510kDecisions.com

FDA 510(k) Decisions During January, 2013  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K132712 11/19/2013 AFFINITY CP CENTRIFUGAL BLOOD PUMP WITH OR WITHOUT COATING, AFFINITY CP ADAPTER MEDTRONIC INC. LISA STONE
K122914 01/09/2013 AFFINITY FUSION CARDIOTOMY/VENOUS RESERVIOR WITH BALANCE BIOSURFACE MODEL BB841, AFFINITY FUSION CARDIOTOMY/ VENOUS RESE MEDTRONIC INC. JULIA A NELSON
K123314 01/22/2013 AFFINITY FUSION OXYGENATOR WITH INTEGRATED ARTERIAL FILTER AND CARMEDA BIOACTIVE SURFACE MEDTRONIC INC. MARY E DONLIN
K131782 11/18/2013 LOQTEQ HIGH TIBIA OSTEOTOMY PLATE 4.5 AAP IMPLANTATE AG CHRISTIAN ZIETSCH
K131753 11/14/2013 MERIDIAN AB ARDENT DONNA MARIE HARTNETT
K123372 01/14/2013 ABBOTT LIPID MULTI CONSTITUENT CALIBRATOR ABBOTT LABORATORIES LINDA MORRIS
K123279 01/30/2013 MINI TREK RX CORONARY DILATATION CATHETER (INCLUDING 1.20 MM SIZE), MINI TREK OTW CORONARY DILATATION CATHETER (INCLUDIN ABBOTT VASCULAR SUZANNE REDMAN
K123067 01/29/2013 PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY ABBOTT VASCULAR INC. SEAN MULLIN
K123349 01/29/2013 A-SCAN PLUS CONNECT ACCUTOME, INC. ADAM PICKHOLTZ
K131383 11/27/2013 X10 HEADSET WITH X-SERIES BASIC SOFTWARE, X24 HEADSET WITH X-SERIES BASIC SOFTWARE ADVANCED BRAIN MONITORING INC. ADRIENNE LENZ
K130013 01/31/2013 X4 SYSTEM ADVANCED BRAIN MONITORING INC. ADRIENNE LENZ
K123048 01/11/2013 PATIENT MONITOR MODELS PM-2000A, PM-2000A+, PM-2000A PRO ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K132561 11/05/2013 NURO NEUROMODULATION SYSTEM ADVANCED URO-SOLUTIONS, INC. PENNY NORTHCUTT
K121991 01/07/2013 ENTEROCOCCUS QUICKFISH BC ADVANDX, INC. BENJAMIN S CRYSTAL
K123102 01/03/2013 SOVEREIGN MINI AESCULAP, INC. DENISE ADAMS
K132821 11/20/2013 AGAMATRIX HEALTH MANAGER AGAMATRIX INC WILLIAM H MCGRAIL
K112728 01/23/2013 HEPAIRX VENTILATING AIR PURIFIER AIR INNOVATIONS, INC. LAWRENCE WETZEL
K131165 11/14/2013 ANKER DENTAL IMPLANT SYSTEM ALLIANCE GLOBAL YAYUAN CHANG
K132687 11/27/2013 E-CUBE 7 ALPINION MEDICAL SYSTEMS CO., LTD DONGHWAN KIM
K130845 11/01/2013 AMBU ASCOPE 3 5.0/2.2; AMBU ASCOPE 3 SLIM 3.8/1.2; AMBU AVIEW AMBU A/S SANJAY PARIKH
K132655 11/20/2013 RETROARC RETROPUBIC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. RENEE MELLUM
K131904 11/13/2013 MEDIQA SINGLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SANITIZATION, MEDIQA DOUBLE PASS REVERSE OSMOSIS SYSTEM WITH HEAT SA AMERIWATER BRIAN R BOWMAN
K122685 01/11/2013 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. KIMBERLEY KLINE
K130730 11/22/2013 V-STICK VASCULAR ACCESS SET ARGON MEDICAL JENNIFER BONACCI
K122854 01/04/2013 ARROW GLIDETHRU PEEL-AWAY SHEATH/DILATOR INTRODUCER ARROW INTERNATIONAL(SUBSIDIARY OF TELEFLEX INC.) JULIE LAWSON
