| 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 |
| K160336 |
03/29/2016 |
Full Automatic (NIBP) Blood Pressure Monitor |
Health & Life Co., Ltd. |
Sarah Su |
| K160145 |
03/13/2016 |
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 |
| 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 |
| K160426 |
03/04/2016 |
syngo.via MI Workflows |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
Veronica Padharia |
| K160420 |
03/21/2016 |
SpeqT |
Signostics Limited |
Stewart Bartlett |
| K153485 |
03/10/2016 |
ENROUTE Transcarotid Neuroprotection System |
SILK ROAD MEDICAL, INC. |
KRISTIN ELLIS |
| K151847 |
03/04/2016 |
SMART PERFORMER (Polymacon) Soft (Hydrophilic) Contact Lens |
SMART PERFORMER CORP. LTD. |
JEFFERSION SHEN |
| K152686 |
03/17/2016 |
CONQUEST FN |
Smith & Nephew |
Bradley Heil |
| K160603 |
03/28/2016 |
SMV Scientific Schanz Screws |
SMV SCIENTIFIC |
NEPHI ZUFELT |
| K160069 |
03/10/2016 |
Sonoma Fibula Repair System |
Sonoma Orthopedics Products, Inc |
Rick Epstein |
| K160120 |
03/21/2016 |
D-SPECT Processing and Reviewing Workstation |
SPECTRUM DYNAMICS LTD. |
YORAM LEVY |
| K152662 |
03/09/2016 |
S-Wire |
Spinal Resources Inc |
Bernard Bedor |
| K153042 |
03/28/2016 |
TRYPTIK2C-plate Anterior Cervical Plate System |
SPINEART |
Franck PENNESI |
| K152090 |
03/23/2016 |
Reprocessed Steerable Introducer |
STERILMED, INC. |
Patricia Kaufman |
| K152178 |
03/11/2016 |
StimQ Peripheral Nerve Stimulator (PNS) System |
STIMQ LLC |
ELIZABETH GREENE |
| K151590 |
03/04/2016 |
Straumann RN Gold Abutment for Bridge |
STRAUMANN USA, LLC |
CHRISTOPHER KLACZYK |
| K153248 |
03/10/2016 |
PEEK Customized Cranial Implant |
STRYKER |
Jonathan Schell |
| K151932 |
03/31/2016 |
Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use Tubing |
STRYKER CORPORATION |
SOMI EKWEALOR |
| K153119 |
03/14/2016 |
Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography SystemAmrad Medical FRS Digital Radiography System, |
SUMMIT INDUSTRIES LLC |
Tom Boon |
| K152238 |
03/04/2016 |
Sun Capsule 60/160/1.8/6, Sun Capsule 60/220/1.9/6, Sun Capsule 60/225/2.0/6, Sun Capsule 54/225/2.0/5.5, Sun Capsule 54/200/1.8/6, Sun Capsule 54/160/1.8/6, Sun Capsule 49/225/2.0/5.5, Sun Capsule 49/220/1.9/5.5, Sun Capsule 48/220/1.9/6, Sun Capsule 48/ |
SUN CAPSULE, INC. |
THOMAS P. HOLLAND |
| K152334 |
03/17/2016 |
Sungshim Insulin Pen Needle |
SUNGSHIM MEDICARE CO., LTD. |
KIM YOUNG KWAN |
| K160662 |
03/11/2016 |
Surefire Infusion System |
SUREFIRE MEDICAL, INC |
Lynne Aronson |
| K152200 |
03/25/2016 |
SurgTech Interbody System |
SURGTECH INC |
XUEGONG YU |
| K153281 |
03/30/2016 |
BrightMatter Guide with Surface Trace Registration |
SYNAPTIVE MEDICAL INC. |
Cameron Piron |
| K153284 |
03/29/2016 |
Synaptive ImageDrive Pro |
SYNAPTIVE MEDICAL INC. |
Cameron Piron |
| K153527 |
03/02/2016 |
PicoWay Laser System |
SYNERON CANDELA CORPORATION |
Ruthie Amir |
| K151024 |
03/02/2016 |
Finger Type Pulse Oximeter |
TAIDOC TECHNOLOGY CORPORATION |
C. W. CHEN |
| K160374 |
03/11/2016 |
20G x 1.25 NovaCath Secure IV Catheter System, 24G x 0.56 NovaCath Secure IV Catheter System |
