC   510(k) NO: K182409(Traditional)
ATTN: Michael  Broomhead          PHONE NO : 781 3663848 
99 Derby St., Suite 700           SE DECISION MADE: 11-JAN-19
Hingham MA  02043                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Senhance Ultrasonic System
TransEnterix, Inc.                510(k) NO: K182421(Traditional)
ATTN: Stephanie M. Fitts          PHONE NO : 1 919 7658400 
635 Davis Drive Suite 300         SE DECISION MADE: 11-JAN-19
Morrisville NC  27650             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TruShot with Y-Knot Shallow All-Suture Anchor
ConMed Corporation                510(k) NO: K182439(Traditional)
ATTN: Diana L. Nader-Martone      PHONE NO : 727 3995425 
525 French Road                   SE DECISION MADE: 08-JAN-19
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ICOONE h (also referred to as ICOONE LASER and ICOONE –h LASER)
I-TECH INDUSTRIES SRL             510(k) NO: K182453(Abbreviated)
ATTN: Paolo  Abbreviato           PHONE NO : 39 051 6259797 
Via Cicogna 34/b                  SE DECISION MADE: 11-JAN-19
San Lazzaro di Savena  IT 40068   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Study Watch
Verily Life Sciences LLC          510(k) NO: K182456(Traditional)
ATTN: Shilpa  Mydur               PHONE NO : 415 7360652 
269 E Grand Avenue                SE DECISION MADE: 17-JAN-19
South San Francisco CA  94080     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cervical Spacer
Additive Implants, LLC            510(k) NO: K182477(Traditional)
ATTN: Jeff  Horn                  PHONE NO : 602 7958850 
3101 E. Shea Blvd, Suite 114      SE DECISION MADE: 28-JAN-19
Pheonix AZ  85028                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Whistler Modular Pedicle Screw System
Evolution Spine, LLC              510(k) NO: K182478(Traditional)
ATTN: Douglas  Davis              PHONE NO : 214 2286252 
4225 Office Parkway               SE DECISION MADE: 15-JAN-19
Dallas TX  75204                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Earlens Contact Hearing Aid
Earlens Corporation               510(k) NO: K182480(Traditional)
ATTN: Judith A. Brimacombe        PHONE NO : 650 7394462 
4045 Campbell Avenue              SE DECISION MADE: 25-JAN-19
Menlo Park CA  94025              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 4CIS® Pinehurst Anterior Cervical Plate system
Solco Biomedical Co., Ltd.        510(k) NO: K182489(Traditional)
ATTN: Il  Kim                     PHONE NO : 82 31 6644101 
154 Seotan-Ro, Seotan-Myeon       SE DECISION MADE: 16-JAN-19
Pyeongtaek  KR 17704              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: OsteoCool RF Ablation System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K182497(Traditional)
ATTN: Laveeda  Leflore            PHONE NO : 800 8763133 
1800 Pyramid Place                SE DECISION MADE: 15-JAN-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Catalyst CSR Press-Fit Humeral Components
Catalyst OrthoScience, Inc.       510(k) NO: K182500(Traditional)
ATTN: Dale  Davison               PHONE NO : 1 239 3259976 102
14710 Tamiami Trail North         SE DECISION MADE: 11-JAN-19
Naples FL  34110                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tigon Medical Tissue Anchors
Tigon Medical                     510(k) NO: K182507(Traditional)
ATTN: Jeremy  Clark               PHONE NO : 410 5442833 
517 Benfield Rd                   SE DECISION MADE: 21-JAN-19
Severna Park MD  21146            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Surgical Face Mask
Xiantao Zhibo Non-woven Products C510(k) NO: K182514(Traditional)
ATTN: Yao  Sanyu                  PHONE NO : 
NO.8 in Industrial Park, Hefeng RoSE DECISION MADE: 24-JAN-19
Xiantao  CN 430000                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MULTIX Impact
Siemens Medical Solutions, Inc.   510(k) NO: K182517(Traditional)
ATTN: Denise  Adams               PHONE NO : 610 4486139 
40 Liberty Boulevard, Mail Stop 65SE DECISION MADE: 11-JAN-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: AHMED ClearPath Glaucoma Drainage Device
New World Medical, Inc.           510(k) NO: K182518(Traditional)
ATTN: Mukesh  Sabarad             PHONE NO : 909 4664305 
10763 Edison Ct                   SE DECISION MADE: 18-JAN-19
Rancho Cucamonga CA  91730        510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FastPack IP Sex Hormone Binding Globulin Immunoassay
Qualigen, Inc.                    510(k) NO: K182521(Traditional)
ATTN: Wajdi  Abdul-Ahad           PHONE NO : 760 9189165 234
2042 Corte Del Nogal              SE DECISION MADE: 29-JAN-19
Carlsbad CA  92011                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ELAN 4 Tools
Aesculap, Inc.                    510(k) NO: K182527(Traditional)
ATTN: Kathy A. Racosky            PHONE NO : 610 9849291 
3773 Corporate Parkway            SE DECISION MADE: 19-JAN-19
Center Valley PA  18034           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Merit RadialFlo Arterial Catheter
Merit Medical Singapore Pte. Ltd. 510(k) NO: K182538(Abbreviated)