K123759 01/03/2013 CG+ ARROW PICC POWERED BY ARROW VPS STYLET ARROW INTERNATIONAL, INC. (SUBSIDIARY OF TELEFLEX, INC.) ELIZABETH DUNCAN
K123135 01/28/2013 AXERA 2 ACCESS SYSTEM MODEL AXE200 ARSTASIS, INC. DEBRA COGAN
K132217 11/25/2013 ARTHREX COMPRESSION FT SCREWS ARTHREX, INC. COURTNEY SMITH
K131377 11/19/2013 HEMICAP MTP RESURFACING HEMI-ARTHROPLASTY IMPLANT ARTHROSURFACE, INC. DAWN J WILSON
K122483 01/03/2013 PEARL DIABETES MANAGEMENT SYSTEM ASANTE SOLUTIONS, INC. ROBIN BUSH
K121261 01/08/2013 ASAP MUITISCOPE ASAP ENDOSCOPIC PRODUCTS GMBH ANGELIKA SCHERP
K123760 01/28/2013 MULTIPLE NAME ASSURGUARD SDN. BHD. LIM HUI GUAN
K121810 01/23/2013 OSSEOSPEED ANGLED ABUTMENT EV ASTRA TECH AB LINDA K SCHULZ
K130514 11/21/2013 AUDIFON ARRIVA CIC, IS, IS+, M, S, S+, X TRT, AUDIFON VICO, AUDIFON PRADO, AUDIFON ELIA, CIC, IS, IS+, M, S TRT AUDIFON-USA INC. JANE E PERRONE
K121964 01/23/2013 MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML AUGMENIX , INC. ERIC ANKERUD
K133091 11/27/2013 ZIP MIS INTERSPINOUS FUSION SYSTEM AURORA SPINE JUSTIN EGGLETON
K123874 01/10/2013 INTERLINK SYSTEM BURETROL SOLUTION SETS, INTERLINK SYSTEM BURETROL SOLUTION SETS, CONTINUED, CLEARLINK SYSTEM BURETROL S BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K123868 01/08/2013 INTERLINK SYSTEM LEVER LOCK CANNULA WITH CHECK VALVE, SECONDARY MEDICATION SETS, SOLUTION SETS, CONTINU-FLO SOLUTION SET BAXTER HEALTHCARE CORP. GARY CHUMBIMUNE
K122926 01/24/2013 SUREFLEX STEERABLE GUIDING SHEATH KIT BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K133008 11/20/2013 BNX DELIVERY SYSTEM PRE-LOADED WITH 19, 22 AND 25 GAUGE NEEDLE, 19, 22 OR 25 GAUGE NEEDLES (INDIVIDUALLY STERILE-PACKED, BEACON ENDOSCOPIC ANNETTE M FAGNANT
K123300 01/18/2013 BD PEN NEEDLE BECTON DICKINSON & CO. PASQUALE AMATO
K123213 01/09/2013 BD PHASEAL CLOSED SYSTEM TRANSFER DEVICE BECTON DICKINSON & CO. JOHN ROBERTS
K133138 11/13/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B BECTON DICKINSON & CO. GREGORY P PAYNE
K133140 11/15/2013 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF RSV BECTON DICKINSON & CO. GREGORY P PAYNE
K123734 01/17/2013 BD NEXIVA DIFFUSICS CLOSED IV CATHETER SYSTEM BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. KIMBERLY GEISLER
K132456 11/07/2013 BD VERITOR (TM) SYSTEM FOR RAPID DETECTION OF RSV BECTON, DICKINSON AND COMPANY GREGORY P PAYNE, RAC
K132102 11/12/2013 BECE CAD ZIRKON HT+ BEGO BREMER GOLDSCHLAEGEREI WILH. HERBST GMBH & CO HEIKE GUSTKE
K131423 11/07/2013 G-ARM MULTISCAN SYSTEM BEIJING EAST WHALE IMAGING TECHNOLOGY CO., LTD. BETTER LI