TANGENT MEDICAL TECHNOLOGIES, INC. |
GREG LAST |
| K152835 |
03/07/2016 |
URITEK TC-201 URINE CHEMISTRY TEST SYSTEM |
TECO DIAGNOSTICS, INC. |
YUNYUAN VIVIAN WANG |
| K152933 |
03/23/2016 |
Vesalius |
TELEA ELECTRONIC ENGINEERING SRL |
Simona Daidone |
| K153299 |
03/03/2016 |
Tenex Health TX System |
TENEX HEALTH, INC. |
GLORIA PENDERGRASS |
| K153510 |
03/21/2016 |
Powder Free Polychloroprene Examination Glove Green |
TERANG NUSA SDN BHD |
ROBERT HILL |
| K153202 |
03/24/2016 |
iMESH Tacker |
THD LAP |
Einat Duvdevany |
| K151984 |
03/10/2016 |
Thommen Milling Abutment for CAD/CAM |
THOMMEN MEDICAL AG |
DANIEL SNETIVY |
| K152206 |
03/08/2016 |
SurgiPure XD Reconstructive Tissue Matrix |
TISSUE REGENIX GROUP PLC |
MIKE IZON |
| K152646 |
03/11/2016 |
SYLK PERSONAL LUBRICANT |
TORO MANAGEMENT LLC DBA SYLK |
MARIESSA MAHFOUZ |
| K160386 |
03/10/2016 |
ReadeR, VieweR, QuickScan PSP |
TRIDENT S.R.L |
GIORGIO RIZZO |
| K151135 |
03/15/2016 |
MODEL 621/624 BIOMAGNETOMETER |
TRISTAN TECHNOLOGIES, INC |
KEVIN PRATT |
| K152199 |
03/23/2016 |
RejuvatoneMD |
TROPHY SKIN, INC. |
IMRAN KARIM |
| K153392 |
03/24/2016 |
STERIZONE VP4 Sterilizer |
TS03 INC |
Nathalie Racette |
| K152808 |
03/25/2016 |
U&U Insulin Syringe with/without Safety Retractable Device |
U&U Medical Technology Co., Ltd |
Black Wang |
| K152530 |
03/14/2016 |
UCP Stem |
UNITED ORTHOPEDIC CORPORATION |
KAREN HO |
| K153717 |
03/21/2016 |
Venus Versa System |
Venus Concept Ltd. |
Tal Bresler-Stramer |
| K150588 |
03/18/2016 |
OVA1 Next Generation |
VERMILLION, INC. |
Benjamin A Kimball |
| K151881 |
03/24/2016 |
X-Fix Line Additions |
VILEX IN TENNESSEE, INC |
SYLVIA SOUTHARD |
| K160620 |
03/30/2016 |
Visaris Vision« (Vision C, Vision U. Vision V, Vision X) |
VISARIS D.O.O. BELGRADE |
MILAN RATKOVIC |
| K160150 |
03/16/2016 |
Vitrea CT Colon Analysis |
Vital Images, Inc. |
Alexis Erazo |
| K153513 |
03/04/2016 |
Insufflator 50L FM134 |
W.O.M WORLD OF MEDICINE GMBH |
Soeren Markworth |
| K160114 |
03/15/2016 |
Xspan Laminoplasty Fixation System |
X-SPINE SYSTEMS, INC. |
Kriss Anderson |
| K152719 |
03/01/2016 |
Xinfu Powder-Free Yellow Vinyl Patient Examination Gloves |
XINFU MEDICAL PRODUCTS CO., LTD. |
XIE WENXING |
| K152720 |
03/10/2016 |
Xingda Nitrile Powder Free Patient Examination Gloves, Blue Color |
XINGDA MEDICAL PRODUCTS CO., LTD. |
ZHANG LIXIA |
| K160362 |
03/22/2016 |
Z-Span Plate System |
Zavation, LLC |
Frankie Cummins |
| K160259 |
03/23/2016 |
ZELTIQ CoolSculpting System |
ZELTIQ AESTHETICS, INC. |
SHRUTI JAYAKUMAR |
| K151789 |
03/04/2016 |
LOCATOR F-Tx Attachment System |
ZEST ANCHORS, LLC |
ANNIE WRIGHT |
| K152712 |
03/09/2016 |
Nitrile Powder Free Patient Examination Gloves, Blue Color |
Zhonghong Pulin Medical Products Co., Ltd. |
LI Jinge |
| K160085 |
03/08/2016 |
Anatomical Shoulder System, Anatomical Shoulder Domelock System, Anatomical Shoulder Fracture System |
ZIMMER GMBH |
Roberto Tommasini |
| K153226 |
03/24/2016 |
Solex 7 Intravascular Heat Exchange Catheter, ZOLL Start-Up Kit |
ZOLL CIRCULATION, INC. |
SAM NANAVATI |
