| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K142770 |
06/09/2015 |
Powered Wheelchair |
AAT ALBER ANTRIEBSTECHNIK GMBH |
Mrs.Stefanie D Bankston |
| K150531 |
06/05/2015 |
FreeStyle Freedom Lite Blood Glucose Monitoring System |
Abbott Laboratories |
Sai Sriharshada Tatavarty |
| K150332 |
06/05/2015 |
FreeStyle Lite Blood Glucose Monitoring System |
ABBOTT LABORATORIES |
Sai Sriharshada Tatavarty |
| K141084 |
06/17/2015 |
Matristem Surgery Matrix RS, PSM, PSMX, Matristem Pelvic Floor Matrix |
ACELL, INC |
Salman Elmi |
| K141919 |
06/16/2015 |
VEINOPLUS SPORT NEUROMUSCULAR STIMULATOR |
AD REM TECHNOLOGY SARL |
NORMAN F ESTRIN |
| K143449 |
06/26/2015 |
ADH 200 Analyzer Software |
ADAMS MEDITECH LLC |
CECILIA L. YU |
| DEN140018 |
06/23/2015 |
ESOPHAGEAL COOLING DEVICE |
ADVANCED COOLING THERAPY, LLC |
ERIK KULSTAD |
| K143204 |
06/03/2015 |
AOS Clavicle Intramedullary Device |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
ANNA HWANG |
| K150718 |
06/12/2015 |
Wi-3 HAL-RAR System |
AGENCY FOR MEDICAL INNOVATIONS GMBH |
Stefanie Hoellger |
| K143397 |
06/01/2015 |
ICIS View |
Agfa HealthCare N.V. |
JODI COLEMAN |
| K143604 |
06/25/2015 |
Alvision Interventional Cardiology Diagnostic Catheter, Alvicath Endovascular Diagnostic Catheters |
ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S |
BASAK DEMIRCI |
| K150976 |
06/04/2015 |
Collage |
ANATOMAGE INC. |
SEAN XU |
| K150089 |
06/18/2015 |
NanoKnife System |
ANGIODYNAMICS, INC. |
Suzanne Goodman |
| K150034 |
06/09/2015 |
AMT Enteral Transition Adapters |
APPLIED MEDICAL TECHNOLOGY, INC. |
JOSHUA MEINKE |
| K150625 |
06/09/2015 |
Morrison Steerable Needle |
APRIOMED AB |
Bruno Edling |
| K150721 |
06/17/2015 |
ARDO Calypso Pro Powered Breast Pump |
ARDO MEDICAL AG |
ROGER DUBACH |
| K150109 |
06/05/2015 |
Arrow Pressure Injectable Jugular Axillo-subclavian Central Catheter (JACC) with Sustain Technology |
Arrow International ( a subsidiary of Teleflex, Inc.) |
Karl J Nittinger |
| K142327 |
06/08/2015 |
smARTrack Feeding Tube System |
ART Healthcare Ltd. |
Liron Elia |
| K151230 |
06/19/2015 |
Arthrex FiberTak Anchors |
Arthrex, Inc. |
Ivette Galmez |
| K151103 |
06/23/2015 |
ASAHI Corsair Microcatheter |
ASAHI INTECC CO., LTD. |
YOSHIHIKO FUKUI |
| K150445 |
06/30/2015 |
ASAHI Peripheral Guide Wire Series (ASAHI Gladius, ASAHI Halberd, ASAHI Gaia PV) |
ASAHI INTECC CO., LTD. |
Yoshihiko Fukui |
| K150140 |
06/05/2015 |
MCL 31 Dermablate |
ASCLEPION LASER TECHNOLOGIES GMBH |
Antje Katzer |
| K151211 |
06/04/2015 |
AssureTech Secobarbital Strip, AssureTech Oxycodone Strip, AssureTech Secobarbital/Oxycodone Panel Dip, AssureTech Secobarbital/Oxycodone Quick Cup, AssureTech Secobarbital/Oxycodone Turn Key-Split Cup |
Assure Tech. Co., Ltd |
Eric Lin |
| K150996 |
06/17/2015 |
AtriClip LAA Exclusion System with preloaded Gillinov-Cosgrove Clip |
ATRICURE, INC. |
Brittany Lowe |
| K141680 |
06/30/2015 |
AUXEIN BRAND OF Bone Plates and Bone Screws & AUXEIN Brand of DCS Plate System AUXEIN brand of Locking Plates and Locking Screws |
AUXEIN MEDICAL |
RAHUL LUTHRA |
| K142596 |
06/18/2015 |
Infusomat Space Volumetric Infusion Pump |
B. Braun Medical Inc. |
Gary Johnson |
| K133070 |
06/22/2015 |
SURGICAL FACE MASK (Ear Loops and Tie-on) |
B.H. MEDICAL PRODUCTS CO., LTD. |
LEON LU |
| K142577 |
06/11/2015 |
PANTHER Endo Linear Cutter Staplers with Single Use Loading Units |
B.J.Z.H.F. Panther Medical Equipment Co. Ltd. |
Liu Yu |
| K150184 |
06/15/2015 |
Dymaxeon Spine System |
Back 2 Basics Direct, LLC |
Scot Miller |
| K142480 |
06/16/2015 |
OsteoCool V-2 RF Ablation System |
BAYLIS MEDICAL COMPANY INC. |
MEGHAL KHAKHAR |
| K150709 |
06/17/2015 |
ProTrack RF Anchor Wire |
BAYLIS MEDICAL COMPANY INC. |
Meghal Khakhar |
| K151291 |