K122995 01/22/2013 INTENSE PULSED LIGHT (IPL) SYSTEMS BEIJING KES BIOLOGY TECHNOLOGY CO., LTD. DIANA HONG
K131519 11/06/2013 BELMONT HYPERTHERMIA PUMP BELMONT INSTRUMENT CORP. SABRINA BELLADUE
K122704 01/09/2013 BEST LOCALIZATION NEEDLE WITH I-125 SEED BEST MEDICAL INTL. DHARMENDRA THAKUR
K123775 01/31/2013 LIQUICHEK SPINAL FLUID CONTROL LEVEL 1, LIQUICHEK SPINAL FLUID CONTROL LEVEL 2, LIQUICHEK SPINAL FLUID CONTROL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K123798 01/09/2013 LIQUIDCHEK DIABETES CONTROL; LEVEL 1, LEVEL 2, LEVEL 3, TRILEVEL MINIPAK BIO-RAD LABORATORIES SUZANNE PARSONS
K121461 01/22/2013 BACT/ALERT FA PLUS CULTURE BOTTLE BIOMERIEUX, INC. JOCELYN JENNINGS
K121455 01/25/2013 BACT/ALERT FN PLUS CULTURE BOTTLE BIOMERIEUX, INC. PATRICIA MURPHY
K121446 01/25/2013 BACT/ALERT PF PLUS CULTURE BOTTLE BIOMERIEUX, INC. ELIZABETH LANDON
K132507 11/15/2013 VITEK 2 AST ST MEROPENEM BIOMERIEUX, INC. NATHAN HARDESTY
K122300 01/30/2013 T3 DENTAL IMPLANT BIOMET 3I TAMARA WEST
K132898 11/19/2013 A.L.P.S. CALCANEAL PLATING SYSTEM BIOMET MANUFACTURING CORP. JARED COOPER
K130322 11/15/2013 SPM-300 BIONET CO., LTD. MARC GOODMAN
K123008 01/25/2013 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 GE GE200 BLOOD GLUCOSE MONITORING SYSTEM RIGHTEST BLOOD GLUCOSE MONITORIN BIONIME CORPORATION JIGAR SHAH
K123966 01/25/2013 GLUCOSE METER-CHECK SOLUTION FOR BAYER BIONOSTICS, INC. RANDY BYRD
K122237 01/03/2013 BIOPHOTAS LIFELIGHT BIOPHOTAS, INC. SHEPARD G BENTLEY, RAC
K130777 11/25/2013 INBODY BIOSPACE CORPORATION LIMITED DANIEL KAMM, P.E.
K123324 01/11/2013 SELECTRA 7F CATHETERS BIOTRONIK, INC. JON BRUMBAUGH
K120464 01/18/2013 INNESIS PEEK CAGE BK MEDITECH CO., LTD. SHIN KUK YOO
K123535 01/15/2013 ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP. LORI R SMITH
K133208 11/14/2013 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. MAUREEN SUNDEEN
K131700 11/04/2013 SENSATION SHORT THROW, CAPTIFLEX, CAPTIVATOR, CAPTIVATOR II, PROFILE, SINGLE-USE POLYPECTOMY SNARES BOSTON SCIENTIFIC CORP. JANIS F TARANTO
K122288 01/07/2013 BRAINSWAY DEEP TMS SYSTEM BRAINSWAY, LTD AHAVA STEIN
K122752 01/30/2013 FASTECT II PPX DRUG SCREEN DIPSTICK, FASTECT II DRUG SCREEN DIPSTICK, QUICKTOX DRUG SCREEN DIPCARD BRANAN MEDICAL CORP. OLIVIA CHAN
K130831 11/21/2013 MALDI BIOTYPER CA (MBT-CA) SYSTEM BRUKER DALTONICS, INC FRAN WHITE
K130101 11/08/2013 BYTECH BYTECH DONGTAI CO., LTD. CHU XIAOAN
K123718 01/22/2013 PERMASORB DISPOSABLE FIXATION DEVICE C.R. BARD INC RADHIKA PONDICHERRY
K123911 01/10/2013 SENOMARK ULTRA BREAST TISSUE MARKER C.R. BARD, INC. SARAH MCCARTNEY
K131689 11/20/2013 MRI MARKER C4 IMAGING LLC STEPHEN J GOLDNER, JD, RAC
K121254 01/11/2013 CAMBER SPINE TECHNOLOGIES TLS 5.0 INERBODY CAGE CAMBER SPINE TECHNOLOGIES DAN PONTECORVO
