FDA 510(k) Decisions During March, 2012  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K120453 03/19/2012 FILTEK BULK FILL FLOWABLE RESTORATIVE 3M ESPE DENTAL PRODUCTS SCOTT ERICKSON
K111964 03/02/2012 AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY AALTO SCIENTIFIC LTD. DESSI LYAKOV
K120568 03/29/2012 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. ARUL STERLIN
K113151 03/08/2012 IFS LASER SYSTEM ABBOTT MEDICAL OPTICS INC KESLEY E GALLAGHER
K113464 03/06/2012 NC TREK OTW CORONARY DILATATION CATHETER Abbott Vascular SUZANNE REDMAN
K120233 03/09/2012 SYNCHRONY RESPIRATORY TRACKING SYSTEM ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K120124 03/06/2012 FORESIGHT U120 URINE ANALYZER ACON LABORATORIES, INC. QIYI XIE
K112863 03/29/2012 ENTERAL ADMINISTRATION SET WITH SOLUTION CONTAINER, ENTERAL ADMINISTRATION SET, ENTERAL EXTENSION SET WITH MINITUBE CONN ACTA MEDICAL L.L.C. AARON COMPTON
K112606 03/06/2012 ACTIVATOR V-E ACTIVATOR METHODS INTERNATIONAL LTD. ARLAN W FUHR
K110662 03/12/2012 ADAPTIVE WEDGE ADAPTIVE SPECIALTY, LLC J.D. WEBB
K113365 03/29/2012 INFANT ARRAY ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS RAVI SPRINIVASAN
K112568 03/01/2012 AONGEN DENTAL COLLAGEN MATRIX AEON ASTRON EUROPE B.V. HORNG JI LAI
K112682 03/19/2012 METHA HIP SYSTEM AESCULAP IMPLANT SYSTEMS, LLC KATHY A RACOSKY
K120120 03/15/2012 AMPLATZER TORQVUE 45X45 DELIVERY SHEATH AMPLATZER TORQVUE LA1 DELIVERY SHEATH AMPLATZER TORQVUE LA2 SELIVERY SHEATH AGA MEDICAL CORPORATION RASHMI BHUSHAN
K112977 03/27/2012 MONARCH III IOL DELIVERY SYSTEM, MONARCH III C CARTRIDGE, MONARCH III HANDPIECE (H4) ALCON RESEARCH, LTD. Catherine Goble
K112538 03/29/2012 ACE CHOLESTEROL REAGENT, ACE HDL-C REAGENT, ACE LDL-C REAGENT, ACE TRIGLYCERIDES REAGENT ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. HYMAN KATZ
K113810 03/08/2012 MODIFIED ALMA LASERS HARMONY 1064NM (ND:YAG) MODULES ALMA LASERS INC. TATIANA EPSTEIN
K120060 03/16/2012 E-CUBE 9 ALPINION MEDICAL SYSTEMS CO., LTD YUCHI CHU
K113131 03/08/2012 LIASYS 450 AMS STEFANO CORRADI
K112452 03/30/2012 ANGIODYNAMICS SOFT-VU ANGIOGRAPHIC CATHETERS ANGIODYNAMICS, INC. TERI JUCKETT
K113547 03/28/2012 GAL-1E BLOOD GLUCOSE MONITORING SYSTEM GAL-1E BLOOD GLUCOSE TEST STRIPS GAL-1E MULTI BLOOD GLUCOSE MONITORING SYSTEM GAL APEX BIOTECHNOLOGY CORP. HSUE-MEI LEE
K113569 03/01/2012 APNEARX APNEA SCIENCE CORPORATION GARY MOCNIK
K111549 03/30/2012 ATTUNE SLEEP APNEA SYSTEM APNICURE, INC. CHRIS DANIEL
K120044 03/08/2012 ARTHREX UNIVERSII XL GLENOID-PEGGED, ARTHREX UNIVERS II XL GLENOID-KEELED ARTHREX, INC. COURTNEY SMITH
K120540 03/20/2012 BIOBOLT ARTHREX, INC. COURTNEY SMITH
K120096 03/27/2012 MULTIFIX P KNOTLESS FIXATION DEVICE ARTHROCARE CORPORATION CHERYL FREDERICK
