| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K140649 |
12/29/2014 |
VECTRIX EXTERNAL FIXATOR |
3D MEDICAL CONCEPTS, LLC |
BEVERLY LAIRD |
| K142415 |
12/19/2014 |
Hi-Torque JET Guide Wire Family |
ABBOTT VASCULAR INC. |
JANET BENSON |
| K142391 |
12/22/2014 |
Mission U120 Ultra Urine Analyzer, Mission Urinalysis Reagent Strips ( Microalbumin/Creatinine ) |
ACON LABORATORIES, INC. |
QIYI XIE |
| K140772 |
12/19/2014 |
AEROSURE MEDIC |
Actegy Ltd |
John j Smith, M.D., J.D. |
| K140977 |
12/22/2014 |
EVOTECH ECR |
ADVANCED STERILIZATION PRODUCTS |
REUBEN LAWSON |
| K141693 |
12/19/2014 |
Tyvek« Pouch/Roll with STERRAD« Chemical Indicator |
ADVANCED STERILIZATION PRODUCTS |
SUN CHOI |
| K142122 |
12/04/2014 |
RADAR VASCULAR COMPRESSION DEVICE |
ADVANCED VASCULAR DYNAMICS |
MATTHEW SEMLER |
| K142686 |
12/18/2014 |
StimPad OTC |
AEMED, INC. |
John K Burke |
| K142707 |
12/19/2014 |
AIS Odontoid Fracture Fixation System |
AESCULAP IMPLANT SYSTEM, INC. |
Lisa M Boyle |
| K142528 |
12/22/2014 |
AnthroBridge-Screw 25,30,35,40,45,50mm; AnthroBridge- Proximal Module 4.0,4.5,5.0mm |
Agent Medical, LLC |
Scott Munday |
| K142672 |
12/03/2014 |
AliveCor Heart Monitor |
ALIVECOR, INC. |
Albert Boniske |
| K140680 |
12/12/2014 |
LEADPOINT FOCUS WORKSTSTION, LEADPOINT FOCUS NOTEBOOK SYSTEM |
ALPINE BIOMED APS |
Seamus O'Connor |
| K141529 |
12/03/2014 |
ALVIGUIDE BLUE+ INTERVENTIONAL CARDIOLOGY GUIDING CATHETER |
ALVIMEDICA TIBBI URUNLER SANAYI VE DIS TICARET A.S |
LORI E ADELS |
| K142264 |
12/08/2014 |
Valeo C Spacer System, Valeo II C IBF Device |
Amedica Corp. |
William D Jordan |
| K142333 |
12/18/2014 |
SMART LABEL, PROPOFOL |
AMERICAN I.V. PRODUCTS, INC dba AIV, INC |
SHANNON HOUCHEN |
| K142285 |
12/01/2014 |
AmeriWater Heatsan, 3-phase, 208v, 60hz, AmeriWater Heatsan, 3-phase, 460V, 60hz, Ameriwater Heatsan, 3-phase, 575v, 60hz |
AmeriWater |
Brian R Bowman |
| K141213 |
12/10/2014 |
AMERIWATER OZONE DISINFECTION SYSTEM |
AMERIWATER |
BRIAN BOWMAN |
| K142607 |
12/11/2014 |
AngioVac Circuit |
ANGIODYNAMICS |
Gary Barrett |
| K140931 |
12/05/2014 |
IGROW II HAIR GROWTH SYSTEM |
APIRA SCIENCE, INC. |
RAYMAND R BLANCHE |
| K142427 |
12/23/2014 |
TISSUE CONTAINMENT SYSTEM; 10, 14, 17, 25 |
APPLIED MEDICAL RESOURCES |
AEREE LEE |
| K141969 |
12/19/2014 |
FIRSTSTIC N INTRODUCER |
ARGON MEDICAL DEVICES, INC |
SUZANNE CHEANG |
| K140855 |
12/18/2014 |
ARTHREX SUTURETAK SUTURE ANCHORS |
ARTHREX, INC. |
DAVID L ROGERS |
| K141695 |
12/30/2014 |
ACROSSPINE PEDICLE SCREW SYSTEM |
ARTHRO-DIF |
RICH JANSEN |
| K142944 |
12/16/2014 |
ArthroPlan Digital Templating Software |
Arthromeda, Inc |
Elsa Abruzzo |
| K142942 |
12/19/2014 |
HemiCAP Humeral Head XL (HHXL) Articular Resurfacing System |
ARTHROSURFACE INC. |
Dawn J. Wilson |
| K141920 |
12/23/2014 |
Wrist Hemiarthroplasty System |
ARTHROSURFACE, INC. |
DAWN J WILSON |
| K133924 |
12/03/2014 |
ENDOLUMINAL OCCLUSION SYSTEM (EOS) |
ARTVENTIVE MEDICAL GROUP, INC |
Roberta Hines |
| K142619 |
12/18/2014 |
Snap Insulin Pump System |
ASANTE SOLUTIONS, INC |
EDWARD SINCLAIR |
| K142124 |
12/31/2014 |
AEU-6000 IMPLANT / ENDODONTIC DENTAL SYSTEM |
ASEPTICO, INC. |
CHERIE TREGONING |
| K140838 |
12/05/2014 |
IV ADMINISTRATION SET WITH HAND PUMP |
B. BRAUN MEDICAL, INC. |
ANGELA J CARAVELLA |
| K133994 |
12/01/2014 |
SIVR56-T KIT |
BARCO N.V. |
LIEVEN DE WANDEL |
| K143067 |
12/22/2014 |
Carnation Ambulatory Monitor |
BARDY DIAGNOSTICS, INC. |
JON P. HUNT |
| K142373 |
12/22/2014 |
Access 25(OH) Vitamin D Total for Use on the Access 2 Immuno. Syst., Access 25(OH) Vitamin D Total Calibrators for Use on the Access 2 Immuno. Syst |
BECKMAN COULTER, INC. |
Ryan Severson |
| K142362 |
12/19/2014 |
Access 25(OH) Vitamin D Total for Use on the UniCel Dxl Immuno. Syst. Access 25(OH) Vitamin D Total Calibrators for Use on the UniCel Dxl Immuno. |
BECKMAN COULTER, INC. |
RYAN SEVERSON |
| K141474 |
12/18/2014 |
BECTON DICKINSON INTELLIPORT SYSTEM |
BECTON DICKINSON & CO. |
DANIEL OLIVIER |
| K141810 |
12/10/2014 |
BD BACTEC PLUS ANAEROBIC/F (PLASTIC) |
Becton, Dickinson and Company |
Paul Swift |
| K142340 |
12/02/2014 |
Infrared Therapy System |
Beijing Huatai Healthcare Technology Co., Ltd. |
Bingxian Zheng |
| K140285 |
12/04/2014 |
B TRAVELSAVVY SHARPS CONTAINER |
BELLEGROVE MEDICAL SUPPLY, INC. |
WAYNE MORSE |
| K142463 |
12/18/2014 |
Bio2 CLM BG Bioactive Scaffold |
Bio2 Technologies, Inc. |
