FDA 510(k) Decisions During March, 2016  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K151748 03/11/2016 Clean & More 3M DEUTSCHLAND GMBH DESI W SOEGIARTO
K153754 03/14/2016 MicroMatrix ACELL, INC THOMAS GILBERT
K153613 03/16/2016 Cerafix Dura Substitute ACERA SURGICAL, INC. MATTHEW MACEWAN
K152480 03/31/2016 Revitive Medic; Revitive MV; Revitive LV Actegy, Ltd. Angela Glover
K152547 03/04/2016 DNAP Electrode Ad-Tech Medical Instrument Corporation Lisa Theama
K153412 03/14/2016 Sleep Profiler ADVANCED BRAIN MONITORING, INC. DANIEL J. LEVENDOWSKI
K160409 03/15/2016 AOS Anterolateral Proximal Humeral Plate ADVANCED ORTHOPAEDIC SOLUTIONS, INC KAZU MIYAHARA
K150144 03/06/2016 VisuCon-F Low Fibrinogen Control Plasma AFFINITY BIOLOGICALS INC. Denise Foulon
K151722 03/18/2016 Slim UP ULTRA AIME MEDICAL INC PAUL GUILBAUD
K153564 03/29/2016 PURE CRYOGEN AIR LIQUIDE HEALTHCARE AMERICA CORPORATION STEVE MILLER
K153335 03/15/2016 AlertWatch: OR ALERTWATCH LLC Justin Adams
K152845 03/14/2016 Allied Biocompat Abutment for Nobel Replace Interface ALLIED DENTAL SOLUTIONS Peter Zhou
K153779 03/31/2016 Abutment for Bridges ALTATEC GmbH Colleen Boswell
K151694 03/09/2016 Gammex PI Hybrid Surgical Gloves ANSELL HEALTHCARE PRODUCTS, LLC Vasudev Dobariya
K160301 03/04/2016 Platinum dRF Imaging System Apelem-DMS Group Krishna Mahadea
K153633 03/15/2016 Endoform Reconstructive Template Aroa Biosurgery Limited (Formerly Mesynthes Limited) Yasmin Rai
K151342 03/24/2016 Arthrex SwiveLock Anchors ARTHREX, INC. David L. Rogers
K152249 03/04/2016 ASAHI Corsair Armet ASAHI INTECC CO., LTD. YOSHIHIKO FUKUI
K160185 03/01/2016 Wrist 3 ASPECT IMAGING LTD ISRAEL CITRON
K153465 03/31/2016 AssureTech Amphetamine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Cocaine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup), AssureTech Morphine Tests (Strip, Dip Card, Quick Cup, Turn-Key Split Cup) Assure Tech (Hangzhou) Co., Ltd. Shisheng Ling
K152337 03/22/2016 cryoFORM cryoICE cryoablation probe ATRICURE, INC JONATHAN MCELWEE
K160454 03/18/2016 AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip ATRICURE, INC. JONATHAN MCELWEE
K153460 03/01/2016 Pantheris Catheter (8Fr), Pantheris Catheter (7Fr) AVINGER, INC. Patty Hevey
K153079 03/17/2016 Axeo 3 Patient Monitor AXEO MEDICAL TECHNOLOGIES, LLC Stamatios Parimeros
K143482 03/01/2016 xevonta dialyzer B. Braun Avitum AG Giuliana Gavioli
K152050 03/02/2016 Pencylcap B. BRAUN MELSUNGEN AG HANS-ULRICH GAUDIN
K153019 03/21/2016 Disposable Adhesive Surface Electrodes, Disposable/Reusable Cup Electrodes BIO PROTECH, INC. DANIEL WOO