K113003 03/01/2012 ATLANTIS(TM) ABUTMENT AND ATLANTIS(TM) CROWN ABUTMENT FOR KEYSTONE GENESIS IMPLANT, ATLANTIS GEMINI(TM) ABUTMENT... ASTRA TECH INC. BETSY A BROWN
K113420 03/16/2012 RNARETAIN ASURAGEN, INC. Luc Van Hove
K120273 03/30/2012 KITTYCAT CATHETER, KITTYCAT 2 CATHETER AVINGER, INC. Albert Boniske
K113838 03/12/2012 WILDCAT CATHETER AVINGER, INC. SEVRINA CIUCCI
K120660 03/15/2012 CONQUEST 40 PTA DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. ASHLEY FICKETT
K111268 03/06/2012 CONTOUR (R) NEXT BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE WEIPING ZHONG
K110894 03/28/2012 CONTOUR NEXT LINK WIRELESS BLOOD GLUCOSE METER BAYER HEALTHCARE ROGER SONNENBURG
K110587 03/28/2012 CONTOUR LINK BLOOD GLUCOSE METER, CONTOUR BLOOD GLUCOSE TEST STRIPS, CONTOUR CONTROL SOLUTION (HIGH, NORMAL, LOW) BAYER HEALTHCARE, LLC CHUCK RYAN
K111523 03/13/2012 OSTEOCOOL (TM) RF ABLATION SYSTEM BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K113558 03/16/2012 BD BACTEC PLUS AEROBIC/F (PLASTIC) Becton, Dickinson and Company Paul Swift
K112774 03/28/2012 BD RECYKLEEN SHARPS COLLECTORS Becton, Dickinson and Company EILEEN HILLER
K120049 03/23/2012 BD VERITOR SYSTEM FOR THE RAPID DETECTION OF FLU A+B Becton, Dickinson and Company Gregory P Payne
K113791 03/15/2012 B-GENIN, R-GENIN BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K103116 03/13/2012 AP-2000, AP-2010, AND AP-2020 BLOOD GLUCOSE MONITORING SYSTEM BESTGEN BIOTECH CORP. STEVEN SHEN
K113431 03/30/2012 CERAMIC PRODUCTS MADE IN YTTRIA-STABILIZED ZIRCONIA BETTINI S.P.A. Claude Berthoin
K103834 03/30/2012 BIOPLEX 2200 APLS IGG AND IGA KIT AND CALIBRATOR AND CONTROL SETS Bio-Rad Laboratories Juang Wang
K120439 03/14/2012 BIOPLEX 2200 EBV IGG AND SYPHILIS IGG BIO-RAD LABORATORIES, INC. Juang Wang
K120572 03/26/2012 BIOPLEX 2200 TORC IGG BIO-RAD LABORATORIES, INC. Juang Wang
K120504 03/27/2012 LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAK BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K113688 03/13/2012 MEGABEAM REUSABLE FIBER OPTIC DELIVERY SYSTEM BIOLITEC MEDICAL DEVICES, INC HARRY HAYES
K103081 03/02/2012 COVAORTHO-NERVE RESORBABLE COLLAGEN MEMBRANE BIOM'UP SAS VALERIE CENTIS
K120557 03/19/2012 SOLITARIE PEEK ANTERIOR SPINAL SYSTEM-TO BE CALLED COLITAIRE 35 BIOMET SPINE & BONE HEALING TECHNOLOGIES MARGARET F CROWE
K110737 03/29/2012 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM GM700 BIONIME CORPORATION JIGAR SHAH
K113822 03/08/2012 QUADRASPHERE 30 TO 60 BIOSPHERE MEDICAL, INC. LINDA J VARROSO
K113832 03/06/2012 SONICEYE ULTRASOUND TRANSDUCER BLACKTOE MEDICAL III, INC. KENDRA RATHKEY
K111820 03/14/2012 SYNSTER CERVICAL CAGE, ALIF CAGE, PLIF CAGE, PTLIF CAGE, TLIF CAGE BM KOREA CO., LTD. Priscilla Chung
