| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K133436 |
03/07/2014 |
FLASH AR; FLASH AR QUICK |
3M DEUTSCHLAND GMBH |
DESI SOEGIARTO |
| K133400 |
03/06/2014 |
FLASH BITE |
3M ESPE AG |
RUEDIGER FRANKE |
| K131506 |
03/06/2014 |
AIRWAY SUPPORT SYSTEM / AIRPORT |
ABEON MEDICAL CORPORATION |
ALLISON SLAGA |
| K140637 |
03/26/2014 |
PEREGRINE SYSTEM INFUSION CATHETER |
ABLATIVE SOLUTIONS, INC. |
SHARON ROCKWELL |
| K133469 |
03/10/2014 |
ACUMED SUTURE ANCHOR SYSTEM |
ACUMED, LLC |
LINO TSAI |
| K132206 |
03/19/2014 |
MELYS ATRIAL FIBRILLATION SCREENING MONITOR |
ADVANCED FLUIDICS, LLC |
E J SMITH |
| K130263 |
03/28/2014 |
STERRAD 50/100S/200 TEST PACK |
ADVANCED STERILIZATION PRODUCTS |
NANCY CHU |
| K132011 |
03/21/2014 |
APOTECA DUG COMPOUNDING DOSING DEVICE,APOTECA I.V. TRANSFER SET |
AEA SRL |
MICHELE MENGONI |
| K140452 |
03/25/2014 |
VEGA KNEE SYSTEM |
AESCULAP IMPLANT SYSTEMS |
JULIE TOM WING |
| K133135 |
03/07/2014 |
IMPAX VOLUME VIEWING 3.0 |
AGFA HEALTHCARE N.V. |
KOEN COBBAERT |
| K132800 |
03/03/2014 |
SKINTELL |
AGFA HEALTHCARE N.V. |
SHAEANN CAVANAGH |
| K131386 |
03/14/2014 |
EZ-OX PLUS GENERATION II |
AIR LIQUIDE HEALTHCARE AMERICA |
ANGIE BEYER |
| K122298 |
03/28/2014 |
AJEX 1200 H / AJEX 240H MOBILE X-RAY GENERATOR |
AJEX MEDITECH., LTD |
WILLIAM LITTLE |
| K132975 |
03/18/2014 |
SPHINX JR |
ALLMED SYSTEMS INC. |
PETER ALLEN |
| K133221 |
03/13/2014 |
ARSENAL SPINAL FIXATION SYSTEM |
ALPHATEC SPINE, INC. |
RENEE L MURPHY |
| K133036 |
03/06/2014 |
APOLLO SUTURE ANCHOR SYSTEM AND TITAN SCREWS |
AMENDIA INC. |
RICH JANSEN |
| K131939 |
03/26/2014 |
AMICO DH-W35 OPHTHALMOSCOPE SERIES |
AMICO DIAGNOSTIC INCORPORATED |
LAUREN CHRAPOWITZKY |
| K132965 |
03/25/2014 |
SOLACE SOUND GENERATORS |
AMPLISOUND HEARING PRODUCTS & SERVICES |
RALPH T CAMPAGNA |
| K140126 |
03/04/2014 |
SONIC WINDOW |
ANALOGIC CORPORATION |
ALBERT C CEFALO |
| K140093 |
03/07/2014 |
TABLE |
ANATOMAGE INC. |
MIKE MENDEZ |
| K133117 |
03/04/2014 |
ANDON BLOOD PRESSURE CUFF |
ANDON HEALTH CO., LTD |
LIU YI |
| DEN080009 |
03/04/2014 |
AIRPURGE |
ANESTHESIA SAFETY PRODUCTS, LLC |
IHSAN A HADDAD |
| K131750 |
03/06/2014 |
AUTOSURE HT BLOOD GLUCOSE MONITORING SYSTEM |
APEX BIOTECHNOLOGY CORP. |
HSUE-MEI LEE |
| K140201 |
03/28/2014 |
AXERA 2 ACCESS SYSTEM |
ARSTASIS, INC. |
GRACE LI |
| K140328 |
03/10/2014 |
CMC MINI TIGHTROPE |
ARTHREX, INC. |
NANCY HOFT |
| K133865 |
03/18/2014 |
ASAHI GAIA FIRST, SECOND, THIRD |
ASAHI INTECC CO., LTD. |
CANDACE CEDERMAN |
| K131877 |
03/21/2014 |
SAVE II, SAVE II BASIC |
AUTOMEDX INC. |
PAUL DRYDEN |
| K133764 |
03/13/2014 |
CHLORASHIELD IV DRESSING WITH CHG ANTIMICROBIAL |
AVERY DENNISON BELGIE, BVBA |
LISA BARTAKOVICS |
| K132031 |
03/21/2014 |
AFINION LIPID PANEL AND AFINION LIPID PANEL CONTROL |
AXIS-SHIELD POC AS |
KARI SKINNEMOEN |
| K133663 |
03/25/2014 |
NIO COLOR 2MP |
BARCO N.V. |
|
| K133984 |
03/28/2014 |
CORONIS 5MP |
BARCO NV |
LIEVEN DE WANDEL |
| K133486 |
03/12/2014 |
STELLARIS PC VISION ENHANCEMENT SYSTEM |
BAUSCH & LOMB |
TIMOTHY W CAPEHART |
| K133608 |
03/14/2014 |
TRINIA |
BICON, LLC |
RICHARD WU |
| K133780 |
03/19/2014 |
SPEED XL |
BIOMEDICAL ENT., INC. |
JOE SOWARD |
| K132373 |
03/27/2014 |
BIOMET ACCESS SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY, MS, RAC |
| K133746 |
03/12/2014 |
POLARIS SPINAL SYSTEM |
BIOMET SPINE (AKA EBI, LLC) |
VIVIAN KELLY, MS, RAC |
| K133940 |
03/28/2014 |
OXFORD FIXED LATERAL BEARING PARTIAL KNEE REPLACEMENT (BEARINGS / TRAYS) |
BIOMET UK LTD. |
JASON HECKAMAN |