K123857 01/23/2013 DURABLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K122696 01/31/2013 POWDER-FREE NITRILE EXAMINATION GLOVES (COOL BLUE) CARDINAL HEALTH, INC. TATYANA BOGDAN
K133399 11/22/2013 DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM CARDIOVASCULAR SYSTEMS INCORPORATED BLAIR BUTH
K122400 11/05/2013 CARDIOX FLOW DETECTION SYSTEM CARDIOX CORP. KAREN MATIS
K122873 01/15/2013 VASOPOUSE DEEP VEIN THROMBOSIS COMPRESSION DEVICE MODEL IPCS, MODEL SQS CAREMED SUPPLY, INC. MICHAEL LEE
K123967 01/22/2013 CATHETER CONNECTIONS' DARK BLUE DUALCAP FOR MALE LUERS CATHETER CONNECTIONS, INC. DONALD D SOLOMON
K123258 01/31/2013 THE ADVANCE CATHETER FOR HSG AND SIS CATHETER RESEARCH, INC. BABACAR DIOUF
K123905 01/14/2013 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT-PCR DIAGNOSTIC PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM, PHARM. D
K122490 11/13/2013 KULAVAC CGBIO CO., LTD JUNGEUN IM
K133357 11/25/2013 CHARRUAPACS SYSTEM CHARRUASOFT SA CARL ALLETTO
K121587 11/22/2013 BREATH SHAKE CHEEN HOUNG ENT. CO. LTD. PAUL DRYDEN
K123946 01/17/2013 WARMAIR MODEL 135 HYPERTHERMIA SYSTEM INCLUDING FILTEREDFLO BLANKETS CINCINNATI SUB-ZERO PRODUCTS, INC STEVEN J BERKE
K130853 11/13/2013 IDYS(TM) C CLARIANCE JANICE M HOGAN
K132799 11/07/2013 CLARISO PACS CLARISO, INC. CARL ALLETTO
K132085 11/12/2013 ONE STEP HCG TEST STRIP, ONE STEP HCG TEST CASSETTE, ONE STEP HCG TEST MIDSTREAM CO-INNOVATION BIOTECH CO., LTD. HONG FENG
K123752 01/14/2013 ACCULIF TL AND PL CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K123281 01/23/2013 ACCULIF TL-PEEK CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K131240 11/07/2013 COCHLEAR BAHA IMPLANT SYSTEM, COCHLEAR BAHA ATTRACT COCHLEAR AMERICAS SEAN BUNDY
K123560 01/25/2013 VASCULAR OCCLUSION SYSTEM (TRUFILL PUSHABLE COILS), AND TRUFILL DCS ORBIT DETACHABLE COIL SYSEM CODMAN & SHURTLEFF, INC. RICHARD KIMURA
K100695 01/03/2013 COLLADENTAL BARRIER COLLAMATRIX, INC DENNIS J. N. SEAH
K121621 01/08/2013 SOLOCEM COLTENE/WHALEDENT AG SILKE WALLASCHEK
K122870 01/14/2013 ITOTAL CRUCIATE RETAINING (CR) KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K131998 11/26/2013 ASPIRE RX-LP6 ASPIRATION CATHETER CONTROL MEDICAL TECHNOLOGY, LLC SHAWN FOJTIK
K102689 01/17/2013 CONVENTUS ORTHOPAEDICS FRACTURE FIXATION SYSTEM CONVENTUS ORTHOPAEDICS HOLLACE S RHODES
K132307 11/05/2013 VIDA LED SURGICAL LIGHTING SYSTEM CONVIDA HEALTHCARE & SYSTEMS CORPORATION RYAN HUNG
K123712 01/03/2013 RETRACTA DETACHABLE EMBOLIZATION COIL COOK INCORPORATED JENNIFER RICHARDSON
K132504 11/25/2013 TIGER OCCIPITAL-CERVICAL-THORACIC SPINAL FIXATION SYSTEM CORELINK LLC JUSTIN EGGLETON