DEN150058 03/28/2016 Amplichek II, Negative and Amplichek II, Negative MiniPak, Amplichek II, Level 1 and Amplichek II, Level 1 MiniPak, Amplichek II, Level 2 and Amplichek II, Level 2 MiniPak, Amplichek II, Level 3 and Amplichek II, Level 3 MiniPak Bio-Rad Laboratories Elizabeth Platt
K150876 03/07/2016 Bead Block BIOCOMPATIBLES UK LTD PEDRO GARCIA
K160457 03/15/2016 FilmArray Blood Culture Identification (BCID) panel for use with FilmArray Torch BIOFIRE DIAGNOSTICS, LLC Kristen J. Kanack
K160462 03/17/2016 FilmArray Meningitis/Encephalitis (ME) Panel for use with FilmArray Torch BIOFIRE DIAGNOSTICS, LLC Kristen J. Kanack
K151688 03/11/2016 chromID MRSA bioMerieux, Inc. Jewell Coulson
K151923 03/25/2016 VITEK 2 AST-Yeast Micafungin (0.06-8 mcg/mL) BIOMERIEUX, INC. Cherece L Jones
K160058 03/09/2016 Biomet Variable Pitch Compression Screw System Biomet Inc Julie Largent
K152262 03/08/2016 Ventix Knotless Anchors BIOMET MANUFACTURING CORP. JARED COOPER
K152253 03/24/2016 Biomet Microfixation RibFix Blu Thoracic Fixation System BIOMET MICROFIXATION LAUREN JASPER
K153270 03/08/2016 TruGuard Custom Tongue and Jaw Positioner BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K152280 03/02/2016 BioPhotas Celluma3 BIOPHOTAS, INC PATRICK JOHNSON
K160637 03/30/2016 Rotatable Snares BOSTON SCIENTIFIC CORPORATION Michael Secondini
K160861 03/31/2016 Proxis Ureteral Access Sheath C.R. Bard, Inc. Beatrice Wan
K160020 03/02/2016 Captiva Spine and CapLOX II/TowerLOX Pedicle Screw System Captiva Spine Tamala J. Wampler
K160002 03/09/2016 Piccolo Composite(R) Distal Volar Radius Plate System CARBOFIX ORTHOPEDICS LTD. Yael Rubin
K160257 03/04/2016 PROTEK Duo 31 Fr. Veno-Venous Cannula Set CARDIAC ASSIST, INC. GREG JOHNSON
K151778 03/24/2016 Cardinal HealthTM Sterile Latex Powder-Free Orthopedic Surgical Gloves with Hydrogel Coating CARDINAL HEALTH 200, INC. CAROLINE MICELI
K153554 03/21/2016 Genesis Low Temperature Reusable Rigid Container System CareFusion 2200 Inc Jane Weber
K151499 03/18/2016 CareTaker Continuous Non-Invasive Blood Pressure Monitor, CareTaker Wireless VItal Signs Monitor CARETAKER MEDICAL, LLC JEFF POMPEO
K153519 03/16/2016 DReal CAREVATURE MEDICAL LTD Orly Maor
K160237 03/04/2016 Cefaly CEFALY TECHNOLOGY JEAN-YVES MIGNOLET
K151597 03/04/2016 Family of Steam Sterilizers B 28 series CEFLA S.C. SILVIA SANSAVINI
K152614 03/07/2016 Xpert Carba-R CEPHEID SCOTT A. CAMPBELL
K153326 03/08/2016 Erisma-LP Spinal Fixation System CLARIANCE, SAS PASCAL ROKEGEM
K153245 03/02/2016 Baha 5 Super Power Sound Processor COCHLEAR AMERICAS TRISTAN MANUS
K153721 03/25/2016 iTotal Cruciate Retaining (CR) Knee Replacement System CONFORMIS, INC. Amita Shah
K160025 03/07/2016 iTotal Posterior Stabilized (PS) Knee Replacement System, iTotal Cruciate Retaining (CR) Knee Replacement System CONFORMIS, INC. Amita Shah
