FDA 510(k) Decisions During February, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K162375 12/29/2016 Envision 3D: Image Guidance System 7D SURGICAL INC. DANIEL ZISKIND
K153330 02/19/2016 FreeStyle Precision Neo H Blood Glucose Monitoring System Abbott Diabetes Care Inc. Arul Sterlin
K151185 02/05/2016 AGRX Wound Wash Antibacterial Silver Skin and Wound Cleanser (Rx) and AGX Wound Wash Skin and Wound Cleanser (OTC) ABL Medical, LLC Robert Holladay
K153341 02/12/2016 Relieva Scout Multi-Sinus Dilation System ACCLARENT, INC. JAMES PATRICK GARVEY
K153718 02/12/2016 Spirit Hair Removal laser Family ACTIVE OPTICAL SYSTEMS , LTD. GIL Bidas
K162005 12/08/2016 Acuity 100 (hexafocon A) Rigid Gas Permeable Contact Lens Acuity Polymers, Inc. James A. Bonafini
K153488 02/25/2016 Occlusion Perfusion Catheter Advanced Catheter Therapies, Inc. Paul Joseph Fitzpatrick
K160171 02/26/2016 Illuminated Mediastinal Access Port Aegis Surgical Ltd William Starling
K162134 12/14/2016 ENNOVATE Spinal System Aesculap Implant Systems, LLC Paul Amudala
K151165 02/17/2016 Aesculap Dafilon Nonabsorbable Polyamide Surgical Suture AESCULAP, INC. KATHY A. RACOSKY
K163000 12/23/2016 AMPLATZER TorqVue 45x45 Delivery Sheath AGA Medical Corporation (Wholly Owned by St. Jude Medical Co Mary Johnson
DEN150055 12/21/2016 AeroForm Tissue Expander System AIRXPANDERS, INC Robin` Bush
K152420 12/01/2016 AK Body Toning Device AK BEAUTY ENTERPRISES, LLC Robert Applebaum
K151717 02/23/2016 twion Alber GmbH Bernd Engels
K163266 12/21/2016 Alere i Influenza A & B, Alere i Influenza A & B Control Swab Kit, Alere i Instrument ALERE SCARBOROUGH, INC. Angela Drysdale
DEN150022 12/20/2016 Ultravision Visual Clearing System Alesi Surgical Ltd. DOMINIC GRIFFITHS
K162721 12/22/2016 Stimucel System, Stimucel Generator, Stimucel Treatment Wand, Stimucel Applicator ALLIQUA BIOMEDICAL, INC. KATHY SIMPSON
K153424 02/26/2016 E-CUBE i7 ALPINION MEDICAL SYSTEMS CO., LTD. Donghwan KIM
K152819 02/05/2016 Amecath Peripheral inserted Central Venous Catheter Sets AMECO MEDICAL INDUSTRIES Samy Hamboly
K160291 02/18/2016 Optimus ALIF System Amendia, Inc. Kristen Allen
K160014 02/02/2016 iHealth Track Blood Pressure Monitor Andon Health Co., Ltd Liu Yi
K161299 12/23/2016 BGM014 Blood Glucose Monitoring System, BGM014 Pro Blood Glucose Monitoring System APEX BIOTECHNOLOGY CORP. Hsue-mei Lee
K152160 02/23/2016 Navik 3D APN Health, LLC David Geddam
K151480 02/19/2016 Epix Electrosurgical Probe with Smoke Evacuation APPLIED MEDICAL RESOURCES FRANS VANDENBROEK
K162676 12/01/2016 Voyant Open Fusion Device Applied Medical Resources Jessica Cho
K153416 02/02/2016 ArcScan Insight 100 ARCSCAN, INC. Andy Levien
K160574 12/20/2016 K3PRO SURGICAL TRAY ARGON MED. PRODUCTIONS VERTRIEBS GESELLSCHAFT MBH CO KG RICHARD DONACA
K160785 12/08/2016 Worker Guidewire ARGON MEDICAL DEVICES, INC. SUZANNE CHEANG
K152555 02/11/2016 Dental Implant System AriaBio International Inc Hagai Jacobsen
K162461 12/20/2016 Endoform Plastics and Reconstructive Matrix AROA BIOSURGERY (FORMERLY MESYNTHES LIMITED) Yasmin Rai
K160925 12/22/2016 VPS Rhythm Device with TipTracker Technology ARROW INTERNATIONAL, INC. (A SUBSIDIARY OF TELEFLEX, INC.) KARL J. NITTINGER
K153487 02/04/2016 CG+ Arrow PICC powered by Arrow VPS Stylet PLUS and Arrow VPS Stylet PLUS ARROW INTERNATIONAL, INC. (Subsidiary of Teleflex Inc.) Elizabeth Duncan
K153586 02/19/2016 Arthrex iBalance TKA System Arthrex, Inc. Leon Brown
K161060 12/15/2016 Arthrex iBalance UKA System Vitamin E Tibial Bearing Arthrex, Inc. David L Rogers
K151092 02/23/2016 Arthrex Short Suture Anchors Arthrex, Inc. David L Rogers
K153218 02/12/2016 Arthrex Synergy UHD4 System ARTHREX, INC. DAVID L ROGERS
K151311 02/10/2016 Safe Block Pen Needle Artsana S.P.A Cassani Mauro
K153443 02/25/2016 ASAHI Astato XS 40 ASAHI INTECC CO., LTD. YOSHIHIKO FUKUI
K152768 02/24/2016 Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test Strip ASSURE TECH. CO., LTD. ERIC LIN
K151404 02/12/2016 ProTrach Dualcare ATOS MEDICAL AB Ferenc Dahner
K152994 02/03/2016 Adaptivo Aurora Technology Development, LLC Gustavo H Olivera
K163264 12/21/2016 Pantheris Catheter (8F); Pantheris Cather (7F); Lightbox HS Imaging Console; Lightbox Sled Avinger, Inc. Patty Hevey
K151772 02/09/2016 Actreen Mini Intermittent Urinary Catheters B. BRAUN MEDICAL INC. SIERRA M. MERTZ
K151423 02/19/2016 APEX Compounding System Transfer Set B. BRAUN MEDICAL INC. TRACY MADDOCK
K152765 02/26/2016 VENATECH CONVERTIBLE VENA CAVA FILTER SYSTEM B.BRAUN INTERVENTIONAL SYSTEMS INC. PETER FLOSDORF
DEN150009 02/20/2016 B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GMBH BERNHARD CIOMMER
K151918 02/11/2016 Biotrue ONEday with NaturMoist, Biotrue ONEday for Presbyopia with NaturMoist, Biotrue ONEday for Astigmatism with NaturMoist BAUSCH & LOMB INCORPORATED Barbara Klube-Falso
K160007 12/19/2016 Paclitaxel Sets BAXTER HEALTHCARE CORPORATION Tiffany Lin