K120893 03/29/2012 IMAGER II ANGIOGRAPHIC CATHETERS BOSTON SCIENTIFIC CORP. ANNE V ROSSI
K113220 03/22/2012 EMERGE PTCA DILATATION CATHETER (MONORAIL) EMERGE PTCA DILATATION CATHETER (OVER-THE-WIRE) Boston Scientific Corporation VICKY L HAGENS
K113090 03/15/2012 LEVEEN SUPERSLIM NEEDLE ELECTRODE Boston Scientific Corporation ASHLEY PYLE
K113866 03/23/2012 PORCINE DERMAL XENOGRAFTS PORCINE DERMAL MATRIX BRENNEN MEDICAL, LLC KENNETH B HERLAND
K113811 03/16/2012 V2.6 SOFTWARE FOR THE LABSYSTEM PRO EP RECORDING SYSTEM C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION ANASTASIA C RANDALL
K113808 03/19/2012 THE SHERLOCK 3CG TIP CONFIRMATION SYSTEM (TCS) C.R. BARD, INC. HENRY BOLAND
K113854 03/19/2012 PLEURX PERITONEAL CATHETER SYSTEM CAREFUSION JOY GREIDANUS
K112052 03/15/2012 CAREFUSION NICOLET EDX CAREFUSION 209, INC. ROBERT BURDGE
K110535 03/26/2012 ALARIS PC UNIT MODULE 8000 WITH SOFTWARE CORRECTION CAREFUSION 303,INC. GABRIELA MURANEVICI
K111423 03/02/2012 CS 1600 INTRAORAL CAMERA CARESTREAM HEALTH,INC. DANIEL HOEFER
K120154 03/21/2012 INTRAUTERINE INSEMINATION (IUI) CATHETER CATHETER RESEARCH, INC. BABACAR DIOUF
K111841 03/01/2012 SHIFENG DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE CHENGDU XINJIN SHIFENG MED APPRATUS INST CO., LTD XINGLONG TIAN
K111501 03/23/2012 I-LIPO SYSTEM CHROMOGENEX TECHNOLOGIES LIMITED PETER R BEVAN
K113168 03/30/2012 DAILIES TOTAL DALIES TOTAL FOR ASTIGMATISM DAILIES TOTAL MULTIFOCAL DAILIES TOTAL MULTIFOCAL TORIC CIBA VISION CORPORATION ALICIA M PLESNARSKI
K113387 03/15/2012 CITIEFFE TITANIUM NAILING SYSTEM CITIEFFE Claude Berthoin
K113618 03/19/2012 CLEARCORRECT SYSTEM CLEARCORRECT, INC. CHERYL FISHER
K112268 03/19/2012 CODAN SAFEFEED ENTERAL FEEDING RESERVOIR CODAN US CORP. JEFF NIELSEN
K120274 03/02/2012 DELTAMAXX 18 MICROCOIL SYSTEM CODMAN AND SHURTLEFF, INC. KIM FONDA
K112404 03/15/2012 CONCENTRIC BALLOON GUIDE CATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K113260 03/09/2012 MODIFIED CONCENTIRC MICROCATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K113058 03/29/2012 TIGER SPINE SYSTEM CORELINK LLC JUSTIN EGGLETON
K112077 03/09/2012 HBIDB - HUMAN BRIAN INDEX SOFTWARE CORSCIENCE GMBH & CO. KG PATRIK R KAREM
K113372 03/07/2012 NUVANT, MOBILC CARDIAC TELEMETRY CORVENTIS, INC. KATHLEEN LUNDBERG
K111933 03/15/2012 COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 COVIDIEN Jean Simon
K120061 03/27/2012 WOUND PROTECTOR COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H JOSEPH CANAVAN
K113255 03/07/2012 PUREGRAFT 850/PURE SYSTEM CYTORI THERAPEUTICS, INC. KENNETH K KLEINHENZ
K103329 03/13/2012 DIATRUE PLUS BLOOD GLUCOSE MONITORING SYSTEM; DIATRUE PLUS BLOOD GLUCOSE TEST STRIP; DIATRUE GLUCOSE CONTROL SOLUTION DELBIO INCORPORATION NICKY PAN