06/10/2015 |
BD Veritor (TM) System for the Rapid Detection of Flu A+B |
BECTON DICKINSON AND COMPANY |
GREGORY P PAYNE |
| K151301 |
06/08/2015 |
BD VeritorÖ System Flu A+B Assay |
Becton Dickinson and Company |
Gregory P Payne |
| K150591 |
06/30/2015 |
Besmed Reusable Jet Nebulizer |
BESMED HEALTH BUSINESS CORP. |
WINNIE CHUNG |
| K143715 |
06/05/2015 |
Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Better Plastic Co., Ltd. |
Du Wei |
| K143524 |
06/02/2015 |
Fiber Disks and Blocks (TRINIA) |
Bicon, LLC |
Richard Wu |
| K132058 |
06/08/2015 |
VIDAS FT4 |
BIOMERIEUX SA |
AURELIE PERMEZEL |
| K142814 |
06/25/2015 |
Biomet Orthopaedic Salvage System (OSSTM) - Proximal Femoral & Hybrid Tibial |
BIOMET MANUFACTURING LLC |
TRACY BICKEL JOHNSON |
| K151224 |
06/30/2015 |
Lineum OCT Spine System |
BIOMET SPINE |
Spencer Kimber |
| K150867 |
06/10/2015 |
Affixus Tibial Nailing System |
BIOMET, INC. |
SUZANA OTANO |
| K143387 |
06/03/2015 |
GE333 Blood Glucose Monitoring System |
Bionime Coporation |
Tino Lee |
| K141292 |
06/09/2015 |
Rightest Blood Glucose Monitoring System GM700, Rightest Blood Glucose Monitoring System GM650, GE200 Blood Glucose Monitoring System, and GE300 Talking Blood Glucose Monitoring System |
BIONIME COPORATION |
Feng-Yu Lee |
| K141637 |
06/03/2015 |
SPB SKIN EMULSION |
BIOTD, S.A. |
RICHARD GILLIS, PH.D. |
| K143110 |
06/24/2015 |
GALAXY MIS Screw System |
BM KOREA |
JUNE HAN |
| K150781 |
06/19/2015 |
Tissue Removal Pouch |
BOEHRINGER LABORATORIES, LLC |
Chris Radl |
| K150186 |
06/05/2015 |
Chariot Guiding Sheath |
BOSTON SCIENTIFIC CORP. |
KURTIS HUNSBERGER |
| K150303 |
06/15/2015 |
XXL Vascular Balloon Dilatation Catheter |
BOSTON SCIENTIFIC CORP. |
Melanie Raska |
| K151253 |
06/10/2015 |
2cm Peripheral Cutting Balloon Microsurgical Dilatation Catheter |
BOSTON SCIENTIFIC LIMITED |
LISA MEE |
| K141943 |
06/12/2015 |
BREATHE TECHNOLOGIES LIFE2000 VENTILATION SYSTEM |
BREATHE TECHNOLOGIES |
Samir Ahmad |
| K150951 |
06/25/2015 |
aeris Balloon Dialation Catheter |
Bryan Medical , Inc. |
ANDY BLACK |
| K143559 |
06/11/2015 |
XP1000 RF |
BTL INDUSTRIES, INC |
Jan Zarsky |
| K150569 |
06/10/2015 |
LaparoVue |
Buffalo Filter, LLC |
Pamela Netzel |
| K143380 |
06/05/2015 |
Phasix ST Mesh |
C. R. Bard Inc |
Tony John |
| K141531 |
06/01/2015 |
POWER-TRIALYSIS SLIM-CATH SHORT-TERM DIALYSIS CATHETER |
C.R. BARD, INC. |
BRYAN U STONE |
| K150667 |
06/17/2015 |
True Dilatation Balloon Valvuloplasty Catheter |
C.R. Bard, Inc. |
Aaron Conovaloff |
| K150578 |
06/09/2015 |
Capillus 272 Office Pro |
Capillus, LLC |
Patricia Schnoor |
| K151116 |
06/26/2015 |
CapLOX II/TowerLOX Pedicle Screw System |
CAPTIVA SPINE |
TAMALA WAMPLER |
| K141332 |
06/11/2015 |
Captiva Spine SmartLOX Cervical Plate System |
CAPTIVA SPINE |
TAMALA J WAMPLER |
| K143432 |
06/03/2015 |
Cardio-TriTest |
CARDIO-PHOENIX INC. |
MARC BISNAIRE |
| K151260 |
06/10/2015 |
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD |
Cardiovascular System, Inc. |
Kim Wallner |
| K150766 |
06/24/2015 |
Carestream DRX-1 System |
Carestream Health, Inc. |
Carolyn L Wagner |
| K150320 |
06/30/2015 |
COMPASS |
CENTERVUE SPA |
ROBERTO GABRIOTTI |
| K150643 |
06/08/2015 |
Centinel Spine STALIF TT, STALIF MIDLINE, MIDLINE II, MIDLINE II-Ti |
CENTINEL SPINE, INC. |
MR. JOHN PARRY |
| K150053 |
06/24/2015 |
STALIF C; STALIF C-Ti |
Centinel Spine, Inc. |
John Parry |
| DEN130033 |
06/05/2015 |
COGNIVUE |
CEREBRAL ASSESSMENT SYSTEMS, INC |
CHARLES J DUFFY |
| K142751 |
06/15/2015 |
Chang Gung ComMed Series Dental Implant System |
Chang Gung Medical Technology Co., Ltd. |
Chao-Chun Chiu |
| K143002 |
06/05/2015 |
Metallic Locking Bone Plate and Screw System |
Changzhou Dingjian Medical Appliance Co., Ltd |
Li Qingsong |
| K140021 |
