| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K150694 |
10/01/2015 |
3M Comply Hydrogen Peroxide Indicator Tape 1228 |
3M Company |
Hilary B. Hovde |
| K151636 |
10/19/2015 |
AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance Linear (Four-Button) Foot Pedal, WHITESTAR Signature Pro (Wireless) Remote Control |
ABBOTT MEDICAL OPTICS INC |
Christine Chun |
| K152709 |
10/21/2015 |
HI-TORQUE BALANCE |
ABBOTT VASCULAR |
JOCHEN REICH |
| K143560 |
10/05/2015 |
CygneX I System |
Accuthera Inc. |
Eiji Tanabe |
| K151886 |
10/30/2015 |
Acumed Ankle and Small Fragment Base Set Update |
Acumed, LLC |
Kara Budor |
| K152040 |
10/30/2015 |
X8 System - Sleep Profiler (SP40), X8 System - Sleep Profiler PSG2 (SP29), X8 System - Stat X8 (XS29) |
ADVANCED BRAIN MONITORING, INC. |
DANIEL J. LEVENDOWSKI |
| K151182 |
10/26/2015 |
LiquiBand Exceed |
ADVANCED MEDICAL SOLUTIONS (PLYMOUTH) LTD |
MARTIN MITCHELL |
| K151971 |
10/29/2015 |
STERRAD CYCLESURE 24 Biological Indicator |
ADVANCED STERILIZATION PRODUCTS |
SUN CHOI |
| K151938 |
10/21/2015 |
S4 Cervical Spinal and Occiput Systems |
AESCULAP IMPLANT SYSTEMS, LLC |
LISA BOYLE |
| K151865 |
10/27/2015 |
PremiPatch PTFE Pledget |
AESCULAP, INC. |
KATHY A. RACOSKY |
| K151242 |
10/09/2015 |
SterilContainer S |
Aesculap, Inc. |
Denise R. Adams |
| K151599 |
10/02/2015 |
iSy Implant System |
Altatec GmbH |
Colleen Boswell |
| K151648 |
10/16/2015 |
Altus Spine Pedicle Screw System, Altus Spine MIS Pedicle Screw System, Valencia Pedicle Screw System, Valencia MIS Pedicle Screw System |
Altus Partners, LLC |
Claudia Hill |
| K143518 |
10/02/2015 |
Valeo Spacer System and Valeo II Interbody Fusion Device System |
Amedica Corp. |
William D. Jordan |
| K152455 |
10/15/2015 |
Amendia Cervical Plate System |
Amendia, Inc |
Kristen Allen |
| K143117 |
10/29/2015 |
Wire Sterilization Package with Indicators |
AMERICAN ORTHODONTICS |
TRANG ADAMS |
| K151724 |
10/14/2015 |
AngioDynamics Mariner Angiographic Catheters |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K150396 |
10/14/2015 |
Autosure Voice II Blood Glucose Monitoring System, Autosure Voice II Pro Blood Glucose Monitoring System, Autosure Blood Glucose Test Strips, Autosure Pro Blood Glucose Test Strips |
APEX BIOTECHNOLOGY CORP. |
Hsue-mei Lee |
| K143308 |
10/13/2015 |
GelPOINT Transvaginal Access Platform |
APPLIED MEDICAL RESOURCES |
Frans VandenBroek |
| K143235 |
10/23/2015 |
RF20000a Controller, FLOW 50 Wand |
ARTHROCARE CORPORATION |
Ashley J Dawson |
| K152527 |
10/29/2015 |
Integra DigiFuse Cannulated Intramedullary Fusion System |
Ascension Orthopedics |
Jayana Kenana |
| K150693 |
10/13/2015 |
PHIN-FX Cannulated Lag Screw System |
ASCENT MEDICAL, LLC |
DAVID FORD |
| K150232 |
10/19/2015 |
Radifocus Optitorque Angiographic Catheter |
ASHITAKA FACTORY OF TERUMO CORP. |
Monika McDole-Russell |
| K152025 |
10/05/2015 |
AssureTech Buprenorphine Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup), AssureTech Methadone Tests (Strip, Panel Dip, Quick Cup, Turn-Key Split Cup) |
ASSURE TECH. CO., LTD. |
ERIC LIN |
| K151386 |
10/22/2015 |
C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic |
ATRIUM MEDICAL CORPORATION |
Timothy J Talcott |
| K152275 |
10/14/2015 |
Pantheris System |
Avinger, Inc. |
Patty Hevey |
| K152474 |
10/23/2015 |
Avitus Bone Harvester |
Avitus Orthopaedics Inc. |
Maxim Budyansky |
| K152675 |
10/29/2015 |
EXTENDED LIFE CAPD TRANSFER SET, PERITONEAL DIALYSIS TITANIUM CATHETER ADAPTER AND LOCKING CAP FOR TITANIUM CATHETER ADAPTER |
BAXTER HEALTHCARE |
JOHN LAMELA |
| K152129 |
10/29/2015 |
FlexiCap Disconnect Cap with Povidone-Iodine Solution, MiniCap with Povidone-Iodine Solution |
BAXTER HEALTHCARE CORPORATION |
TIFFANY LIN |
| K151489 |
10/26/2015 |
Retrieval bag system |
BEACON SURGICAL, INC. |