Janet Krevolin, PhD |
| K142204 |
12/19/2014 |
Bioceptive Suction Cervical Retractor |
Bioceptive Inc. |
Steward B. Davis, M.D. |
| K141893 |
12/18/2014 |
VIBRANCE KEGEL DEVICE (VKD) |
BIOINFINITY (M)SDN.BHD. |
Carrie Hetrick |
| K143188 |
12/30/2014 |
3.Omm Biomet Cannulated Screw System |
BIOMET MANUFACTURING CORP. |
VICTORIA SCHEITLIN |
| K142746 |
12/29/2014 |
G7 Finned Acetabular Shell |
BIOMET MANUFACTUTING CORP. |
TRACY JOHNSON |
| K142933 |
12/23/2014 |
Biomet Tibial trays |
BIOMET, INC. |
JASON HECKAMAN |
| K143009 |
12/18/2014 |
Echo Bi-Metric Microplasty Hip System |
BIOMET, INC. |
Julie Gantenberg, M.S.,RAC |
| K140669 |
12/11/2014 |
G7 OSSEOTI ACETUBLAR SHELLS |
BIOMET, INC. |
BECKY EARL |
| K133047 |
12/18/2014 |
RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CALIBRATORS, RAPIDFRET ORAL FLUID CONTROLS, RAPIDEASE ORAL FLU |
BIOPHOR DIAGNOSTICS, INC. |
Nathaniel G Butlin |
| K142379 |
12/05/2014 |
Passeo-35 PTA Catheter |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K133333 |
12/31/2014 |
UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT, UNI NPWT FOAM DRESSING KIT |
BLUE OCEAN MEDICAL PRODUCT, LLC. |
E.J. Smith |
| K142973 |
12/01/2014 |
Resolution Clip |
Boston Scientific Corporation |
Elena Nieves |
| K142975 |
12/12/2014 |
Bovie Ultimate High Frequency Electrosurgical Generator |
Bovie Medical Corporation |
Moshe Citronowicz |
| K142108 |
12/16/2014 |
RT ELEMENTS, DOSE REVIEW, BRAIN METASTASES, ADAPTIVE HYBRID SURGERY ANALYSIS |
BRAINLAB AG |
ALEXANDER SCHWIERSCH |
| K143208 |
12/09/2014 |
Denali Filter System - Femoral Delivery Kit, Denali Filter System - Jugular/Subclavain Delivery Kit |
C.R. Bard, Inc |
Laurie Sang |
| K141936 |
12/29/2014 |
MICROBLAB, MICROLOOP |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIEDERMEYER |
| K141064 |
12/04/2014 |
VESOFLOW PLUS DVT COMPRESSION DEVICE |
CAREMED SUPPLY, INC. |
MICHAEL LEE |
| K142490 |
12/15/2014 |
ProxiFuse Hammer Toe Device |
Cartiva, Inc. |
Richard Knostman |
| DEN140009 |
12/18/2014 |
AMIGO REMOTE CATHETER SYSTEM |
CATHETER ROBOTICS INC |
JENNIFER ENGLUND |
| K141092 |
12/04/2014 |
MARK3 |
CAVEX HOLLAND B.V |
R, WOORTMAN |
| K140592 |
12/17/2014 |
CERAGEM AUTOMATIC THERMAL MASSAGER |
Ceragem International Inc. |
E.J. Smith |
| K142580 |
12/01/2014 |
Chemtrue Multi-Panel DOA DIP Card Tests |
CHEMTRON BIOTECH, INC. |
Jane Zhang |
| K142800 |
12/11/2014 |
Rapid Single/Multi-drug Test Cup and Rapid Single/Multi-drug Test Dipcard |
Co-Innovation Biotech Co., Ltd. |
Hong Feng |
| K142429 |
12/24/2014 |
CODMAN Microcoil Delivery System, DELTAMAXX Microcoil Delivery System, ORBIT GALAXY G2 Microcoil Delivery System, EnPower Control Cable, Connector Cable |
Codman & Shurtleff, Inc |
Hannah Foley |
| K141721 |
12/22/2014 |
BOVINE PERICARDIUM PATCH |
COLLAFIRM LLC |
Surendra P Batra |
| K142404 |
12/11/2014 |
iTotal Posterior Stabilized (PS) Knee Replacement System |
ConforMIS Inc. |
Amita Shah |
| K142688 |
12/19/2014 |
Echotip Procore HD Ultrasound Biopsy Needle |
COOK IRELAND LTD |
Nora O'Connor |
| K140593 |
12/15/2014 |
ADVANCE SALIVARY BALLOON CATHETER WITH WIRE GUIDE |
COOK, INC. |
LARRY D POOL |
| K142547 |
12/09/2014 |
Bluntport Blunt Trocar with Threaded Anchor 5mm-12mm |
COVIDIEN |
MARY MELLOWS |
| K143161 |
12/19/2014 |
Force FX-8(S), Force FX-8C(S), Force FX-8CA(S) |
COVIDIEN |
Sharon McDermott |
| K141479 |
12/23/2014 |
KANGAROO ENTERAL FEEDING SET WITH ENFIT CONNECTORS |
COVIDIEN |
TEGHPAL SINGH |
| K142643 |
12/15/2014 |
Stabilynx PEEK Suture Anchor |
D3 DC, LLC /Stabilynx, Inc |
Mike Rosenthal |
| K142329 |
12/15/2014 |
BBS REVOLUTION |
dBMEDx INC. |
DAVE SHINE |
| K143378 |
12/29/2014 |
AQUARIUS Gastrostomy Replacement Tube |
DEGANIA SILICONE LTD |
Zoya Lee |
| K142168 |
12/04/2014 |
NATURE'S BOND 600 AND NATURE'S BOND 603 |
DEVON MEDICAL PRODUCTS, INC. |
Ruth Wu |
| K141575 |
12/15/2014 |
PLAC TEST FOR LP-PLA2 ACTIVITY |
DIADEXUS, INC. |
Lorry Weaver Huffman |
| K142132 |
12/12/2014 |
POOL NORM |
Diagnostics Stago S.A.S. |
MARIE COMPAGNON-RIOBE |
| K141463 |
12/10/2014 |
LIASON XL1,25 DIHYDROXYVITAMIN D; CONTROL SET, CALIBRATION VERIFIERS |
DiaSorin Inc. |
CAROL A DEPOUW |
| K141586 |
12/30/2014 |
OWL CANNULAE |
DIROS TECHNOLOGY, INC. |
GEORGE DARMOS |
| K141054 |
12/10/2014 |
DISTAL ACCESS TORQUE DEVICE |
DISTAL ACCESS, LLC |
CAROL STAMP |
| K140663 |
12/12/2014 |
THERASNORE |
DISTAR, LLC |