06/05/2015 |
TI-OSS |
CHIYEWON |
DANIEL NAM |
| K150042 |
06/02/2015 |
PleuraFlow System |
ClearFlow, Inc. |
Dov Gal |
| K150319 |
06/12/2015 |
MICRUSFRAME 10/18, DELTAFILL 18, DELTAXSFT 10, GALAXY G3 FILL/XSFT STRETCH RESISTANT MICROCOIL DELIVERY SYSTEMS |
CODMAN & SHURTLEFF, INC. |
Hannah Foley |
| K140836 |
06/17/2015 |
ZIBONE ZIRCONIA BLOCKS |
COHO TECHNOLOGY CO., LTD |
JACKY HSEIH |
| K150218 |
06/23/2015 |
Fill-Up! |
COLTENE/WHALEDENT AG |
SILKE WALLASCHEK |
| K150616 |
06/12/2015 |
Trevo XP ProVue Retriever (4x30mm) |
Concentric Medical, Inc. |
Rhoda M. Santos |
| K142357 |
06/25/2015 |
DuraSheath Introducer Sheath System |
CONTRACT MEDICAL INTERNATIONAL GMBH |
JAN KLOBOUCNIK |
| K150041 |
06/26/2015 |
CORA (Coagulation Resonance Analysis) System |
Coramed Technologies, LLC |
Norman E Brunner |
| K142934 |
06/17/2015 |
CrossCountry Transbronchial Access Tool straight, CrossCountry Transbronchial Access Tool curved |
COVIDIEN |
Deborah Fleetham |
| K151356 |
06/18/2015 |
Spacemaker Pro Access and Dissector System |
Covidien LLC |
Rebecca Magnanimo |
| K150012 |
06/04/2015 |
CreoDent Solidex Customized Abutment |
CREODENT PROSTHETICS, LTD. |
CALVIN SHIM |
| K143520 |
06/09/2015 |
SPSmedical VH202 External Indicator (Container Cards), SPSmedical VH202 External Indicator (Label) |
CROSSTEX |
Michael G Nolan |
| K150920 |
06/17/2015 |
truFreeze System |
CSA MEDICAL, INC. |
SHERRIE COVAL-GOLDSMITH |
| K142679 |
06/12/2015 |
CARESCAPE R860 |
Datex-Ohmeda, Inc. |
Trishia Dwyer |
| K150535 |
06/16/2015 |
Cavitron Touch Ultrasonic Scaling System |
DENTSPLY INTERNATIONAL, INC. |
HELEN LEWIS |
| K133279 |
06/25/2015 |
MEDIHONEY WOUND DRESSINGS |
DERMA SCIENCES, INC. |
SHARMINI ATHERAY |
| K151240 |
06/09/2015 |
extriCARE Negative Pressure Wound Therapy Gel Strip - 8pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 7pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 6pc, extriCARE Negative Pressure Wound Therapy Gel Strip - 5pc, extriCARE Negative |
Devon Medical Products |
JOHN SIEGEL |
| K150696 |
06/23/2015 |
Jade 37% Phosphoric Acid Etchant Gel |
Dharma Research, Inc. |
Ricardo Carles |
| K151509 |
06/25/2015 |
GSI TympStar Pro Middle Ear Analyzer |
Diagnostic Group, dba Grason-Stadler |
Ron Rolfsen |
| K150879 |
06/22/2015 |
LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers |
DiaSorin Inc. |
John Walter |
| K143071 |
06/26/2015 |
Nacera Pearl |
DOCERAM MEDICAL CERAMICS GMBH |
Stefan Drude |
| K150076 |
06/02/2015 |
Sonic Surgeon 310L, Sonic Surgeon 600L and Sonic Surgeon 800L |
DONG IL TECHNOLOGY LTD. |
DONG BUM KIM |
| K151281 |
06/30/2015 |
AGE Automatic Wrist Blood Pressure Monitor |
DONGGUAN AGELESS HEALTH INDUSTRIAL CO., LTD |
VICTOR WAN |
| K151485 |
06/30/2015 |
GENESIS |
DORNIER MEDTECH AMERICA, INC. |
JOHN HOFFER |
| K150327 |
06/29/2015 |
Dunamis Force DFX Suture, Size 5, Dunamis Force DFX Suture Size 2 |
Dunamis LLC |
Prithviraj Chavan |
| K150518 |
06/29/2015 |
Airway with Bite Block and Tongue Depressor 80 mm, Airway with Bite Block and Tongue Depressor 90 mm |
DUPACO INC. |
AN VU |
| K150949 |
06/03/2015 |
FibroScan |
ECHOSENS |
CELINE FOURNIER |
| K150882 |
06/16/2015 |
Edwards Suture Fastening System |
EDWARDS LIFESCIENCES, LLC. |
NINA BROOKE |
| K150074 |
06/19/2015 |
Elevate Moisturizing Spray |
ELEVATE ORAL CARE |
STEVE PARDUE |
| K142518 |
06/05/2015 |
HumaPen Luxura |
ELI LILLY AND COMPANY |
LeeAnn Chambers, MS., RAC |
| K151131 |
06/19/2015 |
PRECICE Intramedullary Limb Lengthening System |
Ellipse Technologies, Incorporated |
Rebecca Shelburne |
| K150029 |
06/24/2015 |
Habib EUS RFA |
EMCISION, LTD. |
FRANCOIS POULIN |
| K142794 |
06/02/2015 |
Everyway Facial MENS |
EVERYWAY MEDICAL INSTRUMENTS CO., LTD. |
ROBERT TU |
| K150761 |
06/05/2015 |
Ez3D-i/E3 |