ALLAN ALWARD |
| K152870 |
10/27/2015 |
BD Veritor System for the Rapid Detection of Flu A + B CLIA waived kit |
BECTON DICKINSON AND CO. |
GREGORY P. PAYNE |
| K152874 |
10/27/2015 |
BD Veritor System for the Rapid Detection of Flu A + B Laboratory kit |
BECTON DICKINSON, AND CO. |
GREG PAYNE |
| K152516 |
10/13/2015 |
BD BBL Sensi-Disc Ceftazidime Avibactam (30/20ug), Antimicrobial Susceptibility Test Disks |
BECTON, DICKINSON AND COMPANY |
LAURA STEWART |
| DEN150013 |
10/08/2015 |
FilmArray Meningitis/Encephalitis(ME) Panel |
BioFire Diagnostics, LLC |
Kristen J Kanack |
| K151873 |
10/07/2015 |
Etest Ceftaroline (0.002 - 32ug/ml) |
BIOMERIEUX SA |
CLAIRE DUMAS |
| K151615 |
10/02/2015 |
TiTHON Staple with OsseoTi Technology |
BIOMET MANUFACTURING CORP. |
Patricia Sandborn Beres |
| K151603 |
10/06/2015 |
Arcos One-piece Femoral Revision System |
Biomet, Inc. |
Tracy Johnson |
| K152621 |
10/14/2015 |
OSS/Arcos IM Total Femur Rod |
BIOMET, INC. |
BRYAN MCMAHON |
| K152240 |
10/08/2015 |
Passeo-14 Peripheral Dilatation Catheter |
BIOTRONIK, INC. |
JON BRUMBAUGH |
| K151744 |
10/08/2015 |
Passeo-18 Peripheral Dilation Catheter |
BIOTRONIK, INC. |
JON BRUMBAUGH |
| K151910 |
10/05/2015 |
Ultrasound Scanner System BK2300 |
BK MEDICAL APS |
Randi Hauerberg |
| K152574 |
10/20/2015 |
Navio |
BLUE BELT TECHNOLOGIES, INC |
RICHARD G. CONFER |
| K152607 |
10/27/2015 |
Express SD Biliary Monorail Premounted Stent System |
BOSTON SCIENTIFIC |
ANNA DERANEY |
| K152572 |
10/06/2015 |
AXIOS Stent and Delivery System |
BOSTON SCIENTIFIC CORPORATION |
ASHLEY SANTOS |
| K152693 |
10/21/2015 |
CLEARSIGN II Amplifier 40 Channels, CLEARSIGN II Amplifier 80 Channels, CLEARSIGN II Amplifier 120 Channels, CLEARSIGN II Amplifier 160 Channels |
BOSTON SCIENTIFIC CORPORATION |
MAYLIN TRUESDELL |
| K151610 |
10/06/2015 |
Comet Pressure Guidewire |
BOSTON SCIENTIFIC CORPORATION |
JAMES KLEINEDLER |
| K151895 |
10/22/2015 |
Expect Pulmonary Endobronchial Ultrasound Transbronchial Aspiration Needle |
BOSTON SCIENTIFIC CORPORATION |
YINGYING GAO |
| K151613 |
10/06/2015 |
iLab Polaris Multi-Modality Guidance System |
BOSTON SCIENTIFIC CORPORATION |
ARLENE ROCHE |
| K152605 |
10/29/2015 |
Impulse Angiographic Catheter, Expo Angiographic Catheter |
BOSTON SCIENTIFIC CORPORATION |
MAC MCKEEN |
| K152140 |
10/13/2015 |
Boa Endoscopic Valve |
C2 THERAPEUTICS, INC. |
THERESA BRANDNER-ALLEN |
| K151788 |
10/30/2015 |
Cardinal Health Sterilization Wrap |
Cardinal Health 200, LLC |
MEGAN MIDDAUGH |
| K152694 |
10/21/2015 |
Diamondback 360 Peripheral Orbital Atherectomy System |
Cardiovascular Systems Inc. |
Kim Wallner |
| K150523 |
10/29/2015 |
AVAmax Vertebral Balloon |
CAREFUSION |
JOY GREIDANUS |
| K151535 |
10/28/2015 |
Cavex Cream Alginate |
CAVEX HOLLAND BV |
RICHARD WOORTMAN |
| K151875 |
10/29/2015 |
Pavati Zirconia |
CCRI, INC. |
ROBIN CARDEN |
| K151565 |
10/16/2015 |
Xpert« TV Assay on the Cepheid GeneXpert Instrument Systems (GeneXpert Dx, GeneXpert Infinity-48, GeneXpert Infinity-48s, and GeneXpertInfinity-80 systems), Xpert Vaginal/Endocervical Specimen Collection Kit, and Xpert Urine Specimen Collection Kit |
CEPHEID |
KERRY J. FLOM |
| K152481 |
10/30/2015 |
DURAFORM Dural Graft Implant |
CODMAN & SHURTLEFF, INC. |
JENNIFER SIU |
| K150902 |
10/22/2015 |
330psi Extension Y-Line with Dual Check Valve |
COEUR, INC. |
Erin Rheinscheld |
| K152704 |
10/21/2015 |
iTotal Posterior Stabilized Knee Replacement System, iTotal Cruciate Retaining Knee Replacement System |
CONFORMIS, INC |
AMITA SHAH |
| K150936 |
10/23/2015 |
SureClip |
CONMED CORPORATION |
ANNA D'LIMA |
| K142887 |
10/01/2015 |
SIS Inguinal Hernia Repair Graft |
COOK BIOTECH INCORPRATED |
Perry W Guinn |
| K151408 |
10/02/2015 |
LOSPA IS Spinal System |
CORENTEC CO., LTD |
GOON HEE LEE |
| K150063 |