| K140318 |
03/12/2014 |
SOUNDSTAR ECO 8F GULTRASOUND CATHETER, SOUNDSTAR ECO 8F ULTRASOUND CATHETER |
BIOSENSE WEBSTER |
MARINA GUEVREKIAN |
| K140323 |
03/07/2014 |
NAVIGATOR HD URETERAL ACCESS SHEATH SETS |
BOSTON SCIENTIFIC |
NICHOLE RIEK |
| K134054 |
03/17/2014 |
BOVIE IDS-310 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, AARON A3350 HIGH FREQUENCY ELECTROSURGICAL GENERATOR |
BOVIE MEDICAL CORPORATION |
RICHARD A KOZLOFF |
| K131708 |
03/10/2014 |
BWCSH-1 SHARPS CONTAINER |
BRADFORD WRIGHT COMPANIES, INC |
MIKE DEMELLO |
| K131562 |
03/06/2014 |
BREATHE NIOV VENTILATION SYSTEM |
BREATHE TECHNOLOGIES |
CRAIG COOMBS |
| K131402 |
03/03/2014 |
VISICLEAR SMOKE EVACUATION SYSTEM |
BUFFALO FILTER CO., INC. |
CARRIE TERMIN |
| K140345 |
03/14/2014 |
THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) |
C.R. BARD, INC. |
JAMES R DAVIS |
| K130751 |
03/05/2014 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
CABIN PLASTIC CO., LTD. |
CHU XIAOAN |
| K133073 |
03/20/2014 |
CAIR DRIVE, NEUTRACLEAR |
CAIR LGL |
IRVING WIESEN |
| K133508 |
03/26/2014 |
RESOLUTIONMD MOBILE |
CALGARY SCIENTIFIC, INC. |
KYLE PETERSON |
| K133529 |
03/20/2014 |
CAMBER SPINE COVERIS CERVICAL CAGE |
CAMBER SPINE |
DANIEL A PONTECORVO |
| K134038 |
03/20/2014 |
CAMBER SPINE DIAGON OBLIQUE CAGE |
CAMBER SPINE |
DANIEL A PONTECORVO |
| K134044 |
03/31/2014 |
EP-TRACER SYSTEM, EP-TRACER SYSTEM, EP-TRACER SYSTEM |
CARDIOTEK, B.V. |
MELISSA WALKER |
| K133442 |
03/11/2014 |
BONE SUPPRESSION SOFTWARE |
CARESTREAM HEALTH, INC. |
CAROLYN WAGNER |
| K133217 |
03/19/2014 |
CIRRUS PHOTO |
CARL ZEISS MEDITEC AG |
MANDY AMBRECHT |
| K130618 |
03/03/2014 |
SFI-ANCHOR |
CENDRES & METAUX SA |
TANJA BONGNI |
| K133525 |
03/04/2014 |
LOCKING COMPRESSION BONE PLATES AND SCREW SYSTEM |
CHANGZHOU DEAN MEDICAL INSTRUMENT CO, LTD |
Diana Hong |
| K133214 |
03/07/2014 |
BLACKBIRD SPINAL SYSTEM |
CHOICE SPINE, LP |
KIM FINCH |
| K133560 |
03/28/2014 |
ITOTAL CRUCIATE RETAINING KNEE REPLACMENT SYSTEM |
CONFORMIS, INC. |
AMITA SHAH |
| K133116 |
03/28/2014 |
VIDEO EXTENDED LENGTH TRAY (PLASTIC - RADEL), VIDEO TRAY SINGLE LEVEL (PLASTIC - RADEL), VIDEO ARTHROSCOPE TRAY (PLASTIC |
CONMED CORPORATION |
NANCY GERTLAR |
| K131900 |
03/05/2014 |
CONTEC ELECTROCARDIOGRAPH |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K130981 |
03/12/2014 |
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM; S.M.A.R.T. RE-FLEX BILIARY ELF-EXPANDING STENT SYSTEM |
CORDIS CORP. |
KIM FONDA |
| K140286 |
03/07/2014 |
OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER |
CORDIS, A JOHNSON & JOHNSON CO. |
SHAMSA KARIMI |
| K133599 |
03/26/2014 |
CORGRIP |
CORPAK MEDSYSTEMS |
STEPHANIE WASIELEWSKI |
| K131258 |
03/17/2014 |
SATURN DENTAL IMPLANT |
CORTEX DENTAL IMPLANTS INDUSTRIES, LTD |
SIMHA SIBONY |
| K140064 |
03/12/2014 |
SURGISLEEVE WOUND PROTECTOR |
COVIDIEN |
MICHAEL KOCZOCIK |
| K133144 |
03/19/2014 |
SONOSURE SONOHYSTEROGRAPHY & ENDOMETRIAL SAMPLING DEVICE |
CrossBay Medical, Inc. |
CINDY DOMECUS |
| K133254 |
03/05/2014 |
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM |
CYNOSURE, INC. |
HUDA YUSUF |
| K132393 |
03/14/2014 |
CERCOM II CEMENT |
DENALI CORPORATION |
JAN G STANNARD |
| K132959 |
03/10/2014 |
DEPUY PINNACLE ALTRX ACETABULAR LINERS |
DEPUY ORTHOPAEDICS, INC. |
MEGAN BURNS |
| K133209 |
03/17/2014 |
FORESEE (4C) IMAGING SYSTEM |
DIAGNOSTIC PHOTONICS, INC |
JANICE HOGAN |
| K133410 |
03/14/2014 |
DIAZYME 25-OH VITAMIN D ASSAY; DIAZYME 25-OH VITAMIN D CONTROL SET |
DIAZYME LABORATORIES |