JANEEN VILVEN-DOGGETT |
| K141756 |
12/12/2014 |
INFINITY EXPLORER SOFTWARE, C700 FOR IT PATIENT VICINITY WORKSTATION |
Draeger Medical Systems, Inc. |
KAREN PROVENCHER |
| K140734 |
12/15/2014 |
NEXTGEN ALTIUS OCT SYSTEM |
EBI, LLC |
TED KUHN |
| K142514 |
12/18/2014 |
UniWeb 8.0 |
EBM Technologies Incorporated |
John Su |
| K142173 |
12/30/2014 |
NON-STERILE ORS-400N SCOPE PILLOW WARMER DRAPE |
ECOLAB, INC. |
JENNIFER WILLNER |
| K132313 |
12/05/2014 |
PESSARY |
EIS CORPORATION |
YANG HO DONG |
| K142194 |
12/19/2014 |
CytoSure Urinary Access System |
Emmy Medical |
Christine G Santagate |
| K140796 |
12/02/2014 |
MEDUSA VASCULAR PLUG, |
ENDOSHAPE, INC. |
MICHAEL PARMENTER |
| K141330 |
12/15/2014 |
ENDO-CORD |
ENROXTECH, INC. |
LEWIS WARD |
| K143186 |
12/18/2014 |
Endo Quickconnect Olympus Scope Port Connector, Endo Quickconnect Pentax Scope Port Connector |
ERBE USA, INC. |
JOHN TARTAL |
| K140224 |
12/09/2014 |
EUROIMMUN EUROLINE ENA PROFILE 9AG (IGG) |
EUROIMMUN US |
MICHAEL LOCKE |
| K142571 |
12/17/2014 |
Powder Free Vinyl Patient Examination Gloves |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
ZHANG LITAO |
| K142570 |
12/18/2014 |
Powder Free Vinyl Patient Examination Gloves ( Yellow, White, BLue, Pink ) |
EVER LIGHT PLASTIC PRODUCTS CO., LTD. |
ZHANG LITAO |
| K142620 |
12/12/2014 |
0.9% Sodium Chloride Injection, USP - 2.5 mL in 3 mL Syringe, 0.9% Sodium Chloride Injection, USP-3mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 5 mL in 10 mL Syringe, 0.9% Sodium Chloride Injection, USP - 10 mL in 10 mL Syringe |
Excelsior Medical Corporation |
John Linfante |
| K142365 |
12/05/2014 |
Simplexa Flu A/B & RSV Direct & Simplexa Flu A/B RSV Positive Control Pack |
FOCUS DIAGNOSTICS |
Sharon Young |
| K141009 |
12/16/2014 |
FORT DEFIANCE AUTOMATED STEAM STERILIZER |
Fort Defiance Industries, Inc. |
Chris Yerger |
| K141691 |
12/17/2014 |
GEN_3 |
FREE WHEELCHAIR MISSION |
SHARON ROCKWELL |
| K142521 |
12/01/2014 |
Synapse 3D Liver and Kidney Analysis |
FUJIFILM MEIDCAL SYSTEMS U.S.A.,INC. |
JYH-SHYAN LIN |
| K140436 |
12/23/2014 |
ARCHITECT GALECTIN-3 Reagent Kit, ARCHITECT GALECTIN-3 CALIBRATORS, ARCHITECT GALECTIN-3 CONTROLS |
FUJIREBIO DIAGNOSTICS, INC. |
STACEY DOLAN |
| K141557 |
12/08/2014 |
HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - CERVICAL, HERNIATOME PERCUTANEOUS DISECTOMY DEVICE - LUMBAR |
GALLINI MEDICAL DEVICES, SRL |
ARTHUR S GODDARD |
| K142288 |
12/03/2014 |
MAC 800 Resting ECG Analysis System |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
Sun YanLi |
| K142361 |
12/05/2014 |
Discovery MR750 3.0T |
GE MEDICAL SYSTEMS, LLC |
Jenny Wong |
| K140665 |
12/08/2014 |
GenPrime Snap-Top Split Key Cup |
GENPRIME, INC |
Darby McLean |
| K140284 |
12/17/2014 |
GIVEN PILLCAM UGI CAPSULE ENDOSCOPY SYSTEM |
GIVEN IMAGING LTD. |
HILA DEBBY |
| K140668 |
12/19/2014 |
PLATINUMGMT IPL SYSTEM CLOUD |
GLOBAL MEDICAL TECHNOLOGY S.L. |
Derliz David Diaz Sanchez |
| K142409 |
12/05/2014 |
Vinyl Co-Polymer Powder Free Examination Gloves |
GRAND WORK PLASTIC PRODUCTS CO., LTD. |
DENG ZHANYONG |
| K141412 |
12/03/2014 |
STERILUCENT SELF-SEAL STERILIZATION POUCH |
GS MEDICAL PACKAGING, INC. |
PETER KALKBRENNER |
| K142609 |
12/18/2014 |
CR3 Keyless Split Sample Cup Nortriptyline-Buprenorphine |
Guangzhou Wondfo Biotech Co., Ltd. |
Ben Chen |
| K142700 |
12/19/2014 |
InsufflatOR Needle |
GYNETECH PTY. LTD. |
Kevin MacDonald |
| K142164 |
12/17/2014 |
MANIPULATOR; MANIPULATOR PRO |
GYNETECH PTY. LTD. |
KEVIN MACDONALD |
| K142289 |
12/31/2014 |
PK Spatula |
Gyrus ACMI Inc. |
Neil Kelly |
| K142154 |
12/19/2014 |
PK NEEDLE |
GYRUS ACMI, INC. |
NEIL KELLY |
| K141862 |
12/02/2014 |
HEALTH2SYNC MOBILE APPLICATION, HEALTH2SYNC SMART CABLE |
H2 Inc. |
Feng-Yu Lee |
| K141712 |
12/18/2014 |
KIMGUARD ONE STEP STERILIZATION WRAP |
Halyard Health |
Thomas Kozma |
| K142805 |
12/18/2014 |
Nitrile Powder Free Examination Glove with Colloidal Oatmeal USP Skin Protectant Drug- Dark Violet Blue (DVBU) |
HARTALEGA SDB. BHD. |
KUAN KAM HON |
| K142588 |
12/18/2014 |
Nitrile Powder Free Examination Glove (Blue) |
HARTALEGA SDN BHD |
KUAN KAM HON |
| K142968 |
12/19/2014 |
Full Automatic (NIBP) Blood Pressure Monitor |
Health & Life Co.,Ltd. |
Sarah Su |
| K142997 |
12/17/2014 |
RTHawk, HeartVista Workstation with RTHawk |
HEARTVISTA, INC. |
James J Rogers |
| K140989 |
12/22/2014 |
