FDA 510(k) Applications Received During March, 2012

FDA 510(k) Number Submission Date Device Name Applicant Contact
K120808 03/16/2012 EXPORT XT CATHETER, EXPORT AP CATHETER MEDTRONIC INC. ANU GAUR
K120704 03/08/2012 3M LITTMANN TELESTETH ONLINE AUSCULATION SYSTEM 3M COMPANY JON PLATT
K120662 03/05/2012 PICCOLO HDL-CAPILLARY TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K120664 03/05/2012 PICCOLO TRGLYCERIDES-CAPILLARY TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K120730 03/09/2012 LOUTREX TOPICAL CREAM ACELLA PHARMACEUTICALS, LLC LARA NOAH
K120903 03/26/2012 CONGRUENT BONE PLATE SYSTEM: ACU-LOC 2 PLATE ACUMED LLC BRITTANY CUNNINGHAM
K120631 03/02/2012 PATIENT MONITOR ADVANCED INSTRUMENTS, INC. JORGE MILLAN
K120939 03/29/2012 AERONEB PRO AEROGEN LTD MARTHA FOLAN
K120955 03/30/2012 COLUMBUS TOTAL KNEE SYSTEM AS COLUMBUS REVISION KNEE SYSTEM ENDURO KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, LLC KATHY A RACOSKY
K120889 03/23/2012 AESKUSLIDES ANA HEP-2 AESKU DIAGNOSTICS HELENE PAXTON
K120732 03/09/2012 LENSSX LASER SYSTEM ALCON LENSX, INC. JUDY GORDON
K120912 03/26/2012 INFINITI(R) VISION SYSTEM ALCON MANUFACTURING, LTD. MARTIN A KAUFMAN
K120870 03/22/2012 GREENLIGHT MOXY FIBER OPTIC AMERICAN MEDICAL SYSTEMS DOREEN NAKAMURA
K120836 03/30/2012 0.9% SODIUM CHLORIDE FLISH SYRINGE AMUSA KAREN THOMISON
K120896 03/26/2012 WI-FI BODY SCALE ANDON HEALTH CO., LTD LIU YI
K120672 03/05/2012 KD-936 FULLY AUTOMATIC WIRELESS BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD THOMAS BECZE
K120813 03/22/2012 BLOOD GLUCOSE MONITORING SYSTEM ANDON MEDICAL CO., LTD YI LIU
K120805 03/16/2012 PROTEUS PTA BALLOON CATHETER WITH EMBOLIC CAPTURE FEATURE ANGIOSLIDE, LTD CLAY ANSELMO
K120827 03/19/2012 QUILL PDO KNOTLESS TISSUE-CLOSURE DEVICE (POLYDIXANONE) ANGIOTECH KIRSTEN STOWELL
K120649 03/02/2012 AUTOSURE VOICE 3 PLUS BLOOD GLUCOSE MONITORING SYSTEM APEX BIO TECHNOLOGY CORP LISA LIU
K120620 03/01/2012 CLEAN AND BOOST APEX DENTAL MATERIALS, INC. CHRIS KULTON
K120969 03/30/2012 AC LENS BRANDED CONTACT LENS CASE ARLINGTON CONTACT LENS SERVICES,INC. CHRISTIAN SMITH
K120791 03/15/2012 AMBIENT TURBOFLASH 90 IFS ARTHOCARE CORPORATION CHERYL FREDERICK
K120943 03/29/2012 SPEEDLOCK HIP KNOTLESS FIXATION IMPLANT SPEEDLOCK HIP DRILL SPEEDLOCK HIP GUIDE CROWN TIP SPEEDLOCK HIP PATHFINDER ARTHROCARE CORPORATION CHERYL FREDRICK
K120701 03/07/2012 M2 WRIST MRI SYSTEM ASPECT IMAGING LTD AHAVA STEIN
K120937 03/28/2012 SUNFLOWER WARNER ATOM MEDICAL CORPORATION PAUL DRYDEN
K120875 03/22/2012 B&W DENTAL IMPLANT SYSTEM B&W SRL PRIYA BHUTANI
K120882 03/23/2012 SITE RITE PREVUE ULTRASOUND SYSTEM AND PINPOINT NEEDLE GUIDE BARD ACCESS SYSTEMS, INC. HENRY BOLAND