10/02/2015 |
One Step hCG Pregnancy Test |
Coretests, Inc. |
Wen Li |
| K150892 |
10/02/2015 |
CorPath 200 System |
CORINDUS, INC. |
Milind Gramopadhye |
| K152273 |
10/30/2015 |
Cosmedico Ultraviolet Lamps of Various Models |
Cosmedico Light, Inc |
Steven Schlitt |
| K152095 |
10/28/2015 |
Ultraviolet Lamps Intended for Use in Sunlamp Products (commonly known as metal halide sunlamps) |
COSMEDICO LIGHT, INC. |
STEVEN SCHLITT |
| K152565 |
10/09/2015 |
Auto Suture Locking Trocar |
COVIDIEN |
MICHAEL KOCZOCIK |
| K150835 |
10/15/2015 |
LigaSure Advance Monopolar Tip Laparoscopic Sealer/Divider, Pistol Grip |
COVIDIEN |
Nancy Sauer |
| K150711 |
10/08/2015 |
Salem Sump Dual Lumen Stomach Tube with Multi-functional Port |
COVIDIEN |
Jim Welsh |
| K152668 |
10/14/2015 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
| K151500 |
10/05/2015 |
Arthrex Glenoid Intelligent Reusable Instrument System (Arthrex Glenoid IRIS) |
CUSTOM ORTHOPAEDIC SOLUTIONS |
Peter D O'Neill |
| K151501 |
10/02/2015 |
OrthoVis Web Portal |
CUSTOM ORTHOPAEDIC SOLUTIONS,INC. |
Justin Baker |
| K151525 |
10/09/2015 |
Amia Automated PD System with Sharesource |
DEKA RESEARCH AND DEVELOPMENT |
ROGER LEROUX |
| K151619 |
10/30/2015 |
Prime&Bond Elect Universal Dental Adhesive |
DENTSPLY INTERNATIONAL INC. |
HELEN LEWIS |
| K150209 |
10/06/2015 |
Healix BR Anchor, Healix PEEK Anchor, Healix Transtend, Gryphon T and P BR Anchor, Gryphon PEEK Anchor, VersaLok Anchor, Bioknotless BR Anchor, Lupine BR Anchor, PanaLok Anchor,PanaLok Anchor with Orthocord, PanaLok RC QuickAnchor Plus; PanaLok RC QuickAn |
Depuy Mitek, a Johnson and Johnson Company |
YAYOI FUJIMAKI |
| K143494 |
10/05/2015 |
ADX6000 Portable X-Ray System; iRayA6 |
DEXCOWIN CO., LTD |
Ryu Seung-Bum |
| K152591 |
10/08/2015 |
Medilas H RFID Laser Fibers |
Dornier MedTech America, Inc. |
John Hoffer |
| K151942 |
10/21/2015 |
EVS 3643 |
DRTECH Corporation |
Choul-Woo Shin |
| K151693 |
10/09/2015 |
Dr-Ho's Foot Pad Electrode |
DRTV ASIA LTD |
MICHAEL HO |
| K143716 |
10/29/2015 |
DSM Biomedical DPR Cable |
DSM BIOMEDICAL |
Lori Burns |
| K151220 |
10/14/2015 |
Dunamis Interference Screw |
Dunamis LLC |
PRITHVI RAJ CHAVAN |
| K143499 |
10/09/2015 |
eCligner |
eClear International Co., Ltd. |
Tae Weon Kim |
| K152633 |
10/15/2015 |
Chandler Transluminal Bipolar Pacing Probe, Flextip Transluminal Bipolar Pacing Probe |
EDWARDS LIFESCIENCES, LLC |
DEANA BOUSHELL |
| K151159 |
10/29/2015 |
Leksell Gamma Knife Perfexion |
ELEKTA INSTRUMENT AB |
MATILDA FORSBERG |
| K142410 |
10/30/2015 |
Elliquence Electrodes |
ELLIQUENCE LLC |
Paul D Buhrke |
| K151640 |
10/16/2015 |
ELTRAC 471 |
ENRAF-NONIUS B.V. |
ANNE-MARIE VAN MAURIK |
| K152788 |
10/21/2015 |
EOS System |
EOS IMAGING |
MATHIAS BREUIL |
| K143306 |
10/27/2015 |
ERBE WaterJet Model ERBEJET« 2 System with HybridAPC Probe |
ERBE USA, INC. |
JOHN TARTAL |
| K152096 |
10/22/2015 |
DERMABOND Advanced Topical Skin Adhesive, High Viscosity DERMABOND Mini Topical Skin Adhesive |
Ethicon, Inc. |
Donna Marshall |
| K151715 |
10/29/2015 |
T3 Software |
Etiometry, Inc. |
DIMITAR BARONOV |
| K151479 |
10/16/2015 |
EV-820 OTC Pain Relief TENS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
Robert Tu |
| K152710 |
10/15/2015 |
HammerFiX Device |
EXTREMITY MEDICAL, LLC |
BRIAN SMEKAL |
| K152677 |
10/23/2015 |
geko T-2 Neuromuscular Stimulator |
FIRSTKIND LIMITED |
NEIL BUCKLEY |
| K150568 |
10/29/2015 |
ARROW Humeral stems size 6 and 16 |
FOURNITURES HOSPITALIERES INDUSTRIE |
Patricia Donnard |
| K151893 |
10/22/2015 |
P.R.O. CG Manual Wheelchair |
FREEDOM DESIGNS, INC. |
Nancy F Schmidt |
| K152367 |
10/29/2015 |
Optiflux dialyzer |
FRESENIUS MEDICAL CARE NORTH AMERICA |
Denise Oppermann |
| K151888 |
10/30/2015 |
Frontier Medical Devices In-line Orthopedic Cable Cerclage System |