ATTN: Xing Ting Seow              PHONE NO : 65 6750 9188 
198 Yishun Avenue 7               SE DECISION MADE: 16-JAN-19
Singapore  SG 768926              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Tamper Evident Cap with Male Luer Lock
International Medical Industries, 510(k) NO: K182545(Traditional)
ATTN: Kathleen  Lavender          PHONE NO : 954 9179570 
2981 Gateway Drive                SE DECISION MADE: 11-JAN-19
Pompano Beach FL  33069           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Accucuff Cuff Pressure Indicator
Tianjin Medis Medical Device Co., 510(k) NO: K182548(Traditional)
ATTN: Yongzhi  Wu                 PHONE NO : 86 13 920213115 
No. 15-A, Saida One Avenue, XiqingSE DECISION MADE: 25-JAN-19
Tainjin  CN 300385                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System
STERIS Corporation                510(k) NO: K182568(Traditional)
ATTN: Bill  Brodbeck              PHONE NO : 440 3927690 
5960 Heisley Road                 SE DECISION MADE: 03-JAN-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Freedom Ultra-Congruent CR Tibial Liner
Maxx Orthopedics, Inc.            510(k) NO: K182574(Special)
ATTN: Priscilla  Herpai           PHONE NO : 484 3420092 
2460 General Armistead Avenue, SuiSE DECISION MADE: 22-JAN-19
Norristown PA  19403              510(k) STATEMENT
                                                    

DEVICE: E-CUBE i7
Alpinion Medical Systems Co., Ltd.510(k) NO: K182594(Traditional)
ATTN: Boyeon  Cho                 PHONE NO : 82 70 74652104 
5fl, i dong, 77, heungan-daero 81 SE DECISION MADE: 24-JAN-19
Anyang-si  KR 14117               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRI Compatibility for Existing Neodent Implant System
JJGC Industria e Comercio de Mater510(k) NO: K182620(Traditional)
ATTN: Julianne  Lachechem         PHONE NO : 41 61 9651260 
Av. P. Juscelino Kubitschek de OliSE DECISION MADE: 18-JAN-19
Curitiba  BR 81270-200            510(k) STATEMENT
                                                    

DEVICE: CrossFT Knotless Deep Thread Suture Anchor with Disposable Driver
ConMed Corporation                510(k) NO: K182621(Special)
ATTN: Diana L. Nader-Martone      PHONE NO : 727 3995425 
525 French Road                   SE DECISION MADE: 04-JAN-19
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Omnipod Insulin Management System, Omnipod DASH Insulin Management System
Insulet Corporation               510(k) NO: K182630(Traditional)
ATTN: Julie  Perkins              PHONE NO : 978 6007951 
600 Technology Park Drive, Suite 2SE DECISION MADE: 08-JAN-19
Billerica MA  01821               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HS30 Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K182632(Traditional)
ATTN: Jee Young Ju                PHONE NO : 82 2 21940861 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 08-JAN-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signal Catheter
Safe Medical Design               510(k) NO: K182635(Traditional)
ATTN: Raymond "Buzz"  Bonneau     PHONE NO : 1 650 2690048 
2722 Fulton Street                SE DECISION MADE: 10-JAN-19
San Francisco CA  94118           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DC-60/DC-60S/DC-60 Exp/DC-55 Diagnostic Ultrasound System
Shenzhen Mindray Bio-Medical Elect510(k) NO: K182636(Traditional)
ATTN: Jiang  Haosen               PHONE NO : 86 755 81886183 
Keji 12th Road South, Hi-tech InduSE DECISION MADE: 10-JAN-19
Shenzhen  CN 518057               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GenesisZr™ 4Y Zirconia
United Dental Resources Corporatio510(k) NO: K182642(Traditional)
ATTN: John Von Thaden             PHONE NO : 708 7465730 
70 Towncenter Drive               SE DECISION MADE: 25-JAN-19
University Park IL  60484         510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: X5 Series Digital Color Doppler Ultrasound System
Sonoscape Medical Corp.           510(k) NO: K182648(Traditional)
ATTN: Toki  Wu                    PHONE NO : 86 755 26722890 
4/f, 5/f, 8/f, 9/f & 10/f Yizhe buSE DECISION MADE: 29-JAN-19
Shenzhen  CN 518051               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HbA1c Advanced
Beckman Coulter Ireland Inc.      510(k) NO: K182651(Traditional)
ATTN: Catriona  Hourigan          PHONE NO : 353 65 6831417 
Lismeehan                         SE DECISION MADE: 16-JAN-19
O' Callaghan's Mills  IE V94 PP63 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Polygon Resection Device
Polygon Medical, Inc.             510(k) NO: K182675(Traditional)
ATTN: Ronald  Adams               PHONE NO : 775 8007300 
18 Hillside Drive                 SE DECISION MADE: 04-JAN-19
Holliston MA  01746               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BD MAX CTGCTV2, BD MAX System
Becton, Dickinson and Company     510(k) NO: K182692(Traditional)
ATTN: Katie  Edwards              PHONE NO : 410 3164975 
7 Loveton Circle                  SE DECISION MADE: 08-JAN-19
Sparks MD  21152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Choice Spine Navigation System