K132567 11/05/2013 ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER SINGLE LUMEN, ARGYLE PERIPHERALLY INSERTED CENTRAL CATHETER DUAL LUMEN COVIDIEN DOLLY MISTRY
K123196 01/31/2013 PALINDROME PRECISION H CHRONIC CATHETER, PALINDROME PRECISION SI CHRONIC CATHETER, PALINDROME PRECISION HSI CHRONIC CATH COVIDIEN JENNIFER SULLIVAN
K130357 11/06/2013 SUPERDIMENSION TRIPLE-NEEDLE CYTOLOGY BRUSH COVIDIEN LLC KRISTEN SWANSON
K123444 01/30/2013 LIGASURE IMPACT CURVED, LARGE JAW, OPEN SEALER / DIVIDER COVIDIEN, FORMERLY VALLEYLAB, A DIVISION OF TYCO HEALTHCARE DAWN TINDALL
K122585 01/17/2013 CRUX VENA CAVA FILTER SYSTEM CRUX BIOMEDICAL ELISA HEBB
K122172 01/25/2013 SYSTEM 83 PLUS CUSTOM ULTRASONICS FRANK J WEBER
K132795 11/26/2013 CYBERWAND STERILE PROBE SET CYBERSONICS, INC. LORI COLVIN
K131850 11/15/2013 TENSYN BAND DALLEN MEDICAL, INC. AL MEMMOLO
K130135 11/25/2013 DANA REUSABLE BI TEST PACK DANA PRODUCTS, INC. HARRY BALA
K131839 11/07/2013 DC 7 DC INTERNATIONAL, LLC DAVID BOEGLER
K113787 01/04/2013 DDU-120 FULLY AUTOMATIC EXTERNAL DEFIBRILLATOR AND ACCESSORIES DEFIBTECH, LLC ED HORTON
K123849 01/10/2013 NEW COMFORT-FIT DENTAL GUARD DENTEK ORAL CARE, INC. LINDA GILES
K132241 11/05/2013 GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY, GRYPHON BR ANCHOR W/ PROKNOT TECHNOLOGY - HIP, GRYPHON PEEK ANCHOR W/ PROKNOT T DEPUY MITEK, A JOHNSON & JOHNSON COMPANY YAYORI FUJIMAKI
K121929 01/17/2013 ZEPHYR 'X-SERIES" PATIENT TRANSFER SLED DIACOR, INC. KEVIN ANDERSON
K121944 01/01/2013 LIAISON DIRECT RENIN LIAISON CONTROL DIRECT RENIN LIAISON ENDOCRINOLOGY DILUENT DIASORIN, INC. MARI MEYER
K132515 11/08/2013 LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS DIASORIN, INC. CAROL A DEPOUW
K122793 01/25/2013 LIAISON TESTOSTERONE; LIAISON TESTOSTERONE CONTROL SET DIASORIN, INC. JOHN ESKDALE
K112120 01/24/2013 DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET DIAZYME LABORATORIES ABHIJIT DATTA
K123408 01/15/2013 ERGO IMAGING SYSTEM DIGIRAD CORP. MATTHEW OLOW
K131302 11/26/2013 SOLAX DONGGUAN PRESTIGE SPORTING GOODS CO., LTD. JUNNATA CHANG
K122768 01/18/2013 GENESIS DORNIER MEDTECH AMERICA, INC. JOHN J SMITH
K132443 11/22/2013 PIEZON 150 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA NOLTE
K122922 01/10/2013 E-BEAM ND: YAG LASER ECLIPSE AESTHETICS, LLC TOM OBRIEN
K131819 11/22/2013 PC ECG EDAN INSTRUMENTS, INC. QUEENA CHEN
K122125 01/25/2013 ASA LASER SH1 EL.EN. ELECTRONIC ENGINEERING SPA PAOLO PERUZZI
K122336 01/09/2013 Q-FIX SUTURE ANCHOR, 1.8MM Q-FIX ACCESS TOOLS (DRILL GUIDE W/OBTURATOR, DRILL BIT) 1.8MM ELEVEN BLADE SOLUTIONS, INC. MICHAEL KOLBER
K123038 01/16/2013 SWISS LITHOBREAKER EMS ELECTRO MEDICAL SYSTEMS SA SUZANNE GOODMAN