POWDER FREE NITRILE SURGICAL GLOVES, WHITE COLOR (BRAND NAME: TITANFINE) |
HEBEI HONGSEN PLASTICS TECHNOLOGY CO, LTD |
CHARLES SHEN |
| K142891 |
12/17/2014 |
HEPATIQ |
HEPATIQ LLC |
Dipu Ghosh |
| K142631 |
12/18/2014 |
Hermes Medical Imaging Suite v5.5 |
HERMES MEDICAL SOLUTIONS, AB |
Joakim Arwidson |
| K133800 |
12/19/2014 |
ODOROX(R) IDU/RX (TM) IN-DUCT MODELS, ODOROX(R) IDU/RX (TM) MOBILE DISINFECTION UNITS, ODOROX(R) SLIMLINE/RX (TM) SLIMLI |
HGI INDUSTIRES |
CONNIE ARAPS, PHD |
| K141161 |
12/20/2014 |
ABX MICROS ES 60 CT; (OPEN TUBE MODEL), (CLOSE TUBE MODEL) |
HORIBA ABX SAS |
FERRER CAROLINE |
| K142433 |
12/08/2014 |
Hospira Extension Set |
Hospira, Inc. |
David Blonski |
| K141287 |
12/03/2014 |
HUIKANG NITRILE POWDER FREE PATIENT EXAM GLOVES, BLUE COLOR |
HUIKANG GLOVE CO., LTD. |
CHU XIAOAN |
| K141105 |
12/04/2014 |
PULSE OXIMETER |
HUNAN ACCURATE BIO-MEDICAL TECHNOLOGY CO., LTD. |
LI ZHANG |
| K143339 |
12/19/2014 |
Mini me |
ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.) |
BOBAE KIM |
| K140860 |
12/16/2014 |
ImmersiveTouch3 and MicrovisTouch |
IMMERSIVE TOUCH |
PRASHANT BANERJEE |
| K140554 |
12/19/2014 |
IDS-ISYS 25-HYDROXY VITAMIN DS, AND IDS-ISYS 25 HYDROXY VITAMIN DS CONTROL SET |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK HENDERSON |
| K141764 |
12/18/2014 |
TRISTAR BONE GRAFT FIXATION SYSTEM |
IMPLADENT, LTD. |
MAURICE VALEN |
| K140926 |
12/03/2014 |
INMODE WMFACE DEVICE |
INMODE MD LTD. |
AHAVA STEIN |
| K142638 |
12/19/2014 |
ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273) |
InnovaQuartz LLC |
Stephen Griffin |
| K142477 |
12/15/2014 |
Intact Advance and Intact Excision XL, Intact BLES |
INTACT MEDICAL CORPORATION |
JOHN VACHA |
| K143217 |
12/03/2014 |
12 mm & Stapler Bladeless Obturators |
INTUITIVE SURGICAL, INC. |
Manish Patel |
| K142683 |
12/10/2014 |
12 mm Endoscopes and Accessories |
INTUITIVE SURGICAL, INC. |
Crystal Ong |
| K141701 |
12/05/2014 |
I-125 RSLN [RADIOACTIVE SEED AND LOCALIZATION NEEDLE] |
ISOAID, L.L.C. |
MARY ANN GREENAWALT |
| K140657 |
12/04/2014 |
CUROS RED PORT PROTECTOR |
IVERA MEDICAL, INC. |
DON CANAL |
| K140705 |
12/05/2014 |
NAVIGABLE BRAIN BIOPSY CANNULA SET |
IZI MEDICAL PRODUCTS |
QIANG CAO |
| K130447 |
12/22/2014 |
SPEEDY FLAP SYSTEM |
Jeil Medical Corporation |
Jieun Kim |
| K142043 |
12/18/2014 |
INSYNC ZR HIGH TRANSLUCENCY ZIRCONIA |
JENSEN INDUSTRIES, INC. |
JORDAN SCHRECK |
| K140202 |
12/12/2014 |
TRAUSIM DENTAL IMPLANT SYSTEM |
JIANGSU TRAUSIM MEDICAL INSTRUMENT |
LUO ZHICONG |
| K142564 |
12/23/2014 |
JMS SysLoc MINI A.V. Fistula Needle Set (V4), JMS SysLoc MINI Apheresis Needle Set (V4) |
JMS North America Corporation |
Sho Hosoki |
| K142558 |
12/22/2014 |
Caspian OCT/MESA Mini/DENALI Mini Spinal System |
K2M |
Nancy Giezen |
| K143164 |
12/02/2014 |
ON-Q Pain Relief System, QuikBloc Over-the-Needle Catheter Set |
KIMBERLY-CLARK CORPORATION |
MARIA E WAGNER |
| K140847 |
12/05/2014 |
CARDIOSPY ECG HOLTER SYSTEMS |
LABTECH KFT. |
ZSOLT KATONAI |
| K140536 |
12/17/2014 |
HI TORQUE CONNECT GUIDEWIRE, HI TORQUE CONNECT FLEX GUIDEWIRE, HI TORQUE CONNECT 250T GUIDEWIRE |
LAKE REGION MEDICAL |
KENNETH WALSH |
| K142803 |
12/02/2014 |
Skintact, various other tradenames |
Leonhard Lang GmbH |
Burrhus Lang |
| K142573 |
12/01/2014 |
HairMax LaserComb, HairMax LaserComb |
LEXINGTON INTERNATIONAL, LLC |
DAVID MICHAELS |
| K141727 |
12/18/2014 |
DENTAL LITHIUM DISILICATE GLASS CERAMIC BLOCK (UP. PRESS SERIES AND UP. CAD SERIES) |
LIAONING UPCERA CO.,LTD |
CHARLES SHEN |
| K142326 |
12/23/2014 |
HP Tissue Matrix |
LifeCell Corporation |
Mira Leiwant |
| K132407 |
12/19/2014 |
VITAL SIGNS PATCH SYSTEM (IN SHORT VSP) |
LIFEWATCH TECHNOLOGIES LTD |
ASHER KASSEL |
| K143145 |
12/04/2014 |
SafeAir Smoke Pencil |
LiNA Medical ApS |
Anne Klitgard |
| K142682 |
12/22/2014 |
The Lipogems System |
Lipogems International SpA |
Carlo Russo |
| K140290 |
12/02/2014 |
STOPLOSS JONES TUBE |
LJT SURGICAL LTD |
PATSY J TRISLER, JD, RAC |
| K143119 |
12/18/2014 |
LT-300 Video Colposcope |
Lutech Industries, Inc. |
Ron Vachula |
| K142069 |
12/02/2014 |
GMK EXTENSION |
MEDACTA INTERNATIONAL |
ADAM GROSS |
| K141926 |
12/19/2014 |
INVIA ENDURE NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
MEDELA AG |
ADRIENNE LENZ |
| K142728 |
12/04/2014 |
ActiveCare+SFT; ActiveCare+SFT HomeCare (ActiveCare+SFT-sub-category), ActiveCare+DTx ; ActiveCare+DTx HomeCare (ActiveCare+DTx-sub-category) |