Choice Spine, LP.                 510(k) NO: K182721(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433969 
400 Erin Drive                    SE DECISION MADE: 08-JAN-19
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Trident HD Specimen Radiography System
Hologic, Inc.                     510(k) NO: K182727(Traditional)
ATTN: Meghan  Wakeford            PHONE NO : 203 7027819 
36 Apple Ridge Road               SE DECISION MADE: 10-JAN-19
Danbury CT  06810                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SculpSure
Cynosure                          510(k) NO: K182741(Traditional)
ATTN: Amy  Tannenbaum             PHONE NO : 781 9932454 
5 Carlisle Road                   SE DECISION MADE: 03-JAN-19
Westford MA  01886                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Cufitec Surgical Mask
NBC Meshtec Inc.                  510(k) NO: K182766(Traditional)
ATTN: Tomokazu  Nagao             PHONE NO : 81 42 5822413 
2-50-3 Toyoda                     SE DECISION MADE: 03-JAN-19
Hino  JP 191-0053                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
Alcon Laboratories, Inc.          510(k) NO: K182782(Traditional)
ATTN: Martina  Heim               PHONE NO : 678 4153565 
6201 South Freeway                SE DECISION MADE: 18-JAN-19
Fort Worth TX  76134              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MUTYH-Associated Polyposis (MAP)
23andMe, Inc.                     510(k) NO: K182784(Traditional)
ATTN: Sarah  Rys                  PHONE NO : 650 9339455 
899 W. Evelyn Ave., CA            SE DECISION MADE: 18-JAN-19
Mountain View CA  94041           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SYSTEM 1 endo Liquid Chemical Sterilant Processing System, Model 6900
STERIS Corporation                510(k) NO: K182827(Traditional)
ATTN: Marcia L. Benedict          PHONE NO : 440 3927063 
5976 Heisley Rd                   SE DECISION MADE: 31-JAN-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: M.U.S.T. Mini Extension
Medacta International SA          510(k) NO: K182837(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 22-JAN-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PENTAX Medical EPK-3000 Video Imaging System
PENTAX of America, Inc.           510(k) NO: K182846(Special)
ATTN: William  Goeller            PHONE NO : 201 5712300 2318
3 Paragon Drive                   SE DECISION MADE: 09-JAN-19
Montvale NJ  07645-1782           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProKnow DS
ProKnow LLC                       510(k) NO: K182855(Traditional)
ATTN: Salvadore  Gerace           PHONE NO : 844 4052170 
121 Central Park Place            SE DECISION MADE: 02-JAN-19
Sanford FL  32771                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: INVOS PM7100 Patient Monitor, INVOS Adult rSO2 Sensor
Covidien llc                      510(k) NO: K182868(Traditional)
ATTN: Samir  Ibrahim              PHONE NO : 720 2532752 
6135 Gunbarrel Avenue             SE DECISION MADE: 08-JAN-19
Boulder CO  80301                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Fit SA
Shofu Dental Corporation          510(k) NO: K182869(Traditional)
ATTN: Mauro  Malzyner             PHONE NO : 760 7363277 202
1225 Stone Drive                  SE DECISION MADE: 09-JAN-19
San Marcos CA  92078              510(k) STATEMENT
                                                    

DEVICE: STRATAFIX Symmetric PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral PDS Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Plus Knotless Tissue Control Devices, STRATAFIX Spiral MONOCRYL Knotless Tissue Control Devices
Ethicon, Inc.                     510(k) NO: K182873(Traditional)
ATTN: Ariell  Joiner              PHONE NO : 908 2182348 
Route 22 West, P.O. Box 151       SE DECISION MADE: 10-JAN-19
Somerville NJ  08876              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HM70A Diagnostic Ultrasound System
Samsung Medison Co., Ltd.         510(k) NO: K182894(Traditional)
ATTN: Scully  Kim                 PHONE NO : 82 2 21941312 
3366, Hanseo-ro, Nam-myeon        SE DECISION MADE: 22-JAN-19
Hongcheon-gun  KR 25108           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wilson-Cook Achalasia Balloon
Wilson-Cook Medical, Inc          510(k) NO: K182895(Traditional)
ATTN: Theresa  de Prat            PHONE NO : 336 7440157 396518
4900 Bethania Station Road        SE DECISION MADE: 25-JAN-19
Winston-Salem NC  27105           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: TenoTac Soft Tissue Fixation System
Paragon 28, Inc                   510(k) NO: K182898(Traditional)
ATTN: Eric  Lintula               PHONE NO : 888 7281888 
4B Inverness Ct. E, STE 280       SE DECISION MADE: 14-JAN-19
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SPY Elite Intraoperative Perfusion Assessment System
Novadaq Technologies ULC. (now a p510(k) NO: K182907(Traditional)
ATTN: Agatha  Szeliga             PHONE NO : 604 4227516 
8329 Eastlake Drive, Unit 101     SE DECISION MADE: 23-JAN-19