FRONTIER MEDICAL DEVICES, INC. |
BETHANY BYMAN |
| K150221 |
10/01/2015 |
EPX-4440HD and EPX-4400HD with FICE |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
MARY MOORE |
| K151674 |
10/20/2015 |
Ultraviolet Sun Tanning Lamp |
G.I.E.- GESELLSCHAFT FUR LICHTTECHNISCHE ERZEUGNISSE MBH |
MICHAEL ANDERS |
| K151528 |
10/09/2015 |
Powder Free Nitrile (Black) Examination Gloves |
GALLANT QUALITY SDN. BHD. |
SUMATHI SARAVANA SAMI |
| K151541 |
10/09/2015 |
G-Fix |
GC America Inc. |
Mark Heiss |
| K153003 |
10/27/2015 |
SIGNA Pioneer |
GE HEALTHCARE |
Andrew Menden |
| K152039 |
10/28/2015 |
Genesys Spine TiLock2 Spinal System |
Genesys Spine |
William W Sowers |
| K151844 |
10/16/2015 |
Rainbow Shade |
GENOSS |
BYUNGSUN KIM |
| K151723 |
10/28/2015 |
Rainbow Trans |
GENOSS |
SANGPIL YOON |
| K143670 |
10/23/2015 |
ICS CHARTR EP 200 WITH VEMP |
GN OTOMETRICS A/S |
ANDERS RASMUSSEN |
| K151836 |
10/21/2015 |
NITRILE POWDER FREE EXAMINATION GLOVES-PINK, NITRILE POWDER FREE EXAMINATION GLOVES-GREEN,NITRILE POWDER FREE EXAMINATION GLOVES-ORANGE, NITRILE POWDER FREE EXAMINATION GLOVES-BLACK |
HARTALEGA NGC SDN BHD |
KUAN MUN LEONG |
| K150308 |
10/20/2015 |
Palm TENS |
HEAT IN A CLICK LLC |
GUY LEVI |
| K150595 |
10/30/2015 |
SCENARIA Phase 3 Whole-body X-ray CT System |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
Doug Thistlethwaite |
| K152207 |
10/02/2015 |
Extended Range Shifter for PROBEAT-V |
Hitachi,Ltd. , Health Care Company |
Naoya Nishimura |
| K151415 |
10/21/2015 |
Oregon Scientific |
IDT TECHNOLOGY LIMITED |
LILY LI |
| K151941 |
10/07/2015 |
DEXIS Webview |
Imaging Sciences International /Gendex/Dexis |
Sanjay Ahuja |
| K143420 |
10/30/2015 |
SYMBIS Surgical System |
IMRIS, Inc. |
Sanjay Shah |
| K151360 |
10/06/2015 |
Inion Spinal Graft Containment System |
Inion Oy |
Kati Marttinen |
| K151785 |
10/14/2015 |
Px HA PEEK IBF System |
INNOVASIS, INC. |
MARSHALL MCCARTY |
| K151027 |
10/02/2015 |
zensor system |
INTELESENS LIMITED |
PATRICIA PEPPER |
| K152156 |
10/19/2015 |
Opticage Expandable Interbody Fusion Device |
INTERVENTIONAL SPINE, INC. |
Jane Metcalf |
| K152663 |
10/16/2015 |
Bladeless Optical Obturators |
INTUITIVE SURGICAL, INC. |
VISHAL KANANI |
| K151894 |
10/29/2015 |
IPS Ivocolor |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K151949 |
10/02/2015 |
Disposable Insulin Syringe |
JIANGYIN CAINA TECHNOLOGY CO., LTD. |
JUN LU |
| K140325 |
10/13/2015 |
Joinsoon EON L Glucose Monitoring System and Joinsoon EON LS Glucose Monitoring System |
JOINSOON MEDICAL TECHNOLOGY CO, LTD. |
MARIA GRIFFIN |
| K151044 |
10/09/2015 |
CLICKLINE Scissor Insert for Single Use |
KARL STORZ Endoscopy America, Inc. |
Winkie Wong |
| K152577 |
10/08/2015 |
ULTRASOUND SYSTEM SONIMAGE HS 1 |
KONICA MINOLTA, INC. |
SHIGEYUKI KOJIMA |
| K151719 |
10/09/2015 |
REVE134 |
KW EAR LAB, INC |
Sungwoo Cho |
| K151336 |
10/23/2015 |
LightStim Professional 2-Panel Light |
LED INTELLECTUAL PROPERTIES, LLC |
STEVE MARCHESE |
| K152453 |
10/15/2015 |
LENSAR Laser System - fs 3D (LLS-fs 3D) |
LENSAR, Inc. |
Mohinder Merchea |
| K151600 |
10/23/2015 |
R-40 EEG Amplifier |
LIFELINES LTD. |
Michael Hulin |
| K152120 |
10/29/2015 |
OPTIS Mobile System |
LIGHTLAB IMAGING, INC. |
PADMINI SURAVARAM |
| K150855 |
10/21/2015 |
H-MAX S Femoral Hip System |
Limacorporate S.P.A. |
Sara Viel |
| K151266 |
10/06/2015 |
Physica CR Knee System |
Limacorporate S.P.A. |
Emanuele Buttazzoni |
| K152008 |
10/29/2015 |
Physica PS Knee System |
LIMACORPORATE S.P.A. |
EMANUELE BUTTAZZONI |
| K134036 |
10/08/2015 |
WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT |
LOKTAL MEDICAL ELECTRONICS IND. COM. LTDA- EPP |
Carrie Hetrick |
| K151109 |
10/30/2015 |
Lumenis Smart532 Laser System |
LUMENIS, INC. |
Jayce R. McLane |
| K151906 |
10/06/2015 |