K122383 01/10/2013 EM3 AEM MONITOR AEM CONNECTORS ENCISION, INC. JIM LEWIS
K123982 01/23/2013 TURON GLENOID PEGGED, E+, TURON KEELED GLENOID, E+ ENCORE MEDICAL, L.P. MICHAELA NORRIS
K123223 01/10/2013 EC SINGLE USE, POLYPECTOMY SNARE ENDOCHOICE, INC. SHOSHANA FRIEDMAN
K122290 01/23/2013 ENVITEC MYSIGN O OXYGEN MEASURING DEVICE ENVITEC-WISMAR GMBH STEPHEN GORSKI
K123237 01/25/2013 ZERONA 2.0 LASER ERCHONIA CORPORATION KEVIN WALLS
K132231 11/27/2013 MYLABSEVEN, MYLABALPHA ESAOTE, S.P.A. ALLISON SCOTT
K113375 01/25/2013 ESWALLOW USA ELECTRODE,ESWALLOW USA LEADWIRE ESWALLOW USA WILLIAM INGRAM
K122797 01/25/2013 ENSEAL G2 ARTICULATING TISSUE SEALERS, STRAIGHT JAW, ENSEAL G2 ARTICULATING TISSUE SEALERS, CURVED JAW ETHICON ENDO-SURGERY, LLC EMILY KRUETZKAMP
K131298 11/26/2013 EXACTECH EQUINOXE RESURFACING HUMERAL HEAD SYSTEM EXACTECH, INC. SHING JEN TAI, PHD
K121392 01/16/2013 NOVATION CROWN CUP LINERS; NEUTRAL, LIPPED, +5MM LATERALIZED, +5/10 DEGREE EXACTECH, INC. LINDY KNISELY
K123342 01/10/2013 OPTETRAK LOGIC CRC TIBIAL INSERT EXACTECH, INC. PATRICK HUGHES
K113516 01/04/2013 THERASOM-CAST FAMILY DENTAL SERVICES, P.C. DEANNA L BAXAM
K121975 01/03/2013 AIRVO HUMIDIFIER MYAIRO HUMIDIFIER FISHER & PAYKEL HEALTHCARE, LTD. BRETT WHISTON
K133102 11/18/2013 FLOWER ANKLE PLATING SET FLOWER ORTHOPEDICS CORPORATION JANICE M HOGAN
K121860 01/25/2013 ESA615 FLUKE BIOMEDICAL JOHN NELSON
K121706 01/14/2013 FORA V10 BLOOD GLUCOSE MONITORING SYSTEM FORA CARE INC. PINJUNG CHEN
K121206 01/10/2013 DETECT FORUM ENGINEERING TECHNOLOGIES LTD YULIYA YUKEVICH
K112880 01/31/2013 CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE FREEDOM MEDITECH, INC. CRAIG H MISRACH
K121421 01/17/2013 FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE COLLEEN DURRAN
K123566 01/22/2013 SYNAPSE 3D COLON ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., INC. JYH-SHYAN LIN
K132509 11/25/2013 FDR D-EVO FLAT PANEL DETECTOR SYSTEM FUJIFILM MEDICAL SYSTEMS USA, INC. KATHERINE Y CHOI
K133134 11/04/2013 X-PORTE ULTRASOUND SYSTEM FUJIFILM SONOSITE,INC. SCOTT PAULSON
K123612 01/17/2013 FDI GLUCOSE CONTROL SOLUTION FOR USE WITH ACCU-CHEK AVIVA FUJIREBIO DIAGNOSTICS, INC. KENT PRUETT
K130759 11/09/2013 HUMELOCK II CEMENTLESS SHOULDER SYSTEM FX SOLUTIONS JEAN-JACQUES MARTIN
K113816 01/30/2013 GC AADVA ABUTMENT- ZIRCONIUM-BO AC BH SV GC AMERICA, INC. CARL H JENKINS
K123417 01/17/2013 BRIVO MR355, OPTIMA MR360 GE HANGWEI MEDICAL SYSTEMS CO., LTD. RUOQIAN LIU
K122457 01/02/2013 GE INNOVA/INNOVA IGS/DISCOVERY IGS/OPTIMA ANGIOGRAPHIC, FLUOSCOPIC X-RAY SYSTEMS WITH CATHLAB FRONTIERS SOLUTIONS GE HEALTHCARE MALCA