Medical Compressions System (DBN) Ltd. |
Eyal Sandach |
| K142702 |
12/18/2014 |
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad |
MEDIVANCE, INC. |
Stacci Cronk |
| K142022 |
12/19/2014 |
MEDLINE RENEWAL REPROCESSED GYRUS-DIEGO SINUS APPLICATION BLADES |
MEDLINE RENEWAL |
RICHARD D WYNKOOP |
| K141420 |
12/18/2014 |
FASTFORWARD |
MEDSHAPE, INC |
JEREMY BLAIR |
| K143175 |
12/31/2014 |
AEx Generator; PlasmaBlade T |
MEDTRONIC ADVANCED ENERGY |
Deep Pal |
| K143141 |
12/01/2014 |
CD HORIZON Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC |
Gregory Maschek |
| K142591 |
12/01/2014 |
CD HORIZON Spinal System |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LILA JOE |
| K141632 |
12/04/2014 |
ZEVO (TM) ANTERIOR CERVICAL PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
KRISTI FRISCH |
| K142611 |
12/31/2014 |
TYRX Neuro Absorbable Antibacterial Envelope |
MEDTRONIC TYRX, INC. |
REGINA NOVAK |
| K140091 |
12/12/2014 |
XPEED ANYRIDGE INTERNAL IMPLANT SYSYEM |
MEGAGEN IMPLANT CO., LTD |
SUSAN PARK |
| K142772 |
12/16/2014 |
Phlebo Press DVT 603 |
Mego Afek AC Ltd. |
Aharon Cohen |
| K142998 |
12/19/2014 |
CPX Control Breast Tissue Expander |
MENTOR WORLDWIDE LLC |
Manchi Cheung |
| K142051 |
12/17/2014 |
PRELUDE PLASTIC JACKETED GUIDE WIRE |
MERIT MEDICAL SYSTEMS INC. |
MICHAEL O'SULLIVAN |
| K141295 |
12/16/2014 |
MERIT HYDROPHILIC GUIDEWIRE |
MERIT MEDICAL SYSTEMS, INC. |
MICHAEL O'SULLIVAN |
| K143429 |
12/22/2014 |
Passage Hemostasis Valve |
MERIT MEDICAL SYSTEMS, INC. |
MARK MULLANEY |
| K140589 |
12/03/2014 |
STERRAD CYCLESURE 24 PLUS BIOLOGICAL INDICATOR |
MESA LABORATORIES, INC. |
Kurt McCauley |
| DEN130004 |
12/18/2014 |
MOERAE SURGICAL MARKING PEN |
MOERAE MATRIX, INC. |
ROBERT J CHIN |
| K141020 |
12/03/2014 |
SURVEYOR S4 MOBILE MONITOR |
MORTARA INSTRUMENT, INC. |
AMY YANG |
| K142342 |
12/18/2014 |
NacrousPowder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Nacrous Plastic Co., Ltd |
WANG LI |
| K142951 |
12/10/2014 |
MD210C3 21.3 Diagnostic Imaging LCD Monitor |
NEC DISPLAY SOLUTIONS LTD. |
Satoru Kotani |
| K142419 |
12/16/2014 |
Mini and Micro Fragments Reconstruction System-NEOFIX |
NEOORTHO PRODUCTOS ORTHOPEDICOS S/A |
Mariana de Oliveira Quinzani |
| K142697 |
12/23/2014 |
NExCT 7 |
NEUROLOGICA CORPORATION |
Ninad Gujar |
| K133373 |
12/03/2014 |
CLEARVIEW |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YUEHUI |
| K142388 |
12/05/2014 |
Neo Total Knee System |
New Era Orthopedics, LLC |
Craig Corrance |
| K142502 |
12/23/2014 |
ALIANS ULNA LOCKING PLATING SYSTEM |
NEWCLIP TECHNICS |
Gaδlle LUSSORI |
| K143197 |
12/23/2014 |
Nice1 |
NICE RECOVERY SYSTEMS, LLC |
MICHAEL ROSS |
| K140440 |
12/19/2014 |
NORIS MEDICAL DENTAL IMPLANTS SYSTEM |
NORIS MEDICAL LTD. |
RAANAN ALONI |
| K142111 |
12/19/2014 |
ARCAD COMPRESSIVE OSTEOSYNTHESIS STAPLE, EXPRESS COMPRESSIVE OSTEOSYNTHESIS STAPLE |
NOVATSEP |
GILLES AUDIC |
| K142737 |
12/18/2014 |
MAS PLIF Fixation system |
NUVASIVE, INCORPORATED |
OLGA LEWIS |
| K142328 |
12/23/2014 |
nvc |
NVISION BIOMEDICAL TECHNOLOGIES, LLC |
BRIAN KIESER |
| K141752 |
12/19/2014 |
NXSTAGE SYSTEM ONE |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K140624 |
12/10/2014 |
HICURA HAND INSTRUMENTS |
OLYMPUS WINTER & IBE GMBH |
SHERI L MUSGNUNG |
| K142917 |
12/01/2014 |
BP652N (HEM-6300-Z) |
OMRON Healthcare, Inc |
Renee Thornborough |
| K141978 |
12/03/2014 |
MAXPOWER RELIEF |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K142671 |
12/05/2014 |
ONEFIT HIP PLANNER |
ONEFIT MEDICAL |
JULIEN SIMON |
| K142639 |
12/16/2014 |
StitchKit |
ORIGAMI SURGICAL LLC |
Patrick Culligan |
| K141611 |
12/05/2014 |
LYTHOS DIGITAL IMPRESSION SYSTEM |
ORMCO CORP. |
COURTNEY CLARK |
| K142146 |
12/11/2014 |
IBIS PEDICLE SCREW SYSTEM |
ORTHO DEVELOPMENT CORP. |
MIKE ENSIGN |
| K143069 |
12/22/2014 |
HEMASORBPLUS press Resorable Hemostatic Bone Putty |
ORTHOCON, INC. |
Howard L Schrayer |
| K142052 |
12/05/2014 |
ORTHOFIX GALAXY UNYCO DIAPHYSEAL TIBIA KIT |
ORTHOFIX SRL |
CHERYL WAGONER |
| K141760 |
12/08/2014 |
ORTHOFIX GALAXY WRIST |
ORTHOFIX SRL |
CHERYL WAGONER |
| K143125 |
12/10/2014 |
Orthofix True Lok Hexapod System VI.3 |
Orthofix Srl |
Gianluca Ricadona |
| K142081 |
12/12/2014 |
CONTRAST MONITORING SYSTEM DISPLAY, CONTRAST MONITORING SYSTEM SYRINGES |
OSPREY MEDICAL, INC. |
MELANIE HESS |
| K140978 |
12/18/2014 |