K151482 02/26/2016 BCR-30-min BIÖ and RBIP-ST30Ö Readout Accessory BCR DIAGNOSTICS, INC. BORIS ROTMAN
K161837 12/16/2016 ISE Reagent, Glucose, CRP Latex, DxC 700 AU Clinical Chemistry Analyzer BECKMAN COULTER INC. GERALDINE FUENTESPINA
K151866 02/25/2016 BD BACTEC Peds Plus/F Culture Vials (plastic) BECTON DICKINSON AND COMPANY ASHANTI C. BROWN
K160161 02/24/2016 BD Veritor System for Rapid Detection of Flu A + B CLIA waived kit Becton, Dickinson & Co. Gregory P. Payne
K160164 02/25/2016 BD Veritor System for Rapid Detection of Flu A + B Labratory Kit Becton, Dickinson & Co. Gregory P. Payne
K162081 12/19/2016 BD 1ml Luer-lok Hypodermic Syringe, BD 1 mL Luer-Lok Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse Hypodermic Needle, BD 1ml Luer-lok Insulin Syringe Becton, Dickinson and Company Murtaza Rana
K162516 12/09/2016 BD Pen Needle BECTON, DICKINSON AND COMPANY MERIAM YOUSSEF
K153309 02/12/2016 BD Vacutainer UltraTouch Push Button Blood Collection Set BECTON, DICKINSON AND COMPANY Pasquale Amato
K152898 02/09/2016 DIODE LASER THERAPY SYSTEMS BEIJING SINCOHEREN SCIENCE AND TECH. DEVELOPMENT CO., LTD XIN WANG
K152324 02/01/2016 YAHUA Spinal System BEIJING WEIGAO YAHUA ARTIFICIAL JOINT DEVELOPMENT CO. LTD. XINJIAN LV
K162180 12/29/2016 Disposable Insulin Syringe BERPU MEDICAL TECHNOLOGY CO., LTD JUNDONG TAN
K161844 12/13/2016 Matrix Pre-Treatment Controller BETTER WATER, LLC. MIKE CLINE
K153474 02/23/2016 Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm series BIOCHEMICAL DIAGNOSTICS, INC ALLEN PANETZ
K162373 12/16/2016 LC Bead LUMI Biocompatibles UK Limited Simon Leppard
K160068 02/08/2016 FilmArray Respiratory Panel (RP) for use with FilmArray Torch BioFire Diagnostics, LLC KRISTEN J. KANACK
K151955 02/05/2016 YuGo System BIOGAMING LTD. RONIT HARPAZ
K152185 02/11/2016 ARCHITECT SHBG BIOKIT, S.A. ANGELS ROMA
K151817 02/18/2016 VITEK 2 AST-YS Caspofungin <=0.125 - >=8 ug/mL BIOMERIEUX INC KAREN RUSSELL
K160854 12/19/2016 MaxBraid BroadBand Suture and Expressbraid BroadBand Graft Manipulation Suture Biomet Manafacturing Corp. Adam Cargill
K153398 02/03/2016 Comprehensive SRS/Nexel Elbow BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K152868 02/08/2016 ExpressBraid Graft Manipulation BIOMET MANUFACTURING CORP. ADAM CARGILL
K162974 12/09/2016 Biomet Microfixation RibFix Blu Thoracic Fixation System Biomet Microfixation Lauren Jasper
K162783 12/09/2016 EnFocus 2300, EnFocus 4400 Bioptigen, Inc. Ravi Kommineni
K161632 12/08/2016 FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) BIOS S.R.L. Riccardo Pisati
K161704 12/01/2016 Phasor Drill BIOTEX, INC. RICHARD WAITE
K150492 02/19/2016 Ora-GUARD Dental Grind Guard Bite Tech Inc. Jeff Padovan
K162192 12/15/2016 BluePro BlueSom Erwan Floch
K152141 02/25/2016 High Pressure Tanning Lamps BLV Licht-und Vakuumtechnik GmbH Heinz-Jurgen Wesseling
K162205 12/09/2016 Arc EndoCuff and Arc EndoCuff Vision BODDINGTONS PLASTICS LTD SARAH GIBSON
K152297 02/09/2016 OBS Anchorage Screw BOMEI CO., LTD LINNEY CHIANG
K153066 02/09/2016 BostonSight IC Corneal Lens, BostonSight IC Scleral Lens Boston Foundation for Sight Eugene Bonte
K163174 12/14/2016 Emerge PTCA Dilatation Catheter Boston Scientific Corporation Jane Horan
K152231 02/12/2016 Hornet Guidewire, Hornet 10 Guidewire, Hornet 14 Guidewire BOSTON SCIENTIFIC CORPORATION Nikki M Wahlberg
K163200 12/14/2016 Maverick XL Percutaneous Transluminal Coronary Angioplasty Monorail Dilatation Cathete BOSTON SCIENTIFIC CORPORATION Ka Zoua Xiong
K153617 02/25/2016 OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) BOSTON SCIENTIFIC CORPORATION Eric Elliott
K160173 02/26/2016 Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter(eDFU), Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (Paper DFU) Boston Scientific Corporation Eric Elliott
K161215 12/21/2016 Brightway Brand Nitrile Examination Gloves, Powder Free, [Sterling/Grey] Tested For Use With Chemotherapy Drugs BRIGHTWAY HOLDINGS SDN BHD G. BASKARAN
K160941 12/13/2016 Castor, Achilles and Hermes NC PTA Balloon Dilatation Catheter Brosmed Medical Co., Ltd. Tina Yin
K162010 12/13/2016 HPM-6000U BTL Industries, Inc. Jan Zarsky
K161716 12/21/2016 TEETHAN 2.0 BTS S.P.A. VERONICA BARTOLINI
K152736 02/25/2016 SKIN CARE C.I.S LTD ILAN SHARON
K162193 12/23/2016 XenMatrix AB Surgical Graft C.R. Bard Tony John
K162900 12/14/2016 PowerMidline Catheter C.R. Bard, Inc. Casey Coombs
K152136 02/18/2016 Recovery Cone Removal System C.R. Bard, Inc. Joni Creal
K151635 02/09/2016 CapsoCam (SV-1) CapsoVision, Inc. AZIMUN JAMAL
K153295 02/26/2016 TandemLung Oxygenator CARDIAC ASSIST, INC. GREG JOHNSON
K152568 02/11/2016 C-VBR CARDINAL SPINE, LLC NATASHA LONNON
K152310 02/24/2016 HeartLight Deflectable Sheath CARDIOFOCUS, INC. Seema Paliwal
K151036 02/01/2016 Snowden-Pencer Ergonomic Take-Apart In-Line and Pistol Grip Laparoscopic Instruments CAREFUSION 2200 INC. JANE WEBER
K152593 02/25/2016 LATEX EXAMINATION GLOVE POWDER FREE Careplus (M) SDN BHD LIM KWEE SHYAN