EWOO SOFT CO., LTD |
Young Seok Kim |
| K142446 |
06/04/2015 |
Fixtemp Cement |
EXACTA DENTAL DIRECT, INC |
JOHN PANKUCH |
| K143484 |
06/29/2015 |
BioZorb Marker |
FOCAL THERAPEUTICS |
George Hermann |
| K133080 |
06/24/2015 |
Plus Surgical Drapes (EO Sterilized), PMDB-XXX |
FOSHAN NANHAI PLUS MEDICAL CO., LTD. |
LEON LU |
| K133075 |
06/24/2015 |
Plus Surgical Gowns (EO Sterilized), PMGB-XXX |
FOSHAN NANHAI PLUS MEDICAL CO., LTD. |
LEON LU |
| K143570 |
06/04/2015 |
WIRION |
GARDIA MEDICAL |
OHAD HAAS |
| K151028 |
06/18/2015 |
LOGIQ e |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIAGNOSTICS |
TRACEY ORTIZ |
| K143726 |
06/19/2015 |
XLR8 PLUS (XLR8+) |
GENADYNE BIOTECHNOLOGIES, INC. |
CHIEN MING GOH |
| K143438 |
06/23/2015 |
Flowtron ACS900 |
Getinge (Suzhou) Co., Ltd |
Lenda Hou |
| K150552 |
06/04/2015 |
ELLIPSE and PROTEX CT OCCIPITO-CERVICO-THORACIC SPINAL SYSTEMS |
GLOBUS MEDICAL INC. |
Kelly J. Baker |
| K150373 |
06/11/2015 |
Digital Automatic Blood Pressure Monitor BPM25 & BPM26 Series [Model No.: MD25x0/ MD26x0] |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
Patrick Chow |
| K142369 |
06/17/2015 |
Urinary Incontinence System |
GUANGZHOU FINECURE MEDICAL EQUIPMENT CO., LTD |
Chiping Ma |
| K150113 |
06/18/2015 |
Fusion Black Powder-Free Nitrile Exam Glove |
Halyard Health |
Christine L Macauley |
| K150593 |
06/09/2015 |
Nitrile Powder Free Examination Glove with Low Dermatitis Potential Claim (Blue) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K141110 |
06/25/2015 |
CRYOCARE CS SURGICAL SYSTEM |
HEALTHTRONICS |
MARITZA WARD |
| K142783 |
06/12/2015 |
HEARTWAY Electrically Powered Wheelchair P27 |
HEARTWAY Medical Products Co., Ltd. |
JEN KE-MIN |
| K150340 |
06/18/2015 |
POWDER FREE Nitrile GLOVES (White), POWDER FREE Nitrile GLOVES (Cobalt Blue), POWDER FREE Nitrile GLOVES (Black), POWDER FREE Nitrile GLOVES (Ice Blue) |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
Shaozhang Nan |
| K150119 |
06/17/2015 |
PALACOS R pro |
HERAEUS MEDICAL GMBH |
ASTRID MARX |
| K151132 |
06/01/2015 |
PROBEAT-V |
Hitachi, Ltd.,Health Care Company |
Naoya Nishimura |
| K143093 |
06/24/2015 |
0.018 Arrow GPSCath Balloon Dilatation Catheter (150 cm) |
HOTSPUR TECHNOLOGIES, INC., |
Eric Ankerud, JD |
| K143437 |
06/25/2015 |
Droplet Pen Needles |
HTL-STREFA S.A. |
Aleksandra Prazmowska-Wilanowska |
| K150925 |
06/29/2015 |
Immunalysis Benzoylecgonine Urine Enzyme Immunoassay, Immunalysis Benzoylecgonine Urine Calibrators, Immunalysis Benzoylecgonine Urine Control Set |
Immunalysis Corporation |
Joseph Ginete |
| K151203 |
06/05/2015 |
Immunalysis Cannabinoids Urine Enzyme Immunoassay, Immunalysis cTHC Urine Calibrators, Immunalysis cTHC Urine Control Set |
IMMUNALYSIS CORPORATION |
JOSEPH GINETE |
| K141188 |
06/02/2015 |
MICRODENT GENIUS IMPLANT SYSTEM |
IMPLANT MICRODENT |
RHONDA ALEXANDER |
| K150414 |
06/12/2015 |
Midas Touch-Nitrile Examination Gloves- Powder free, Orange, XS, Model SNAEFT-240OR-XS; Midas Touch-Nitrile Examination Gloves -Powder free, Orange, XXL, Model SNAEFT-240OR-XXL |
INDUSTRIAL CLOTHINGS (PVT) LTD |
S.N. HARI |
| K150500 |
06/19/2015 |
Px PEEK IBF System |
INNOVASIS, INC. |
Marshall McCarty |
| K142503 |
06/05/2015 |
IMED-Z FLUID STATUS MONITOR |
INTERSECTION MEDICAL, INC. |
WARREN CRAYCROFT |
| K143003 |
06/18/2015 |
iPulse Smooth Skin Gold Hair Removal System |
Ipulse Limited |
Mike Kiernan |
| K143513 |
06/19/2015 |
ZIO SR ECG Monitoring Service |
iRhythm Technologies, Inc. |
Rich Laguna |
| K150393 |
06/09/2015 |
TETRIC EVOFLOW BULK FILL |
IVOCLAR VIVADENT AG |
SANDRA CAKEBREAD |
| K143730 |
06/10/2015 |
GBR System |
JEIL MEDICAL CORPORATION |
HYEROUNG LEE |
| K142833 |
06/04/2015 |
INTRAGen |
JEISYS MEDICAL, INC. |
Kyung Won Hwang |
| K142797 |
06/18/2015 |
