FDA 510(k) Applications Received During March, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K090569 03/02/2009 MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 3M COMPANY BRYAN BECKER
K090718 03/18/2009 BELLUS SHADING KIT 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K090665 03/13/2009 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM-SMALL/LARGE, MODEL 22437-19/22438-19 ABBOTT VASCULAR-VASCULAR SOLUTIONS DANIELLE TAYLOR
K090660 03/12/2009 AIRWAY BALLOON CATHETER INFLATION DEVICE ACCLARENT, INC. KERI YEN
K090730 03/19/2009 AKITA JET ACTIVAERO AMERICA, INC. PAUL DRYDEN
K090837 03/27/2009 STRATAPULSE TS AND STRATAPULSE ADVANCED MEDICAL PHOTONICS SCOTT PORTER
K090657 03/12/2009 MODIFICATION TO: S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS LISA M BOYLE
K090672 03/13/2009 AGFA COMPUTED RADIOGRAPHY SYSTEMS WITH NX WORKSTATIONS AGFA HEALTHCARE N.V. JEFFERY A JEDLICKA
K090571 03/03/2009 ALMA LASERS ALEX755 MODULE ALMA LASERS LTD. HOWARD KELLY
K090782 03/23/2009 NOVEL ALIF SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K090779 03/23/2009 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC SPINE, INC. CHERYL ALLEN
K090854 03/30/2009 ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GROMLEY
K090663 03/12/2009 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC. STEPHANIE GEORGE
K090713 03/18/2009 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP AMERICAN MEDICAL SYSTEMS, INC. DENISE THOMPSON
K090772 03/23/2009 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5903, KD-5909 ANDON HEALTH CO.,LTD LIU YI
K090770 03/23/2009 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL KD-5905 ANDON HEALTH CO.,LTD LIU YI
K090771 03/23/2009 FULLY AUTOMATIC ELECTRONC BLOOD PRESSURE MONITOR, MODEL, KD-5962 ANDON HEALTH CO.,LTD LIU YI
K090769 03/23/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-7961 ANDON HEALTH CO.,LTD LIU YI
K090768 03/23/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD 5901, KD-7909, ANDON HEALTH CO.,LTD LIU YI
K090676 03/13/2009 MONTBLANC IMPLANTOLOGY AND OMNIPRATIQUE CONTRA-ANGLES ANTHOGYR BRAYETTE SABINE
K090850 03/30/2009 ACTIFUSE BONE GRAFT SUBSTITUTE, ACTIFUSE MICROGRANULES BONE GRAFT SUBSTITUTE APATECH LTD. CANDACE F CEDERMAN
K090583 03/04/2009 ENDOSCOPIC MONOPOLAR SCISSORS, MODELS EMS-235, EMS-165 APOLLO ENDOSURGERY, INC. GREG MATHISON
K090751 03/20/2009 COMET ANTERIOR CERVICAL PLATE SYSTEM APOLLO SPINE, INC. ANN-MARIE FRANCIS
K090738 03/20/2009 THERMOFLO HCH, THERMOFLO FILTER ARC MEDICAL, INC. PAUL DRYDEN
K090653 03/11/2009 POCKETCHEM EZ BLOOD GLUCOSE MONITORING SYSTEM ARKRAY Factory USA, Inc. HAMID IDRISSI
K090615 03/09/2009 OPUS SPEEDLOCK KNOTLESS FIXATION DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K090838 03/27/2009 STIMULUS/DISSECTION INSTRUMENTS AXON SYSTEMS, INC. HOWARD BAILIN
K090884 03/31/2009 PERIFIX ONE PEDIATRIC CATHETER, 20 GA. & 24 GA. B. BRAUN MEDICAL, INC. ANGELA J CARAVELLA
K090603 03/05/2009 BARCO 5MP MAMMO, MODEL MDMG-5221 BARCO NV ALBERT XTHONA
K090732 03/19/2009 NIO COLOR 3MP AND MDNC-3121 BARCO NV LIEVEN DE WANDEL
K090628 03/09/2009 DIDGET BLOOD GLUCOSE METER, MODEL 6181; CONTOUR BLOOD GLUCOSE TEST STRIPS, MODEL 7080 BAYER HEALTHCARE, LLC SUSAN BROCCHI