K163019 12/01/2016 CareView 750Cw/750C X-ray Flat Panel Detectors CARERAY DIGITAL MEDICAL SYSTEM CO., LTD. Xu Wei
K163203 12/13/2016 Carestream DRX-Evolution Carestream Health, Inc. Carolyn L. Wagner
K153103 02/12/2016 CARESTREAM Vue PACS CARESTREAM HEALTH, INC. Diane Koetter
K162568 12/15/2016 INTRABEAM 600 CARL ZEISS MEDITEC AG Christian Muenster
K161654 12/30/2016 NuFACE Gel Primer Carol Cole Company Merle Kovacic
K161900 12/09/2016 HYPERION X5 CEFLA SC SILVIA SANSAVINI
K151337 02/24/2016 Strialite Centre Light Solutions, LLC Carrie Colburn
K162352 12/22/2016 derma+flex QS High Viscosity Tissue Adhesive CHEMENCE MEDICAL INC Kenneth Broadley
K152476 02/09/2016 Exofin High Viscosity Tissue Adhesive CHEMENCE MEDICAL PRODUCTS INC. Kenneth Broadley
K161329 12/02/2016 Chrono-log Platelet Aggregometer, 4 channel; Chrono-log Platelet Aggregometer, 8 channel Chrono-log Corp. Nicholas J Veriabo
K153004 02/12/2016 Clear Guide SCENERGY CLEAR GUIDE MEDICAL Jack Kent
K161959 12/28/2016 ClearView cCAD ClearView Diagnostics Inc. Christine Podilchuk
K151569 02/12/2016 Tranberg CLS Laser Fiber Clinical Laserthermia Systems AB Lars Erik Eriksson
K151406 02/25/2016 Cogent Lateral Interbody System COGENT SPINE LLC JUDE PAGANELLI
K160515 12/19/2016 PS2 Knee System CONSENSUS ORTHOPEDICS, INC. JUSTIN CREEL
K162717 12/21/2016 Evolution Esophageal Stent System û Partially Covered Cook Ireland Ltd. Jane Kennedy
K163018 12/23/2016 Zilver 635 Biliary Stent Cook Ireland Ltd. Nora O'Connor
K161755 12/14/2016 Integrity-SI TM Fusion System CoorsTek Medical Steve Brown
K153211 02/02/2016 M-Fix Acromioclavicular Device CORACOID SOLUTIONS, INC. STEVE GOLDEN
K152237 02/04/2016 The Entasis Dual-Lead Sacroiliac Implant CoreLink, LLC Dan Hoehn
K162127 12/05/2016 Bencox M Stem Lateralized & Bencox Mirabo Cup System CORENTEC CO., LTD J. S. DANIEL
K160157 12/01/2016 LOSPA Modular Knee System CORENTEC CO., LTD Goon Hee Lee
K152127 02/04/2016 CorMatrix Tyke CORMATRIX CARDIOVASCULAR, INC. ANDREW M. GREEN
K150277 02/12/2016 Pain Therapy System, Model PTS-II COUNTER SCIENTIFIC DEVELOPMENT (GZ) LTD Eagle Eagle
K163055 12/23/2016 Reprocessed Kendall SCD Express Foot Cuff COVIDIEN Jennifer Sullivan
K163105 12/06/2016 Emprint Ablation System COVIDIEN LLC PATTI ARNDT
K163098 12/05/2016 Tri-Staple 2.0 Intelligent Cartridge Covidien LLC REBECCA BREWER
K160566 12/02/2016 Cerasorb Ortho Foam CURASAN AG Wolf-Dietrich Hubner
K153215 02/19/2016 SmartBase for Arthrex Glenoid IRIS Custom Orthopaedic Solutions, Inc. Keith Grafmeyer
K162512 12/09/2016 truSculpt CUTERA, INC. BRADLEY RENTON
K163067 12/01/2016 CyMedica e-viveÖ System; CY-1000 CyMedica Orthopedics, Inc. Kereshmeh Shahriari
K161566 12/21/2016 DMS Disposable Subdermal Needle Electrodes Daehan Medical Systems Co., Ltd. Dong Cheul Kim
K152878 02/03/2016 SUNTEC Mechanical Wheelchair, model ST-WL-1000 DANYANG SUNTEC AUTO PARTS CO., LTD. JEN KE-MIN
K153191 02/26/2016 Calcium Bridge DENALI CORPORATION Jan G Stannard
K151945 02/18/2016 Triumph Resin Dam DENALI CORPORATION JAN G. STANNARD
K161244 12/07/2016 s-Clean OneQ-SL Narrow Implant System Dentis Co., Ltd. Sun Chul Shin
K161713 12/16/2016 Dentium CAD/CAM Abutments Dentium Co., Ltd Sangpil Yoon
K151439 02/19/2016 ATLANTIS ISUS DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K153144 02/10/2016 TIO-H DIGITAL RADIOGRAPHY SENSOR DENTTIO, INC. YOUNG HAN
K152587 02/04/2016 DermaScalp Laser Cap DERMASCALP LLC JOHN CARULLO
K152989 02/25/2016 Mammotome revolve Dual Vacuum Assist Biopsy System DEVICOR MEDICAL PRODUCTS, INC. SHAWNA M. ROSE
K162227 12/10/2016 STA« - Liatest« D-Di Diagnostica Stago Arnaud Berthier
K152645 02/09/2016 Dictum Health DICTUM HEALTH, INC PAUL LANDESMAN
K153224 02/17/2016 VitalStim(R) Plus Electrotherapy System DJO, LLC Natalia Shirina
K151580 02/16/2016 D.N.E. External Fixation System DNE, LLC NICHOLAS RICCIONE
K162421 12/21/2016 IntelliCartTM System DORNOCH MEDICAL SYSTEMS LARRY SMITH
K162552 12/02/2016 EVS 3643, EVS 3643G DRTECH Corporation Choul-Woo Shin
K162555 12/21/2016 EVS 4343, EVS 4343G DRTECH CORPORATION CHOUL-WOO SHIN
K143290 02/18/2016 DBSWIN and VistaEasy Imaging Software Durr Dental AG Oliver Lange
K151912 02/03/2016 AIR-FLOW handy 3.0 PLUS E.M.S. ELECTRO MEDICAL SYSTEMS S.A. Suzanne Fassio-Hardy
K152034 02/23/2016 FS-PACS EC-WEB CO., LTD. KE-MIN JEN
K160981 12/22/2016 Patient Monitor EDAN INSTRUMENTS, INC. QUEENA CHEN
K152427 02/05/2016 PC ECG EDAN INSTRUMENTS, INC. QUEENA CHEN
K160982 12/22/2016 SphynxÖ Eden Spine LLC Guillaume Viallaneix
K160247 02/23/2016 2MP Color LCD Monitor, RadiForce RX250 and RX250-AR EIZO Corporation Hiroaki Hashimoto
K163335 12/15/2016 6MP Color LCD Monitor, RadiForce RX660, RX660-AR EIZO CORPORATION HIROAKI HASHIMOTO
K160949 12/22/2016 Go Dose System ELI LILLY AND COMPANY SUMITRA M GHATE
K162140 12/01/2016 RemLogic EMBLA SYSTEMS SHANE T. SAWALL
K161906 12/01/2016 SCIg60 Infuser EMED TECHNOLOGIES CORPORATION PETER KOLLINGS