K112547 03/06/2012 NEO NEST DENOVO PROUCTS LLC DALE WALTERS
K111663 03/12/2012 TRAUMA INTERNAL FIXATION SYSTEMS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K112411 03/20/2012 MAMMOTOME ELITE BIOPSY SYSTEM DEVICOR MEDICAL PRODUCTS INC. SHAWNA M ROSE
K112755 03/27/2012 ABACUS 5 DIATRON US INC MICHAEL SWITZER
K111664 03/30/2012 DIAZYME CYSTATIN C POC TEST KIT DIAZYME LABORATORIES Abhijit Datta
K113324 03/28/2012 REXIOUS HOOK FIXATION SYSTEMS DIO MEDICAL CO., LTD. APRIL LEE
K111947 03/01/2012 DUET MAGNA DIREX SYSTEMS CORP. LARISA GERSHTEIN
K103035 03/28/2012 SMARTPILOT VIEW MODEL MK04500 DRAEGER MEDICAL GMBH JOYCE KILROY
K113798 03/22/2012 INFINITY ACUTE CARE SYSTEM, INFINITY MCABLE- MASIMO RAINBOW SET Draeger Medical Systems, Inc. BETH A ZIS
K113095 03/02/2012 E-CARE INFRARED EAR THERMOMETER E-CARE TECHNOLOGY CORPORATION KIN-YUAN KO
K120188 03/16/2012 ELECTROCARDIOGRAPH EDAN INSTRUMENTS INC YUE QIUHONG
K113478 03/05/2012 PLIF CAGE EISERTECH, LLC LUKAS EISERMANN
K113784 03/02/2012 3MP MONOCHROME LCD MONITOR, RADIFORCE GX340 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K113695 03/28/2012 ELLIPSE PRECICE TRAUMA NAIL SYSTEM ELLIPSE TECHNOLOGIES, INC. JOHN MCLNTYRE
K113756 03/14/2012 HIGHLY CROSS LINKED VE CENTRAL PEG PATELLA HIGHLY CROSS LINKED VE TRI-PEG PATELLA HIGHLY CROSS LINKED VE METAL BACKED PA ENCORE MEDICAL, L.P. TEFFANY HUTTO
K113475 03/20/2012 ESTECH COBRA ADHERE XL 2 SURGICAL SYSTEM ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH TAMER IBRAHIM
K112663 03/12/2012 ENHATCH ORTHOPAEDICS PATIENT/TECHNIQUE-SPECIFIC HUMERAL ENHATCH ORTHOPAEDICS LLC MICHAEL PHIPPS
K113243 03/28/2012 EM50 SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. Cynthia Hung
K111541 03/16/2012 ENDO-EXPRESS (R) HANDPIECE ESSENTIAL DENTAL SYSTEMS, INC. JEFFREY WAN
K113320 03/16/2012 NOVATION ELEMENT FEMORAL STEM, 12/14 COLLARLESS STANDARD/HIGH OFFSET HA COATED PRESS-FIT, SZ 8-12 EXACTECH, INC. VLADISLAVA ZAITSEVA
K111702 03/22/2012 AMICUS SEPARATOR SYSTEM- USE IN THERAPEUTIC PLASMA EXCHANGE AND FILTER SET FOR AMICUS TPE FENWAL, INC. Kim Forch
K110019 03/30/2012 RESPIRATORY HUMIDIFER FISHER & PAYKEL HEALTHCARE, LTD. ADELE BINDON
K120304 03/01/2012 FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER FOOTPRINT MEDICAL INC. CLYDE BAKER
K113702 03/28/2012 FOTONA XP ND: YAG LASER SYSTEM FOTONA D.D. STOJAN TROST
K120505 03/06/2012 FRESENIUS 2008T HEMODIALYSIS MACHINE FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE DENISE OPPERMANN
K111703 03/29/2012 INFRARED EAR THEROMETER FUDAKANG INDUSTRIAL CO LTD DANIEL NAM
K111654 03/01/2012 FD TENS 2070 FUJI DYNAMICS LTD CHING KONG (FELIX) LEE
K113284 03/07/2012 BIOPSY POSITIONER FUJI FILM MEDICAL SYSTEMS KIMERLY A SHARP