I.V. Catheter |
Jiangxi Sanxin Medtec Co., Ltd |
Bingrong Liu |
| K150758 |
06/18/2015 |
Safety Disposable Insulin Syringe |
JIANGYIN CAINA TECHNOLOGY CO., LTD |
JUN LU |
| K151246 |
06/30/2015 |
Aneroid Sphygmomanometer |
Jiaxing Zhongfa Medical Products Co., Ltd. |
Mao Xiaohua |
| K150199 |
06/15/2015 |
Neodent Implant System |
JJGC INDUSTRIA E COMERCIO DE MATERIAIS DENTARIOS S |
Jacson Cambruzzi |
| K142920 |
06/10/2015 |
KM Needles (Acupuncture Needle) |
K.M.S. INC. |
CHUL HUI KIM |
| K151465 |
06/29/2015 |
AeroDR SYSTEM 2 |
KONICA MINOLTA, INC. |
SHIGEYUKI KOJIMA |
| K151060 |
06/05/2015 |
Ultrasound System SONIMAGE HS1 |
KONICA MINOLTA, INC. |
Shigeyuki Kojima |
| K151221 |
06/23/2015 |
Kubtec DIGIVIEW 395 |
KUB TECHNOLOGIES, INC |
VIKRAM BUTANI |
| K151244 |
06/11/2015 |
Pre-Formed Guidewire |
Lake Region Medical |
Mathew Pexa |
| K142645 |
06/11/2015 |
Avenue T TLIF Cage |
LDR SPINE USA INC. |
BRADLEY W. STRASSER |
| K151331 |
06/30/2015 |
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch |
LUMENIS LTD |
ELISSA BURG |
| K143086 |
06/01/2015 |
VX120 Ophthalmic Diagnostic Device |
LUNEAU SAS |
Isabelle Durand |
| K150466 |
06/08/2015 |
ZX2 Laser System |
LZR7, Inc |
Randy Rinkleib |
| K150548 |
06/11/2015 |
Tek RMD (Tek Robotic Mobilization Device) |
MATIA ROBOTICS MEKATROIK SIS. AR-GE MUH. YAZ.SAN ve TIC.A.S |
Necati Hacikadiroglu |
| K150680 |
06/26/2015 |
Freedom Cementless Femoral Component |
MAXX ORTHOPEDICS, INC. |
Gabriela Gottlieb |
| K142906 |
06/09/2015 |
APTUS Wrist 2.5 System |
MEDARTIS AG |
Andrea Schweizer |
| K142626 |
06/12/2015 |
Invia Liberty Negative Pressure Wound Therapy System, Invia Liberty Tubing Set, Y-connector, Drain Adaptor, Invia Liberty Canisters |
MEDELA, AG |
Orlando Antunes |
| K142548 |
06/23/2015 |
MIDSLEEVE |
MEDICAL INNOVATION DEVELOPMENT |
Melanie Fouilland |
| K151001 |
06/05/2015 |
MUSE System |
MEDIGUS LTD. |
YANIV SAGIE |
| K120577 |
06/24/2015 |
MEDIKRO SPIROSTAR, M929 Medikro Spirostar USB and M921 Medikro SpiroStar DX |
MEDIKRO OY |
MIKKO ELORANTA |
| K150216 |
06/11/2015 |
Synergy Cranial |
MEDTRONIC NAVIGATION, INC. |
KAYE E. WAITE |
| K150231 |
06/16/2015 |
Navigated Disc Prep Instruments and CAPSTONE Trials |
MEDTRONIC SOFAMOR DANEK USA, INC |
Nicholas Tabrizi |
| K150135 |
06/11/2015 |
DIVERGENCE-L Anterior/Oblique Lumbar Fusion System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LILA JOE |
| K142559 |
06/09/2015 |
ELEVATE Spinal System |
Medtronic Sofamor Danek USA, Inc. |
Becky Ronner |
| K142835 |
06/12/2015 |
Iliad Pedicle Screw System and Zenius Pedicle Screw System |
MEDYSSEY USA, INC. |
JOHN KUCZYNSKI |
| K150257 |
06/19/2015 |
PreludeEASE Hydrophilic Sheath Introducer |
Merit Medical Systems, Inc. |
Michaela Rivkowich |
| K142912 |
06/23/2015 |
Merits Yoga Power Scooter, S542 |
MERITS HEALTH PRODUCTS CO., LTD. |
Vincent Chen |
| K150434 |
06/02/2015 |
Injection Needle |
Micro-Tech (Nanjing) CO., Ltd. |
Becky Li |
| K143020 |
06/23/2015 |
LiverMultiScan |
MIRADA MEDICAL LTD. |
Gwilym Owen |
| K150419 |
06/19/2015 |
miraDry System MD4000 |
MIRAMAR LABS, INC. |
KATHY O'SHAUGHNESSY |
| K150574 |
06/30/2015 |
Modular Power Positioning System |
MOTION CONCEPTS |
Dona Bhamra |
| K143622 |
06/17/2015 |
dynaMX Compression Staple |
MX Orthopedics, Corp. |
Howard L. Schrayer |
| K151238 |
06/12/2015 |
JUSHA-M23C LCD Monitor |
NANJING JUSHA DISPLAY TECHNOLOGY CO., LTD |
Ma Jing |
| K150623 |
06/18/2015 |
Nanova Flowable Composite |
NANOVA BIOMATERIALS, INC. |
Andrew Ritts |
| K143041 |
06/04/2015 |
Ebony PTA 0.014'' over the wire Catheter and Ebony PTA 0.018 over the wire Catheter |
Natec Medical Ltd |
Xavier De Buchere |
| K141933 |
06/28/2015 |
FILAO NC RX PTCA DILATATION CATHETER |
NATEC MEDICAL LTD |
JUDITH DANIELSON |
| K150562 |