K120660 03/05/2012 CONQUEST 40 PTA DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. ASHLEY FICKETT
K120722 03/09/2012 RIVAL PTA DILATATION CATHETER BARD PERIPHERAL VASCULAR, INC. MARK JOB
K120771 03/14/2012 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM BECKMAN COULTER, INC. ERIC GRACE
K120959 03/30/2012 BIOPLEX 2200 HSV-1 AND HSV-2 IGG KIT BIO-RAD LABORATORIES JUANG WANG
K120776 03/14/2012 ABUTMENT FOR COMPETITIVE IMPLANT NOBEL ACTIVE CONNECTION BIOMET 3I TAMARA WEST
K120853 03/21/2012 NESS L300 SYSTEM KIT, LEFT, NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, RIGHT, SMALL NESS L300 SYSTEM KIT, BIONESS, INC. KIM TOMPKINS
K120694 03/07/2012 ENCORE 26 ADVANTAGE KIT BOSTON SCIENTIFIC CORP. ADRIENNE HOTCHKISS
K120893 03/23/2012 IMAGER II ANGIOGRAPHIC CATHETERS BOSTON SCIENTIFIC CORP. ANNE V ROSSI
K120789 03/15/2012 EXACTRAC X-RAY X-RAY BRAINLAB AG ALEXANDER SCHWIERSCH
K120881 03/23/2012 MANTARAY GUIDEWIRES BRIDGEPOINT MEDICAL JILL MUNSINGER
K120668 03/05/2012 SENTINEL C-RAD POSITIONING AB JANINA OSTLING
K120728 03/09/2012 PHASIX PLUG AND PATCH C.R. BARD INC SHERMA WINSTON
K120926 03/27/2012 ENDOBEAM HOLMIUM LASER FIBERS C.R. BARD, INC. TERRI MORRIS
K120785 03/15/2012 OMNI 3 OXYGEN SYSTEM CAIRE, INC. BRIAN JARRELL
K120746 03/12/2012 DISPOSABLE POWDER FREE VINYL EXAM GLOVES CANOPUS MEDICAL SUPPLY CO., LTD. GLORIA CHANG
K120798 03/15/2012 DISPOSABLE POWER FREE VINYL EXAM GLOVE, PINK COLOR CANOPUS MEDICAL SUPPLY CO., LTD. GLORIA CHANG
K120658 03/05/2012 DURABLUE STERILIZATION WRAP CARDINAL HEALTH 200, LLC LAVENIA FORD
K120934 03/28/2012 PROTEXIS LATEX BASIC STERILE LATEX POWDER-FREE SURGICAL GLOVE WITH PROTEIN CONTENT LABEL CLAIM OF 50 UG/DM OR LESS CARDINAL HEALTH, INC. TATYANA BOGDAN
K120830 03/19/2012 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL INC TANYA EBERLE
DEN120012 03/12/2012 CDC DENV-1-4 REAL TIME RT-PCT ASSAY CENTERS FOR DISEASE CONTROL AND PREVENTION HYE-JOO KIM
K120819 03/19/2012 STALIF C CENTINEL SPINE, INC. JOHN PARRY
K120911 03/26/2012 XPERT FLU GENEXPERT DX SYSTEMS (GX-I, GX-IV) CEPHEID KERRY J FLOM
K120801 03/16/2012 CHISON DIAGNOSTIC ULTRASOUND SYSTEM CHISON MEDICAL IMAGING CO., LTD. BOB LEIKER
K120706 03/08/2012 NIRVANA A PERSONAL LUBRICANT CHURCH & DWIGHT CO., INC. EMILY PEREZ
K120751 03/12/2012 NIRVANA B PERSONAL LUBRICANT CHURCH & DWIGHT CO., INC. EMILY PEREZ
K120804 03/16/2012 CIANNA MEDICAL TISSUE MARKER AND DELIVERY SYSTEM CIANNA MEDICAL GARY MOCNIK
K120708 03/08/2012 ONETOUCH VERIO SYNC BLOOD GLUCOSE MONITORING SYSTEM CILAG GMBH INTERNATIONAL NADINE NASR
K120757 03/13/2012 SLEEPWEAVER ELAN NASAL CPAP MASK CIRCADIANCE LLC DAVID GROLL
K120900 03/26/2012 I-STAT PT CONTROL LEVIEL 1 I-STAT PT CONTROL LEVEL 2 CLINIQA CORPORATION DAWN GAST