Burnaby  CA V5A 4W2               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SI-Restore® Sacroiliac Joint Fixation System
Biofusion Medical                 510(k) NO: K182919(Traditional)
ATTN: Rylan  Reed                 PHONE NO : 1 866 4890602 
2503 Cedarview Drive              SE DECISION MADE: 25-JAN-19
Austin TX  78704                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CD Horizon™ Spinal System
Medtronic Sofamor Danek USA, Inc. 510(k) NO: K182928(Traditional)
ATTN: Raphael  McInnis            PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 11-JAN-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pristina Serena 3D
GE Healthcare                     510(k) NO: K182951(Traditional)
ATTN: Nicole  Landreville         PHONE NO : 289 2082365 
28 rue de la Miniere              SE DECISION MADE: 18-JAN-19
Buc  FR 78530                     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EZStart Interference Screw
ConMed Corporation                510(k) NO: K182955(Traditional)
ATTN: Jeremy  Walter              PHONE NO : 727 3995418 
525 French Road                   SE DECISION MADE: 22-JAN-19
Utica NY  13502                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Puffin Lite Infant Resuscitation System
International Biomedical          510(k) NO: K182956(Special)
ATTN: Amy  Pieper                 PHONE NO : 512 8730033 
8206 Cross Park Drive             SE DECISION MADE: 18-JAN-19
Austin TX  78754                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ROSA Knee System
Orthosoft Inc. (d/b/a Zimmer CAS) 510(k) NO: K182964(Traditional)
ATTN: Eric  DesRosiers            PHONE NO : 514 8614074 371
75 Queen Street Ste. 3300         SE DECISION MADE: 24-JAN-19
Montreal  CA H3C 2N6              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Hoffmann LRF System
Stryker GmbH                      510(k) NO: K182968(Traditional)
ATTN: Jackie  Perri               PHONE NO : 732 7705616 
325 Corporate Drive               SE DECISION MADE: 25-JAN-19
Mahwah NJ  07430                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: EUROPA™ Pedicle Screw System
MiRus, LLC                        510(k) NO: K182970(Traditional)
ATTN: Jordan  Bauman              PHONE NO : 678 3246272 
2150 Newmarket Parkway, Suite 108 SE DECISION MADE: 22-JAN-19
Marietta GA  30067                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: DigitalDiagnost C90
Philips Medical Systems DMC GmbH  510(k) NO: K182973(Traditional)
ATTN: Ming  Xiao                  PHONE NO : 49 40 349712306 
Roentgenstrasse 24                SE DECISION MADE: 11-JAN-19
Hamburg  DE 22335                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: BridalVeil Navigated Instruments
Astura Medical                    510(k) NO: K182982(Traditional)
ATTN: Parker  Kelch               PHONE NO : 760 8148047 
3186 Lionshead Ave. Suite 100     SE DECISION MADE: 04-JAN-19
Carlsbad CA  92010                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Boston Keratoprosthesis, Type I Lucia
Massachusetts Eye and Ear Infirmar510(k) NO: K182986(Special)
ATTN: James  Chodosh              PHONE NO : 617 5734463 
Keratoprosthesis 243 Charles StreeSE DECISION MADE: 30-JAN-19
Boston MA  02114                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WEGO-PGLA RAPID
Foosin Medical Supplies Inc., Ltd 510(k) NO: K183001(Traditional)
ATTN: Lei  Tang                   PHONE NO : 86 631 5661968 
No.20, Xingshan Road, Weihai TorchSE DECISION MADE: 28-JAN-19
Weihai  CN 264210                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: WEGO-PGA RAPID
Foosin Medical Supplies Inc., Ltd 510(k) NO: K183004(Traditional)
ATTN: Lei  Tang                   PHONE NO : 86 631 5661968 
No.20, Xingshan Road, Weihai TorchSE DECISION MADE: 28-JAN-19
Weihai  CN 264210                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Additive Orthopaedics Patient Specific 3D Locking Lattice Plates
Additive Orthopaedics             510(k) NO: K183011(Traditional)
ATTN: Gregory  Kowalczyk          PHONE NO : 732 8826633 
44 Riverdale Ave                  SE DECISION MADE: 10-JAN-19
Monmouth Beach NJ  07750          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Endosee System
CooperSurgical, Inc.              510(k) NO: K183020(Traditional)
ATTN: Roaida  Johnson             PHONE NO : 203 6015200 3325
95 Corporate Drive                SE DECISION MADE: 31-JAN-19
Trumbull CT  06611                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Solitaire 4 Revascularization Device
Micro Therapeutics, Inc. d/b/a ev3510(k) NO: K183022(Traditional)
ATTN: Helen  Chow                 PHONE NO : 949 2975474 
9775 Toledo Way                   SE DECISION MADE: 29-JAN-19
Irvine CA  92618                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOBIO Total Knee System Posterior Stabilized (PS and PS+) Tibial Inserts, MOBIO Total Knee System Patellar Component
b-One Ortho Corp.                 510(k) NO: K183025(Traditional)
ATTN: Allison  Gecik              PHONE NO : 973 5878431 
3 Wing Drive Suite #259           SE DECISION MADE: 28-JAN-19