K113750 03/05/2012 DISPOSABLE POWDER FREE VINYL EXAM GLOVE, WHITE COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113749 03/15/2012 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES, WITH ALOE VERA, GREEN COLOR FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113797 03/02/2012 DISPOSABLE VINYL EXAM GLOVE, POWDER FREE FULL SYNERGY MEDICAL PRODUCTS INC ELIZABETH DENG
K113790 03/06/2012 DISPOSABLE VINYL EXAM GLOVE, POWDERED FULL SYNERGY MEDICAL PRODUCTS INC ELIZABTEH DENG
K113860 03/12/2012 VISUAL-ICE CRYOABLATION SYSTEM GALIL MEDICAL INC. AMY MCKINNEY
K120778 03/27/2012 BRIVO MR355 GE HANGWEI MEDICAL SYSTEMS CO., LTD. RUOQIAN LIU
K120221 03/30/2012 GE ECHOPAC GE HEALTHCARE BRYAN BEHN
K113265 03/22/2012 GENII GI 4000 ELECTROSUGICAL GENERATOR GENII, INC. JULIE POWELL
K120101 03/27/2012 INDEPENDENCE SPACER GLOBUS MEDICAL INC. MERIAM YOUSSEF
K110745 03/02/2012 HELICOBACTER PYLORI ELISA IGG TEST KIT GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K113624 03/12/2012 WONDFO BUPRENORPHINE URINE TEST WONDFO OXYCODONE URINE TEST Guangzhou Wondfo Biotech Co., Ltd. Joe Shia
K113238 03/01/2012 FULL AUTOMATIC (NIBP) BLOOD PRESSUE MONITOR HEALTH & LIFE CO., LTD. SARAH SU
K113239 03/16/2012 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR (MODEL HL168KF) HEALTH & LIFE CO., LTD. SARAH SU
K102900 03/21/2012 HEITER 3000 HYPERTHERMIC PERFUSION SYSTEM HEI, INC. GREGORY MATHISON
K113575 03/07/2012 HILLA DIGITAL TRANSFERS HILLA TECHNOLOGIES, INC. CAROLYN M PRIMUS
K112392 03/19/2012 HIVOX BIOTEK INC. HIVOX BIOTEK, INC. JEN KE-MIN
K113356 03/06/2012 HOLOGIC VISCERAL FAT SOFTWARE HOLOGIC, INC. EILEEN M BOYLE
K120593 03/23/2012 MYOSURE CONTROL UNIT HOLOGIC, INC. SARAH FAIRFIELD
K120358 03/06/2012 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) HONGXIN PLASTIC PRODUCTS CO., LTD CHU XIAOAN
K110901 03/05/2012 SYMBIQ INFUSION AND ADMINSTRATION SET HOSPIRA, INC. Ray Silkaitis
K111426 03/01/2012 EUCLID (TM) TIER 1-GW ACCESS SYSTEM HOUSTON MEDICAL ROBOTICS DARLA J ELKIN
K120578 03/29/2012 ACCOLADE II HIP STEM HOWMEDICA OSTEONICS VALERIE GIAMBANCO
K120602 03/23/2012 APACERAM BONE GRAFT SUBSTITUTE HOYA CORPORATION PATSY J TRISLER
K112422 03/28/2012 CRAG LATERAL FLOW ASSAY (LFA) IMMUNO-MYCOLOGICS, INC. SEAN K BAUMAN
K112702 03/29/2012 IMPERIAL SURGICAL LTD. BLANKEY AND SOLUTION WARNING CABINETS IMPERIAL SURGICAL LTD. KATHRYN RONALDS
K113748 03/23/2012 IMRIS MR/X-RAY HEAD FIXATION DEVICE (HFD) IMRIS, INC. Sanjay Shah
K120373 03/16/2012 INSORB ABSORBALBE STAPLE INCISIVE SURGICAL, INC. DAVID HERRIDGE
K120005 03/29/2012 ACDS ISOPURE CORP. KEVIN GILLESPIE
K113357 03/21/2012 POSEY BED J. T. POSEY CO. BONNIE BISHOP
K112950 03/28/2012 JIANGSU HEALTHY WAY MECHANICL WHEELCHAIR JIANGSU HEALTHY MEDICAL EQUIPMENT CO;LTD JEN KE-MIN