K151475 02/08/2016 EndoChoice Select Injection Needle ENDOCHOICE, INC. THERON GOBER
K153588 02/24/2016 EndoChoice Water Bottle Cap System ENDOCHOICE, INC. Daniel Hoefer
K152702 02/18/2016 ENT BIOTECH SOLUTIONS TISSUE REMOVAL DEVICE (ELASSO) ENT BIOTECH SOLUTIONS LAURA YAMADA
K153340 02/09/2016 Epic Extremity Plate System Epic Extremity, LLC DAN SCHWARTZBAUER
K152196 02/18/2016 Erchonia EVRL ERCHONIA CORPORATION STEVEN SHANKS
K162578 12/16/2016 Zerona Z6 OTC ERCHONIA CORPORATION STEVEN SHANKS
K152691 02/25/2016 EDS Universal Cement ESSENTIAL DENTAL SYSTEMS, INC JEFFREY WAN
K152438 02/25/2016 ETView VivaSight-SL (TVT) system ETVIEW LTD. YORAM LEVY
K163539 12/23/2016 Ez3D-i / E3 EWOO SOFT Co., Ltd. Young Seok Kim
K162972 12/02/2016 ExactVu High Resolution Micro-Ultrasound System Exact Imaging Karina Torres
K161550 12/22/2016 DynaMesh-VENTRAL FEG TEXTILTECHNIK FORSCHUNGS-UND ENTWICKLUNGSGESELLSCHAFT STEFAN SCHNEEMELCHER
K162176 12/01/2016 Fiagon Navigation System Fiagon GmbH Dirk Mucha
K160707 12/17/2016 CustomizedBone Service FIN-CERAMICA FAENZA SPA Monticelli Marina
DEN160020 12/21/2016 CipherOx CRI Tablet Flashback Technologies, Inc. Gordon Van Dusen
K152529 02/04/2016 NaturaLase CO2 Laser System FOCUS MEDICAL, LLC JOHN B LEE
K151474 02/18/2016 Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) FUJIFILM MEDICAL SYSTEM U.S.A., INC. MARY MOORE
K160196 02/23/2016 Fujifilm Video Colonoscope Model EC-600WL V2 FUJIFILM Medical Systems U.S.A., Inc. Shraddha More
K160108 02/03/2016 Synapse PACS FUJIFILM MEDICAL SYSTEMS U.S.A., INC. Jyh-Shyan Lin
K163053 12/01/2016 Lumipulse G E2-III Calibrators Fujirebio Diagnostics, Inc. Stacey Dolan
K152557 02/23/2016 Winch Kyphoplasty(15 and 20 mm) 11 Gauge Balloon Catheters G21 s.r.l. Maurizio Foroni
K160182 02/26/2016 LOGIQ S7 Expert GE Healthcare Bryan Behn
K160184 02/25/2016 Voluson S6, Voluson S8, Voluson S10 GE HEALTHCARE TRACEY ORTIZ
K161682 12/02/2016 GE Lunar DXA Bone Densitometers with enCORE version 17 GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS,LLC Nicole Landreville
K163213 12/16/2016 Revolution CT GE Medical Systems, L.L.C. Helen Peng
K160972 12/28/2016 Gexfix External Fixation Gexfix International Corp. Maurizio Longo
K153203 02/03/2016 Navigation Instruments GLOBUS MEDICAL INC. Kelly J Baker
K153368 02/16/2016 Radiance V3 GMV SOLUCIONES GLOBALES INTERNET S.A.U. CARLOS ILLANA
K151274 02/04/2016 Dr's Finder GOOD DOCTORS CO., LTD. Sungro Joo
K162442 12/12/2016 ComfortGuard Plus Surgical Gown, i500, ComfortGuard Surgical Gown, i500 GRI MEDICAL & ELECTRICAL TECHNOLOGY CO., LTD. Martin D. Paugh
K152739 02/09/2016 Electronic Thermometer GUANGDONG BIOLIGHT MEDITECH CO., LTD JING LIANG
K153135 02/25/2016 VITAL SIGNS MONITOR GUANGDONG BIOLIGHT MEDITECH CO., LTD. Jin Liang
K162747 12/08/2016 Proture Double Electric Breast Pump Guangdong Horigen Mother & Baby Products Co., Ltd. Jun Deng
K160306 12/13/2016 Cloud Smart Thermometer GUANGZHOU BOSMA TECHNOLOGY CO LTD Guoxing Dai
K163373 12/12/2016 PK AIM Gyrus ACMI Inc. Graham A.L. Baillie
K152715 02/25/2016 HAINING NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR HAINING MEDICAL PRODUCTS CO., LTD ZHANG LIANG
K162048 12/05/2016 EZstim*III Peripheral Nerve Stimulator/Nerve Locator HALYARD HEALTH - IRVINE Maria Pronina
K163236 12/16/2016 COOLIEF Cooled Radiofrequency Kit Halyard Health, Inc. Mary Ann B Kinard
K153304 02/01/2016 Hansen Medical Magellan Robotic Catheter eKit Hansen Medical, Inc. Marysa Loustalot
K160928 12/20/2016 Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Natural), Latex Polymer Coated Powder Free Surgical Glove with Protein Labeling Claim of 50 microgram or Less per Gram of Glove (Green) HARTALEGA SDB. BHD. KUAN KAM HON
K153489 02/05/2016 Cryocare CS Surgical System Health Tronics Maritza Ward
K162902 12/15/2016 ARIETTA Prologue Diagnostic Ultrasound system and Transducers HITACHI, LTD. ANGELA VAN ARSDALE
K160492 12/06/2016 Hospira Sapphire Sets Hospira, Inc David Blonski
K150157 02/16/2016 AnapnoGuard 100 Respiratory Guard System HOSPITECH RESPIRATION LTD. Yoram Levy
K161237 12/16/2016 HyperView Hyperspectral Tissue Oxygenation Measurement System HYPERMED IMAGING, INC. Carlyn Reynolds
K160742 12/16/2016 NoCoding1 Plus Blood Glucose Monitoring System i-SENS, INC. Joon Ho Jung
K153570 02/25/2016 Axxent Electronic Brachytherapy System Model 110 XP 1200 ICAD INC. John DeLucia
K151307 02/26/2016 ICONACY(TM) I-Hip (TM) ICONACY ORTHOPEDIC IMPLANTS, LLC ROY Y HORI
K153204 02/01/2016 In2Bones Kirschner wire IN2BONES SAS Morgane Grenier
K153395 02/18/2016 OS2-C Compression Staple IN2BONES SAS MORGANE GRENIER
K161947 12/16/2016 Chagas Detect Plus Rapid Test INBIOS INTERNATIONAL, INC. ESTELA RAYCHAUDHURI
K151793 02/19/2016 InMode RF System INMODE MD LTD. AHAVA STEIN
K163190 12/12/2016 InMode RF System INMODE MD LTD. Amit Goren
K162344 12/20/2016 INNOLUX RIC INNOLUX CORPORATION Andy Kuo
K161827 12/08/2016 Reprocessed Response Diagnostic Electrophysiology Catheters INNOVATIVE HEALTH, LLC. SHARON HIGGINS