K152969 03/31/2016 ENHANCE ALLOGRAFT WEDGE INSTRUMENT TRAY CONMED CORPORATION DIONNE SANDERS
K153430 03/07/2016 Flexor Tuohy-Borst Side-Arm Introducers Shuttle Select COOK INCORPORATED SARAH REEVES
K160229 03/21/2016 Echotip Ultra Endobronchial High Definition Ultrasound Needle, Echotip Procore Endobronchial High Definition Ultrasound Biopsy Needle Cook Ireland Ltd. Lynsey Shine
K151845 03/18/2016 Infant Heel Warmer (Model 24401) and WarmGel Infant Heel Warmer (Model 20418) COOPERSURGICAL, INC. ROAIDA JOHNSON
K153725 03/25/2016 Corin TaperFit Hip Stem CORIN USA LIMITED DIANA L. NADER-MARTONE
K153772 03/31/2016 Corin TriFit TS Hip CORIN USA LIMITED Diana L. Nader-Martone
K152999 03/18/2016 CorPath 200 System CORINDUS, INC. Tal Wenderow
K160230 03/01/2016 VersaOne Optical Trocar 15mm, VersaOne Bladeless Trocar 15mm COVIDIEN TRANG HUYNH
K153371 03/28/2016 Sonicision Cordless Ultrasonic Dissection Device COVIDIEN LLC NANCY SAUER
K151252 03/29/2016 Puritan Bennett 840 Series Ventilator System Covidien LP Kelsey Lee
K160273 03/25/2016 truFreeze System CSA MEDIAL, INC. Sherrie Coval-Goldsmith
K153612 03/15/2016 ArthrexVIP Web Portal CUSTOM ORTHOPAEDIC SOLUTIONS, INC. Keith Grafmeyer
K153671 03/09/2016 Family of CoolGlide Aesthetic Lasers CUTERA, INC. Julia Brown
K152766 03/08/2016 CharmFlex DENTKIST, INC SHIN HEANG LEE
K152861 03/04/2016 Aquasil Ultra + Smart Wetting Impression Material DENTPLY INTERNATIONAL INC. HELEN LEWIS
K152978 03/25/2016 DeRoyal Angiography Kits DEROYAL INDUSTRIES, INC. Elizabeth Wheeler
K153746 03/03/2016 Dunamis Force DFX Tensile Tape Dunamis LLC Prithvi Raj Chavan
K160524 03/18/2016 FibroScan 530 Compact ECHOSENS KARINE BONENFANT
K152558 03/02/2016 Leksell Stereotactic System, Injection/ Aspiration Needle Kit ELEKTA INSTRUMENT AB EMMA WIDMARK
K160267 03/31/2016 PRECICE Trauma Nail System Ellipse Technologies, Incorporated Cora Sim
K160041 03/07/2016 Cobbra RF Tissue Dissector ELLIQUENCE LLC. PAUL D. BUHRKE
K153044 03/02/2016 Sentimag System, Sentimark Magnetic Marker Systerm ENDOMAGNETICS LTD. ANDREW SHAWCROSS
K160272 03/04/2016 Endophys Pressure Sensing Sheath Kit Endophys, Inc. Rebecca K Pine
K160521 03/22/2016 ECHELON FLEX 60 Powered Plus Compact Articulating Endoscopic Linear Cutter, 280mm ETHICON ENDO-SURGERY, LLC Marjorie Medina
K151136 03/04/2016 HARMONIC HOOK ETHICON ENDO-SURGERY, LLC MARJORIE MEDINA
K152258 03/31/2016 T3 Software ETIOMETRY, INC. DIMITAR BARONOV
K152217 03/10/2016 Exactech Vantage Total Ankle System EXACTECH INC SHING JEN TAI
K160484 03/18/2016 Optetrak Advanced Patella EXACTECH INC PATRICK HUGHES
K153595 03/25/2016 Optetrak Logic Metaphyseal Cones EXACTECH INC PATRICK HUGHES
K153776 03/10/2016 Optetrak One Logic Femoral Components Exactech Inc Patrick Hughes