K120686 03/06/2012 ORBIT GALAXY G2 MICROCOIL DELIVERY SYSTEM CODMAN & SHURTLEFF, INC. KIM FONDA
K120892 03/23/2012 DISPOSABLE 330PSI EXTENSION LINES COEUR, INC. DEBRA F MANNING
K120828 03/19/2012 BIATAIN SILICONE AG FOAM DRESSING - ADHESIVE: 3X3 INCHES, 4X4 INCHES, & 5X5 INCHES COLOPLAST A/S REBEKA STOLTMAN
K120851 03/21/2012 COMMUNIFY PACS VIEWER COMMUNIFY HEALTH, LLC CHRIS RELYEA
K120961 03/30/2012 TREVO RETRIEVER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K120941 03/29/2012 CONSTANT CARE LILAH HOME HEALTH MONITORING SYSTEM CONSTANT CARE, LLC SETH A MAILHOT
K120696 03/07/2012 TIGER SPINE SYSTEM CORELINK LLC J.D. WEBB
K120924 03/27/2012 BENCOX MIRABO CUP BENCOX MIRABO INSERT (STANDARD& ELEVATED TYES) BENCOX MIRABO CUP SCREW HOLE PLUG CORENTEC CO., LTD J.S. DANIEL
K120834 03/19/2012 CORPATH 200 SYSTEM CORINDUS INC. MONA ADVANI
K120671 03/05/2012 DIGITAL PACIFIER THERMOMETER (MODEL NO.: TM-03) COTRONIC TECHNOLOGY LIMITED TANI MOK
K120944 03/29/2012 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN JENNIFER SULLIVAN
K120674 03/05/2012 MAHURKAR ELITE ACUTE DUAL LUMEN CATHETER, ELITE ACUTE TRIPLE LUMEN CATHETER COVIDIEN WING NG
K120773 03/14/2012 NELLCOR BEDSIDE SPO2 PATIENT MONITORING SYSTEM COVIDIEN LLC CHARLIE MACK
K120863 03/22/2012 WHOLEY GUIDE WIRE SYSTEM COVIDIEN LLC DAVID RBERTSON
K120861 03/22/2012 FIN-S MICROIMPLANT CREEKSIDE ORTHODONTICS JOHN T KALANGE
K120663 03/05/2012 MONOCLONAL RABBIT ANTI-HUMAN ESTROGEN RECEPTOR (ER) A, CLONE EPI DAKO NORTH AMERICA, INC. XIAOLEI XU
K120868 03/22/2012 MEGA(TM) 7.5FR. 30CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MEGA(TM) 7.5FR. 40CC INTRA-AORTIC BALLOON CATHETER DATASCOPE CORP., CARDIAC ASSIST DIVISION HELDER A SOUSA
K120866 03/22/2012 DA01 BLOOD GLUCOSE MONITORING SYSTEM DELBIO INCORPORATION NICKY PAN
K120695 03/07/2012 DENTIST IN A BOX DENTAL EMERGENCY KIT PLUS TOOTH TRAUMA CARE KIT DENTIST IN A BOX PTY. LTD JOHN BANKY
K120642 03/02/2012 RESUSCITAIRE WITH AUTOBREATH DRAEGER MEDICAL SYSTEMS, INC. GALE WINARSKY
K120835 03/20/2012 DYNATRON THERMOSTIM PROBE-DONE DYNATRONICS CORPORATION DOUGLAS SAMPSON
K120780 03/14/2012 EDWARD PROPLEGE PERIPHERAL RETROGRADE CARDIOPLEGIA DEVICE EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K120624 03/01/2012 ELCAM DISPOSABLE INTEGRATED PRESSURE TRANSDUCER (DIPT) ELEAM MEDICAL A.C.A.L AHARON COHEN
K120811 03/16/2012 LEKSELL GAMMA KNIFE PERFEXION ELEKTA INSTRUMENT AB VIVEKA WRETMAN
K120862 03/22/2012 WATER BOTTLE CAP IRRIGATON SYSTEM ENDOCHOICE, INC. THERON GOBER
K120962 03/30/2012 PATHASSIST LIGHT FIBER ENTELLUS MEDICAL, INC. GARRETT P AHLBORG
K120735 03/09/2012 PATHASSIT LIGHT SEEKER ENTELLUS MEDICAL, INC. GARRETT P AHLBORG