Abhijit Datta |
| K132759 |
03/26/2014 |
VENTRAIN |
DOLPHYS MEDICAL B.V. |
FABIENNE PETERS |
| K133786 |
03/21/2014 |
DORNOCH DUO SUCTION CART WITH: DL2800 LID, CL500 LID, DORNOCH QUAD SUCTION CART WITH: DL2800 LID, CL500 LID |
DORNOCH MEDICAL SYSTEMS, INC. |
LARRY SMITH |
| K133097 |
03/13/2014 |
E-Z LINK |
DUOJECT MEDICAL SYSTEMS, INC. |
MARIE-CHRISTINE MESSIER |
| K131971 |
03/20/2014 |
IM60/IM70 PATIENT MONITOR |
EDAN INSTRUMENTS, INC. |
CHERRY SUN |
| K131627 |
03/06/2014 |
CATHETER INTRODUCER SHEATH |
EDWARDS LIFESCIENCES, LLC. |
LUKE MEIDELL |
| K140398 |
03/19/2014 |
EMBOL-X INTRODUCER SHEATH |
EDWARDS LIFESCIENCES, LLC. |
LUKE MEIDELL |
| K140208 |
03/05/2014 |
FERM-FLEX AND FEM-FLEX II ( FEMORAL ACCESS ARTERIAL CANNULAE) FEMTRAK,VFEM, AND FEM-FLEXII |
EDWARDS LIFESCIENCES, LLC. |
LINDSAY MARTIN |
| K140107 |
03/13/2014 |
EMERGE MEDICAL DISTAL RADIUS SET |
EMERGE MEDICAL |
MEREDITH MAY |
| K140119 |
03/12/2014 |
EMERGE MEDICAL PERIARTICULAR AND LOCKING LARGE FRAGMENT SYSTEM |
EMERGE MEDICAL |
MEREDITH MAY MS, RAC |
| K140098 |
03/12/2014 |
EMERGE MEDICAL SMALL FRAGMENT LOCKED PLATING SYSTEM |
EMERGE MEDICAL |
MEREDITH MAY MS, RAC |
| K130550 |
03/24/2014 |
RSP MODULAR GLENOID BASEPLATE, GLENOID TAPER ADAPTER, RETAINING SCREW |
ENCORE MEDICAL, L.P. |
WILLIAM GARZON |
| K133734 |
03/19/2014 |
SEAL SINGLE-USE BIOPSY VALVE |
ENDOCHOICE, INC. |
JANNA BABSON |
| K130501 |
03/13/2014 |
INTENSIF |
ENDYMED MEDICAL LTD |
YORAM LEVY |
| K133104 |
03/10/2014 |
VAN HIP FRACTURE SYSTEM |
EPIX ORTHOPAEDIC, CORP. |
MICHELLE MCDONOUGH |
| K131675 |
03/12/2014 |
BODIHEALTH SYSTEM |
EPRT TECHNOLOGIES, INC. |
JEFF MORGAN |
| K133864 |
03/10/2014 |
DERMABOND PRINEO SKIN CLOSURE SYSTEM |
ETHICON, INC. |
DONNA MARSHALL |
| K133775 |
03/26/2014 |
EXSALT SD7 WOUND DRESSING WITH ADHESIVE BACKING |
EXCITON TECHNOLOGIES INC. |
MELANIE USSYK |
| K133636 |
03/28/2014 |
EXTREMITY MEDICAL HAMMERTOE DEVICE |
EXTREMITY MEDICAL, LLC. |
BRIAN SMEKAL |
| K132017 |
03/25/2014 |
HC550 RESPIRATORY HUMIDIFIER, ADULT VENTILATOR CIRCUIT |
FISHER & PAYKEL HEALTHCARE, LTD. |
ELIZABETH GOLDSTEIN |
| K140113 |
03/06/2014 |
O2 NASAL CANNULA WITH CO2 MONITORING |
FLEXICARE MEDICAL LTD. |
CHRIS WATKINS |
| K133930 |
03/27/2014 |
FLOWER REAR FOOT PLATING SET, FLOWER CALCANEUS PLANTING SET, FLOWER REARFOOT PLATING SET |
FLOWER ORTHOPEDICS CORPORATION |
GARY BARNETT |
| DEN130049 |
03/21/2014 |
SIMPLEXA HSV 1&2 DIRECT |
FOCUS DIAGNOSTICS |
SHARON YOUNG |
| K132611 |
03/06/2014 |
MICROTABLE SYSTEM |
FRED HAER COMPANY, INC. |
KERI SEITZ |
| K133972 |
03/25/2014 |
ASPIRE CRISTALLE |
FUJIFILM MEDICAL SYSTEMS, USA INC. |
PETER ALTMAN |
| K140584 |
03/31/2014 |
ICEROD CX CRYOABLATION NEEDLE |
GALIL MEDICAL LTD. |
LYNNE DAVIES |
| K133807 |
03/26/2014 |
MARS MONITOR ITC US, MARS TREATMENT KIT TYPE 1116/1 - X-MARS US, PRISMAFLEX CONTROL UNIT |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K133836 |
03/06/2014 |
OPTIGLAZE COLOR |
GC AMERICA INC. |
MARK HEISS |
| K133824 |
03/14/2014 |
CERASMART |
GC AMERICA, INC. |
MARK HEISS |
| K132944 |
03/14/2014 |
ADVANTAGESIM MD MR PELVIC ORGAN AT RISK SEGMENTATION |
GE HUNGARY KFT |
STEPHEN SLAVENS |
| K133640 |
03/25/2014 |
ASIR-V |
GE MEDICAL SYSTEMS, LLC |
HUY DOAN |
| K133657 |
03/21/2014 |
DISCOVERY PET/CT 710 |
GE MEDICAL SYSTEMS, LLC |
DAVID DUERSTELER |
| K133350 |
03/11/2014 |
REVERE STABILIZATION SYSTEM |
GLOBUS MEDICAL, INC. |
CHRISTINA KICHULA |
| K123193 |
03/03/2014 |
IPM WOUND GEL BIO |
GLYCOBIOSCIENCES, INC |
KEVIN DRIZEN |
| K133619 |