K132913 11/08/2013 VOLUSON E6 / E8 / E8EXPERT / E8EXPERT LIMITED EDITION / E10 GE HEALTHCARE BRYAN BEHN
K132376 11/15/2013 DISCOVERY MR750 3.0T, DISCOVERY MR450 1.5T, DISCOVERY MR750W 3.0T, OPTIMA MR450W 1.5T GE HEALTHCARE (GE MEDICAL SYSTEMS, LLC) MICHELLE HUETTNER
K123327 01/11/2013 1.5T GEM RT OPEN ARRAY GE HEALTHCARE COILS (USA INSTRUMENTS INC.) ANDREW MENDEN
K121762 01/18/2013 CARDIAC VX GE MEDICAL SYSTEMS, LLC MICHELLE HUETTNER
K132261 11/18/2013 DISCOVERY XR656 WITH VOLUMERAD (DIGITAL TOMOSYNTHESIS) GE MEDICAL SYSTEMS, LLC JOHN L SCHMIDT
K123894 01/29/2013 GE ECHOPAC GE VINGMED ULTRASOUND AS BRYAN BEHN
K123838 01/16/2013 PRO HMPV+ ASSAY GEN-PROBE PRODESSE, INC. KAREN HARRINGTON
K123274 01/16/2013 PROGASTRO SSCS ASSAY GEN-PROBE PRODESSE, INC. KAREN HARRINGTON
K122062 01/09/2013 APTIMA TRICHOMONAS VAGINALIS ASSAY - PANTHER GEN-PROBE, INC. MARIA CARMELITA S BALUYOT
K132822 11/26/2013 BD MAX STAPHSR ASSAY, INSTRUMENT GENEOHM SCIENCES CANADA, INC. (BD DIAGNOSTICS) PATRICIA DIONNE
K123090 11/22/2013 GLB BENECHECK PREMIUM GLU MONITORING SYSTEM GENERAL LIFE BIOTECHNOLOGY CO., LTD. FENG-YU LEE
K131142 11/27/2013 GENESIS LED WANDS GENESIS BIOSYSTEMS, INC. JIM LAFFERTY
K130419 11/06/2013 PAPAYA PLUS, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM GENORAY CO., LTD. JAE KIM
K123731 01/04/2013 BIOTENE ORAL BALANCE GEL, BIOTENE DRY MOUTH ORAL RINSE, BIOTENE MOISTURIZING MOUTH SPRAY GLAXOSMITHKLINE CONSUMER HEALTHCARE (GSKCH) PAUL KRUMM
K132191 11/22/2013 SP-FIX SPINOUS PROCESS FIXATION PLATE GLOBE MEDICAL, INC. CHRISTINA KICHULA
K123231 01/18/2013 CALIBER SPACERS GLOBUS MEDICAL INC. CHRISTINA KICHULA
K122687 01/10/2013 BLOOD CULTURE HOLDER GREINER BIO-ONE NORTH AMERICA, INC. JUDI SMITH
K130997 11/15/2013 NEOVEIL GUNZE LIMITED NOBUYA ONISHI
K122438 11/20/2013 HAMILTON-MR1 HAMILTON MEDICAL AG RALPH AGUILA
K132006 11/07/2013 STERILE NITRILE POWDER FREE EXAMINATION GLOVE(VBLU), STERLE NITRILE POWDER FREE EXAMINATION GLOVE(ABLU) HARTALEGA SDN BHD NURUL AISYAH KONG
K132883 11/01/2013 HEMODIA ARTHROSCOPY PUMP TUBE SETS (HATS) HEMODIA S.A.S. REMI TEULIERE
K123828 01/18/2013 PROSOUND F75 DIAGNOSTIC ULTRASOUND SYSTEM HITACHI ALOKA MEDICAL, LTD. ANGELA VAN ARSDALE
K123873 01/29/2013 CONTRAST ENHANCED DIGITAL MAMMOGRAPHY HOLOGIC, INC. DEBORAH THOMAS
K122408 01/17/2013 POWDER FREE NITRILE EXAMINATION GLOVES (BLACK, WHITE, GREEN) HONGYE PLASTIC PRODUCTS CO., LTD. KATHY LIU
K132276 11/12/2013 STERILE EMPTY GLASS CONTAINER, 250ML, STERILE EMPTY GLASS CONTAINER, 500 ML, STERILE EMPTY GLASS CONTAINER, 1000 ML HOSPIRA, INC. ABIGAIL FERGUSON
K121108 01/03/2013 DOPPLEX ABILITY HUNTLEIGH HEALTHCARE DAVID MOYNHAM