K120721 03/08/2012 EOS EOS IMAGING JOHN J SMITH
K120748 03/12/2012 SPEEDUP SOFTWARE OPTION ESAOTE, S.P.A. ALLISON SCOTT, RAC
K120729 03/09/2012 HARONIS ACE LAPAROSCOPIC 5MM DIAMETER SHEARS 36CM LENGTH +ADAPTIVE TISSUE TECHNOLOGY HARMONIC ACE 5MM DIAMETER SHEARS 23 ETHICON ENDO-SURGERY, LLC DONOVAN MAY
K120810 03/16/2012 FIBEROPTIC LASER DELIVERY SYSTEM FIBEROPTIC FABRICATIONS INC CAROL J MORELLO
K120726 03/09/2012 FLIGHT 60 VENTILATOR FLIGHT MEDICAL INNOVATIONS LTD. CHOSHANA FRIEDMAN
K120740 03/12/2012 COLS FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K120823 03/21/2012 BVM HEMODIALYSIS BLOOD TUBING SET WITH ATTACHED PRIMING SET AND TRANSDUCER PROTECTORS FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE DENISE OPPERMANN
K120781 03/15/2012 CELLO BALLOON GUIDE CATHETER (6F), 950 MM AND 1020 MM LENGTH FUJI SYSTEMS CORP. PAUL MASON
K120629 03/01/2012 FDR GO FLEX FUJIFILM MEDICAL SYSTEM U.S.A., INC. PETER ALTMAN
K120637 03/01/2012 SYNAPSE 3D BRAIN PERFUSION FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K120636 03/01/2012 SYNAPSE 3D CARDIAC TOOLS FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K120648 03/02/2012 SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS FUJIFILM MEDICAL SYSTEM U.S.A., INC. JYH-SHYAN LIN
K120679 03/06/2012 SYNAPSE 3D NODULE ANALYSIS FUJIFILM MEDICAL SYSTEMS U.S.A., INC. JYH-SHYAN LIN
K120778 03/14/2012 BRIVO MR355 GE HANGWEI MEDICAL SYSTEMS CO., LTD. RUOQIAN LIU
K120741 03/12/2012 VOLUSON S6, VOLUSON S8 GE HEALTHCARE BRYAN BEHN
K120770 03/14/2012 QT GUARD PLUS ANALYSIS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES KRISTIN PABST
K120910 03/26/2012 CARDIQ XPRESS 2.0 WITH SNAPSHOT FREEZE OPTION CARDIQ XPRESS 2.0 REVEAL GE MEDICAL SYSTEMS SCS STEPHEN SLAVENS
K120833 03/19/2012 DISCOVERY CT750 HD GE MEDICAL SYSTEMS, LLC JOHN JAECKLE
K120641 03/06/2012 GLOBAL MEDI PRODUCTS RETRACTABLE SAFETY SYRINGE GLOBAL MEDI PRODUCTS ROBERT O DEAN
K113846 03/07/2012 BORRELIA BURGDORFERI IGM BLOT TEST GOLD STANDARD DIAGNOSTICS NAPOLEON MONCE
K120675 03/05/2012 DIGITAL AUTOMATIC BLOOD PRESSURE MONITOR BPM11 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
K120673 03/05/2012 DIGITAL AUTOMATIC WRIST BLOOD PRESSURE MONITOR WBPM15 SERIES GRANDWAY TECHNOLOGY (SHENZHEN) LIMITED PATRICK CHOW
DEN120013 03/02/2012 PORTRAIT ANALYZER GREAT BASIN SCIENTIFIC LARRY REA
K120670 03/05/2012 HAMILTON-T1 HAMILTON MEDICAL AG RALPH AGUILA
K120894 03/23/2012 HAYMAX HAYMAX LIMITED MAX WISEBERG
K120958 03/30/2012 POSISEP AND POSISEP X HEMOSTAT DRESSINGS HEMOSTASIS, LLC BERNARD HORWATH
K120914 03/27/2012 FLEXITIME FAST & SCAN LIGHT FLOW HERAEUS KULZER, LLC JAMIE MEARNA
K120886 03/23/2012 LACRIFAST HIROYASU HIGUCHI FUMIAKI KANAI, PH.D.