K160191 03/25/2016 Align Anterior Ankle Fusion Plate Extremity Medical, LLC Brian Smekal
K160369 03/10/2016 GuideWire FIAGON GMBH Dirk Mucha
K160479 03/23/2016 PointerShell Universal, PointerShell LS FIAGON GMBH DIRK MUCHA
K143035 03/30/2016 Flight 60 Ventilator FLIGHT MEDICAL INNOVATIONS LTD. Yanir Shaked
K152640 03/28/2016 Infrared Thermometer (FT-F11-BT, FT-F21-BT, FT-31-BT, FT-F41-BT) FUDAKANG INDUSTRIES CO., LTD BOB YU
K153206 03/03/2016 Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 FUJIFILM MEDICAL SYSTEM U.S.A., INC. Shraddha More
K160406 03/16/2016 FUJIFILM FC1 Ultrasound System FUJIFILM SonoSite, Inc. Scott Paulson
K152274 03/25/2016 MSCB-001 GC AMERICA INC. MARK HEISS
K153253 03/03/2016 GC Reline II GC AMERICA, INC. MARK HEISS
K153429 03/09/2016 SmartView 3D Option GE HANGWEI MEDICAL SYSTEM CO., LTD LV RUI
K160621 03/29/2016 SIGNAPioneer GE HEALTHCARE GLEN SABIN
K153355 03/16/2016 Xeleris 4.0 Processing and Review Workstation GE HEALTHCARE EFRAT HARTOG-DAVID
K160277 03/25/2016 LOGIQ F8 Expert, LOGIQ F8, LOGIQ F6 GE Medical Systems Ultrasound and Primary Care Diagnostics, Tracey Ortiz
K160078 03/10/2016 Vivid T8 GE Medical Systems Ultrasound and Primary Care Diagnotics, L Tracey Ortiz
K151665 03/16/2016 SUSTAIN Additional Implants GLOBUS MEDICAL INC. KELLY J BAKER
K152955 03/22/2016 Great Basin Shiga Toxin Direct Test GREAT BASIN SCIENTIFIC, INC. Chuck Owen
K152470 03/25/2016 Great Basin Staph ID/R Blood Culture Panel GREAT BASIN SCIENTIFIC, INC. Chuck Owen
K150702 03/24/2016 Exceed Tx GREAT LAKES ORTHODONTICS, LTD. DAVE GRAVER
K153708 03/31/2016 Halyard Black-Orange Powder-Free Nitrile Exam Glove Halyard Health Christine L Macauley
K153741 03/18/2016 CLUNGENE Methamphetamine Test, CLUNGENE Morphine Test, CLUNGENE Marijuana Test HANGZHOU CLONGENE BIOTECH CO., LTD. ZHENG SHUJIAN
K151271 03/11/2016 BellaFuse Hans Biomed Corp. Lucy Choi
K151997 03/31/2016 Nitrile Powder Free Examination Gloves Tested for Use with Chemotherapy Drugs-Violet Blue (VBLU) HARTALEGA NGC SDN BHD Kuan Mun Leong
K160145 03/13/2016 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co., Ltd. Sarah Su
K160336 03/29/2016 Full Automatic (NIBP) Blood Pressure Monitor Health & Life Co., Ltd. Sarah Su
K151905 03/01/2016 3400E series; E5400 series; E6400 series; Sundazzler series HEARTLAND TANNING, INC. Jon Marcum
K151689 03/17/2016 MetaNeb 4 System Hill-Rom Services Pte Ltd Huifang Zhu
K153547 03/31/2016 ECHELON Oval V 5.1 MRI System Hitachi Medical Systems America, Inc. Doug Thistlethwaite
K150789 03/01/2016 SPINAUT-E, SPINAUT-I IMEDICOM CO., LTD. Bonngu Ha
K150915 03/18/2016 SPINAUT-P IMEDICOM CO., LTD. BONGGU HA
K151268 03/16/2016 SPINAUT-V, SPINAUT-S, SPINAUT-I IMEDICOM CO., LTD. BONGGU HA