OSTEOMED LOW PROFILE ORBITAL FLOOR PLATE SYSTEM |
OSTEOMED |
Ally Baduel |
| K143244 |
12/15/2014 |
The Panthera Anti-Snoring Device |
Panthera Dental Inc. |
Guy Bernard Bantsiele |
| K143057 |
12/03/2014 |
M3290B Philips IntelliVue Information Center iX |
PHILIPS MEDICAL SYSTEMS |
Theresa Poole |
| K142126 |
12/09/2014 |
EP NAVIGATOR REL. 5.0 |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LISELOTTE KORNMANN |
| K142430 |
12/19/2014 |
LIFEPAK 15 monitor/defibrillator |
PHYSIO-CONTROL, INC. |
Sylvia Lemke |
| K141282 |
12/02/2014 |
PGS 5.5 MM CANNULATED PEDICLE SCREW |
PINNACLE SPINE GROUP |
MEREDITH MAY |
| K143488 |
12/17/2014 |
InFill Graft Delivery System |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K142041 |
12/19/2014 |
POROSTEON PHUSION METAL CERVICAL CAGE |
POROSTEON, INC. |
ROBERT A POGGIE, PHD |
| K142378 |
12/18/2014 |
Interspinous Plate System |
Precision Spine, Inc. |
Michael C. Dawson |
| K143248 |
12/19/2014 |
Reform Pedicle Screw System |
PRECISION SPINE, INC. |
MICHAEL C. DAWSON |
| K142471 |
12/01/2014 |
Pressure Right, Single-Use, Disposable, Acupressure, Pressure-Sensitive Wrist Strip |
Pressure Point Inc. |
Joseph DiLustro |
| K140350 |
12/12/2014 |
VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL |
PREVENTIVE TECHNOLOGIES, INC. |
KENNETH S PETERSON |
| K143330 |
12/15/2014 |
BruxZir Anterior |
PRISMATIK DENTALCRAFT, INC. |
Armin Zehtabchi |
| K133502 |
12/03/2014 |
5000Z FIREFLY SYSTEM |
PRIZM MEDICAL, INC. |
CARL BEAURLINE |
| K141389 |
12/11/2014 |
SAPPHIRE INFUSION PUMP |
Q CORE MEDICAL LTD |
Rhona Shanker |
| K142738 |
12/19/2014 |
artus HSV-1/2 QS-RGQ MDx Kit |
QIAGEN |
Lindsey Howard |
| K142384 |
12/12/2014 |
DESIO (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted) |
QUALIMED SRL |
Tereza Uhrova |
| K143206 |
12/10/2014 |
AmpliVue Bordetella Assay |
QUIDEL CORPORATION |
RONALD H. LOLLAR |
| K141775 |
12/16/2014 |
SOFIA (R) STREP A+ FIA |
QUIDEL CORPORATION |
JOHN D TAMERIUS |
| K141795 |
12/08/2014 |
BATTER PACK, REPLACEMENT FOR PHYSIO CONTROL LIFEPAK 500 |
R & D BATTERIES, INC. |
KAREN MANLEY |
| K142718 |
12/17/2014 |
Radlink GPS |
RADLINK, INC. |
Brian Kordich |
| K140971 |
12/08/2014 |
LIQUID ASSAYED CHEMISTRY CONTROL PREMIUM PLUS LEVEL 1,2 AND LEVEL 3. |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K143307 |
12/18/2014 |
RaySert PLUS Injector, Single Use Soft Tipped Disposable Injector |
RAYNER INTRAOCULAR LENSES LTD. |
Juliette Cook |
| K131643 |
12/17/2014 |
DUREX REALFEEL PLEASURE GEL PERSONAL LUBRICANT |
RECKITT BENCKISER, LLC |
SAPANA AMIN |
| K142676 |
12/05/2014 |
Siemens 3.0T PROCURE Array Coil |
RESONANCE INNOVATIONS LLC |
RANDALL JONES |
| K143284 |
12/16/2014 |
Elecsys Estradiol III Calcheck |
ROCHE DIAGNOSTICS |
Kelli Turner |
| K143342 |
12/19/2014 |
Elecsys T-Uptake Calset |
Roche Diagnostics |
Kelli Turner |
| K142089 |
12/17/2014 |
ACCU-CHEK AVIVA EXPERT SYSTEM |
ROCHE DIAGNOSTICS CORPORATION |
Greg Mondics |
| K141925 |
12/09/2014 |
TOTAL PROTEIN URINE/CSF GEN.3 |
Roche Diagnostics Operations (RDO) |
PATRICK STIMART |
| K142721 |
12/17/2014 |
cobas MRSA/SA Test |
ROCHE MOLECULAR SYSTEMS, INC. |
Wilk von Gustedt |
| K133496 |
12/03/2014 |
X TWIN SYSTEM |
ROESYS GMBH |
JOCHEN DYSZBALIS |
| K142789 |
12/16/2014 |
A1c iGear System |
Sakae Corporation |
Shinji Nakayama |
| K142701 |
12/19/2014 |
SMD Sr90-1 Radionuclide Brachytherapy Source |
Salutaris Medical Devices, Inc. |
Laurence Marsteller |
| K142492 |
12/17/2014 |
GM60A-32S, GM60A-40S |
SAMSUNG ELECTRONICS CO., LTD. |
KIM CHULSIN |
| K143264 |
12/09/2014 |
H60 V2.00 Diagnostic Ultrasound System |
SAMSUNG MEDISON CO., LTD |
Kyeong-Mi Park |
| K143221 |
12/05/2014 |
Schoelly Laparoscope |
Schoelly Fiberoptic Gmbh |
Sandra Baumann |
| K141366 |
12/17/2014 |
VIDEO BRONCHOSCOPE SYSTEM |
SCHOLLY FIBEROPTIC GMBH |
SANDRA BAUMANN |
| K142180 |
12/12/2014 |
TELESENSE |
SCOTTCARE CORPORATION |
SNEHRAJ MERCHANT |
| K142488 |
12/18/2014 |
SeaSpine Spacer System - (Hollywood, Pacifica, Redondo, Ventura) NanoMetalene, Cambria NanoMetalene , Vu aPOD-L NanoMetalene, Vu ePOD NanoMetalene |
SeaSpine, Inc. |
Michelle Willis |
| K142715 |
12/16/2014 |
Sensor Medical Family of Vitrectomy Lenses and Products |
Sensor Medical Technology, LLC |
Louise Culham |
| K143195 |
12/22/2014 |
Passport Series Patient Monitors (including Passport 17M, Passport 12M and T1) |