K120945 03/29/2012 HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE ALT, HITACHI CLINICAL ANALYZER S TEST REAGENT CARTRIDGE AST HITACHI CHEMICAL DIAGNOSTICS, INC. CHARLES TSOU
K120947 03/29/2012 THS INSTRUMENT TRAY HOLOGIC, INC. SARAH FAIRFIELD
K120920 03/27/2012 HSINER CPAP SILICONE NASAL MASK SIZE XS/PETITE HSINER NASAL PILLOW MASK HSINER INFANT CPAP CANNULA HSINER COMPANY TOM SHANKS
K120659 03/05/2012 HU-FRIEDY DENTAL CARTRIDGE SYRINGE HU-FRIEDY MFG. CO. LLC MARIA VRABIE
K120759 03/13/2012 CARESENS N MINI BLOOD GLUCOSE MONITORING SYSTEM, MINI BLOOD GLUCOSE METER, BLOOD GLUCOSE TEST STRIP, CONTROL SOLUTION I-SENS, INC. HYUN JOON OH
K120753 03/28/2012 CLARISCT ICRCO INC. GREG WACHTLER
K120783 03/15/2012 ABLE-X IM-ABLE LTD SIGI CARON
K120946 03/29/2012 ALPHA CRYPTOCOCCAL ANTIGEN EIA IMMUNO-MYCOLOGICS, INC. SEAN K BAUMAN
K120949 03/30/2012 INFRASCANNER INFRASCAN, INC. STEVEN B DATLOF, M.D., J.D.
K120817 03/19/2012 QUANTA FLASH ACL LGA, QUANTA FLASH B2GP1 IGA INOVA DIAGNOSTICS, INC. ROSANNA KEIVENS
K120822 03/19/2012 STRAUMANN CARES VARIOBASE ABUTMENT NNC, STRAUMANN CARES VARIOBASE ABUTMENT RN, STRAUMANN CARES VARIOBASE ABUTMENT WN, ST INSTITUT STRAUMANN AG ANDREAS PETERMANN
K120633 03/01/2012 MAYFIELD SKULL CLAMP INTEGRA LIFESCIENCES CORPORATION LINDSAY MIGNONE
K120935 03/28/2012 SECURACATH INTERRAD MEDICAL INC SEW-WAH TAY
K120895 03/26/2012 REMOTE PRESENCE SYSTEM INTOUCH HEALTH, INC. STEVE SIDWELL
K120702 03/08/2012 E.G. SCAN II ESPHAGOSCOPE SYSTEM INTROMEDIC CO., LTD JIN YOUNG LEE
K120736 03/19/2012 SR PHONARES II IVOCLAR VIVADENT AG DONNA M HARTNETT
K120711 03/08/2012 NON-CONTACT THERMOMETER K-JUMP HEALTH CO., LTD. JM LIN
K120656 03/05/2012 EVEREST SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K120899 03/26/2012 RANGE SPINAL SYSTEM, UNIT ROD K2M, INC. NANCY GIEZEN
K120769 03/14/2012 MODULTH SLK KARL STORZ ENDOSCOPY-AMERICA, INC. LEIGH SPOTTEN
K120852 03/21/2012 ZIRCONIA BLANKS (ZIRCOSTAR) KEROX LTD SANGRAM YADAV
K120841 03/20/2012 APPIANFX SUTURE ANCHOR (6MM) (5MM) APPIANFX TISSUE ANCHOR KFX MEDICAL GAYLE HIROTA
K120650 03/02/2012 POISE PERSONAL LUBRICANT KIMBERLY-CLARK CORPORATION SWARNA MUKUND
K120752 03/12/2012 AERODR STITCHING SYSTEM KONICA MINOLTA MEDICAL & GRAPHIC, INC. RUSSEL MUNVES
K120879 03/26/2012 LEXUS CERVICAL FIXATION SYSTEM L & K BIOMED CO., LTD KI HYANG KIM
K120840 03/21/2012 LEXUS CERVICAL INTERVERTEBRAL BODY FUSION CAGE SYSTEM L&K BIOMED CO., LTD KI HYANG KIM
K120760 03/13/2012 LDR SPINE SPINETUNE TL SPINAL SYSTEM LDR SPINE USA INC. KIERSTEN SODERMAN
K120792 03/15/2012 TIXOS IMPLANT SYSTEM LEADER ITALIA S.R.L. STUART R GOLDMAN
K120775 03/14/2012 LIGHT FOR WRINKLES LED INTELLECTUAL PROPERTIES, LLC STEVE MARCHESE
K120640 03/06/2012 INSUFLOW SYNERGY PORT LEXION MEDICAL, LLC. BERNARD HORWATH