K151559 03/11/2016 ImmuLisa Enhanced Centromere Antibody ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K153693 03/18/2016 Immunalysis Methamphetamine Urine Enzyme Immunoassay, Immunalysis Multi-Drug Calibrators IMMUNALYSIS CORPORATION JOSEPH GINETE
K153348 03/31/2016 JAZZ LOCK Implanet, S.A. Regis Le Couedic
K153389 03/30/2016 Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom) IN LIGHT WELLNESS SYSTEMS, INC. JANE MELONE
K153770 03/21/2016 OS2(R)-VP Varisation Staple IN2BONES SAS MORGANE GRENIER
K160064 03/11/2016 MoMe Kardia Wireless Ambulatory ECG Monitoring and Detection System INFOBIONIC, INC. NANCY BRIEFS
K153090 03/10/2016 Reprocessed Diagnostic Ultrasound Catheter INNOVATIVE HEALTH, LLC RAFAL CHUDZIK
K153153 03/14/2016 Reprocessed Electrophysiology Catheter INNOVATIVE HEALTH, LLC RAFAL CHUDZIK
K151433 03/18/2016 AUDICOR CA300/CC100 Analyzer with SDB INOVISE MEDICAL, INC. Earl Anderson
K153758 03/23/2016 Straumann Bone Level Tapered Implants INSTITUT STRAUMANN AG Christopher Klaczyk
K160276 03/03/2016 ACL TOP (ACL TOP 700, ACL TOP 700 CTS, ACL TOP 700 LAS, ACL TOP 500 CTS, ACL TOP 300 CTS) INSTRUMENTATION LABORATORY CO. NIKITA MALLADI
K160445 03/16/2016 HemosIL Silica Clotting Time INSTRUMENTATION LABORATORY CO. Heather L Harvey
K153041 03/14/2016 Bundled Neurological Shunts and Accessories Product Families Labeling Modification to Support MR Conditional Labeling INTEGRA LIFESCIENCES CORPORATION Timothy Connors
K152897 03/04/2016 Integra DP Valve Systems (including Burr Hole Reservoirs and Stainless Steel Connectors), Gravity Compensating Accessory INTEGRA LIFESCIENCES CORPORATION JENNIFER SIEGEL
K152448 03/09/2016 da Vinci Single-Site Instrument and Accessories INTUITIVE SURGICAL, INC. Melissa Gonzalez
K152578 03/30/2016 da Vinci Surgical System, Model IS4000 INTUITIVE SURGICAL, INC. Brandon Hansen
K152421 03/04/2016 IS4000 Stapler 30 Instrument and Stapler 30 Reloads INTUITIVE SURGICAL, INC. MANISH PATEL
K152705 03/17/2016 Jiayuan Nitrile Powder Free Patient Examination Gloves, Blue Color Jiayuan Medical Products Co., Ltd Wang Lihong
K160212 03/28/2016 ACUVUE (senofilcon C) Soft Contact Lens Johnson & Johnson Vision Care, Inc. Ramona Haile
K160547 03/24/2016 Cascadia Interbody System K2M NANCY GIEZEN
K160208 03/18/2016 NILE Alternative Fixation Spinal System K2M, Inc. NANCY GIEZEN
K152748 03/01/2016 Braun Thermoscan PRO 6000 Ear Thermometer KAZ USA, INC (A SUBSIDIARY OF HELEN OF TROY, INC) RAJ KASBEKAR
K152975 03/23/2016 VDT985US Vicks SmartTemp Thermometer Kaz USA, Inc., a Helen of Troy Company Raj Kasbekar
K153027 03/14/2016 Cryotop US KITAZATO BIOPHARMA CO., LTD. FUTOSHI INOUE
K153495 03/31/2016 Avenue L Lateral Lumbar Cage, Avenue T TLIF Cage System, ROI-A ALIF Cage System, ROI-T Implant System LDR Spine USA Brad Strasser