Cedar Knolls NJ  07927            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MOTO Partial Knee System
Medacta International SA          510(k) NO: K183029(Traditional)
ATTN: Stefano  Baj                PHONE NO : 41 91 6966060 
Strada Regina                     SE DECISION MADE: 30-JAN-19
Castel San Pietro  CH CH-6874     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ETEST Meropenem/Vaborbactam (MEV) (0.004/8-64/8 µg/mL)
bioMerieux SA                     510(k) NO: K183031(Traditional)
ATTN: Marine  Taravant            PHONE NO : 33 04 78872126 
376 Chemin de l'Orme              SE DECISION MADE: 11-JAN-19
Marcy L'Etoile  FR 69280          510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Sensititre 18-24 hour MIC or Breakpoint Susceptibility System with Omadacycline in the dilution range of 0.03-32ug/ml
Thermo Fisher Scientific          510(k) NO: K183033(Traditional)
ATTN: Cynthia  Knapp              PHONE NO : 800 8718909 322
1 Thermo Fisher Way               SE DECISION MADE: 04-JAN-19
Oakwood Village OH  44146         510(k) STATEMENT
                                                    

DEVICE: SMR Lateralized Connectors with screws
Limacorporate S.p.A.              510(k) NO: K183042(Traditional)
ATTN: Roberto  Gabetta            PHONE NO : 39 04 32945511 
Via Nazionale 52                  SE DECISION MADE: 25-JAN-19
Villanova di San Daniele  IT 33038510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CervAlign™ Anterior Cervical Plate System
Pioneer Surgical Technology, Inc. 510(k) NO: K183060(Traditional)
ATTN: Jaclyn  Holli               PHONE NO : 906 2269909 5647
375 River Park Circle             SE DECISION MADE: 17-JAN-19
Marquette MI  49855               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ASAHI Neurovascular Guide Wire, ASAHI CHIKAI X 010
Asahi Intecc Co., Ltd.            510(k) NO: K183070(Traditional)
ATTN: Yasuyuki  Kawahara          PHONE NO : 81 561 485551 
3-100 Akatsuki-cho                SE DECISION MADE: 29-JAN-19
Seto  JP 489-0071                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VLIFT-s Vertebral Body Replacement System
Stryker Spine                     510(k) NO: K183071(Special)
ATTN: Renee  Norby                PHONE NO : 201 7498074 
2 Pearl Court                     SE DECISION MADE: 10-JAN-19
Allendale NJ  07401               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Kangzhou One Step hCG Test Strip, Kangzhou One Step hCG Test Cassette, Kangzhou One Step hCG Test Midstream
Weihai Kangzhou Biotechnology Engi510(k) NO: K183097(Traditional)
ATTN: Yong  Qi                    PHONE NO : 086 631 5678070 
Room401, Building B, Innovation EnSE DECISION MADE: 10-JAN-19
Weihai City  CN 264200            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MRCP+ v1.0
Perspectum Diagnostics Ltd        510(k) NO: K183133(Traditional)
ATTN: Jaco  Jacobs                PHONE NO : 441 865 655329 
23-38 Hythe Bridge Street         SE DECISION MADE: 09-JAN-19
Oxford  GB OX1 2ET                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Zimmer Segmental System Proximal Femoral Component
Zimmer, Inc.                      510(k) NO: K183136(Special)
ATTN: Jason  Heckaman             PHONE NO : 574 3733364 
P.O. Box 708                      SE DECISION MADE: 30-JAN-19
Warsaw IN  46581-0708             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: uMR 580, uMR 588
Shanghai United Imaging Healthcare510(k) NO: K183137(Traditional)
ATTN: Xin  GAO                    PHONE NO : 86 21 67076888 5386
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 11-JAN-19
Shanghai  CN 201807               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MTS Tetracycline 0.016 - 256 ug/mL
Liofilchem s.r.l.                 510(k) NO: K183140(Traditional)
ATTN: Fabio  Brocco               PHONE NO : 39 085 8930745 
Via Scozia zona ind.le            SE DECISION MADE: 11-JAN-19
Roseto degli Abruzzi  IT 64026    510(k) STATEMENT
                                                    

DEVICE: uCT 520, uCT 528
Shangai United Imaging Healthcare 510(k) NO: K183143(Traditional)
ATTN: Shumei  Wang                PHONE NO : 86 2167 0768886776 
No. 2258 Chengbei Rd., Jiading IndSE DECISION MADE: 03-JAN-19
Shangai  CN 201807                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optilite IgA CSF Kit
The Binding Site Group Ltd.       510(k) NO: K183151(Traditional)
ATTN: Natasha  Verhaak            PHONE NO : 44 0 1214569500 
8 Calthorpe Road                  SE DECISION MADE: 23-JAN-19
Birmingham  GB B15 1qt            510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Pristine Scope
Pristine Surgical                 510(k) NO: K183165(Traditional)
ATTN: Stewart B. Davis            PHONE NO : 603 2065597 
Brady Sullivan Tower, 6th Floor, 1SE DECISION MADE: 16-JAN-19
Manchester NH  03104              510(k) STATEMENT
                                                    

DEVICE: BostonSight Scleral
BostonSight                       510(k) NO: K183175(Traditional)
ATTN: Gene  Guselli               PHONE NO : 781 7267503 