K112948 03/28/2012 JIANGSU HEALTHY WAY MECHANICAL WHEELCHAIR JIANGSU HEALTHY WAY MEDICAL EQUIPMENT CO;LTD JEN KE-MIN
K120526 03/08/2012 YUYUE K2 WHEELCHAIR, YUYUE K4 WHEELCHAIR JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. NED DEVINE
K112351 03/30/2012 ULTRA BEAUTY JOHARI DIGITAL HEALTHCARE, LTD. POOJA JOHARI
K120031 03/16/2012 CHESAPEAKE SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K113247 03/27/2012 ANESTHESIA INJECTION TOOL SET KI WORKS CO., LTD. EILEEN YANG
K113423 03/09/2012 KIMBERLY CLARK PURPLE NITRILE, AND PURPLE NITRILE XTRA POWDER FREE EXAM GLOVE KIMBERLY-CLARK CORP. LESTER F PADILLA
K112064 03/23/2012 RESORB X-G KLS-MARTIN L.P. JENNIFER DAMATO
K120538 03/23/2012 PALLS M SPINAL SYSTEM KOREA BONE BANK CO., LTD APRIL LEE
K120379 03/30/2012 PANAVIA SA CEMENT AUTOMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT AUTOMIX (UNIVERSAL (A2), WHITE) PANAVIA S KURARAY MEDICAL INC. MICHIO TAKIGAWA
K120378 03/30/2012 PANAVIA SA CEMENT HANDMIX VALUE PACK (UNIVERSAL (A2), WHITE) PANAVIA SA CEMENT HANDMIX (UNIVERSAL (A2), WHITE) PANAVIA S KURARAY MEDICAL INC. MICHIO TAKIGAWA
K120270 03/26/2012 VENUS SPINAL FIXATION SYSTEM L&K BIOMED CO., LTD HEE KYEONG JOO
K120399 03/09/2012 LANX SPINAL FIXATION SYSTEM LANX, LLC MICHAEL FUNK
K102189 03/14/2012 POWDER FREE NITRLE EXAMINATION GLOVES WITH CHEMOTHERAPY LABELING CLAIM LATEXX MANUFACTURING SDN.BHD. NEIL BURRIS
K113264 03/02/2012 ELECTRO SENSOR COMPLEX SOFTWARE (ES COMPLEX SOFTWARE) LD TECHNOLOGY LLC ABBERT MAAREK
K113157 03/13/2012 AILERON INTERSPINOUS FIXATION SYSTEM LIFE SPINE RANDY LEWIS
K110761 03/09/2012 MICT TSH MAGNABIOSCIENCES, LLC JAMES L WYATT
K112507 03/01/2012 RESTORIS PARTIAL KNEE APPLICATION (PKA), RIO STANDARD SYSTEM MAKO SURGICAL CORPORATION DIONNE SANDERS
K112078 03/19/2012 ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) MARUCHI Priscilla Chung
K111558 03/27/2012 SURGICASE GUIDE MATERIALISE N.V. Alexandra Razzhivina
K113232 03/01/2012 MAXMIXING BLOCK MAXTEC, INC. TAMMY LAVERY
K113686 03/06/2012 KIMONO MICROTHIN WITH AQUA LUBE, REALITY ULTRA LUBRICATED MAYER LABORATORIES, INC. DAVID P MAYER
K113515 03/16/2012 HORIZON CARDIOLOGY ECG MANAGEMENT MCKESSON ISRAEL LTD. TOMER LEVY
K111058 03/30/2012 URETRON MODEL URT MED-SONICS CORP WILLIAM A STOLL
K113304 03/23/2012 BLADDER SCANNER MEDA CO. LTD. KAI CHEN
K113487 03/09/2012 HEMO-CATH 10F, HEMO-CATH 12.5F MEDICAL COMPONENTS INC JEAN CALLOW
K112648 03/13/2012 ASFORA BULLET CAGE MEDICAL DESIGNS, LLC KRISTI VONDRA
K112769 03/01/2012 CURAD COMPRESSION HOSIERY MEDLINE, INDUSTRIES, INC. MATT CLAUSEN
K120088 03/29/2012 MCOMPASS ANORECTAL MANOMETRY SYSTEM MEDSPIRA, LLC JIM QUACKENBUSH
K120206 03/29/2012 MEDTRONIC MINIMED PARADIGM INSULIN PUMPS MEDTRONIC MINIMED TAMAR JAGHASBANIAN