K090588 03/04/2009 POWER PROCESSOR SAMPLE PROCESSING SYSTEM WITH GENERIC CONNECTION MODULE, MODEL: 4210 BECKMAN COULTER, INC. MARY B TANG
K090680 03/16/2009 HEPARIN LOCK FLUSH SOLUTION, USP BD POSIFLUSH HEPARIN LOCK FLUSH SYRINGE BECTON DICKINSON & CO. JOHN ROBERTS
K090824 03/26/2009 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SABA MODJARRAD
K090827 03/26/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SABA MODJARRAD
K090716 03/18/2009 BEGO SEMADOS S-LINE BEGO IMPLANT SYSTEMS GMBH & CO. KG MARTIN ELLERHORST
K090599 03/05/2009 MD300K1 PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K090873 03/31/2009 I OPEN 0.5T BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD. WANG WEIMIN
K090847 03/30/2009 PLATELIA TOXO IGM KIT MODEL 26211 Bio-Rad Laboratories PRIYA BONDRE
K090737 03/20/2009 HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI BIO-RAD LABORATORIES, INC. JOLENE BARTILSON
K090699 03/17/2009 VARIANT II TURBO HBA1C KIT KIT-20 AND WASH/DILUENT SOLUTION SET, MODELS 270-2455, 270-2730 BIO-RAD LABORATORIES, INC. JACKIE H BUCKLEY
K090793 03/24/2009 BONGROS HA BIOALPHA, INC. HYUN-SEUNG RYU
K090759 03/23/2009 BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM BIODRAIN MEDICAL, INC. CHAD RUWE
K090757 03/23/2009 BIOMET MODULAR FEMORAL REVISION SYSTEM BIOMET, INC. BECKY EARL
K090895 03/30/2009 EKG-PLUS II SOFTWARE BIONET CO., LTD. HL JUNG
K090607 03/06/2009 BLUE SKY BIO PLAN, VERSION .38 BLUE SKY BIO, LLC ALBERT ZICKMANN
K090871 03/30/2009 CERAMENT IBONE VOID FILLER HIGH CONTRAST, MODEL A 0210-12 BONESUPPORT AB ANN-CHRISTINE PROVOOST
K090554 03/02/2009 ACUITY MAILMAN AND STRAIT-TRAK GUIDEWIRE BOSTON SCIENTIFIC CORP. STACEY A STRAND
K090586 03/04/2009 BOVIE ICON GS ELECTROSURGICAL GENERATOR (GS100), HANDPIECE (GS-OP-R), REUSABLE HANDPIECE CABLE (GS807-RC) BOVIE MEDICAL RICHARD A KOZLOFF
K090743 03/20/2009 YIELD MINI DOPPLER SYSTEM BRONCUS TECHNOLOGIES, INC. NANCY ISAAC
K090853 03/30/2009 YIELD TISSUE SAMPLER BRONCUS TECHNOLOGIES, INC. NANCY ISAAC
K090851 03/30/2009 DEFENDO (TM) BIOPSY VALVE FOR OLYMPUS(R) AND FUJINON(R) ENDOSCOPES, MODEL 100301, DEFENDO(TM) BIOPSY VALVE FOR PENTAX(R) BYRNE MEDICAL INC. JENNIFER JAMES
K090739 03/20/2009 BARD SACROCOLPOPEXY GRAFT C.R. BARD, INC. TERRI MORRIS
K090547 03/02/2009 ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U C.R. BARD, INC. CINDY MOSS
K090735 03/19/2009 C.T.M. MOBILITY SCOOTER, HS-528 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K090623 03/09/2009 DIGITAL RADIOGRAPHY CXDI-40G COMPACT CANON U.S.A., INC. SHEILA DRISCOLL
K090872 03/30/2009 MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. KIMBERLEE LEON
K090602 03/05/2009 CARDIODYNAMICS BIOZ RX, MODEL 7101-SYS CARDIODYNAMICS INTERNATIONAL CORP. DON BROOKS
K090598 03/05/2009 CARIESCAN PRO CARIESCAN LTD. NIKOLA SKELLY
K090584 03/03/2009 INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS CARL ZEISS SURGICAL GMBH MARK W SHEEHAN
K090634 03/09/2009 PHASEAL PROTECTOR P14, P21, P28 AND P50 CARMEL PHARMA AB. KJELL ANDREASSON
K090791 03/24/2009 DAKIN'S ANTIMICROBIAL WOUND CLEANSER, MODEL 0.0125% TO 5% CENTURY PHARMACEUTICALS, INC. PAUL DRYDEN
K090632 03/09/2009 COMPEX REHAB CHATTANOOGA GROUP NORA C.R. YORK