K153710 03/18/2016 Tuxedo Digital Dental Sensor LED DENTAL INC Wesley Newsom
K152935 03/17/2016 LiDCOunity Monitor LIDCO LTD ERIC MILLS
K153400 03/07/2016 ProLift Expandable System LIFE SPINE, INC. RANDY LEWIS
K153687 03/31/2016 Liofilchem MIC Test Strip (MTS)-Vancomycin 0.016 -256 ug/mL Liofilchem s.r.l Fabio Brocci
K151965 03/11/2016 Dentti System Martz, Inc Andrew Martz
K153238 03/15/2016 Dignity Dual Port Medcomp ( Medical Components) Beth Ann Giammaruti
K153441 03/25/2016 VibraPEP Medica Holdings, LLC George Reed
K152394 03/11/2016 Rapicide PA High-Level Disinfectant Test Strips MEDIVATORS INC. MEGAN DICKEY
K151754 03/22/2016 Glide-On Vinyl Examination Gloves MEDLINE INDUSTRIES, INC. Jennifer Mason
K150731 03/07/2016 Medline Epidural Catheter MEDLINE INDUSTRIES, INC. Matt Clausen
K152428 03/31/2016 SensiCare PI Surgical Gloves MEDLINE INDUSTRIES, INC. JENNIFER MASON
K153667 03/24/2016 TRUESPAN Meniscal Repair System Medos International SARL Kristine Christo
K153438 03/02/2016 PERIMETER C (Titanium) Spinal System MEDTRONIC SOFAMOR DANEK USA, INC MICHAEL SCOTT
K160418 03/07/2016 PERIMETER Interbody Fusion Device Medtronic Sofamor Danek USA, Inc Ankit K. Shah
K160528 03/28/2016 ANATOMIC PEEK PTC Cervical Fusion System MEDTRONIC SOFAMOR DANEK, USA, INC. LEE GRANT
K153160 03/30/2016 AVIVO Mobile Patient Management (MPM) System MEDTRONIC, INC. CHERYL L. SWANSON
K153661 03/14/2016 ImmunoCard STAT! HpSA Meridian Bioscience, Inc Susan Rolih
K153337 03/25/2016 Corvocet Biopsy System MERIT MEDICAL SYSTEMS, INC. Ileana Davis
K152625 03/09/2016 MMS Guide Catheter MicroMedical Solutions, Inc. Gregory Mathison
K152631 03/23/2016 MPO Total Knee Systems MR Labeling MICROPORT ORTHOPEDICS, INC. USMAN RASHID
K151763 03/15/2016 PerioLase Nd:YAG Pulsed Dental Laser System MILLENNIUM DENTAL TECHNOLOGIES, INC. DAVID M HARRIS
K152707 03/17/2016 Minghao Nitrile Powder Free Patient Examination Gloves, Blue Color MINGHAO MEDICAL PRODUCTS CO.,LTD. PANG CUIRU
K160434 03/17/2016 ClearPoint System MRI INTERVENTIONS, INC. Peter Piferi
K160129 03/26/2016 MRII Cranial Drill and Accessories MRI INTERVENTIONS, INC. PETER PIFERI
K152051 03/22/2016 ClearMet Mycone Dental Supply Co., t/a Keystone Industries Tracey Schwear
K151943 03/25/2016 Vas-Q-Clip NANOVA BIOMATERIALS INC ANDREW RITTS
K152598 03/17/2016 Endo Keeper NELIS SEO OU NAM
K153584 03/15/2016 NeoTract UroLift System UL500 NeoTract, Inc. Nancy E Isaac
K151706 03/17/2016 Specular Microscope CEM- 530 NIDEK CO., LTD. YONEJI MIZUNO
K152938 03/18/2016 DBB-06 Hemodialysis Delivery System NIKKISO, CO.,LTD. SEIYA RAIJYU
K160389 03/11/2016 NovaCross Microcatheter Nitiloop Ltd. Chanan Schneider
K152093 03/16/2016 NobelZygoma 45? NOBEL BIOCARE AB JI EUN HWANG