03/05/2014 |
DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM18 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K133618 |
03/05/2014 |
DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM22 SERIES |
GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED |
PATRICK CHOW |
| K133966 |
03/06/2014 |
MODEL-BASED RSA SOFTWARE |
HALIFAX BIOMEDICAL, INC. |
DANIEL KAMM |
| K133719 |
03/27/2014 |
PDE-NEO |
HAMAMATSU PHOTONICS, K.K. |
JEFFREY K SHAPIRO |
| K133252 |
03/14/2014 |
HEALTHINTERLINK BEACON |
HEALTHINTERLINK, LLC |
SUSAN D GOLDSTEIN-FALK |
| K131916 |
03/11/2014 |
BPROSOFT CASP PC SOFTWARE |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
STEPHEN GORSKI |
| K131788 |
03/04/2014 |
HEALTHSTATS A-PULSE CASPAL + AND MC3100+ MONITORS AND MY-BP BP MANAGEMENT APPLICATION SOFTWARE |
HEALTHSTATS INTERNATIONAL PTE. LTD. |
STEPHEN GORSKI |
| K131959 |
03/07/2014 |
HEINE MINI 3000(R) OPHTHALMOSCOPE |
HEINE OPTOTECHNIK GMBH & CO. KG. |
MANFRED BARTSCH-TITTMANN |
| K134016 |
03/28/2014 |
ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER |
HITACHI ALOKA MEDICAL,LTD. (HITACHI ALOKA MEDICAL |
ANGELA VANARSDALE |
| K140248 |
03/11/2014 |
S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) |
HITACHI CHEMICAL DIAGNOSTICS, INC. |
ERIKA AMMIRATI |
| K122358 |
03/11/2014 |
NOVEON |
HOGAN LOVELLS US, L.L.P. |
JANICE HOGAN |
| K132945 |
03/07/2014 |
CFN-CANNULATED FEMUR NAIL, CTN-CANNULATED TIBIA NAIL, CHN-CANNULATED HUMERAL NAIL |
I.T.S. GMBH |
AL LIPPINCOTT |
| K132572 |
03/28/2014 |
I-HIP TOTAL HIP SYSTEM |
ICONACY ORTHOPEDIC IMPLANTS, LLC |
MARC E RUHLING |
| K133196 |
03/10/2014 |
IMPACT MODEL 323 ASPIRATOR |
IMPACT INSTRUMENTATION, INC. |
ALAN GIORDANO |
| K133459 |
03/06/2014 |
ELITE IBF |
INNOVA SPINAL TECHNOLOGIES, LLC |
RICH JANSEN, PHARM. D. |
| K132244 |
03/06/2014 |
N-FORCE FIXATION SYSTEM |
INNOVISION, INC. |
MICHELLE MCDONOUGH |
| K133231 |
03/20/2014 |
DIGORA OPTIME |
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY |
TERHO TURKUMAKI |
| K133005 |
03/13/2014 |
HEMOSIL VON WILLEBRAND ACTIVITY ASSAY |
INSTRUMENTATION LABORATORY CO. |
Jacqueline Emery |
| K132250 |
03/24/2014 |
INTEGRA FREEDOM WRIST ARTHROPLASTY SYSTEM |
INTEGRA LIFE SCIENCES CORPORATION |
FREDERIC TESTA |
| K133754 |
03/06/2014 |
INTEGRA CAMINO FLEX VENTRICULAR INTRACRANIAL PRESSURE MONITORING KIT WITH FLEX ADAPTER |
INTEGRA LIFESCIENCES CORPORATION |
ELIZABETH MCMENIMAN |
| K133613 |
03/20/2014 |
INTRA-LOCK DENTAL IMPLANTS |
INTRA-LOCK INTERNATIONAL, INC. |
MARY L JEAN |
| K131861 |
03/28/2014 |
DA VINCI SURGICAL SYSTEM, ENDOWRIST INSTRUMENTS AND ACCESSORIES |
INTUITIVE SURGICAL, INC. |
BRANDON HANSEN |
| DEN130040 |
03/28/2014 |
IOGYN SYSTEM |
IOGYN, INC. |
MARY EDWARDS |
| K131433 |
03/11/2014 |
ISYS 1 (U.S),ACCESSORY, NON-STERILE |
ISYS MEDIZINTECHNIK GMBH |
CORNELIA DAMSKY |
| K133493 |
03/27/2014 |
SINGLE USE STERILE SYRINGE WITH NEEDLE |
JIANGXI KELUN MEDICAL DEVICES MANUFACTURING CO.,LT |
HELEN NAN |
| K133944 |
03/21/2014 |
RANGE, SPINAL SYSTEM, EVEREST SPINAL SYSTEM |
K2M, INC. |
NANCY GIEZEN |
| K132104 |
03/21/2014 |
ELIBRA SOFT-TISSUE FORCE SENSOR |
Kamm & Associates |
DANIEL KAMM, P.E. |
| K133232 |
03/24/2014 |
PREVENA INCISION MANAGEMENT SYSTEM WITH CUSTOMIZABLE DRESSING, PREVENA INCISION MANAGEMANT SYSTEM WITH PEEL& PLACE DRES |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
BRIAN YOUNG |
| K132123 |
03/20/2014 |
TRC-PEX, RADIC-SEALER |
KM CORPORATION |
Priscilla Chung |
| K133755 |
03/11/2014 |
KOWA SL-17 |
KOWA CO. LTD. |
HIROYUKI KOIDE |