ARIES HSV 1&2 Assay Cassettes - Carton of 24 (IVD), ARIES HSV 1&2 Assay Protocol File Kit (IVD), ARIES HSV 1&2 Assay Cassette (IVD) |
LUMINEX CORPORATION |
RONALD DUNN |
| K151917 |
10/06/2015 |
ARIES System |
LUMINEX CORPORATION |
RONALD DUNN |
| K150717 |
10/14/2015 |
Megasorb, Mitsu, Mitsu FST, Filaxyn, Filapron |
M/s. Meril Endo Surgery Private Limited |
Umesh Sharma |
| K150314 |
10/22/2015 |
Masimo MightySat Rx Fingertip Pulse Oximeter |
MASIMO CORPORATION |
Marguerite Thomlinson |
| K152028 |
10/26/2015 |
Volpara Imaging Software |
MATAKINA TECHNOLOGIES LIMITED |
RALPH HIGHNAM |
| K150780 |
10/27/2015 |
Acetabular Cup Orientation System |
MATERIALISE NV |
OLIVER CLEMENS |
| K151593 |
10/23/2015 |
Cellvizio 100 Series System with Confocal Miniprobes |
MAUNA KEA TECHNOLOGIES |
SOPHIE REHAULT |
| K151531 |
10/30/2015 |
MasterLoc Stem |
MEDACTA INTERNATIONAL |
MICHAEL G. LOITERMAN |
| K150804 |
10/19/2015 |
QBioScan |
MEDEIA, INC. |
SLAV DANEV |
| K151261 |
10/07/2015 |
Invia Foam Dressing Kit Small, Invia Foam Dressing Kit Medium, Invia Foam Dressing Kit Large |
Medela AG |
Orlando Antunes |
| K150203 |
10/23/2015 |
Medentika CAD/CAM Abutments |
MEDENTIKA GMBH |
Dr. Gerhard Polzer |
| K152550 |
10/08/2015 |
MEDICALGORITHMICS UNIFIED ARRHYTHMIA DIAGNOSIC SYSTEM |
MEDICALGORITHMICS S.A. |
MAREK J. DZIUBINSKI |
| K150918 |
10/16/2015 |
PASS OCT Spinal System |
MEDICREA INTERNATIONAL S.A. |
Jean-Denys Marechal |
| K150160 |
10/20/2015 |
Temple Touch Pro (TTP) Non-invasive temperature monitoring system |
MEDISIM LTD. |
Avi Ben Yaish |
| K150788 |
10/14/2015 |
Talos Intervertebral Body Fusion Devices, Talos -C Cervical Intervertebral Body Fusion Devices, Talos -C(HA) Cervical Intervertebral Body Fusion Devices |
MEDITECH SPINE, LLC |
Jason Gromek |
| K152152 |
10/27/2015 |
Codman Certas Plus Programmable Valve |
Medos International Sarl |
Jocelyn Raposo |
| K151352 |
10/08/2015 |
CONCORDE Bullet Spinal System |
MEDOS INTERNATIONAL SARL |
JEFFREY SHIFFMAN |
| K152338 |
10/28/2015 |
VERTEX(r) Reconstruction System |
MEDTRONIC SOFAMOR DANEK USA, INC |
Victoria Scheitlin |
| K152457 |
10/27/2015 |
CD HORIZON Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
Laveeda Leflore |
| K151758 |
10/29/2015 |
ALAR Nasal Valve Stent |
MEDTRONIC XOMED INC. |
GABRIELA ANCHONDO |
| K152800 |
10/23/2015 |
illumigene Mycoplasma DNA Amplification Assay |
MERIDIAN BIOSCIENCE, INC. |
Stefanie Johns |
| K152381 |
10/30/2015 |
Prelude SNAP Splittable Hydrophilic Sheath Introducer |
MERIT MEDICAL SYSTEMS, INC. |
Alina Stubbs |
| K150031 |
10/01/2015 |
hemoFISH Masterpanel |
MIACOM DIAGNOSTICS GMBH |
EVE BLOMEKE |
| K151671 |
10/16/2015 |
Disposable Multistage Dilation Balloon Catheter |
MICRO-TECH (NANJING) CO., LTD. |
BECK LI |
| K150502 |
10/09/2015 |
DRI Hydrocodone Assay, DRI Hydrocodone Calibrators, DRI Hydrocodone Controls |
Microgenics Corporation |
Tammy Wharton |
| K152770 |
10/21/2015 |
ProBP 2400 Digital Blood Pressure Device |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
GERHARD FRICK |
| K152867 |
10/21/2015 |
MHI-TM2000 Linear Accelerator System, VERO, Imavis |
MITSUBISHI HEAVY INDUSTRIES, LTD. |
KATSUHISA TOYAMA |
| K142505 |
10/21/2015 |
ClearPoint System |
MRI INTERVENTIONS, INC. |
E F Waddell |
| K152560 |
10/23/2015 |
Bard Snare Retrieval Kit |
NEOMETRICS, INC |
DAVE LIEBL |
| K152180 |
10/22/2015 |
PEAK |
Neosil Co., Ltd |
Park Dong Min |
| K150669 |
10/08/2015 |
Neoss TiBase, Neoss CoCr Abutments (Mono and Multi) |
Neoss Ltd |
Karin Darle Olsson |
| K152312 |
10/30/2015 |
RECON system-V-TEK-IVP Plates and Screws |
NORMED MEDIZIN-TECHNIK GMBH |
Arne Briest |
| K152261 |
10/21/2015 |
PICC Tip Positioning Aid |
NOSTIX LLC |
Peter Nelson |
| K152665 |
10/26/2015 |
PolarCath Peripheral Dilatation System |
NUCYRO VASCULAR, LLC |
MIKE FOURKAS |