K151708 03/02/2016 RECON system - Compression Screws NORMED MEDIZIN-TECHNIK GMBH ARNE BRIEST
K151832 03/31/2016 NOVATECH TALCAIR NOVATECH S.A. JENNIFER NEFF
K153627 03/17/2016 NuVasive« TLX Interbody System NUVASIVE INCORPORATED CYNTHIA ADAMS
K153782 03/24/2016 NuVasive« Lumbar Interbody Implants NUVASIVE, INCORPORATED MARTIN YAHIRO
K160417 03/17/2016 Rezum System NxThera, Inc. J. Robert Paulson
K152814 03/17/2016 Giraffe OmniBed Carestation CS1 Ohmeda Medical, a Division of Datex-Ohmeda,Inc. A GE Company Kenny M Bello
K152602 03/03/2016 Olea Sphere V3.0 OLEA MEDICAL CAROLINE LENE
K160098 03/22/2016 Single Use Aspiration Needle NA-U401SX OLYMPUS MEDICAL SYSTEMS CORP. TOSHIYUKI NAKAJIMA
K160241 03/02/2016 Single Use Sphincterotome V (Distal Wireguided) KD-VC412Q-0215 OLYMPUS MEDICAL SYSTEMS CORP. Toshiyuki Nakajima
K152919 03/10/2016 OMNI Skirted Heads OMNILIFE SCIENCE INC. Vani Sindwani
K142993 03/10/2016 QuikRead go CRP, QuikRead go CRP Verification Set, QuikRead go CRP Control Set, and QuikRead go Instrument ORION DIAGNOSTICA OY ANJA KONTIO
K153237 03/01/2016 OrthAlign Plus System OrthAlign, Inc. David Vancelette
K160466 03/23/2016 Response 5.5 Spine System ORTHOPEDIATRICS CORP. Mark Fox
K160234 03/17/2016 OVENT OVENTUS MANUFACTURING PTY LTD Neil Anderson
K151123 03/03/2016 Pac-Dent Barrier Sleeve, Cover-It(TM) Barrier Film Pac-Dent International, Inc. Wenying Zhu
K152699 03/17/2016 Apollo System PENUMBRA, INC. MARY ROSE
K151799 03/25/2016 EliA anti-TG Immunoassay, EliA anti-TPO Immunoassay, EliA Thyroid Positive Control 250, EliA Thyroid Positive Control 2500/5000 PHADIA AB CARINA MAGNUSSON
K153324 03/22/2016 Ingenia 1.5T and Ingenia 1.5T S R5.2 PHILIPS MEDICAL SYSTEMS, NEDERLANDS B.V. Henrie Daniels
K151780 03/11/2016 CAAS Workstation PIE MEDICAL IMAGING B.V. FLORIE DANIELS
K151461 03/24/2016 Hybernite RT PLASTIFLEX GROUP NV RAF VAN ROY
K151940 03/10/2016 Thora-3Di, Model T-01 PneumaCare LIMITED MARK HARWOOD
K152021 03/31/2016 Pure Tilt Proactive Comfort, LLC Tracy Augustine
K152716 03/24/2016 EV Insite System PSP Corporation Kenji Ishida
K143468 03/22/2016 QbCheck QBTECH AB Hans Bostrom
K160347 03/03/2016 Hisense LDC monitor models HMD2G21/HMD3G21/HMD5G21 QINGDAO HISENSE MEDICAL EQUIPMENT CO.,LTD Liu zhitang
K151612 03/31/2016 NewTom VGi evo QR S.r.l. LORENZO BORTOLOTTI
K160513 03/18/2016 Quanta System Surgical Laser fibers QUANTA SYSTEM SPA FRANCESCO DELL'ANTONIO
K152482 03/04/2016 Propeller Sensor Model 2014-R RECIPROCAL LABS DAVID HUBANKS
K152882 03/08/2016 Propeller System RECIPROCAL LABS DAVID HUBANKS
K153250 03/16/2016 Renovis Tesera SC Stand-alone Anterior Cervical Fusion (ACF) System RENOVIS SURGICAL TECHNOLOGIES ANTHONY DEBENEDICTIS
K152105 03/29/2016 Rocket IPC Insertion Set, Rocket IPC Mini Insertion Set ROCKET MEDICAL PLC TRACY CHARLTON