K161769 12/06/2016 Reprocessed Supreme Diagnostic Electrophysiology Catheters INNOVATIVE HEALTH, LLC. Sharon Higgins
K162251 12/21/2016 Reprocessed Viking Diagnostic Electrophysiology Catheters Innovative Health, LLC. Sharon Higgins
K152505 02/01/2016 C2 NerveMonitor System INOMED MEDIZINTECHNIK GMBH SASCHKA BUSCH
K151429 02/12/2016 QUANTA Flash Jo-1, QUANTA Flash Jo-1 Calibrators, and QUANTA Flash Jo-1 Ciontrols INOVA DIAGNOSTICS, INC. GABRIELLA LAKOS
K160415 12/14/2016 GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation) Instrumentation Laboratory Co. Carol Marble
K160412 12/14/2016 GEM Premier 5000 (Measured Parameters: pH, pCO2 and pO2) Instrumentation Laboratory Co. Carol Marble
K160402 12/14/2016 GEM Premier 5000 (Measured Parameters:Glucose, Lactate and Total Bilirubin) Instrumentation Laboratory Co. Carol Murble
K160225 12/14/2016 GEM Premier 5000 (Measured Parameters:Sodium, Potassium, Chloride, Ionized Calcium), GEM CVP 5 tBili, GEM System Evaluator, GEM Hematocrit Evaluator INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K152596 02/15/2016 Intact« Gen2 System INTACT MEDICAL CORPORATION JOHN VACHA
K160811 12/06/2016 CRW STEREOTACTIC SYSTEM INTEGRA LIFESCIENCES CORPORATION TIMOTHY CONNORS
K153275 02/26/2016 Aingeal Activity System Intelesens, Ltd. Patricia Pepper
K162696 12/28/2016 Kuschall Advance Manual Wheelchair INVACARE CORPORATION ELIJAH N. WREH
K162686 12/28/2016 Kuschall Champion Manual Wheelchair Invacare Corporation Elijah N. Wreh
K162692 12/28/2016 Kuschall K-Series Attract Manual Wheelchair INVACARE CORPORATION Elijah N. Wreh
K143369 12/15/2016 MRidium 3860+ MRI infusion Pump/ Monitoring System IRADIMED CORPORATION FRANCIS X CASEY
K161730 12/08/2016 Wireless Digital Flat Panel Detector IRAY TECHNOLOGY (SHANGHAI) LTD. WEI PAN
K160798 12/15/2016 IPS e.max« Press Abutment Solutions for Viteo Base Ti IVOCLAR VIVADENT AG Sandra Cakebread
K162478 12/22/2016 ivWatch ivWatch, LLC Jaclyn Lautz
K153605 02/11/2016 ivWatch Model 400 ivWatch, LLC Jaclyn Lautz
K163308 12/27/2016 SMARTO JEIL MEDICAL CORPORATION JAEHAN PARK
K162600 12/09/2016 Jewel Precision Reusable Rigid Sterilization Container System JEWEL PRECISION SHEET METAL & MACHINE, INC. GARY SCHNEBERGER
K160326 02/23/2016 5MP Monochrome LCD Monitor MS55i2, 5MP Color LCD Monitor CCL550i2 (CL21550) JVC KENWOOD Corporation Tsukasa Tashiro
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K153370 02/16/2016 Caspian OCT/MESA Mini/DENALI Mini Spinal System K2M, Incorporated Nancy Giezen
K161488 12/08/2016 ESTETICA Dental Treatment Unit and Accessories KALTENBACH & VOIGT GMBH STEFAN TRAMPLER
K160044 02/01/2016 Image1 SPIES System KARL STORZ ENDOSCOPY AMERICA, INC. SUSIE S. CHEN
K153199 02/29/2016 Prevena Plus Incision Management System Kit with Peel & Place Dressing, Prevena Plus Peel & Place Dressing 5-Pack, Prevena Plus Incision Management System Kit with Customizable Dressing, Prevena Plus Customizable Dressing 5-Pack KCI USA, INC. MARGARET MARSH
K160487 12/09/2016 V.A.C. Rx4 Negative Pressure Wound Therapy (NPWT) System KCI USA, Inc. Kristen Weniger Hopewell
K162436 12/21/2016 EndoVac Pure Kerr Corporation Mohammad Saad Ansari
K161470 12/01/2016 Internal Distraction - Sterile KLS MARTIN LP JENNIFER DAMATO
K161259 12/19/2016 KLS Martin Cannulated Headless Screws KLS MARTIN LP JENNIFER DAMATO
K161127 12/22/2016 The Small PLATEAU (PLATEAU-C) Spacer System LIFE SPINE INC. RANDY LEWIS
K151835 02/05/2016 Vital Signs Patch System LIFEWATCH TECHNOLOGIES LTD. ASHER KASSEL
K162854 12/19/2016 Liofilchem MIC Test Strip (MTS) Meropenem 0.002-32.0 ug/ml Liofilchem s.r.l. Fabio Brocco
K162428 12/06/2016 DiLumen Endolumenal Interventional Platform Lumendi, LLC Dennis Daniels
K162772 12/23/2016 ARIES GBS Assay LUMINEX CORPORATION CHRISTIE HUGHES
K163347 12/15/2016 xTAG Cystic Fibrosis 39 Kit v2 Luminex Molecular Diagnostics, Inc. Tina Ip
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K160695 12/06/2016 Talymed Suspension Marine Polymer Technologies, Inc. Sergio Finkielsztein
K162675 12/28/2016 Masimo Rainbow SET Intellivue Module Pulse CO-Oximeter MASIMO CORPORATION MARGUERITE THOMLINSON
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K142969 02/23/2016 ANI Monitor MDOLORIS MEDICAL SYSTEMS SAS MATHILDE COLLET
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K163311 12/21/2016 GMK Revision Femoral Distal Augmentation Medacta International SA Stefano Baj
K153246 02/12/2016 PTFE Super Sheath Introducer 2.1 MEDCOMP (MEDICAL COMPONENTS, INC.) COURTNEY NIX
K161128 12/01/2016 Invia Motion-Endure Negative Pressure Wound Therapy System, Invia Motion-7-120 Days Negative Pressure Wound Therapy System, Invia Motion Canister/Tubing Set 0.151, Invia Motion Carrying Case, Power Supply Medela AG Markus Butler
K152410 02/02/2016 Top Fine Pen Needle MEDEXEL CO., LTD. CHA DONG IK
K153091 02/25/2016 IMPLANT 3D Media Lab S.r.l. Massimo Ivani