K090646 03/11/2009 CARDIOTECH SPIROMETRY SYSTEM, MODEL GT-105 CHEST M.I., INC. JEAN ASQUITH
DEN090005 03/24/2009 PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. BRUCE KRATTENMAKER
K090744 03/20/2009 CLARO CLRS TECHNOLOGY CORPORATION MAUREEN O'CONNELL
K090720 03/18/2009 COCHLEAR BAHA BP100 COCHLEAR BONE ANCHORED SYSTEMS AB SEAN BUNDY
K090894 03/31/2009 COLLAWOUND WOUND DRESSING COLLAMATRIX CO., INC. DENNIS J.N. SEAH
K090560 03/02/2009 CONMED LINVATEC ANODIZED ALUMINUM STERILIZATION TRAYS CONMED LINVATEC REBECCA ROBERTS
K090671 03/13/2009 PULSE OXIMETER, MODELS CMS50E, CMS50F, CMS60C, CMS60D CONTEC MEDICAL SYSTEM CO., LTD. Diana Hong
K090773 03/23/2009 CFI ULTRASOUND PROBE DRAPE CONTOUR FABRICATORS, INC. JOHN W SCHAEFER
K090688 03/16/2009 COOK UROLOGICAL GRAFT COOK BIOTECH, INC. MARY A FADERAN
K090822 03/26/2009 ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER COOK, INC. NATHAN SIMON
K090624 03/09/2009 COOK MREYE EMBOLIZATION COILS COOK, INC. SUSANNE GALIN
K090709 03/18/2009 CORTEX DENTAL IMPLANT SYSTEM CORTEX DENTAL IMPLANTS INDUSTRIES, LTD BENNY AZARY
K090696 03/16/2009 NUVANT CARDIAC EVENT MONITORING SYSTEM; NUVANT MOBILE CARDIAC TELEMETRY SYSTEM CORVENTIS, INC. MADHURI BHAT
K090566 03/03/2009 PATHWAY AVID CUSTOM SPINE, INC. SAAD ATTIYAH
K090618 03/09/2009 CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C CYNOSURE, INC. GEORGE CHO
K090669 03/13/2009 RIGIDFIX BIOCRYL CROSS PIN KITS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K090877 03/31/2009 PROXIMAL TIBIA LOCKING PLATE STANDARD AND LARGE, 3.5MM LOW PROFILE AND MULTIDIRECTIONAL SCREWS DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K090799 03/24/2009 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K090648 03/11/2009 VIPER 2 SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K090664 03/13/2009 DEVON ACCUBP CUFF DEVON MEDICAL INC. RUTH WU
K090695 03/16/2009 DINKLER SURGICAL SKULL CLAMP, MODEL 0308 DINKLER SURGICAL DEVICES, INC. CHARLES E DINKLER III
K090682 03/16/2009 EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 EDWARDS LIFESCIENCES SERVICES GMBH NEIL R ARMSTRONG
K090681 03/16/2009 TANSCU O2 ELECTROCHEMICAL OXYGEN CONCEPTS, INC. CARL JENKINS
K090889 03/31/2009 EMSI GARMENT ELECTRODES EMSI CHERITA JAMES
K090717 03/18/2009 FLEX-TENS EMSI CHERITA JAMES
K090796 03/24/2009 MULTI-BITE HOT BIOPSY FORCEPS ENDO-THERAPEUTICS, INC. MARK R WADDELL
K090867 03/31/2009 AIRBLOC TRANSSEPTAL INTRODUCER, 53 CM, MODEL FA001, AIRBLOCK TRANSSEPTAL INTRODUCER, 72 CM ,MODEL FA002 EP DYNAMICS, INC. ALBERT REGO
K090855 03/30/2009 EQUIVABONE OSTEOINDUCTIVE BONE GRAFT SUBSTITUTE ETEX CORP. CHRISTOPHER KLACZYK
K090728 03/19/2009 HYPERGLIDE OCCLUSION BALLOON SYSTEM EV3 INC. JASON K LYON
K090849 03/30/2009 MODIFICATION TO: NANOCROSS 0.14 OTW PTA DILATATION CATHETER, MODELS AB14W020210090, AB14W020210150 EV3 INC. SARA BAKKAR
K090764 03/23/2009 NOVATION CFS PRESS-FIT AND CEMENTED STEMS EXACTECH, INC. TARA R PATTERSON
K090801 03/24/2009 ELECTRONIC HOUSE CALL EXPRESS MD SOLUTIONS, LLC CHRIS DOHERTY
K090777 03/23/2009 EZC MEDICAL, LLC INTUBAIDFLEX EZC MEDICAL, LLC PAVAN SETHI
K090621 03/09/2009 FLOWCARDIA FLOWMATER INJECTOR, MODEL INJ 100 FLOWCARDIA, INC. Dustin Michaels