K120761 03/13/2012 LZI OPIATE 2000 HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OPIATE 2000 CALIBRATORS, LZI OPIATE 2000 CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K120763 03/13/2012 LZI OXYCODONE HOMOGENEOUS ENZYME IMMUNOASSAY, LZI OXYCONDONE CALIBRATORS, LZI OXYCODONE CONTROLS LIN-ZHI INTERNATIONAL, INC. BERNICE LIN
K120820 03/19/2012 GIRAFFE BLUE SPOT PT LITE LUMITEX, INC. DAVID FELTY
K120617 03/05/2012 PTFE SUPER SHEATH INTRODUCER MARTECH MEDICAL PRODUCTS ALEXIS ERAZO
K120657 03/05/2012 MASIMO SET AND MASIMO RAINBOW SET PULSE OXIMETERS AND SENSORS MASIMO CORPORATION PATRICIA MILBANK
K120733 03/09/2012 SIMPLANT GO MATERIALISE DENTAL NV GEERT APPELTANS
K120812 03/16/2012 RENAISSANCE MAZOR ROBOTICS LTD AHAVA STEIN
K120790 03/15/2012 GMK - LINE EXTENSION MEDACTA INTERNATIONAL ADAM GROSS
K120718 03/08/2012 INSTAPACS/INSTARISPACS MEDDIFF TECHNOLOGIES PVT. LTD CARL ALLETTO
K120956 03/30/2012 VSP SYSTEM MEDICAL MODELING INC JONATHAN S KAHAN
K120860 03/22/2012 INFU BOX TYPE 0412A MEDICAL RESCUE EQUIPMENT HOLDING AS KNUT FANGBERGET
K120555 03/12/2012 LATEX MALE CONDOM (SMOOTH SURFACE) LATEX MALE CONDOM (TEXTURED SURFACE) MEDICAL-LATEX (DUA) SDN. BHD UMA DEVI
K120849 03/20/2012 HYBRID ARCTICGEL PAD MEDIVANCE, INC. LYNNE ARONSON
K120844 03/20/2012 MEDLINX SURGICAL MESH MEDLINX ACALA PTE LTD STEPHEN P RHODES
K120966 03/30/2012 DEPUY PULSE LUMBAR CAGE SYSTEM MEDOS INTERNATIONAL SARL ROBIN DINARDO
K120867 03/22/2012 VIPER AND EXPEDIUM NAVIGATED INSTRUMENTS MEDOS INTERNATIONAL SARL LAURA BLEYENDAAL
K120963 03/30/2012 POWDER FREE NATURAL RUBBER LATEX EXAMINATION GLOVES MEDTEXX MANUFACTURING SDN. BHD. OOI LOON SENG
K120930 03/28/2012 CHG ANTIBACTERIAL FOAM DRESSING, CHG ANTIBACTERIAL PATCH, CHG ANTIBACTERIAL FOAM PATCH, CHG PATCH, CHG DRESSING MEDTRADE PRODUCTS LTD. CLAIRE RYAN
K120909 03/26/2012 EC 2.7 ENDOSCOPIC CUTTER MEDTRONIC ADVANCED ENERGY, LLC MARTIN J LEIGHTON
K120787 03/15/2012 MERETE LOCKING BONE PLATE SYSTEM III MERETE MEDICAL GMBH DONNA COLEMAN
K120644 03/02/2012 MERIT HYDROPHILIC GUIDE WIRE MERIT MEDICAL SYSTEMS, INC. MARK MULLANEY
K120676 03/05/2012 S-250 PROTON BEAM RADIATION THERAPY SYSTEM MEVION MEDICAL SYSTEMS THOMAS H FARIS
K120630 03/01/2012 AZUR DETACHABLE 18 MICRO VENTION, INC. CYNTHIA VALENZUELA
K120936 03/28/2012 ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORS MICROGENICS CORPORATION KAREN LEE
K120734 03/09/2012 MICROSOFT AMALGA UIS IMAGE PROCESSING MODULE MICROSOFT CORP. ADRIENNE LENZ
K120917 03/27/2012 HEADWAY DUO MICROCATHETER MICROVENTION, INC. NAOMI GONG
K120908 03/26/2012 HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. LARAINE PANGELINA
K113597 03/15/2012 MINI-LAP BIPOLAR ELECTROCAUTERY DEVICES MINILAP TECHNOLOGIES ALLAN ALWARD