K152957 03/04/2016 MultiCross Catheter ROXWOOD MEDICAL, INC. Grace Li
K153646 03/18/2016 SAFECARE Urine Test Amphetamine, SAFECARE Urine Test Cocaine, SAFECARE Urine Test Marijuana SAFECARE BIOTECH (HANGZHOU)CO.,LTD. Alex Qiu
K151506 03/11/2016 Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen Cannula Salter Labs Mara Caler
K151421 03/10/2016 Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula, Sample Lines Salter Labs Mara Caler
K150566 03/21/2016 Oniris SAS Oniris Thibault Vincent
K152402 03/04/2016 IRTS Thermal Imaging Probe (TIP);IRTS Patient Monitoring Unit (PMU);IRTS Patient Interface Unit (PIU) SECURUS,INC William J Gorman
K153146 03/31/2016 Infrared Ear Thermometer SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. REN YUNHUA
DEN140017 03/04/2016 SENSIMED TRIGGERFISH SENSIMED AG Marcy Moore
K152824 03/07/2016 MEDT PEN NEEDLE SHANDONG CAREMED MEDICAL PRODUCTS CO., LTD. LIN YANYAN
K152517 03/18/2016 Nitrile Examination Gloves, Powder Free, (White) SHANDONG FEIYANG PROFESSIONAL GLOVES COMPANY LIMITED KEN LU
K151745 03/03/2016 FULL CARE Disposable PVC Nelaton Catheter SHAOXING FUQING HEALTH PRODUCTS CO., LTD. DEAN WU
K153212 03/04/2016 Sheathes Ultrasound Probe Covers Sheathing Technologies, Inc. JENNIFER DOWNING
K152815 03/08/2016 Mailuokang Self-adhesive Electrode SHENZHEN MAILUOKANG TECHNOLOGY CO., LTD. HU PANDENG
K153448 03/03/2016 Passport Series Patient Monitors (Including Passport 8, Passport 12) SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD BAI YANHONG
K160381 03/09/2016 TE7 Diagnostic Ultrasound System SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD WU ZICUI
K153767 03/29/2016 X-cera Zirconia Blanks SHENZHEN XIANGTONG PHOTOELECTRICITY TECHNOLOGY CO., LTD. YONGQING CHEN
K151700 03/02/2016 BEAUTIFIL II Gingiva SHOFU DENTAL CORPORATION MAURO MALZYNER
K152681 03/01/2016 iFuse Implant System(R) SI-BONE, INC. ROXANNE DUBOIS
K153291 03/31/2016 SICAT OPTISLEEP SICAT GMBH & CO. KG MANFRED BREUER
K152061 03/03/2016 IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material SIEMENS HEALTHCARE DIAGNOSTICS, INC. SUSAN BROCCHI
K153244 03/07/2016 Cios Fusion SIEMENS MEDICAL SOLUTIONS USA, INC. DARREN A. DORMAN
K153447 03/31/2016 MAGNETOM Spectra SIEMENS MEDICAL SOLUTIONS USA, INC. CORDELL L. FIELDS
K151765 03/25/2016 SOMATOM Perspective SIEMENS MEDICAL SOLUTIONS USA, INC. KIMBERLY MANGUM
K151749 03/18/2016 somatom Scope(with syngo CT VC30-easyIQ version), SOMATOM Scope Power(with syngo CT VC30-easyIQ version) Siemens Medical Solutions USA, Inc. Eve Davis
K153346 03/04/2016 syngo Application Software VD11 Siemens Medical Solutions USA, Inc. Patricia D Jones
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