06/02/2015 |
Safe'n'Sound Staked Passive Delivery System - Plajex version |
Nemera |
James A WERKAMP |
| K133995 |
06/19/2015 |
NEURON-SPECTRUM-4/P WITH NEURON-SPECTRUM.NET SOFTWARE |
NEUROSOFT LTD |
ENRICO BISSON |
| K142834 |
06/23/2015 |
DiscoverEEG System, Model DE-401 |
NeuroWave Systems Inc. |
Tatjana Zikov |
| K150378 |
06/12/2015 |
NICO BrainPath & Accessories, NICO BrainPath, NICO Shepherd's Hook |
NICO Corporation |
Sean Spence |
| K150363 |
06/29/2015 |
NOVA Dental Implants System |
NOVA Implants Ltd. |
Dan Grimberg |
| K151272 |
06/23/2015 |
Henschke Titanium Applicator Set |
NUCLETRON B.V. |
Lizette Van de Streek |
| K151214 |
06/25/2015 |
ALIF Interfixated System |
NuVasive, Incorporated |
Cynthia Adams |
| K150362 |
06/11/2015 |
NuVasive CoRoent Small Interbody System |
NuVasive, Incorporated |
Martin Yahiro |
| K150994 |
06/17/2015 |
NuVasive CoRoent Thoracolumbar Implants |
NUVASIVE, INCORPORATED |
CYNTHIA ADAMS |
| K150472 |
06/04/2015 |
NxStage System One |
NXSTAGE MEDICAL, INC. |
Mary Lou Stroumbos |
| K143590 |
06/04/2015 |
Alevicyn SG Antipruritic Gel |
OCULUS INNOVATIVE SCIENCES |
Brian W Martin |
| K142786 |
06/23/2015 |
Ontex Unscented Tampons with Colored Plastic Applicators |
ONTEX BVBA |
Henri Lesage |
| K142830 |
06/25/2015 |
Ophthalmed Bending Laser Probes |
OPHTHALMED LLC |
JAY MANSOUR |
| K142598 |
06/12/2015 |
Opto Wire and OptoMonitor System |
Opsens, Inc. |
Vanessa Mootoosamy |
| K142595 |
06/04/2015 |
VITROS Chemistry Products HbA 1c Reagent Kit, VITROS Calibrator Kit 31, VITROS Chemistry Products %A1c Performance Verifiers I and II |
ORTHO CLINICAL DIAGNOSTICS |
Bradley P Boyer |
| K150294 |
06/05/2015 |
DPZ Pedicular Fixation System |
Osteomed Implantes, LTDA |
J. D. Webb |
| K143572 |
06/10/2015 |
Intersomatic Cervical Device - DICOM PEEK, Intersomatic Intervertebral Space Maintenance Device - DIMEI PEEK, Intersomatic Transforaminal - TLIF PEEK |
Osteomed Implantes, LTDA |
Niderdani Ragonha |
| K150415 |
06/12/2015 |
NilRead |
Perceptive Software |
Claudio Gatti |
| K150975 |
06/25/2015 |
Philips IntelliVue MP2/MP5/MPSC Patient Monitors, Philips IntelliVue X1 and X2 multi-msrmt-modules for use with IntelliVue patient monitors |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
Michael Asmalsky |
| K150581 |
06/04/2015 |
Tritium Sternal Cable Plate System |
Pioneer Surgical Technology, Inc. (DBA RTI Surgical, Inc.) |
Sarah Pleaugh |
| K150851 |
06/04/2015 |
Sure Lok Mini Posterior Cervical/Upper Thoracic System |
PRECISION SPINE, INC. |
Michael Dawson |
| K150494 |
06/27/2015 |
Proteus Digital Health Feedback Device |
PROTEUS DIGITAL HEALTH, INC. |
Jessie Duong |
| K143474 |
06/30/2015 |
Artemis Hand Held Imaging System |
QUEST MEDICAL IMAGING |
MARTIN HEUVELMANS |
| K150868 |
06/23/2015 |
Solana GAS Assay, Solana instrument |
QUIDEL CORPORATION |
RONALD H LOLLAR |
| K150719 |
06/16/2015 |
OARtrac System with Skin Sensors |
RadiaDyne, LLC |
John K. Isham |
| K142898 |
06/17/2015 |
ABL800 FLEX with AQURE connectivity |
Radiometer Medical Aps. |
Lasse Post Moller |
| K143671 |
06/19/2015 |
Propeller Model 2014-D Sensor |
Reciprocal Labs |
David Hubanks |
| K142269 |
06/09/2015 |
Reliance Cervical IBF System |
Reliance Medical Systems, LLC |
Bret M Berry |
| K143466 |
06/08/2015 |
Hemogrip Patch |
REMEDIUM TECHNOLOGIES, INC. |
JOHN GUSTIN |
| K150266 |
06/04/2015 |
Remington Medical Inc. Tuohy Epidural Needles |
REMINGTON MEDICAL, INC. |
CAITLIN SENTER |
| K150496 |
06/12/2015 |
Total Knee Arthroplasty System |
Responsive Orthopedics LLC |
Doug Kohrs |
| K150443 |
06/04/2015 |
ToeTac Hammertoe Fixation System |
RESTORE SURGICAL LLC dba Instratek |
JEFF SEAVEY |
| K143476 |
06/23/2015 |
Digi-One |
RIMED LTD. |
AHAVA STEIN |
| K150910 |
06/03/2015 |