Shenzhen Mindray Bio-Meidcal Electronics Co., Ltd |
Yanhong Bai |
| K143376 |
12/23/2014 |
ADIVA Centaur Progesterone Master Curve Material (MCM), ADIVA Centaur Ferritin Master Curve Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
FATIMA PACHECO |
| K143194 |
12/05/2014 |
ADIVA Centaur Prolactin Master Curve Material (MCM), ADIVA Centaur Cortisol Master Curve Material (MCM) |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
FATIMA PACHECO |
| K142758 |
12/05/2014 |
ADVIA Centaur HAV total assay |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Philip Liu |
| K143352 |
12/24/2014 |
IMMULITE 2000 Ferritin Calibration Verification Material, IMMULITE 2000 IGFBP-3 Calibration Verification Material |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Sara Kastrup |
| K143254 |
12/10/2014 |
eSie Apps Suite |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NANCY BURKE |
| K142049 |
12/18/2014 |
MULTIX FUSION VA30 & VA40 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
PATRICIA D JONES |
| K140920 |
12/03/2014 |
SYNGO.CT COLONOGRAPHY |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
KIMBERLY MANGUM |
| K143205 |
12/05/2014 |
Viscoelastic Injector |
Sight Sciences, Inc. |
Paul Badawl |
| K142807 |
12/22/2014 |
ANTHEM PS Total Knee System |
Smith & Nephew, Inc. |
Samir Ibrahim |
| K143050 |
12/18/2014 |
VLP Mini-Mod Small Bone Plating System 1.5mm Plates and Screws |
SMITH & NEPHEW, INC. |
SAMANTHA STAUBACH |
| K142474 |
12/19/2014 |
S12 Digital Color Doppler Ultrasound System |
SONOSCAPE COMPANY LIMITED |
TOKI WU |
| K133218 |
12/10/2014 |
Crystal «; Mosaic «; Vertu « |
SPINAL ELEMENTS, INC. |
JULIE LAMOTHE |
| K142661 |
12/11/2014 |
Bi-Portal Bone Graft Delivery Device |
Spinal Surgical Strategies, LLC |
Jeffrey Kleiner |
| K141135 |
12/01/2014 |
JULIET LL |
SPINEART |
FRANCK PENNESI |
| K143403 |
12/18/2014 |
Threshold Pedicular Fixation System |
Spineology, Inc. |
Tim Crabtree |
| K141046 |
12/24/2014 |
MIDI-SRS |
SRMC CO., LTD |
Priscilla Chung |
| K142235 |
12/18/2014 |
CPS Aim MediGuide Enabled inner catheter, CPS Aim Mediguide Enabled inner Catheter |
St. Jude Medical |
ZACHARY PRICE |
| K142239 |
12/18/2014 |
CPS Direct MediGuide Enabled outer catheter |
St. Jude Medical |
Geena George |
| K140793 |
12/17/2014 |
NANOSTIM INTRODUCER KIT |
ST. JUDE MEDICAL, INC. |
HASSAN LABAY |
| K141530 |
12/18/2014 |
VDRIVE SYSTEM/ VDRIVE DUO/ VDRIVE WITH V-CAS |
STEREOTAXIS, INC. |
DIANA HORWITZ, PH.D., RAC |
| K142407 |
12/24/2014 |
Straight Stud Attachment |
Sterngold Dental, LLC |
Maria Rao |
| K141962 |
12/05/2014 |
XN CAL |
Streck |
Deborah Kipp |
| K141955 |
12/05/2014 |
XN CAL PF |
Streck |
Deborah Kipp |
| K141964 |
12/05/2014 |
XN CHECK |
Streck |
Deborah Kipp |
| K141957 |
12/05/2014 |
XN CHECK BF |
Streck |
Deborah Kipp |
| K142699 |
12/31/2014 |
LITe Plate System |
STRYKER CORPORATION |
KRISTEN MEANY |
| K142310 |
12/02/2014 |
Stryker Infrared Fluorescence (IRF) Imaging System |
Stryker Endoscopy |
Golnaz Moeini |
| K143138 |
12/22/2014 |
AxSOS 3 Ti Locking Plate System |
Stryker Trauma AG |
ELIJAH N WREH |
| K142630 |
12/23/2014 |
Instru-Safe Instrument Protection System |
Summit Medical Inc. |
Nicole Dove |
| K141513 |
12/15/2014 |
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM |
SUMMIT MEDICAL, INC. |
NICOLE DOVE |
| K142142 |
12/05/2014 |
QUALITY REPORTS |
SUN NUCLEAR CORPORATION |
JAMES LUKER |
| K142431 |
12/05/2014 |
WaterProof PROFILER |
SUN NUCLEAR CORPORATION |
NOEL DOWNEY |
| K133795 |
12/12/2014 |
SUMMED INFLATION DEVICE KIT |
SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD |
JAMES QI ZHANG |
| K142457 |
12/18/2014 |
Quickie, Zippie |
Sunrise Medical (US) LLC |
Laurie Roberts |
| K140228 |
12/18/2014 |
DISPOSABLE TRACHEAL TUBE |
SUZHOU WEIKANG MEDICAL APPARATUS CO., LTD |
MIKE GU |
| K141507 |
12/08/2014 |
TWO SKIN TREATMENT SYSTEM |
SYNERON MEDICAL LTD. |
JANICE M HOGAN |
| K141681 |
12/05/2014 |
SYSMEX XN SERIES |
SYSMEX AMERICA, INC. |
SHARITA BROOKS |
| K140848 |
12/17/2014 |
LUMINESSE PORCELAIN SYSTEM |
TALLADIUM, INC. |
EDWARD R HARMS |
| K142343 |
12/10/2014 |
Hongyun Powder-Free Vinyl Patient Examination Gloves, Clear( Non-colored) |
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD |
RJ WANG |
| K141878 |
12/24/2014 |
HONGYUN POWDER-FREE YELLOW VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K141053 |
12/11/2014 |
OVINE TISSUE MATRIX(OTM) |
TELA BIO, INC. |