K152327 12/01/2016 EasyLyte Na/K/Cl/Ca Analyzer Medica Corporation Photios Makris
K161916 12/21/2016 TelePatch Cardiac Monitor MEDICOMP, INC. Sean Marcus
K162194 12/08/2016 MEDICREA INTERNATIONAL Anterior Cervical Locking Plate System MEDICREA INTERNATIONAL S.A DAVID RYAN
K150487 02/12/2016 X-Suit NIR Biliary Metallic Stent MEDINOL LTD. Michal Hershkovitz
K162128 12/21/2016 Scope Buddy Plus Endoscope Flushing Aid MEDIVATORS INC. Kristin Bergeson Padilla
K152948 02/04/2016 Medline Anti-Fog Solution Medline Industries, Inc. Matt Clausen
K162829 12/09/2016 Medline UNITE« Ankle Fracture Plating System MEDLINE, INDUSTRIES, INC. Jennifer Mason
K160879 12/20/2016 CONFIDENCEÖ High Viscosity Spinal Cement, VIPER« and EXPEDIUM« Fenestrated Screw Systems Medos International S?rl KIRSTEN LEMULLER
K163106 12/01/2016 CODMAN Integrated Bipolar Cord and Tubing Set Medos International SARL Megan Palumbo
K162247 12/15/2016 PERMATAPE MEDOS INTERNATIONAL SARL TATYANA KORSUNSKY
K162327 12/12/2016 COUGAR« LS Lateral Cage System and COUGAR« System Medos International, Sarl Eric Zhu
K162912 12/08/2016 VIPER PRIMEÖ additions to the VIPER« System MEDOS INTERNATIONAL, SARL Karen Sylvia
K161400 12/08/2016 ImagingRing System MEDPHOTON GMBH Daniel Schaffarzick
K163158 12/02/2016 MEDSYNAPSE Zero Footprint Viewer MEDSYNAPTIC PRIVATE LTD. Ashish Dhawad
K162604 12/30/2016 Cranial Reducing Tubes MEDTRONIC NAVIGATION, INC. Christopher Perman
K153247 02/18/2016 Fusion Compact Navigation System MEDTRONIC NAVIGATION, INC. RISHI SINHA
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K162896 12/06/2016 Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface MEDTRONIC, INC. RENEE CVEYKUS
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K160771 12/19/2016 Destiknee Total Knee System MERIL HEALTHCARE PRIVATE LIMITED Umesh Sharma
K153081 02/15/2016 Clear Bi-Light Michael Todd, LP Lilia Friend
K161728 12/05/2016 Microlife Digital Infrared Forehead Thermometer, Model FR1MN1-1 MICROFILE INTELLECTUAL PROPERTY GMBH GERHARD FRICK
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K161639 12/22/2016 Y-MIC MICRON CORPORATION Takashi Terui
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K162630 12/20/2016 CP Relief Wand-OTC Mid-America Medical Innovations LLC Norm Schroeder
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K161871 12/19/2016 EVA (Enhanced Visual Assessment) System MobileODT Ltd. Jen Acobas
K153426 12/21/2016 Ox-Imager CS MODULATED IMAGING, INC. DAVID CUCCIA
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K161425 12/05/2016 APEX Manual Wheelchair Motion Composites Stephane Le Beau
K152422 02/17/2016 FRENDÖ Free T4 Test System NANOENTEK USA INC JIMMY CHEN
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K161399 12/22/2016 Neocis Guidance System Neocis Inc. Alon Mozes
K161467 12/22/2016 HydraGuard 10 UltraFilter NEPHROS INC. JAMES SUMMERTON
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K161307 12/21/2016 NICO Myriad NICO CORPORATION SEAN SPENCE
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K160231 12/23/2016 Model X-100C CO-MetÖ Oximetry System NONIN MEDICAL, INC. KIM E. AVES
K152088 02/24/2016 IV-eye Novarix Limited JOHN SCOTT
K160392 02/26/2016 Novilase Laser Therapy System, Model LTS-2 NOVIAN HEALTH, INC. WILLIAM GRAVEMAN
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K150826 02/10/2016 Nutra Face Lift Model PE8050 NUTRA LUXE MD, LLC PETER VON BERG
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K153625 02/12/2016 Single Use Injector NM600/610 OLYMPUS MEDICAL SYSTEMS CORP. TOSHIYUKI NAKAJIMA
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K153080 02/11/2016 RTVue XR OCT Avanti with AngioVue Software OPTOVUE, INC. EDWARD SINCLAIR
K163180 12/29/2016 Hubble II Orbbo Surgical, LLC Eric Garofano
K152813 12/02/2016 FS-500DDR Medical Radiographic X-Ray System ORICH MEDICAL EQUIPMENT (TIANJIN) CO., LTD. JU PENG
K152932 02/29/2016 BlastGen ORIGIO A/S TOVE KJAER
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K162020 12/16/2016 VITROS Chemistry Products Cl- Slides Ortho Clinical Diagnostics Marlene Hanna
K153216 02/18/2016 Alpine Cemented Hip System ORTHO DEVELOPMENT CORPORATION Drew Weaver
K162638 12/16/2016 CETRA Anterior Cervical Plate System Orthofix Inc. Jacki Koch
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K151553 02/10/2016 Anterior Cervical Plate System Osteomed Implantes, LTDA J.D. WEBB
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K150304 02/24/2016 Oxyless Blood Tubing Set Oxyless Ltd Bob Duffy
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K152489 02/04/2016 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray PANORAMIC CORP. Doug Pack
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K161739 12/19/2016 Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses PEGAVISION CORPORATION Judith Hou
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K150597 02/29/2016 ImmunoCAP Allergen d202, Allergen component rDer p 1,House dust mite PHADIA AB Carina Magnusson