ACCU-CHEK Connect Diabetes Management App |
ROCHE DIABETES CARE INC. |
CHUNHONG TAO |
| K150617 |
06/01/2015 |
cobas HSV 1 and 2 Test |
ROCHE MOLECULAR SYSTEMS, INC. |
DAVID W. GATES |
| K142159 |
06/03/2015 |
DISPOSABLE PRE-GELLED SURFACE ELECTRODE |
ROCHESTER ELECTRO MEDICAL, INC. |
WAYNE GLOVER |
| K143335 |
06/01/2015 |
Roosin Silver Calcium Alginate Dressing (Prescription), Roosin Alginate Dressing with Preservative (OTC) |
Roosin Medical Devices Co., Ltd |
Chengyu Shen |
| K151082 |
06/07/2015 |
MicroCross Catheter |
ROXWOOD MEDICAL, INC. |
GRACE LI |
| K143411 |
06/29/2015 |
TRAUS ENDO |
SAESHIN PRECISION CO., LTD. |
Sae Kwan Choi |
| K142416 |
06/12/2015 |
Luma Wrap |
Salter Labs |
Aurelia Browndridge |
| K151419 |
06/23/2015 |
GF50A |
SAMSUNG ELECTRONICS CO., LTD. |
Chulsin Kim |
| K150280 |
06/11/2015 |
PulmoVia Working Channel |
SANOVAS, INC. |
Roy Morgan |
| K150002 |
06/23/2015 |
iNSIGHT Color Doppler Ultrasound System |
SASET (CHENGDU) INC. |
Dong Chyuan Liu |
| K141879 |
06/17/2015 |
BELIMED STEAM STERILIZER MST-H |
SAUTER AG |
MICHAEL HARI |
| K143398 |
06/26/2015 |
Plato MICROCATH 27B Microcatheter |
SCIENTIA VASCULAR , LLC |
Sharon Rockwell |
| K150549 |
06/01/2015 |
Reactor(TM) Trocar and Sleeve |
Sharp Medical Prducts, LLC |
Chris Salvino |
| K150093 |
06/03/2015 |
Pulse Oximeter, Models PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD- 1W; and POD-60NW-1 |
SHENZHEN CREATIVE INDUSTRY CO., LTD. |
JIA WANG |
| K150080 |
06/12/2015 |
DC-8/DC-8 PRO/DC-8 CV/DC-8 EXP/DC-8S |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
Zhai Pei |
| K150167 |
06/30/2015 |
V60 Anesthetic Vaporizer |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
TANG HO |
| K140790 |
06/15/2015 |
Dimension Vista Chemistry 1 Calibrator (CHEM 1 CAL), Dimension Vista Magnesium Flex reagent cartridge (MG) |
SIEMENS HEALTHCARE DIAGNOSTICS |
HELEN M LEE |
| K151192 |
06/23/2015 |
syngo.via MI Workflows |
SIEMENS MEDICAL SOLUTIONS USA, INC |
VERONICA PADHARIA |
| K150493 |
06/30/2015 |
Sensis |
Siemens Medical Solutions, Inc. |
Patricia D Jones |
| K150512 |
06/17/2015 |
STAR 90 |
SKANRAY TECHNOLOGIES PVT LTD. |
Hema ` Singh |
| K150939 |
06/08/2015 |
Ensizor Endoscopic Scissors |
SLATER ENDOSCOPY, LLC |
JOHN STARKEY |
| K150981 |
06/23/2015 |
SMV Scientific Bone Screws |
SMV Scientific |
Nephi Zufelt |
| K150369 |
06/18/2015 |
SomnoDent Classic with DentiTrac Micro-recorder, SomnoDent Flex with DentiTrac Micro-recorder, SomnoDent Herbst Advance (Classic or Flex Retention) with DentiTrac Micro-recorder, SomnoDent G2 (Classic or Flex Retention) with DentiTrac Micro-recorder, Somn |
SOMNOMED INC. |
KIEN T. NGUYEN |
| K150376 |
06/12/2015 |
Sonoma Cancellous Bone Screw and Washer |
Sonoma Orthopedics Products, Inc |
Rick Epstein |
| K150489 |
06/11/2015 |
EOS PMP, EOS PMP Integrated |
SORIN GROUP ITALIA S.R.L. |
LUIGI VECCHI |
| K150895 |
06/19/2015 |
SPEC Model M16 |
Source Production and Equipment Co.,Inc. |
Kelly Richardt |
| K151215 |
06/03/2015 |
Mercury Spinal System |
Spinal Elements Inc. |
JULIE LAMOTHE |
| K150312 |
06/17/2015 |
Vdrive system, Vdrive Duo, Vdrive with V-Sono |
STEREOTAXIS, INC. |
JOHN NADELIN |
| K150250 |
06/11/2015 |
SternSnap Angled Attachment |
Sterngold Dental, LLC |
MARIA RAO |
| K150517 |
06/05/2015 |
Freedom Spinal Cord Stimulator System |
STIMWAVE TECHNOLOGIES INCORPORATED |
Elizabeth Greene |
| K151201 |
06/29/2015 |
Stryker ICONIX with Needles |
Stryker |
TAYLOR WHITE |
| K151387 |
06/24/2015 |
Stryker Universal Neuro III System: UN III AXS Screw, UN III AXS Screwdriver Blade |
STRYKER |
JONATHAN SCHELL |
| K150753 |
06/09/2015 |
OASYS System |
STRYKER CORPORATION |
Garry T Hayeck |
| K150582 |
06/12/2015 |
Vertaplex« High Viscosity (HV) Radiopaque Bone Cement |
STRYKER CORPORATION |