| K133211 |
03/20/2014 |
ZIRTOUGH |
KURARAY NORITAKE DENTAL INC. |
MICHIO TAKIGAWA |
| K140485 |
03/27/2014 |
MANDREL GUIDEWIRE |
LAKE REGION MEDICAL |
MATHEW PEXA |
| K133363 |
03/07/2014 |
INTERBRIDGE INTERSPINOUS POSTERIOR FIXATION SYSTEM |
LDR SPINE, USA, INC. |
MEREDITH MAY |
| K133022 |
03/06/2014 |
ZEDVIEW |
LEXI CO., LTD. |
EDWARD A KROLL |
| K140263 |
03/05/2014 |
INSUFLOW SYNERGY PORT, INSUFLOW SYNERGY XL PORT |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K140457 |
03/25/2014 |
NAUTILUS SPINAL SYSTEM |
LIFE SPINE, INC |
RANDY LEWIS |
| K131652 |
03/21/2014 |
LZI ORAL FLUID METHAMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS |
Lin-Zhi International, Inc. |
BERNICE LIN |
| K131796 |
03/14/2014 |
MANUKA FILL WOUND DRESSING |
LINKS MEDICAL PRODUCTS, INC. |
JAMES SMITH, PH.D. |
| K132144 |
03/21/2014 |
KERATOR |
LK Consulting Group USA, Inc. |
Priscilla Chung |
| K133319 |
03/20/2014 |
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 |
LUMENIS LTD. |
IMAN KHORSHID |
| K140388 |
03/14/2014 |
LUMENIS PULSE 120H |
LUMENIS LTD. |
MERAV YARMUS |
| K132988 |
03/28/2014 |
VITAL COUGH |
LUNG ASSIST, INC. |
LEWIS WARD |
| K133958 |
03/20/2014 |
FLOW-I ANESTHESIA SYSTEM C20, C30 & C40 |
MAQUET CRITICAL CARE AB |
LIA LIEBGOLD |
| K133540 |
03/28/2014 |
FLOCAP |
MAXTEC, INC. |
PAUL DRYDEN |
| K132151 |
03/19/2014 |
SRS ENDOSCOPIC STAPLING SYSTEM |
MEDIGUS, LTD. |
JONATHAN S KAHAN |
| K132908 |
03/04/2014 |
TRUPOINT ARCH, NASION CUSHION, BITE CUP, TRUPOINT ARCH STORAGE PLATE, TRUPOINT ARCH BASE LOCK REPLACEMENT KIT |
MEDTEC, INC. |
AMANDA STAHLE |
| K133665 |
03/13/2014 |
MALLEABLE SUCTION INSTRUMENTS |
MEDTRONIC NAVIGATION, INC. |
CHARLES M COPPERBERG |
| K140276 |
03/13/2014 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K133205 |
03/13/2014 |
CAPSTONE PTC SPINAL SYSTEM, CLYDESDALE PTC SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
JULIE BASSETT |
| K140449 |
03/25/2014 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
GREGORY MASCHEK |
| K133539 |
03/26/2014 |
TOTAL ACROSS |
MEDTRONIC VASCULAR |
DIANA JOHNSON |
| K133004 |
03/27/2014 |
VENTED MILLEX -GV, CATHIVEX -GV |
MERCK MILLIPORE LTD. |
CINDY PENNY |
| K133673 |
03/25/2014 |
ILLUMIGENE PERTUSIS DNA AMPLIFICATION ASSAY, ILLUMIGENE PERTUSSIS EXTERNAL CONTROL KIT, ILLUMIPRO-10 AUTOMATED ISOTHERMA |
MERIDIAN BIOSCIENCE, INC. |
Michelle L Smith |
| K123276 |
03/10/2014 |
MM-SEAL |
MICRO-MEGA SOCIETE ANONYME |
PHILIPPE CONCHE |
| K133170 |
03/28/2014 |
QUICK JET M |
MICRON CORP. |
TAKASHI TERUI |
| K134033 |
03/31/2014 |
MIROMATRIX BIOLOGICAL MESH |
MIROMATRIX MEDICAL INC. |
STEPHEN RHODES |
| K130603 |
03/27/2014 |
PATHFAST CTNL CALIBRATORS |
MITSUBISHI CHEMICAL MEDIENCE CORPORATION |
Judi Smith |
| K131659 |
03/03/2014 |
MOERAE VEIN PREPARATION KIT |
MOERAE MATRIX, INC. |
ROBERT J CHIN |
| K133937 |
03/03/2014 |
HEARTSCAN SOFTWARE |
MORPHEUS IMAGING, INC |
JOHN AXERIO-CILIES |
| K132436 |
03/20/2014 |
VARIOGUIDE DRILL KIT |
MRI INTERVENTIONS, INC. |
E. F WADDELL |
| K133515 |
03/28/2014 |
PEEK FUSION IMPLANT |
MTP SOLUTIONS LLC |
ROBERT HOY |
| K133453 |
03/24/2014 |
IOVERA |
MYOSCIENCE INC |
BIJESH CHANDRAN |
| K131928 |
03/14/2014 |
FREND TSH (REAGENT CARTRIDGE) |
NANOEN TEK USA, INC. |
JUDITH E LOEBEL |
| K140266 |
03/05/2014 |
NMI PICC IV |
NAVILYST MEDICAL, INC. |
BRANDON M BRACKETT |
| K133408 |
03/28/2014 |
NEUROSTAR TMS THERAPY SYSTEM |
NEURONETICS |
JUDY P WAYS, PH.D. |
| K132607 |
03/21/2014 |
NS 2500 HOLMIUM LASER SYSTEM |
NEW STAR LASERS, INC. |