| K150474 |
10/21/2015 |
NuVasive VuePoint II OCT System |
NuVasive, Incorporated |
Cynthia Adams |
| K151571 |
10/14/2015 |
Mini Needle |
OCUJET, LLC |
REBECCA K. PINE |
| K150142 |
10/08/2015 |
Single Use Balloon Dilator V (with Knife) |
OLYMPUS MEDICAL SYSTEMS CORP. |
TOSHIYUJI NAKAJIMA |
| K151011 |
10/01/2015 |
VISERA 4K UHD SYSTEM |
Olympus Medical Systems Corp. |
Toshiyuki Nakajima |
| K152092 |
10/26/2015 |
Resection Electrodes |
Olympus Winter & Ibe GmbH |
Katharina Schnackenburg |
| K152159 |
10/29/2015 |
Oravan Herbst |
OravanOSA, LLC |
Deborah Stein |
| K152169 |
10/27/2015 |
Balanced Knee System TriMax CR Femoral Component and E-Vitalize CR and UC Tibial Inserts |
ORTHO DEVELOPMENT CORPORATION |
DREW WEAVER |
| K152005 |
10/15/2015 |
MONTAGE Settable, Resorbable Hemostatic Bone Putty |
ORTHOCON, INC. |
HOWARD SCHRAYER |
| K151300 |
10/15/2015 |
AVERT Contrast Modulation System |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K151746 |
10/09/2015 |
Dyevert Contrast Modulation System |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K151169 |
10/08/2015 |
OsteoReady ZircoSeal Abutments |
OsteoReady LLC |
Michael D Silverman |
| K141854 |
10/29/2015 |
INSTRUMENT CASSETTE (EFCCL1-F) |
OSUNG MND CO., LTD |
KIRAN SHEIKH |
| K150153 |
10/20/2015 |
Swiss Navy Premium Silicone Lubricant;Swiss Navy Premium Water Based Lubricant;Swiss Navy Premium All Natural Lubricant |
Package Solutions LLC |
Jack Scalisi |
| K151466 |
10/15/2015 |
MrOpen |
Paramed S.r.l. |
Luisella De Benedetti |
| K141876 |
10/28/2015 |
Pasture F550S Surgical N95 Respirator, Pasture F550CS Surgical N95 Respirator, Pasture A520S Surgical N95 Respirator, Pasture A520CS Surgical N95 Respirator, Pasture E520S Surgical N95 Respirator, Pasture E520CS Surgical N95 Respirator |
PASTURE PHARMA PTE LTD |
SARAH HASSAN |
| K143727 |
10/29/2015 |
PENTAX Medical EKP-i5010 Video Processor with EB Family |
PENTAX OF AMERICA, INC. |
KRISHNA GOVINDARAJAN |
| K152899 |
10/30/2015 |
Philips Lumify Diagnostic Ultrasound System |
PHILIPS HEALTHCARE, INC. |
PENNY GRECO |
| K151366 |
10/30/2015 |
Philips CS770 IntelliSpace Critical Care and Anesthesia |
PHILIPS MEDICAL SYSTEMS |
KRISTEN PHILLIPS |
| K152363 |
10/27/2015 |
Value Care Cuff Large Adult, Value Care Cuff Adult XL (extra long), Value Care Cuff Adult, Value Care Cuff Small Adult, Value Care Cuff Pediatric, Value Care Cuff Infant, Efficia Adult NIBP Airhose, 3 M, Efficia Adult NIBP Air Hose, 1.5 M |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
| K151736 |
10/21/2015 |
Philips IntelliVue GuardianSoftware |
PHILIPS MEDIZIN SYSTEME BOBLINGEN GMBH |
MICHAEL ASMALSKY |
| K141656 |
10/02/2015 |
GMATE MINI BLOOD GLUCOSE MONITORING SYSTEM, GMATE STEP BLOOD GLUCOSE MONITORING SYSTEM |
Philosys Inc. |
LINDA CHAN |
| K152014 |
10/20/2015 |
MTS300 Multiple Tray Sterilization System |
PMBS, LLC |
MICHELE E. MAUZERALL |
| K150557 |
10/08/2015 |
Podimetrics Remote Temperature Monitoring System |
Podimetrics, Inc. |
Jon Bloom |
| K151375 |
10/07/2015 |
Inclusive Titanium Abutments compatible with: Hiossen HG Implant System |
PRISMATIK DENTALCRAFT, INC. |
ARMIN ZEHTABCHI |
| K143515 |
10/01/2015 |
Inclusive« Zirconia Abutments compatible with: Zimmer Screw-Vent, Biomet 3i Certain and Nobel Biocare NobelReplace Implants |
PRISMATIK DENTALCRAFT, INC. |
Brandon Shepard |
| K151584 |
10/08/2015 |
AttraX Putty |
PROGENTIX ORTHOBIOLOGY B.V. |
YVONNE P. BOVELL |
| K151646 |
10/21/2015 |
ProTech Plus |
PROTECH PROFESSIONAL PRODUCTS, INC. |
ADAM BLOCH |
| K151821 |
10/23/2015 |
ER-REBOA Catheter |
Pryor Medical Devices, Inc |
Christopher Banas |
| K151629 |
10/27/2015 |
Guardian 1000 |
Quanta System SpA |
Francesco Dell'Antonio |
| K150156 |
10/19/2015 |
Ranfac Fat Aspiration Transfer Syringe (FATS) Procedure Pack, Ranfac Fat Aspiration Transfer Syringe (FATS) Containment Vessel |