K161800 12/06/2016 OnSite-IV PHARMC, LLC CHRIS TICE
K151435 02/25/2016 MRCAT PHILIPS MEDICAL SYSTEMS MR FINLAND JANNE MARVOLA
K162955 12/19/2016 Multi-Modality Tumor Tracking (MMTT) application Philips Medical Systems Nederland B.V. Yoram Levy
K162940 12/30/2016 MultiBand SENSE Philips Medical Systems Nederland B.V. Jan Van de Kerkhof
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K160315 02/19/2016 I4 (Integrated Intelligent Imaging Informatics) system PHILIPS MEDICAL SYSTEMS NEDERLAND BV Ilana Ben Moshe
K162418 12/02/2016 Pioneer Plus Catheter PHILIPS VOLCANO MARY STANNERS
K153593 02/17/2016 CliniscanSM MRI PICOFEMTO LLC Jessica Phillips
K162376 12/08/2016 CAAS MR 4D Flow PIE MEDICAL IMAGING B.V. ANNEMIEK BOUTS
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K161809 12/06/2016 ShurFit CpTi-HA ACIF Interbody Fusion System Precision Spine, Inc. Michael C. Dawson
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K152278 02/09/2016 ENDOFLOW II - Irrigation, Warming and Suction System PROMEPLA SAM ALEXANDRE BAREILLE
K162246 12/08/2016 ProNova SC360 Proton Therapy System ProNova Solutions, LLC ADAM KUHN
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K162623 12/09/2016 16ch T/R Hand Wrist Coil QUALITY ELECTRODYNAMICS, LLC KATHLEEN ARAS
K163222 12/05/2016 Discovery Pico Family Quanta System Spa Francesco Dell'Antonio
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K162304 12/06/2016 Q2 Multiport IV Administration Sets and Extension Sets, Checkmate Multiport IV Administration Sets, Q2 Extension Sets QUEST MEDICAL, INC. Amy Clendening-Wheeler
K162468 12/01/2016 ClearCheck RADFORMATION KURT SYSOCK
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K152343 02/16/2016 Direct Bilirubin RANDOX LABORATORIES LIMITED PAULINE ARMSTRONG
K152085 02/24/2016 Liquid CO2-2 (LCO2-2) RANDOX LABORATORIES LTD PAULINE ARMSTRONG
K162066 12/02/2016 Reliance Spinal Screw System Reliance Medical Systems, LLC Bret M. Berry
K162051 12/14/2016 Cryotec REPROLIFE INC. KOICHI TAKEDA
K160836 12/15/2016 Menai System ResMed Ltd Greg Dockar
K153095 02/17/2016 ROP Resorbable Hemostasis Material Resorbable Orthopedic Products, LLC Barry E Constantine
K160614 12/16/2016 Xcite Clinical Station RESTORATIVE THERAPIES INC. Andrew Barriskill
K162677 12/21/2016 L- OVC Rhondium, Ltd Greer Fricker
K161734 12/09/2016 Vanguard Dental Unit RITTER CONCEPT GMBH WEN FANG
K160475 12/14/2016 Ritter Dental Implant System Ritter Implants GmbH & Co. KG Werner Schmitz
K153307 02/12/2016 HS SutureTape RIVERPOINT MEDICAL Edwin Anderson
DEN150057 12/19/2016 Elecsys AMH, AMH CalSet, PreciControl AMH, AMH CalCheck 5 ROCHE DIAGNOSTICS Edie Eads
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K162531 12/29/2016 STERISPINE CC SAFE ORTHOPAEDICS SOPHIE REHAULT
K163206 12/15/2016 SMD-Sr90-DA Radionuclide Brachytherapy Source Salutaris Medical Devices, Inc. Laurence Marsteller
K163115 12/07/2016 GC70 SAMSUNG ELECTRONICS CO., LTD. CHULSIN KIM
K153529 02/02/2016 WS80A Diagnostic Ultrasound System SAMSUNG MEDISON CO., LTD. Kyeong-Mi Park
K151308 02/09/2016 Schoelly Nephroscope Set, Schoelly Ultra-Mini Nephroscope Set SCHOELLY FIBEROPTIC, GMBH SANDRA BAUMANN
K162351 12/01/2016 SeaSpine« Vu aòPODÖ Prime NanoMetalene« Intervertebral Body Fusion Device SEASPINE ORTHOPEDICS CORPORATION Gina Flores
K161928 12/21/2016 CAPI 3 IMMUNOTYPING, CAPILLARYS 3 TERA, IT/IF CONTROL Sebia Karen Anderson
K163078 12/08/2016 DC-UIBC-CAL SEKISUI DIAGNOSTICS P.E.I. INC. PENNY WHITE
K152781 02/12/2016 Adena-Zina System SHANGHAI SANYOU MEDICAL CO, LTD DAVID FAN
K160092 02/12/2016 Digital Electrocardiograph SHENZHEN BIOCARE BIO-MEDICAL EQUIPMENT CO., LTD. Hongbo Zhong
K152902 02/18/2016 Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD YANHONG BAI
K162845 12/15/2016 DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO.,LTD ZHAI PEI
K151258 02/18/2016 Arm automatic blood pressure monitor SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. Xie Qiongyu
K160969 12/12/2016 ShineMed Reloadable Open Cutting Stapler, ShineMed Curved Intraluminal Cutting Stapler SHINEMED LLC ROGELIO A. INSIGNARES
K163306 12/22/2016 Lithoplasty Peripheral Balloon Dilatation Catheter; Lithoplasty Generator And Connector Cable; Lithoplasty Connector Cable Shockwave Medical, Inc. Plessy Paul
K162420 12/12/2016 Sysmex Automated Blood Coagulation Analyzer CS-5100 SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH PETRA DISSMANN
K162688 12/26/2016 Sysmex CS-2100i Siemens Healthcare Diagnostics Products GmbH Donna Noeh
K151529 02/11/2016 Dimension Vista LOCI Total Testosterone Flex reagent cartridge, Dimension Vista Testosterone Calibrator SIEMENS HEALTHCARE DIAGNOSTICS, INC. JULIE WARREN
K153232 02/10/2016 Cios Select SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K162302 12/16/2016 Somatom Confidence « RT Pro SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