464 Hillside Avenue, Suite 205    SE DECISION MADE: 04-JAN-19
Needham MA  02494                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: iSee (roflufocon D, roflufocon E) Daily Wear Orthokeratology Contact Lenses
C&E GP Specialist, Inc.           510(k) NO: K183200(Traditional)
ATTN: Steve  Wagner               PHONE NO : 949 2722424 
15970 Bernardo Center Drive,      SE DECISION MADE: 09-JAN-19
San Diego CA  92127               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Raven Lumbar Plate System
Choice Spine, LP                  510(k) NO: K183214(Traditional)
ATTN: Kim  Finch                  PHONE NO : 865 2433969 
400 Erin Drive                    SE DECISION MADE: 03-JAN-19
Knoxville TN  37919               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SureForm 45, SureForm 45 Reloads
Intuitive Surgical                510(k) NO: K183224(Traditional)
ATTN: Nadine  Nasr                PHONE NO : 408 5237093 
1266 Kifer Road                   SE DECISION MADE: 18-JAN-19
Sunnyvale CA  94086               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HammerToe Compression System
Paragon 28, Inc.                  510(k) NO: K183228(Traditional)
ATTN: Eric  Lintula               PHONE NO : 888 7281888 
4B Inverness Ct. E, STE 280       SE DECISION MADE: 25-JAN-19
Englewood CO  80112               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: SIGNA Premier
GE Medical Systems, LLC           510(k) NO: K183231(Traditional)
ATTN: Brian R. Zielski            PHONE NO : 262 5216609 
3200 Grandview Blvd               SE DECISION MADE: 18-JAN-19
Waukesha WI  53188                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: MAGNETOM Lumina
Siemens Medical Solutions USA, Inc510(k) NO: K183244(Traditional)
ATTN: Martin  Rajchel             PHONE NO : 610 4486545 
40 Liberty Boulevard, Mail Code 65SE DECISION MADE: 24-JAN-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Magnetom Vida
Siemens Medical Solutions, USA, In510(k) NO: K183254(Traditional)
ATTN: Cordell L. Fields           PHONE NO : 610 4486469 
40 Liberty Boulevard Mailcode 65-1SE DECISION MADE: 18-JAN-19
Malvern PA  19355                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: GlideScope BFlex Single-Use Bronchoscope System
Verathon Medical (Canada) ULC     510(k) NO: K183256(Third Party - Traditional)
ATTN: Teresa  Davidson            PHONE NO : 425 4718229 
2227 Douglas Road                 SE DECISION MADE: 04-JAN-19
Burnaby  CA V3W 1P2               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Flex-THOR scope
KARL STORZ Endoscopy-America, Inc.510(k) NO: K183264(Traditional)
ATTN: Nozomi  Yagi                PHONE NO : 424 2188351 
2151 E. Grand Avenue              SE DECISION MADE: 18-JAN-19
EI Segundo CA  90245              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VERIFY VH202 Indicator Tape
STERIS Corporation                510(k) NO: K183293(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Rd                   SE DECISION MADE: 04-JAN-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack
STERIS Corporation                510(k) NO: K183294(Traditional)
ATTN: Anthony  Piotrkowski        PHONE NO : 440 3927437 
5960 Heisley Rd                   SE DECISION MADE: 03-JAN-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Celerity HP Chemical Indicator (CI)
Steris Corporations               510(k) NO: K183295(Abbreviated)
ATTN: Gregory  Land               PHONE NO : 440 3927424 
5960 Heisley Road                 SE DECISION MADE: 04-JAN-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Vis-U-All Low Temperature Sterilization Pouch/Tubing
STERIS Corporation                510(k) NO: K183297(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Rd                   SE DECISION MADE: 03-JAN-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HardyDisk AST Omadacycline 30µg (OMC30)
Hardy Diagnostics                 510(k) NO: K183298(Traditional)
ATTN: Anna  Klavins               PHONE NO : 800 2662222 5752
1430 West McCoy Lane              SE DECISION MADE: 18-JAN-19
Santa Maria CA  93455             510(k) STATEMENT
                                                    

DEVICE: VERIFY V24 Self-Contained Biological Indicator, VERIFY V24 Biological Indicator Challenge Pack
STERIS Corporations               510(k) NO: K183300(Traditional)
ATTN: Gregory  Land               PHONE NO : 440 3927424 
5960 Heisley Road                 SE DECISION MADE: 03-JAN-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PRO-LITE Sterilization Tray
STERIS Corporation                510(k) NO: K183301(Traditional)
ATTN: Jennifer  Nalepka           PHONE NO : 440 3927458 
5960 Heisley Road                 SE DECISION MADE: 03-JAN-19
Mentor OH  44060                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Treace Medical Concepts (TMC) Plating System
Treace Medical Concepts, Inc.     510(k) NO: K183321(Traditional)
ATTN: Rachel  Osbeck              PHONE NO : 904 3735940 1304
203 Fort Wade Rd., Suite 150      SE DECISION MADE: 25-JAN-19