Ranfac Corp |
Christopher P Whelan |
| K150462 |
10/30/2015 |
Vera |
Reflexion Health, Inc. |
Huan Tran |
| K152124 |
10/28/2015 |
Tempus IC2 |
REMOTE DIAGNOSTICS TECHNOLOGIES LTD |
CHRIS HANNAN |
| K143582 |
10/29/2015 |
MOPYLEN, RESOPREN, SILK, POLYESTER, NYLON, RESOLON, POLYAMIDE PSEUDO, STEEL |
RESORBA MEDICAL GMBH |
KARL JOSEF BECK |
| K152795 |
10/28/2015 |
RiverLon (Nylon) Suture |
RIVERPOINT MEDICAL |
Edwin Anderson |
| K152526 |
10/02/2015 |
Elecsys Progesterone III CalSet |
ROCHE DIAGNOSTICS |
Patty Bates |
| K151578 |
10/22/2015 |
Carbamazepine Gen 4 |
Roche Diagnostics Operations (RDO) |
David Tribbett |
| K151747 |
10/05/2015 |
STERISPINE PS |
SAFE ORTHOPAEDICS |
Pierre Dumouchel |
| K151921 |
10/08/2015 |
STERISPINE PS |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K152094 |
10/16/2015 |
GR40CW |
SAMSUNG ELECTRONICS CO., LTD. |
CHULSIN KIM |
| K150754 |
10/02/2015 |
ARGOS |
SANTEC CORPORATION |
CHANGHO CHONG |
| K152687 |
10/16/2015 |
Arm-Type Fully Automatic Digital Blood Pressure Monitor |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
Ren Yunhua |
| K152308 |
10/13/2015 |
Sensor Medical Single Use Tonometer Prism |
SENSOR MEDICAL TECHNOLOGY, LLC |
Louise Culham |
| K150037 |
10/16/2015 |
Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities |
SENSUS HEALTHCARE |
KAL FISHERMAN |
| K152545 |
10/02/2015 |
DC-60/DC-60S/DC-60 EXP/DC-55 Diagnostic Ultrasound Systems |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
YANG ZHAOHUI |
| K152543 |
10/29/2015 |
M9/M9CV/M9T Diagnostic Ultrasound System |
Shenzhen Mindray Bio-Medical Electronics Co., Ltd |
Wu Zicui |
| K152763 |
10/21/2015 |
Resona 7/Resona 7CV/Resona 7EXP/Resona 7S/Resona 7OB Diagnostic Ultrasound System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Zhai Pei |
| K151954 |
10/27/2015 |
A7 Anesthesia System |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD. |
TANG HAO |
| K152465 |
10/29/2015 |
Disposable Blood Pressure Cuff |
Shenzhen Vistar Medical Supplies Co., Ltd. |
Zhenxun Chen |
| K152468 |
10/29/2015 |
Reusable Blood Pressure Cuff |
Shenzhen Vistar Medical Supplies Co., Ltd. |
Zhenxun Chen |
| K150687 |
10/13/2015 |
DripAssist |
Shift Labs |
Beth Kolko |
| K151718 |
10/29/2015 |
iFuse Implant System |
SI-BONE, INC. |
ROXANNE DUBOIS |
| K143655 |
10/02/2015 |
SICAT OPTIMOTION |
SICAT GMBH & CO. KG |
MANFRED BREUER |
| K150323 |
10/23/2015 |
FEMTO LDV Z8 Surgical Laser |
SIE AG,Surgical Instrument Engineering |
Frank Ziemer |
| K150606 |
10/23/2015 |
Emit II Plus Buprenorphine Assay, Emit II Plus Specialty Drug Calibrator/Control Level 1, Level 2 Level 3, Level 4, Emit II Plus Specialty Drug Control Negative, Emit II Plus Specialty Drug Control Positive |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
FRANCES A. DILLON |
| K152036 |
10/09/2015 |
SOMATOM Definition Edge, SOMATOM Definition AS/AS+ |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K152369 |
10/06/2015 |
ACUSON S1000, S2000, S3000 Diagnostic Ultrasuond System |
SIEMENS MEDICAL SOLUTIONS, USA, INC. ULTRASOUND GROUP |
Nancy Burke |
| K150241 |
10/27/2015 |
Genesis II XLPE Resurfacing Patellar Components |
Smith & Nephew, Inc. |
Allison Chan |
| K152315 |
10/28/2015 |
JOURNEY II Uni Tibial Base and Insert |
Smith & Nephew, Inc. |
Brad Sheals |
| K152726 |
10/21/2015 |
JOURNEY II XR Knee System |
SMITH & NEPHEW, INC. |
BRAD SHEALS |
| DEN150011 |
10/09/2015 |
Sonablate 450 |
SonaCare Medical, LLC. |
Dawn Byrd Burleson |
| K152177 |
10/01/2015 |
SonoStik IV Guide Wire Introducer |
SONOSTIK, LLC |
RICHARD FOGEL |
| K150141 |
10/23/2015 |
Orthodontics Bracket |
Speed Dental Co., Ltd. |
Tae Young Kang |
| K152784 |
10/22/2015 |
Pacel Bipolar Pacing Catheters |
ST. JUDE MEDICAL |
PARITA MEHTA |
| K151911 |
10/22/2015 |