K120484 03/27/2012 VISIA ONCOLOGY MEVIS MEDICAL SOLUTIONS AG THOMAS E TYNES
K113455 03/02/2012 SOLITAIRE FR REVASCULARIZATION DEVICE MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR Laura Heaton
K120630 03/28/2012 AZUR DETACHABLE 18 MICRO VENTION, INC. CYNTHIA VALENZUELA
K120608 03/15/2012 ENDOSCOPIC APPLICATOR MICROMEDICS, INC. LISE W DURAN
K120563 03/30/2012 KEYPATH MRSA/MSSA BLOOD CULTURE TEST-BT MICROPHAGE, INC. DREW SMITH
K113655 03/05/2012 TI-MAX X TURBINE NAKANISHI, INC. DIANE RUTHERFORD
K113712 03/15/2012 IM-11 PNEUMATIC MICROINJECTOR NARISHIGE CO., LTD. MITSUKO YONEYAMA
K113474 03/16/2012 1.5T GEM FLEX COIL NEOCOIL, LLC STEVEN NICHOLS
K113733 03/23/2012 SMALL AND LARGE FRAGMENTS OSTEOSYNTHESIS SYSTEM NEOFIX NEOORTHO PRODUTOS ORTOPEDICOS S/A KEVIN A THOMAS
K120380 03/09/2012 SATURN 8000 NEW MEDICAL CO., LTD. JUN-HSIUNG LIN
K103623 03/20/2012 NEWDEAL INTERPHALANGEAL IMPLANT NEWDEAL SAS MARILYSE LATOUR
K113117 03/22/2012 NIHON KOHDEN EEG-1200A WITH JE-120A MULTI CHANNEL ELECTRODE JUNCTION BOX NIHON KOHDEN AMERICA, INC. STEVE GEERDES
K120485 03/16/2012 NIHON KOHDEN QP-160 AK TREND PROGRAM WITH THE ADDITION OF DSA ASYMMETRY TREND AND FFT P NIHON KOHDEN AMERICA, INC. STEVE GEERDES
K112969 03/14/2012 AIR-BAG SYSTEM NIIGATA MECHATRONICS CO., LTD. TOSHIYA NIMONJI
K113429 03/12/2012 SAFETOUCH PSV WINGED INFUSION SET, AND SET WITH FILTER NIPRO MEDICAL CORPORATION JESSICA OSWALD
K113763 03/16/2012 SRM-STITCH 8F SRM-STITCH 8F WITH GUIDEWIRE NOBLES MEDICAL TECHNOLOGIES II, INC. MARIA HATEGAN
K112638 03/09/2012 NOVA MAX ONE BLOOD GLUCOSE MONITOR, NOVA MAX ONE BLOOD GLUCOSE TEST STRIPS NOVA BIOMEDICAL CORPORATION PAUL W MACDONALD
K112561 03/13/2012 NUVASIVE COROENT NO-PROFILE SYSTEM NUVASIVE, INC. Sheila Bruschi
K112718 03/16/2012 NUVASIVE NVM5 SYSTEM NUVASIVE, INC. Elias Ketchum
K113788 03/16/2012 DEFLEX ACRILATO NUXEN S.R.L. HERNAN ILARI
K112133 03/01/2012 OASYS SURGICAL LIGHT CONTROLLER OASYS HEALTHCARE TANYA M O'BRIEN
K110337 03/16/2012 UNIVERSAL MAXILLARY MOLAR OCO BIOMEDICAL JACK BLOOM
K111756 03/20/2012 V1 SYSTEM OLYMPUS MEDICAL SYSTEMS CORP. STACY ABBATIELLO KLUESNER
K110690 03/28/2012 ONE PERSONAL LUBRICANT (SILICONE) ONE SHARON PIETILA
K120115 03/14/2012 ORTHOSIZE ORTHOSIZE LLC YARMELA PAVLOVIC
K120738 03/29/2012 FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM OSTIAL CORPORATION KAITLIN VON HOFFMANN
K113594 03/02/2012 C-THV SYSTEM PAIEON, INC. EREZ BEN-ZVI
K113188 03/01/2012 SONOLONG SONO, CURL SONO, NANOLINE, BRAND NAMES CARRYINGSONO/SONOLONG PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G QUASS
K113037 03/01/2012 PAIN-AID PDI WORKS, LLC. THU-HA DUNCAN
K113082 03/08/2012 SONOVISION PERIDOT TECHNOLOGIES NY INC OMAR BARLAS
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