Ponte Vedra FL  32081             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Laser Hair Therapy
OMM Imports, Inc. D/B/A Zero Gravi510(k) NO: K183329(Traditional)
ATTN: Moti  Shenfarber            PHONE NO : 786 7125873 
1945 S Ocean Dr Apt 509 HallandaleSE DECISION MADE: 16-JAN-19
Hallandale FL  33009              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: FLOW 90 Wand
Arthrocare Corporation            510(k) NO: K183346(Traditional)
ATTN: Shruthi  Bhat               PHONE NO : 512 8951295 
7000 West William Cannon Drive    SE DECISION MADE: 24-JAN-19
Austin TX  78735                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Optimus Neuro System
Osteonic Co., Ltd                 510(k) NO: K183352(Special)
ATTN: Seyoung  Choi               PHONE NO : 82 2 69028415 
505-3Ho, 1206Ho, Digital-ro 29-gilSE DECISION MADE: 02-JAN-19
Seoul  KR 08381                   510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: XableCath Crossing Catheter
XableCath, Inc.                   510(k) NO: K183357(Traditional)
ATTN: Rick  Gaykowski             PHONE NO : 617 4474000 
417 S. Wakara Way, Ste 3510       SE DECISION MADE: 21-JAN-19
Salt Lake City UT  84108-1457     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Venue GO
GE Medical Systems Ultrasound and 510(k) NO: K183362(Traditional)
ATTN: Tracey  Ortiz               PHONE NO : 262 4701003 
9900 W. Innovation Drive          SE DECISION MADE: 28-JAN-19
Wauwatosa WI  53226               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: PicoLO Nd:YAG Picosecond Laser System
Laseroptek Co., Ltd.              510(k) NO: K183392(Third Party - Traditional)
ATTN: Hong  Chu                   PHONE NO : 82 31 80235150 
#116, #117, #203, #204 Hyundai I VSE DECISION MADE: 04-JAN-19
Seongnam-Si  KR 13212             510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: CereLink ICP Monitor, CereLink ICP Extension Cable
Integra LifeSciences Corp.        510(k) NO: K183406(Special)
ATTN: Megan  Palumbo              PHONE NO : 781 9715679 
11 Cabot Blvd                     SE DECISION MADE: 11-JAN-19
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Digital Flat Panel Detector
iRay Technology Taicang Ltd.      510(k) NO: K183422(Special)
ATTN: Meng  Li                    PHONE NO : 86 0512 53690872 
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 09-JAN-19
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aloka Arietta 850
Hitachi Healthcare Americas       510(k) NO: K183456(Traditional)
ATTN: Doug  Thistlethwaite        PHONE NO : 330 4251313 
1959 Summit Commerce Park         SE DECISION MADE: 28-JAN-19
Twinsburg OH  44087               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Roadrunner Extra Support Wire Guide
Cook Incorporated                 510(k) NO: K183467(Special)
ATTN: Daniel J. Corbin            PHONE NO : 812 3353575 104018
750 Daniels Way                   SE DECISION MADE: 11-JAN-19
Bloomington IN  47404             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Revive Reusable Bladder Support
Rinovum Subsidiary 2, LLC         510(k) NO: K183468(Traditional)
ATTN: Shaylee  Masilunas          PHONE NO : 412 2007996 
300 Oxford Drive, Suite 330       SE DECISION MADE: 25-JAN-19
Monroeville PA  15146             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Precision Ideal Eyes Arthroscopes
Stryker                           510(k) NO: K183470(Special)
ATTN: Jessie  Duong               PHONE NO : 408 7542077 
5900 Optical Court                SE DECISION MADE: 07-JAN-19
San Jose CA  95138                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Carestream DRX-1 System with DRX Core Detectors
Carestream Health, Inc.           510(k) NO: K183474(Special)
ATTN: Victoria  Wheeler           PHONE NO : 585 6278706 
150 Verona Street                 SE DECISION MADE: 16-JAN-19
Rochester NY  14608               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: 3M Filtek Universal Restorative
3M ESPE Dental Products           510(k) NO: K183476(Third Party - Traditional)
ATTN: Lam  Duong                  PHONE NO : 651 7335945 
2510 Conway Ave.                  SE DECISION MADE: 02-JAN-19
St. Paul MN  55144                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: JUSHA-M260G LCD Monitor, JUSHA-M260 LCD Monitor, M260G LCD Monitor, M260 LCD Monitor
Nanjing Jusha Display Technology C510(k) NO: K183497(Traditional)
ATTN: Zilong  Liang               PHONE NO : 0086 25 83305050 
Suite A, 8/F, Bldg 1, No. 301, HanSE DECISION MADE: 15-JAN-19
Nanjing  CN 210036                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: T2 STRATOSPHERE Expandable Corpectomy System
Medtronic Sofamor Danek, USA Inc. 510(k) NO: K183510(Special)
ATTN: Elizabeth  Hamilton         PHONE NO : 901 3963133 
1800 Pyramid Place                SE DECISION MADE: 16-JAN-19
Memphis TN  38132                 510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ZELTIQ CoolSculpting System
ZELTIQ Aesthetics, Inc.           510(k) NO: K183514(Special)
ATTN: Katherine  Prendergast      PHONE NO : 925 6217415 
