FDA 510(k) Decisions During March, 2014  

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
K080644 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
K133621 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 GLOBE 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 AMERICA) ANGELA VANARSDALE
K140248 03/11/2014 S TEST REAGENT CARTRIDGE CARBON DIOXIDE (CO2) HITACHI CHEMICAL DIAGNOSTICS, INC. ERIKA AMMIRATI
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
K132695 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.,LTD 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, INC.) 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
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