DONNA STAUFFER |
| K141214 |
12/18/2014 |
AQUAPAK NEBULIZER ADAPTORS/RESERVOIRS |
Teleflex Medical, Inc. |
JAMES A COCHIE |
| K142777 |
12/19/2014 |
Weck Hem-o-lok Auto Endo5 Ligating Clip Applier |
Teleflex Medical, Inc. |
Ashlea Ricci |
| K142735 |
12/21/2014 |
The Optilite IgG3 kit |
THE BINDING SITE GROUP LTD |
Andrea Thomas |
| K140387 |
12/23/2014 |
Burn Resuscitation Decision Support System - Clinical (BRDSS-C) |
THE SURGEON GENERAL, DEPARTMENT OF THE ARMY |
KENNETH A BERTRAM, MD, PHD |
| K142151 |
12/23/2014 |
SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES |
Thermo Fisher Scientific |
Cynthia Knapp |
| K142901 |
12/19/2014 |
RhythmView Workstation |
Topera, Inc. |
Dennis Pozzo |
| K143296 |
12/16/2014 |
AIA-PACK C-Peptide Control Set |
Tosoh BioScience, Inc. |
Robert L Wick |
| K143144 |
12/03/2014 |
ST AIA-PACK PROG II Calibrator Set |
Tosoh BioScience, Inc. |
Robert L Wick |
| K143407 |
12/23/2014 |
Klassic HD Hip System |
Total Joint Othopedics, Inc. |
Chris Weaber |
| K141868 |
12/30/2014 |
TRIA FANP |
TRIA BEAUTY, INC. |
JONATHAN KAHAN |
| K141698 |
12/17/2014 |
STERIZONE CHEMICAL INDICATOR |
TSO3 INC. |
THOMAS RICHARDS, PH.D. |
| K141580 |
12/17/2014 |
STERIZONE SELF-CONTAINED BIOLOGICAL INDICATOR |
TSO3 INC. |
THOMAS RICHARDS |
| K141163 |
12/17/2014 |
STERIZONE STERILIZER |
TSO3 INC. |
THOMAS RICHARDS, PH.D. |
| K142483 |
12/19/2014 |
TurboSEAL Nasogastric Aspiration Tube |
TurboSEAL, L.P. |
DORON BESSER |
| K141218 |
12/18/2014 |
ZIGIWIRE MODE2 GUIDEWIRE WIRE SYSTEM, ZIGIWIRE MODE3 GUIDEWIRE WIRE SYSTEM |
VADISWIRE CORPORATION |
EDWARD (TED) WULFMAN |
| K143224 |
12/19/2014 |
TrueBeam-TrueBeam STx-Edge |
Varian Medical Systems, Inc. |
Peter J. Coronado |
| K142560 |
12/11/2014 |
Varian Head Frame |
VARIAN MEDICAL SYSTEMS, INC. |
Peter J Coronado |
| K142910 |
12/19/2014 |
Legacy BX |
Venus Concept USA Inc. |
Lilia Schlosberg |
| K142377 |
12/17/2014 |
The OnControl Bone Marrow Biopsy System by Vidacare |
VIDACARE LLC |
DIANA MONTEZ |
| K140797 |
12/12/2014 |
IPACS MEDICAL IMAGE MANAGEMENT SYSTEM |
VISBION LIMITED |
TOM FALCON |
| K143079 |
12/04/2014 |
Endovascular Stent Planning Software |
VITAL IMAGES, INC. |
Parthiv Shah |
| K140207 |
12/18/2014 |
RAPID-I KIT |
VITROLIFE SWEDEN AB |
ANTHONY T PAVEL |
| K142919 |
12/16/2014 |
EXA |
Viztek LLC |
Josip Cermin |
| K143328 |
12/19/2014 |
1.8mm X 149 cm Phoenix Atherectomy Catheter, 2.2mm X 149 cm Phoenix Atherectomy Catheter, Phoenix Handle, Phoenix Wire Support Clip |
Volcano AtheroMed, Inc. |
Jean Chang |
| K140296 |
12/02/2014 |
CLEARLUMEN THROMBECTOMY SYSTEM |
WALK VASCULAR, LLC |
BRAD CULBERT |
| DEN140010 |
12/15/2014 |
PERKINELMER ENLITE NEONATAL TREC TEST SYSTEM |
WALLAC OY |
KAY A TAYLOR |
| K141279 |
12/03/2014 |
WANGHUI NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR |
WANGHUI GLOVE CO., LTD. |
CHU XIAOAN |
| K142356 |
12/19/2014 |
Connex Spot Monitor,901058 Vital Signs Monitor Core |
WELCH ALLYN, INC. |
Kevin Crossen |
| K140667 |
12/15/2014 |
WELL LEAD HYDROPHILIC SILICONE FOLEY CATHETER |
WELL LEAD MEDICAL CO. LTD |
HAN GUANG YUAN |
| K143025 |
12/05/2014 |
TOTAL COMPRESSION PLATING SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
Jeanine Redden |
| K142771 |
12/22/2014 |
Xuanye Powder Free Vinyl Patient Examination Gloves, Clear (non-colored) |
Xuanhua Metallurgical Industry CO., LTD |
Yanlong Dong |
| K141304 |
12/12/2014 |
YONGXIN NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR |
YONGXIN HEALTHCARE CO., LTD. |
CHU XIAOAN |
| K143052 |
12/16/2014 |
Eye Secret 38 UV Aspheric Color(polymacon) Soft(hydrophilic) Contact Lens for Daily;Eye Secret 38 UV Aspheric Color(polymacon) 1-Day Soft(hydrophilic) Contact Lens |
YUNG SHENG OPTICAL CO., LTD. |
Wen-Han Chen |
| K142271 |
12/19/2014 |
Zavation Z-Link Lumbar |
Zavation, LLC |
Lawrence Walker |
| K141303 |
12/12/2014 |
ZHIDA NITRILE POWDER FREE PATIENT EXAMINATION GLOVES, BLUE COLOR |
ZHIDA GLOVE CO., LTD. |
CHU XIAOAN |
| K141613 |
12/04/2014 |
GOLDENLINE POWDER-FREE WHITE VINYL PATIENT EXAMINATION GLOVES |
ZIBO GOLDENLINE PLASTIC PRODUCT CO., LTD |
CHU XIAOAN |
| K142508 |
12/19/2014 |
Powder Free Yellow Vinyl Patient Examination Gloves |
ZIBO HUAQI TRADING Co., Ltd |
Jing Li |
| K142787 |
12/22/2014 |
Zimmer Persona Personalized Knee System |
ZIMMER, INC. |
KEITH PROCTOR |
| K142915 |
12/03/2014 |
ZOLL X Series |
ZOLL MEDICAL CORPORATION |
Tammay Shukla |