KRISTI ASHTON |
| K150538 |
06/25/2015 |
Reprocessed LigaSure ImpactTM Curved, Large Jaw, Open Sealer/Divider |
STRYKER SUSTAINABILITY SOLUTIONS |
SCOTT ENGLISH |
| K151178 |
06/24/2015 |
VariAx 2 Wrist Fusion System |
Stryker Trauma AG |
DR. HEIKE GUSTKE |
| K150540 |
06/22/2015 |
Instru-Safe Instrument Protection System |
SUMMIT MEDICAL, INC. |
Nicole Dove |
| K150559 |
06/19/2015 |
Life Fast Set, Life Regular Set |
SYBRON DENTAL SPECIALTIES |
Kerri Casino |
| K150796 |
06/23/2015 |
Dental Bone Cutting Instruments |
SYNTHES (USA) PRODUCTS, LLC |
SUSAN LEWANDOWSKI |
| K151276 |
06/18/2015 |
DePuy Synthes T-PAL Ti Spacer |
SYNTHES USA PRODUCTS LLC |
Eric Zhu |
| K143090 |
06/15/2015 |
LUMINESSE PRE-SINTERED ZIRCONIA COLORING LIQUID |
TALLADIUM, INC. |
ELINA FASKHUTDINOVA |
| K151161 |
06/24/2015 |
VICTUS Femtosecond Laser Platform |
TECHNOLAS PERFECT VISION GMBH |
FRIEDRICH MORITZ |
| K143581 |
06/26/2015 |
Arrow Epidural Catheter Kit |
Teleflex Medical, Inc. |
Angela Bouse |
| K151398 |
06/25/2015 |
K-Pack II Needle - 29G x 5/16 Thin Wall |
TERUMO EUROPE N.V. |
M. J. Aerts |
| K150783 |
06/23/2015 |
Progressive Orthopaedic Total Knee System |
The Progressive Orthopaedic Company, LLC |
Scott Keiser |
| K150727 |
06/17/2015 |
ESTECEM |
TOKUYAMA DENTAL CORPORATION |
Fumio Takahashi |
| K150967 |
06/18/2015 |
XIDF-AWS801, Angio Workstation, V6.10 |
Toshiba Medical Systems Corporation |
Paul Biggins |
| K150570 |
06/03/2015 |
ANAX OCT Spinal System |
U&I Corporation |
Young-Geun Kim |
| K150666 |
06/22/2015 |
uNion Cervical Plate System |
ulrich medical USA |
Hans Stover |
| K142512 |
06/11/2015 |
Personalized Physiology Analytics Engine software |
VGBio, Inc (DBA PhysIQ) |
Gary Conkright |
| K150725 |
06/08/2015 |
Visaris Avanse |
VISARIS d.o.o. Belgrade |
Milan Ratkovic |
| K141348 |
06/22/2015 |
VISCO SOFT CONTACT LENS |
VISCO VISION INC. |
JENNIFER TING |
| K140820 |
06/26/2015 |
XENOMEM WOUND MATRIX |
VISCUS BIOLOGICS LLC |
ELAINE DUNCAN |
| K150018 |
06/17/2015 |
VS3-IR-MMS System |
Visionsense Ltd. |
Alex Chanin |
| K142750 |
06/26/2015 |
JiveX |
VISUS TECHNOLOGY TRANSFER GMBH |
Axel Schreiber |
| K151115 |
06/03/2015 |
MR Core Software |
Vital Images, Inc |
Parthiv Shah |
| K142642 |
06/30/2015 |
Vitalograph Model 6600 Compact |
VITALOGRAPH(IRELAND) LTD. |
Tom J Healy |
| K142812 |
06/29/2015 |
Vitalograph Model 6800 Pneumotrac |
VITALOGRAPH(IRELAND) LTD. |
Tom J Healy |
| K151441 |
06/29/2015 |
First Sign Drug of Abuse Dip Card Test, First Sign Drug of Abuse Cup Test |
W.H.P.M., INC. |
JOHN WAN |
| DEN130039 |
06/18/2015 |
BRAINPORT V100 DEVICE |
WICAB, INC |
STEVEN B DATLOF |
| K151290 |
06/30/2015 |
Disposable Blood Pressure Cuff, Reusable Blood Pressure Cuff |
XUZHOU MAICUFF TECHNOLOGY CO.,LTD. |
LI ZHAOQIAN |
| K150662 |
06/09/2015 |
Clickfine Pen Needle, Penfine Classic Pen Needle (other trade names anticipated) |
YPSOMED AG |
Stephen Affolter |
| K150630 |
06/15/2015 |
Eye Secret 38 UV Aspheric (polymacon) Soft (hydrophilic) Contact Lens for Daily Wear, Eye Secret 55 UV Aspheric ( methafilcon A) Soft (hydrophilic) Contact lens for Daily Wear |
YUNG SHENG OPTICAL CO., LTD. |
Wen-Han Chen |
| K150730 |
06/16/2015 |
Zimmer PSI Shoulder System |
ZIMMER |
CHRISTOPHER MCLEAN |
| K143505 |
06/25/2015 |
Zimmer Patient-Specific Abutment, Internal Hex, Titanium |
Zimmer Dental, Inc. |
Christina Boydston |
| K151031 |
06/24/2015 |
Virage OCT Spinal Fixation System |
ZIMMER SPINE, INC |
DONNA M. SEMLAK |
| K142752 |
06/18/2015 |
Minit Posterior Cervical-Thoracic Fixation System, Nex-Link Spinal Fixation System, Nex-Link OCT Cervical Plating System, Sequoia Pedicle Screw System including SpeedLink II, ST360║ Spinal Fixatoin System, Title 2 Polyaxial Spinal System |
ZIMMER SPINE, INC. |
DONNA M. SEMLAK |