4410 Rosewood Drive               SE DECISION MADE: 14-JAN-19
Pleasanton CA  94588              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: VIVA combo RF System
STARmed Co., Ltd.                 510(k) NO: K183538(Special)
ATTN: Jun-Young  Jung             PHONE NO : 82 70 46738657 
B-dong, 4F, 158, Haneulmaeul-ro, ISE DECISION MADE: 17-JAN-19
Goyang-si  KR 10355               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: ProRad 2FC and ProRad 3NC Stationary Radiographic Systems
Prognosys Medical Systems Private 510(k) NO: K183541(Traditional)
ATTN: V. Krishna Prasad           PHONE NO : 91 80 26621544 
No. 249, Ground Floor, Front BuildSE DECISION MADE: 24-JAN-19
Bangalore  IN 560018              510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Signature Orthodontic System
Signature Orthodontics            510(k) NO: K183542(Third Party - Traditional)
ATTN: Alfred Charles Griffin      PHONE NO : 540 2991236 
1035 Cambridge Street, Suite 14a  SE DECISION MADE: 02-JAN-19
Cambridge MA  02141               510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: Compress and Mini Compress Anti-Rotation Spindles
Biomet, Inc                       510(k) NO: K183553(Traditional)
ATTN: Michael  McBurney           PHONE NO : 574 3732564 
56 East Bell Drive                SE DECISION MADE: 22-JAN-19
Warsaw IN  46581                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Codman Disposable Perforators
Integra LifeSciences Corp.        510(k) NO: K183581(Special)
ATTN: Jocelyn  Raposo             PHONE NO : 781 9715688 
11 Cabot Blvd                     SE DECISION MADE: 20-JAN-19
Mansfield MA  02048               510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Ellipsys Vascular Access System (Ellipsys System), Power Controller, Ellipsys Vascular Access System (Ellipsys System), Catheter, Ellipsys Vascular Access System (Ellipsys System), Crossing Needle
Avenu Medical, Inc.               510(k) NO: K183615(Special)
ATTN: Dave  Campbell              PHONE NO : 949 2762483 
27123 Calle Arroyo, Suite 2101    SE DECISION MADE: 25-JAN-19
San Juan Capistrano CA  92675     510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: HANAROSTENT LowAx Colon/Rectum (NNN), HANAROSTENT LowAx Duodenum/Pylorus (NNN)
M.I. Tech Co., Ltd.               510(k) NO: K183616(Traditional)
ATTN: Inae  Kim                   PHONE NO : 82 70 43047450 
174, Habuk 2-gil, Jinwi-myeon     SE DECISION MADE: 10-JAN-19
Pyeongtaek-si  KR 17706           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: medi pneumatic compression system (pcs) – brio (Model 651)
Medi USA, LP                      510(k) NO: K183631(Third Party - Traditional)
ATTN: Glenn  Anderson             PHONE NO : 336 4494440 
6481 Franz Warner Pkwy.           SE DECISION MADE: 25-JAN-19
Whitsett NC  27377                510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: SpyScope DS Access and Delivery Catheter, SpyScope DS II Access and Delivery Catheter, SpyGlass DS Digital Controller
Boston Scientific Corporation     510(k) NO: K183636(Special)
ATTN: Carter  Navarro             PHONE NO : 508 6834793 
100 Boston Scientific Way         SE DECISION MADE: 22-JAN-19
Marlborough MA  01752             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Clear Image Aligners
Specialty Appliance Works, Inc.   510(k) NO: K183643(Third Party - Traditional)
ATTN: Carolyn  Thomas             PHONE NO : 678 5134408 
4905 Hammond Industrial Drive     SE DECISION MADE: 03-JAN-19
Cumming GA  30041                 510(k) SUMMARY AVAILABLE FROM FDA
                                  THIRD PARTY REVIEW

DEVICE: LG PRA.L DERMA LED MASK
LG Electronics, Inc.              510(k) NO: K183671(Special)
ATTN: Jooyong  Kim                PHONE NO : 82 2 37775497 
222 LG-ro Jinwi-myeon             SE DECISION MADE: 22-JAN-19
Pyeongtaek-si  KR 17709           510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: O-Scan
Esaote S.p.A                      510(k) NO: K183685(Special)
ATTN: Massimo  Polignano          PHONE NO : 39 055 4229402 
Via Enrico Melen 77               SE DECISION MADE: 22-JAN-19
Genova  IT 16152                  510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Aequalis PerFORM Reversed Glenoid, Aequalis PerFORM + Reversed Glenoid
Tornier, Inc.                     510(k) NO: K183696(Special)
ATTN: Moyees  Kamara              PHONE NO : 952 4267637 
10801 Nesbitt Avenue South        SE DECISION MADE: 30-JAN-19
Bloomington MN  55347             510(k) SUMMARY AVAILABLE FROM FDA
                                                    

DEVICE: Wireless Digital Flat Detector
iRay Technology Taicang Ltd.      510(k) NO: K183713(Special)
ATTN: Meng  Li                    PHONE NO : 86 0512 53690872 
No. 33 Xinggang Rd., Taicang Port SE DECISION MADE: 09-JAN-19
Taicang  CN 215434                510(k) SUMMARY AVAILABLE FROM FDA
                                                    

     TOTAL 510(k)s THIS PERIOD   228                                     
     TOTAL WITH SUMMARIES        214                                     
     TOTAL WITH STATEMENTS        14