PAMELA M BUCKMAN, MSN |
| K131703 |
03/25/2014 |
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM |
NOVA BIOMEDICAL CORPORATION |
PAUL W MCDONALD |
| K132107 |
03/07/2014 |
MALE LATEX CONDOM |
NULATEX SDN. BHD. |
AI SIANG TEO |
| K133547 |
03/03/2014 |
NXSTAGE SYSTEM ONE WITH NXVIEW |
NXSTAGE MEDICAL, INC. |
MARY LOU STROUMBOS |
| K134026 |
03/07/2014 |
ENDOSCOPE POSITION MARKING PROBE,ENDOSCOPE POSITION DETECTING UNIT |
OLYMPUS MEDICAL SYSTEMS CORP. |
DAPHNEY GERMAIN-KOLAWOLE |
| K133381 |
03/13/2014 |
OMNI ARC MONOBLOCK HIP STEM |
OMNILIFE SCIENCE |
CHRISTINA FLORES |
| K133383 |
03/04/2014 |
HEM-7320 |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K133892 |
03/19/2014 |
IVUE 500 |
OPTOVUE, INC. |
MICHAEL J SARRASIN |
| K133386 |
03/11/2014 |
OVATION TRIBUTE HIP STEM; OVATION NARROW HIP STEM |
ORTHO DEVELOPMENT CORP. |
MIKE ENSIGN |
| K133174 |
03/28/2014 |
ORTHOSCAN FD MINI C-ARM |
ORTHOSCAN, INC. |
ADAM MENZIES |
| K133527 |
03/07/2014 |
SUFLEX PUTTY, SUFLEX HEAVY, SUFLEX MONO, SUFLEX LIGHT |
OSSTEM GERMANY GMBH |
PATRICK LIM |
| K133308 |
03/18/2014 |
TINNITUS SOUNDSUPPORT |
OTICON A/S |
SOREN JUEL WITT |
| K133544 |
03/26/2014 |
OP300 |
PALODEX GROUP OY |
TERHO TURKUMAKI |
| K140137 |
03/25/2014 |
SAFETY BIOPSY NEEDLE SYSTEM |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K133292 |
03/05/2014 |
ALLURA XPER FD; OR TABLE |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
KLIEN VAN DAM |
| K132320 |
03/26/2014 |
INTELLIVUE CL RESPIRATION POD |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
JOHANNES SCHMID |
| K133993 |
03/25/2014 |
CAAS WORKSTATION |
PIE MEDICAL IMAGING |
Florie Daniels |
| K133721 |
03/31/2014 |
INFILL 41-TLIF CONVEX OBLIQUE DEVICE, INFILL 43-TLIF CONTOUR OBLIQUE, INFILL 44-TLIF CONTOUR OBLIQUE AND THE INFILL 60 |
PINNACLE SPINE GROUP, LLC |
Rebecca K Pine |
| K133455 |
03/27/2014 |
CROSSFUSE II CORONAL TAPER, CROSSFUSE II HYPERLORDOTIC |
PIONEER SURGICAL TECHNOLOGY, INC |
EMILY DOWNS |
| K133374 |
03/19/2014 |
STREAMLINE OCT OCCIPITO-CERVICO-THORACIC SYSTEM |
PIONEER SURGICAL TECHNOLOGY, INC. (RTI SURGICAL, I |
SARAH MCINTYRE |
| K132936 |
03/04/2014 |
NOVOPORE DRESSING |
POLYNOVO BIOMATERIALS PTY LTD |
Carrie Hetrick |
| K133483 |
03/11/2014 |
PORTABLE THERAPEUTIX SQUID ACTIVE COLD COMPRESSION DEVICE AND COLD PACK FOR OTC USE |
PORTABLE THERAPEUTIX |
Sharyn Orton, Ph.D. |
| K132805 |
03/14/2014 |
BG MORSELS |
PROSIDYAN, INC |
JANICE M HOGAN |
| K134052 |
03/14/2014 |
RADIANCE 330 PROTON THERAPY SYSTEM |
ProTom International, Inc. |
JOHN J SMITH, MD, JD |
| K131848 |
03/31/2014 |
VASHE WOUND SOLUTION (4.0 OZ), (8.5 OZ & (16.0 OZ) |
PURICORE INC. |
ART MORSE |
| K133382 |
03/24/2014 |
QB TEST |
QBTECH AB |
HANS BOSTROM |
| K140029 |
03/26/2014 |
AMIPLIVUE HSV 1&2 ASSAY |
QUIDEL CORPORATION |
Ronald H Lollar |
| K140393 |
03/25/2014 |
RANDOX AMMONIA ETHANOL CONTROL LEVELS 1, 2 AND LEVEL 3 |
RANDOX LABORATORIES LIMITED |
PAULINE ARMSTRONG |
| K132002 |
03/27/2014 |
SINGLE USE SOFT TIPPED DISPOSABLE INJECTOR, RAYSERT SINGLE USE SOFT TIPPED SMALL INCISION DISPOSABLE INJECTOR |
RAYNER INTRAOCULAR LENSES LTD. |
JULIETTE E COOK |
| K140106 |
03/27/2014 |
S128 ANTERIOR LUMBAR INTERBODY FUSION (ALIF) SYSTEM |
Renovis Surgical Technologies, Inc. |
Sharyn Orton |
| K132736 |
03/11/2014 |
ACCURO 3000 ULTRASOUND SCANNER |
RIVANNA MEDICAL, LLC |
WILLIAM MAULDIN |
| K140415 |
03/26/2014 |
MONOTEX |
RIVERPOINT MEDICAL |
DOUGLAS ROWLEY |
| K140534 |
03/27/2014 |
ELECSYS PRECICONTROL TS |
Roche Diagnostics |
JANE PHILLIPS |
| K121123 |