K132288 11/22/2013 CARESENS N VOICE MULTI BLOOD GLUCOSE MONITORING SYSTEM, CARESENS N VOICE MULTI BLOOD GLUCOSE METER I-SENS, INC. CHAE YUN LIM
K131629 11/26/2013 NEURODYN MULTIWAVE, AUSSIE SPORT IBRAMED EQUIPAMENTOS MEDICOS LILIAN LLULL
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K122576 01/11/2013 TRANSFORM OCCLUSION BALLOON CATHETER (COMPLIANT AND SUPER COMPLIANT STRYKER NEUROVASCULAR JAMES LEATHLEY
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K123334 01/24/2013 REPROCESSED STEERABLE INTRODUCER STRYKER SUSTAINABILITY SOLUTIONS, INC. AMANDA BABCOCK
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K130426 11/19/2013 SUMITOMO PROTON THERAPY SYSTEM SUMITOMO HEAVY INDUSTRIES, LTD RONALD S WARREN
K123110 01/17/2013 PRETZELFLEX SURGICAL RETRACTOR MODEL SHR7301 SURGICAL INNOVATIONS PLC TRACEY FEARNLEY
K123877 01/02/2013 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE, VARIABLE LOOP DESIGN SURGICAL SPECIALTIES CORP. DBA ANGIOTECH KIRSTEN STOWELL
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K123917 01/25/2013 DECLIPSESPECT VIEWER SURGICEYE GMBH MORITZ HOYER
K122708 01/14/2013 REMESENSE FOR SENSITIVE TEETH SYLPHAR N.V. ROGER GRAY
K123845 01/10/2013 ME SYNERON BEAUTY LTD. JANICE M HOGAN
K123180 01/08/2013 FALCON SPACER SYNTHES (USA) PRODUCTS LLC MONIKA MCDOLE-RUSSELL
K121592 01/18/2013 POWDER FREE BLUE NITRILE EXAMINATION GLOVE TESTED WITH CHEMOTHERAPY DRUGS TEKMEDIC (M) SDN BHD PATRICK LEONG
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K132544 11/25/2013 TOMTEC-ARENA 1.0, TOMTEC-ARENA 3D ECHO, CARDIO-ARENA TOMTEC IMAGING SYSTEMS, GMBH CHRISTINE KLEIN
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K123644 01/11/2013 VIZION + DR VIZTEK LLC DANIEL KAMM, P.E.
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K122396 01/31/2013 POWERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) WEALTH ON (JIANGSU) CO., LTD CHARLES SHEN
K132808 11/20/2013 VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR WELCH ALLYN, INC. KEVIN CROSSEN
K120603 01/29/2013 VARILIFT -C WENZEL SPINE SOURABH MISHRA
K131387 11/20/2013 WRIGHT GRADIENT 52 - TORSO WRIGHT THERAPY PRODUCTS, INC CAROL WRIGHT
K130212 11/20/2013 SAFETY HYPODERMIC NEEDLES WITH/WITHOUT SYRINGE WUXI YUSHOU MEDICAL APPLICANCES CO., LTD GARFIELD WANG
K130230 11/20/2013 STERILE PISTON HYPODERMIC SYRINGES (WITH/WITHOUT NEEDLE), HYPODERMIC NEEDLES WUXI YUSHOU MEDICAL APPLICANCES CO., LTD GARFIELD WANG
K123438 01/10/2013 XENX STONE MANAGEMENT DEVICE XENOLITH MEDICAL OFER ZIGMAN
K130978 11/06/2013 ZTX ULTRASONIC DIATHERMY DEVICE ZETROZ INC GEORGE K LEWIS, JR.
K123781 01/09/2013 TRANSTEK GLASS BODY FAT ANALYZER ZHONGSHAN TRANSTEK ELECTRONICS CO., LTD. LEO WANG
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