WorkMate Claris System, WorkMate Claris System Display Plus |
ST. JUDE MEDICAL |
MELISSA FRANK |
| K152357 |
10/30/2015 |
MicroSTAAR Injector System Cartridges |
STAAR Surgical Company |
Jack Coggan |
| K152801 |
10/27/2015 |
ULTRACHECK SPACELABS ABP CUFF-CHILD, ULTRACHECK SPACELABS ABP CUFF-SMALL ADULT, ULTRACHECK SPACELABS ABP CUFF-ADULT, ULTRACHECK SPACELABS ABP CUFF-LARGE ADULT |
STATCORP MEDICAL |
WAYNE EMMERT |
| K150306 |
10/10/2015 |
D2RS_AT Digital Dynamic Remote System |
STEPHANIX RADIOLOGICAL SOLUTIONS |
SANDIE PERRET |
| K151769 |
10/27/2015 |
Anchorage 2 CP System |
STRYKER GMBH |
KURDEA LYON |
| K143577 |
10/12/2015 |
XW-100 Automated Hematology Analyzer, XW QC CHECK |
SYSMEX AMERICA, INC. |
Peter Shearstone |
| K152066 |
10/21/2015 |
Luminesse Anterior Zirconia AT |
TALLADIUM, INC. |
Edward Harms |
| K152362 |
10/16/2015 |
Terumo SurGuard 3 Safety Hypodermic Needle |
TERUMO (PHILIPPINES) CORPORATION |
PHEBE VARGHESE |
| K151389 |
10/20/2015 |
Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir |
Terumo Cardiovascular Systems Corporation |
Garry A Courtney |
| K150741 |
10/22/2015 |
TSolution One w/ACG surgical System |
THINK SURGICAL INC. |
IN K. MUN |
| K151347 |
10/16/2015 |
MIS Spine Frame Instrument Case |
THOMPSON SURGICAL INSTRUMENTS |
STEPHANIE MYERS |
| K151596 |
10/09/2015 |
Endoskeleton TCS Interbody Fusion Device |
TITAN SPINE, LLC |
JANE RODD |
| K151952 |
10/01/2015 |
Synergy ODM |
TOPCON MEDICAL SYSTEMS, INC. |
Michael Gusel |
| K151833 |
10/09/2015 |
Aquilion Lightning (TSX-035A/2, V7.0) |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K152371 |
10/23/2015 |
Vantage Titan 3T |
Toshiba Medical Systems Corporation |
Janine Reyes |
| K150270 |
10/26/2015 |
ST AIA-PACK 25-OH Vitamin D, ST AIA-PACK 25-OH Vitamin D Calibrator Set, AIA-PACK 25-OH Vitamin D Control Set, and ST AIA-PACK 25-OH Vitamin D Pretreatment Set |
TOSOH BIOSCIENCE, INC. |
Robert L Wick |
| K150173 |
10/15/2015 |
Aerobika OPEP Devive with Manometer |
Trudell Medical International |
Darryl Fischer |
| K152523 |
10/01/2015 |
JBAIDS Influenza A & B Detection Kit |
U.S. ARMY MEDICAL MATERIEL DEVELOPMENT ACTIVITY |
ROBERT E MILLER |
| K152035 |
10/15/2015 |
iSnare system-Lariat |
United States Endoscopy Group, Inc |
Carroll Martin |
| K151882 |
10/26/2015 |
Varian Treatment (VTx) |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J. CORONADO |
| K152106 |
10/23/2015 |
Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart |
VATECH CO., LTD |
DANIEL KIM |
| K151456 |
10/29/2015 |
Small Bone Nail Implant |
VILEX IN TENNESSEE, INC |
SYLVIA SOUTHARD |
| K151988 |
10/15/2015 |
Visible Patient Suite |
VISIBLE PATIENT, SAS |
AUDE PETITJEAN |
| K152204 |
10/28/2015 |
VS3-IR system |
VISIONSENSE LTD |
ALEX CHANIN |
| K151283 |
10/30/2015 |
Lung Analysis Software |
Vital Images, Inc. |
Parthiv Shah |
| K151919 |
10/10/2015 |
Vitrea CT Lung Density Analysis Software |
VITAL IMAGES, INC. |
KATIE RYAN |
| K143617 |
10/19/2015 |
AquaC UNO H |
VIVONIC GMBH |
Andreas Hessberger |
| K151956 |
10/20/2015 |
Admira Fusion x-tra |
VOCO GMBH |
M TH PLAUMANN |
| K152109 |
10/13/2015 |
HD-Camera HDC1000 |
W.O.M. WORLD OF MEDICINE GmbH |
Soeren Markworth |
| K150554 |
10/06/2015 |
NuBrilliance Light Pain Therapy |
WELLQUEST INTERNATIONAL, INC. |
YVETH KAN |
| K151841 |
10/05/2015 |
Ultraviolet Sunlamps |
Wolff System Technology Corp. |
Michael Stepp |
| K150222 |
10/08/2015 |
X-Guide Surgical Navigation System |
X-Nav Technologies, LLC |
Fred Cowdery |
| K151490 |
10/08/2015 |
PRETTAU ANTERIOR T0 |
ZIRKONZAHN GMBH |
HEINRICH STEGER |
| K150046 |
10/30/2015 |
Start-Up Kit (SUK), Cool Line Intravascular Heat Exchange Catheter, ICY Intravascular Heat Exchange Catheter, Quattro Intravascular Heat Exchange Catheter |
Zoll Circulation, Inc. |
Sam Nanavati |