03/10/2014 |
BIOFUSIONARY BEBE |
ROCKY MOUNTAIN BIOSYSTEMS, INC. |
AMY BENEDICT |
| K140300 |
03/26/2014 |
COLLAGEN TENDON SHEET-DDI (CTS-DDI) |
ROTATION MEDICAL, INC. |
JEFF SIMS |
| K132850 |
03/31/2014 |
BOVINE PERICARDIUM SUTURABLE DURAL GRAFT, TUTOPATCH DM GRAFT, TUTOPLAST BOVINE PERICARDIUM DM |
RTI SURGICAL, INC. |
ESTHER CARBON |
| K133210 |
03/28/2014 |
B&B BUBBLER |
S & T MEDICAL TECHNOLOGIES, INC. |
DERICK CORRENTE |
| K133893 |
03/14/2014 |
STERISPINE LC CAGE |
SAFE ORTHOPAEDICS |
PIERRE DUMOUCHEL |
| K132322 |
03/11/2014 |
NEWTRON P5 XS B.LED |
SATELEC-ACTEON GROUP |
RICK ROSATI |
| K132267 |
03/10/2014 |
NEWTRON P5, NEWTRON P5 B.LED |
SATELEC-ACTEON GROUP |
RICK ROSATI |
| K133740 |
03/05/2014 |
SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT |
SAUFLON PHARMACEUTICALS, LTD. |
CHRISTOPHER SMEJKAL |
| K133344 |
03/28/2014 |
MINICAP HB A1C, MINICAP FLEX-PIERCING, HB A1C CAPILLARYS CONTROLS, HBA1C CAPILLARYS CALIBRATORS |
SEBIA |
KAREN ANDERSON |
| K133782 |
03/21/2014 |
NOVA FA DR SYSTEM |
SEDECAL SA |
DANIEL KAMM, P.E. |
| K140099 |
03/04/2014 |
LIGHTHOUSE URINARY CATHETER |
SEEDINGS LIFE SCIENCE VENTURES, LLC |
KEN SOLOVAY |
| K131899 |
03/14/2014 |
SW-THERM |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
JIANPING KANG |
| K131210 |
03/18/2014 |
ELECTRONIC THERMOMETER |
SHENZHEN PUMP MEDICAL SYSTEM CO., LTD. |
IVY CHEN |
| K131075 |
03/28/2014 |
X-RAY TV SYSTEM SONIAL VISION G4 |
SHIMADZU CORP. |
DON KARLE |
| K133668 |
03/03/2014 |
AFT GREATER TUBEROSITY FRACTURE PLATE, LEFT, AFT GREATER TUBEROSITY FRACTURE PLATE, RIGHT, AFT GREATER TUBEROSITY CANNUL |
SHOULDER OPTIONS, INC. |
JOHN KAPITAN |
| K140267 |
03/10/2014 |
ADVIA CENTAUR TNI-ULTRA MASTER CURVE MATERIAL (MCM), ADVIA CENTAUR DIGOXIN MASTER CURVE MATERIAL (MCM) |
Siemens Healthcare Diagnostics Inc. |
FATIMA PACHECO |
| K140505 |
03/31/2014 |
ADVIA CENTAUR VITAMIN B12 MASTER CURVE MATERIAL, TOTAL HCG MASTER CURVE MATERIAL, AND TESTOSTERONE MASTER CURVE MATERIAL |
Siemens Healthcare Diagnostics Inc. |
FATIMA PACHECO |
| K140258 |
03/05/2014 |
IMMULITE 2000 DHEA-SO4; THIRD GENERATION TSH AND INTACT PTH CALIBRATION VERIFICATION MATERIAL |
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
Asha Gartland |
| K140253 |
03/20/2014 |
MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CORDELL FIELDS |
| K133401 |
03/11/2014 |
SYNO MR NEUROLOGY, SYNGO MR ONCOLOGY, SYNGO. MR BREVIS, SYNGO MMR GENERAL |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
NADIA SOOKDEO |
| K132094 |
03/11/2014 |
CIOS ALPHA |
SIEMENS MEDICAL SOLUTIONS, INC. |
DARREN DORMAN |
| K133680 |
03/26/2014 |
ENCORE SYSTEM |
SIESTA MEDICAL, INC. |
MICHAEL KOLBER |
| K131553 |
03/21/2014 |
XTRA |
SORIN GROUP DEUTSCHLAND GMBH |
BARRY SALL, RAC, FRAPS |
| K133472 |
03/04/2014 |
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL) |
SOUFLON PHARMACEUTICALS LTD |
CHRISTOPHER SMEJKAL |
| K133631 |
03/27/2014 |
LEXIPLIANT DILATOR SHEATH SET |
SPECTRANETICS CORPORATION |
STACEY A STRAND |
| K132080 |
03/12/2014 |
SNAP WOUND CARE SYSTEM |
SPIRACUR, INC. |
SARAH L CANIO |
| K140327 |
03/11/2014 |
ULTIMUM EV HEMOSTASIS INTRODUCER |
ST. JUDE MEDICAL |
LOUCINDA BJORKLUND |
| K133398 |
03/20/2014 |
STRYKER PEDIATRIC MANDIBLE DISTRACTOR |
Stryker |
Manish Patel |
| K121664 |
03/10/2014 |
T4/T5 HYTREL TOGAS |
STRYKER CORPORATION |
CASEY A METZGER |
| K133974 |
03/24/2014 |
VARIAX DISTAL RADIUS PLATING SYSTEM |
STRYKER LEIBINGER GMBH |
ELIJAH N WREH |
| DEN120019 |
03/11/2014 |
CEFALY |
STX-MED SPRL |
JEAN-YVES MIGNOLET |