K120821 03/19/2012 LLICS(TM) LAPARASCOPIC LENS INTERNAL CLEANING SYSTEM MISDER, LLC NANCY SAUER
K120865 03/22/2012 RSCRIBE ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC CHARLES MORREALE
K120628 03/29/2012 HELIO MOTION COMPOSITES VINCENT LECUYER
K120877 03/23/2012 MICROMANIPULATOR SET NARISHIGE CO., LTD. MITSUKO YONEYAMA
K120880 03/23/2012 ORBIT NATIONAL BIOMEDICAL LLC DBA QRS DIAGNOSTIC MARY KAY JENSEN
K120857 03/21/2012 EPI-SENSE GUIDED COAGULATION DEVICE WITH VISITRAX NCONTACT SURGICAL, INC. JANE RICUPERO
K120635 03/01/2012 EASYONE PRO RESPIRATORY TESTING DEVICE NDD MEDIZITECHNIK AG GERARD MASIELLO
K120709 03/08/2012 THE DOME GX4MP COLOR NONITOR NDS SURGICAL IMAGING JIM LENG
K120764 03/13/2012 EPIFLO(R) NEOGENIX, LLC SRINIVASAN SARANGAPANI
K120691 03/07/2012 BRAIN PORT NICO CORPORATION JAY DITTMAN
K120888 03/23/2012 PSG-1100 SLEEP DIAGNOSTIC SYSTEM NIHON KOHDEN CORP. STEVE GEERDES
K120800 03/16/2012 NVISION VLE IMAGING SYSTEM NINPOINT MEDICAL, INC. CINDY DOMECUS, RAC (US & EU)
K120954 03/30/2012 NOBELPROCERA PEEK ABUTMENTS NOBEL BIOCARE AB PHUONG NGUYEN SON
K120918 03/27/2012 NUVASIVE COROENT TITANIUM SYSTEM NUVASIVE, INC. SHEILA BRUSCHI
K120931 03/27/2012 CRITICAL CARE VENTILATOR ORICARE, INC. DAVID JAMISON
K120765 03/13/2012 VITROS CHEMISTRY PRODUCTS ECO2 SLIDES ORTHO-CLINICAL DIAGNOSTICS, INC. GAOZHEN HANG
K120847 03/20/2012 ET/SS IMPLANT SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K120951 03/30/2012 SMARTBUILDER SYSTEM OSSTEM IMPLANT CO.,LTD PATRICK LIM
K120738 03/12/2012 FLASH PTA BALLOON DILATATION CATHETER-4.0X14MMX135CM OSTIAL CORPORATION KAITLIN VON HOFFMANN
K120622 03/01/2012 PALOMAR VECTUS LASER PALOMAR MEDICAL TECHNOLOGIES, INC. SHARON TIMBERLAKE
K120942 03/29/2012 PARCUS TWIST 4 5MM PEEK SUTURE ANCHOR, PARCUS TWIST 5.5MM PEEK SUTURE ANCHOR & PARCUS TRIPLE TWIST 5.5MM PEEK SUTURE ANC PARCUS MEDICAL, LLC PAUL VAGTS
K120884 03/23/2012 PERICAM PSI PERIMED AB MARIA LILJEVRET
K120855 03/21/2012 INTELLISPACE ECG PHILIPS HEALTHCARE GRETEL LUMLEY
K120815 03/19/2012 INNERSENSE ESOPHAGEAL TEMPERATURE/FEEDING TUBE PHILIPS MEDICAL SYSTEMS PETER SCHIPELLITI
K120724 03/09/2012 PIONEER LATERAL PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY, INC SARAH MCINTYRE
K120858 03/21/2012 IMPLANT BAR PRISMATIK DENTALCRAFT, INC. KATHLEEN DRAGOVICH
K120784 03/15/2012 TUFF-TEMP 2.0 PULPDENT CORPORATION KENNETH J BERK
K120846 03/20/2012 TRANSPORT CULTURE MEDIUM DEVICE PURITAN MEDICAL PRODUCTS LLC MEHDI KARAMCHI
K120627 03/01/2012 TOSHIBA 1.5T QD HEAD COIL QUALITY ELECTRODYNAMICS CHRISTIE ZYDYK
K120825 03/19/2012 SUPRA SCAN DELIVERY SYSTEM QUANTEL MEDICAL MAUREEN O'CONNELL
K120859 03/22/2012 PRE-LOADED GOLD VISICOIL CK MARKER RADIOMED CORPORATION GORDON ROBERTS
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