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K153759 02/25/2016 SIGN Compression Screw System SIGN FRACTURE CARE INTERNATIONAL ROB R. TEETER
K152831 02/23/2016 Spot Skan SKANRAY TECHNOLOGIES PRIVATE LIMITED MAHADEVAN J
K151512 02/14/2016 Star 60 SKANRAY TECHNOLOGIES PRIVATE LIMITED MAHADEVAN J
K161233 12/14/2016 OXINIUM DH Fermoral Heads SMITH & NEPHEW, INC. MIKE SCOTT
K163086 12/21/2016 VLP MINI-MOD 2.0mm Column Plates SMITH & NEPHEW, INC. SAMANTHA STAUBACH
K163034 12/07/2016 SUTUREFIX Curved Suture Anchor Smith and Nephew, Inc. Anne-Marie Keefe
K160946 12/05/2016 4.0 and 6.5 Cancellous Bone Screw and Washer SMV SCIENTIFIC Nephi Zufelt
K160942 12/21/2016 Sonablate SonaCare Medical, LLC DAVID M. HERNON
K163063 12/12/2016 UC-5000 Mobile X-Ray SOURCE-RAY, INC. RAY MANEZ
K161548 12/01/2016 Osseointegrated Fixtures SOUTHERN IMPLANTS (PTY) LTD. LAURANDA BREYTENBACH
K151069 02/05/2016 SPECTRA Disposable Single Lumen Echogenic Injection Anesthesia Conduction Needle SPECTRA MEDICAL DEVICES, INC. Agustin Turriza
K153530 02/05/2016 Bridge Occlusion Balloon SPECTRANETICS, INC. Christopher McLellan
K152539 02/24/2016 SpineView X-Pac Expandable Lumbar Cage System SPINE VIEW, INC. Mbithi Muthini
K160003 02/26/2016 Sniper (R) Spine System SPINE WAVE, INC. KELLY Barbieri
K153323 02/23/2016 Palisade Pedicular Fixation System SPINEOLOGY, INC. JACQUELINE A HAUGE
K153082 02/04/2016 Rampart A Lumbar Interbody Fusion Device SPINEOLOGY, INC. JACQUELINE A HAUGE
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K160335 12/13/2016 Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D St. Jude Medical Tamara Stanczak
K160218 12/13/2016 AutoMark Module St. Jude Medical Melissa Frank
K160210 12/13/2016 EnSite Precision Cardiac Mapping System v2.0 ST. JUDE MEDICAL Marlene Peterson
K162643 12/13/2016 MediGuide Technology System ST. JUDE MEDICAL MARLENE PETERSON
K152009 12/05/2016 DENSEEMAMMO v1.0 STATLIFE STEPHANE RAGUSA
K153173 02/05/2016 MOR Implant System STERNGOLD DENTAL, LLC MARIA RAO
DEN160005 12/19/2016 Hem-Avert Perianal Stabilizer STETRIX, INC. MARK BUCHANAN
K162161 12/16/2016 Receiver Kit, Trial Kit, Spare Lead Kit, Sterile Revision Kit, Wearable Antenna Assembly Kit and Charger Kit Stimwave Technologies Incorporated Elizabeth Greene
K162702 12/30/2016 Teeter Manual Inversion Table; Teeter Gravity Boots; Teeter Forward Rotation Decompression Device; Teeter Portable Decompression Device; Teeter Horizontal Decompression Table STL International, Inc. Rylie Teeter Leier
K160585 12/22/2016 XN CAL Streck Deborah Kipp
K160590 12/22/2016 XN CHECK STRECK DEBORAH KIPP
K160588 12/22/2016 XN CHECK BF STRECK DEBORAH KIPP
K160586 12/22/2016 XN-L CHECK STRECK DEBORAH KIPP
K153508 02/05/2016 Stryker CMF MEDPOR Customized Implant Stryker Jonathan Schell
K161821 12/08/2016 Stryker Universal Mesh Stryker Jonathan Schell
K152266 12/02/2016 Altrix Precision Temperature Management System STRYKER MEDICAL BRIAN ORWAT
K160096 02/19/2016 InZone Detachment System STRYKER NEUROVASCULAR KATE TAYLOR
K151520 02/19/2016 Oscar 2 SunTech Medical, Inc. Charles Setzer
K151680 02/12/2016 Powder Free Nitrile Patient Examination Gloves, Blue Color SUQIAN XINGYE GLOVE CO, LTD JIAN ZHONG-DENG
K152271 02/09/2016 Powder Free Nitrile Patient Examination Gloves, Black color SUQIAN XINGYE GLOVE CO,LTD JIAN ZHANG DENG
K163028 12/28/2016 Medline ReNewal Reprocessed Stryker External Fixation Devices SURGICAL INSTRUMENT SERVICE AND SAVINGS INC BRANDI J. PANTELEON
K152648 02/18/2016 Ennova Self-adhesive Electrode Suzhou Ennova Electronics Technology Co.,Ltd N/A N/A
K162004 12/05/2016 PREMIUM Implant Systems SHELTA Implant Systems SWEDEN & MARTINA S.p.A. Alessia Pezzato
K160538 12/22/2016 Sysmex XN-L Automated Hematology Analyzer SYSMEX AMERICA, INC. SHARITA BROOKS
K151263 02/19/2016 Venturi Gauze Wound Care Sets with Portal Drain TALLEY GROUP LTD. ROBERT MACDONALD
K162022 12/22/2016 Collagentex Rx-1 Tanses Technologies inc. Kirk Kiremitci
K153690 02/22/2016 PriMatrix Dermal Repair Scaffold TEI BioSciences Inc. David D Cox
K160309 12/22/2016 Neurosoft TMS TeleEMG, LLC Joe F Jabre
K160070 12/07/2016 Rheumatoid Factor (RF) Kit for use on SPAPLUS THE BINDING SITE GROUP, LTD. Jon Lauder
K162003 12/21/2016 IMSE Cervical Cage The Institute of Musculoskeletal Science & Education Ed McShane
K152168 02/05/2016 Love Liquid Personal Lubricant The Kama Sutra Company Marla Lee
K160328 02/25/2016 DIVA ZSP2105CMI with QUBYX PerfectLum bundle THE LINDEN GROUP CORP. ROBERT COLAIZZO
K160222 12/07/2016 OIC Cervical PEEK Spacer THE ORTHOPAEDIC IMPLANT COMPANY DOUGLAS FULTON
K153647 02/16/2016 TSolution One w/ACG+ Surgical System THINK SURGICAL INC. IN K. MUN
K162648 12/12/2016 U-Blade Veress Needle TIANJIN UWELL MEDICAL DEVICE MANUFACTURING CO.LTD. TAO FAN
K151508 02/25/2016 IRENE Locking Compression Plate System TIANJIN ZHENGTIAN MEDICAL INSTRUMENT CO., LTD YIFAN FU
K161972 12/09/2016 Slit Lamp SL-D301 TOPCON CORPORATION MICHAEL GUSEL
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