| K133015 |
03/13/2014 |
INSTRU-SAFE INSTRUMENT PROTECTION SYSTEM |
SUMMIT MEDICAL, INC. |
NICOLE DOVE |
| K133028 |
03/04/2014 |
RITHM ID ELECTROPHYSIOLOGY CATHETER |
SYNAPTIC MEDICAL LIMITED |
Diana Hong |
| K131984 |
03/31/2014 |
SYNTHES SYNSONIC ULNA NAIL |
SYNTHES (USA) |
THOMAS N SHEA |
| K133593 |
03/24/2014 |
T:SLIM INSULIN DELIVERY SYSTEM |
TANDEM DIABETES CARE, INC. |
JOHN SHERIDAN |
| K131912 |
03/06/2014 |
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN |
TELEFLEX, INC. |
Amanda Webb |
| K140524 |
03/21/2014 |
TERASON USMART3200 AND BENQ UP200ULTRASOUND SYSTEM |
TERATECH CORP. |
BEN CHIAMPA |
| K133894 |
03/18/2014 |
SURFLO WINGED INFUSION SET WITH FILTER & NEEDLE PROTECTION (SURSHIELD) |
TERUMO EUROPE N.V. |
M.J. AERTS |
| K140105 |
03/18/2014 |
HEVYLITE HUMAN IGA KAPPA KIT FOR USE ON SIEMENS BNII, HEVYLITE HUMAN IGA LAMBDA KIT FOR USE ON SIEMENS BNII |
THE BINDING SITE |
Paul Kenny |
| K132078 |
03/19/2014 |
METALLIC INTRAMEDULLARY NAIL SYSTEM |
TIANJIN WALKMAN BIOMATERIAL CO., LTD. |
Diana Hong |
| K133832 |
03/13/2014 |
KLASSIC HD HIP SYSTEM, OFFSET FEMORAL STEM, NON-POROUS / POROUS |
TOTAL JOINT ORTHOPEDICS, INC. |
BEN CASEY |
| K133406 |
03/14/2014 |
CS 8100 3D |
TROPHY |
MARIE PIERRE |
| K133842 |
03/20/2014 |
TYBER MEDICAL TRAUMA SCREW |
TYBER MEDICAL LLC |
JEFF TYBER |
| K132926 |
03/05/2014 |
VELOFIXTM INTERBODY FUSION SYSTEM |
U&I CORP. |
GYEONG JE-KWON |
| K132812 |
03/06/2014 |
UCP MULTI-DRUG TEST KEY CUPS |
UCP BIOSCIENCES, INC. |
NANCY CHEN |
| K132752 |
03/13/2014 |
ULTRACONGRUENT INSERT |
UNITED ORTHOPEDIC CORPORATION |
FANG-YUAN HO |
| K140405 |
03/12/2014 |
TORRENT IRRIGATION SYSTEM |
UNITED STATES ENDOSCOPY GROUP, INC. |
CARROLL MARTIN |
| K133227 |
03/14/2014 |
SMART SEGMENTATION - KNOWLEDGE BASED CONTOURING |
VARIAN MEDICAL SYSTEMS, INC. |
PETER J CORONADO |
| K140465 |
03/20/2014 |
VIRTUOSO SYSTEM FOR IHC ER (SP1) WITH BENCHMARK ULTRA STAINER |
VENTANA MEDICAL SYSTEMS, INC. |
MORT MINAEE |
| K140153 |
03/06/2014 |
VENTRIPOINT MEDICAL SYSTEM |
VENTRIPOINT, INC. |
JIM BODTKE |
| K132698 |
03/14/2014 |
FASTOUCH FIXATION SYSTEM |
VIA SURGICAL LTD. |
LEO BASTA |
| K132714 |
03/05/2014 |
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED) |
VISION SCIENCE CO LTD |
BRET ANDRE |
| K140291 |
03/07/2014 |
VOLCANO CORE CONTROL PAD, ACCESSORY TO THE VOLCANO S5/S5I INTRAVASCULAR ULTRASOUND IMAGING & PRESSURE SYSTEMS |
VOLCANO CORPORATION |
MARCUS GARCIA |
| K133323 |
03/14/2014 |
VOLCANO IFR MODALITY |
VOLCANO CORPORATION |
NEETA SHARMA |
| K133445 |
03/05/2014 |
ANGIOVAC CANNULA |
VORTEX MEDICAL INC |
Lorraine M Hanley |
| K131760 |
03/26/2014 |
WHIP MIX PREPPIES PLUS |
WHIP-MIX CORP. |
JOHN P WATERS |
| K133125 |
03/24/2014 |
WITHINGS BLOOD PRESURE MONITOR |
WITHINGS |
JEN KE-MIN |
| K133713 |
03/07/2014 |
CHARLOTTE (TM) SNAP-OFF SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K140148 |
03/07/2014 |
PRO-TOE HAMMERTOE FIXATION SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
VAL MYLES |
| K132656 |
03/24/2014 |
PRODENSE BONE GRAFT SUBSTITUTE |
WRIGHT MEDICAL TECHNOLOGY, INC. |
LESLIE FITCH |
| K140079 |
03/25/2014 |
SILEX SACROILIAC JOINT FUSION SYSTEM |
X-SPINE SYSTEMS, INC |
DAVID KIRSCHMAN |
| K133735 |
03/21/2014 |
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS |
YUNG SHENG OPTICAL CO., LTD. |
WEN-HAN CHEN |
| K133339 |
03/04/2014 |
ZIMMER DENTAL TAPERED SCREW VENT T IMPLANT, HA COATED;ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT, HA COATED |
ZIMMER DENTAL INC. |
JULIE L CORMAN |