K090559 03/02/2009 FOOTPRINT MEDICAL SILICONE FEEDING TUBE FOOTPRINT MEDICAL CLYDE BAKER
K090576 03/03/2009 FOOTPRINT URINARY DRAINAGE CATHETER FOOTPRINT MEDICAL CLYDE BAKER
K090821 03/26/2009 CHEX SINGLE USE CURVED INTRALUMINAL CIRCULAR STAPLER, MODEL CS 21, CS 25, CS 28, CS 32, CS 21L, CS 25L, CS 28L, CS 32L FRANKENMAN INTERNATIONAL LIMITED JEAN ASQUITH
K090747 03/20/2009 MI FLOW (GCUC-450) GC AMERICA, INC. MARK HEISS
K090892 03/31/2009 GE DATEX-OHMEDA S/5 ADU CARESTATION GE HEALTHCARE FINLAND OY ADRIENNE LENZ
K090702 03/17/2009 MODIFICATION TO DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DAVID WAHLIG
K090638 03/10/2009 GENADYNE A4-XLR8 WOUND VACUUM SYSTEM GENADYNE BIOTECHNOLOGIES, INC. CHIEN-MING GOH
K090557 03/02/2009 GIVEN PILLCAM PLATFORM WILL PILLCAM SB CAPSULES, ESO CAPSULES, GIVEN AGILE PATENCY SYSTEM GIVEN IMAGING LTD. Tim Thomas
K090565 03/02/2009 ELLIPSE OCCIPITO-CERICO-THORACIC SPINAL SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K090814 03/25/2009 MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K090581 03/03/2009 TANTALUM BEAD SET, MODEL P003175 HALIFAX BIOMEDICAL, INC. ROSHANA AHMED
K090803 03/24/2009 HANSON MEDICAL FACIAL IMPLANTS HANSON MEDICAL, INC. GERALD HANSON
K090652 03/11/2009 ALPHA DUO LAP INSUFFLATOR HIPPOKRATEC GMBH CHRISTIAN SIEDERSBERGER
K090882 03/31/2009 FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE HOSPIRA, INC. KEITH DUNN
K090610 03/06/2009 HOSPIRA VITAL SIGNS WIRELESS MONITORING SYSTEM HOSPIRA, INC. Yuliya Matlin
K090794 03/24/2009 OSTEOTAPE IMPLADENT, LTD. MAURICE VALEN
K090712 03/18/2009 EOCENE SYSTEM INFOPIA CO., LTD MARIA F GRIFFIN
K090804 03/25/2009 NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD INNOMED TECHNOLOGIES INC./RESPCARE INC. LINDA MAGILL
K090727 03/19/2009 IMM DENTAL IRRIGATION TUBING SET INNOVATIVE MEDICAL MANUFACTURING CO. JOSEPH J CHANG
K090677 03/16/2009 INNOPORT LAPAROSCOPIC ACCESS DEVICE INNOVIA LLC BRUCE WEBER
K090755 03/20/2009 QUANTA LITE APS/PT IGG AND IGM ELISA INOVA DIAGNOSTICS, INC. D. WALTER L BINDER
K090611 03/06/2009 REVOLUTION FULL CORE BIOPSY INRAD MELISSA LALOMIA
K090563 03/02/2009 HEMOSIL INR VALIDATE, HEMOSIL ISI CALIBRATE, ISIWEB (SOFTWARE) INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K090864 03/30/2009 CUSA SHEAR TIP, AN ACCESSORY OF THE CUSA EXCEL ULTRASONIC SURGICAL ASPIRATOR SYSTEM INTEGRA RADIONICS, INC. KEVIN J O'CONNELL
K090579 03/03/2009 SMARTSCREENER-PLUS2 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K090767 03/23/2009 PERPOS FCD-2 SYSTEM (SINGLE PATIENT USE), ANCHOR, STABILIZER INTERVENTIONAL SPINE, INC. CAROL EMERSON
K090785 03/23/2009 MRI COMPATIBLE PATIENT MONITORING SYSTEM, MODEL 865214 INVIVO CORP. RUSTY KELLY
K090701 03/17/2009 EMPRESS DIRECT IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K090826 03/26/2009 MONOBOND PLUS IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K090704 03/17/2009 MULTILINK IMPLANT IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K090818 03/25/2009 KARL STORZ -ENDOSCOPE STERILIZATION TRAYS, MODELS 39402AS, 39301HCTS, 39301BS KARL STORZ ENDOSCOPY-AMERICA, INC. MONIKA CAMPBELL
K090863 03/30/2009 PERSONAL WHEEZOMETER KARMELSONIX YORAM LEVY
K090786 03/23/2009 KENS INTERNAL FIXATION SYSTEM KENS FINEMEDTECH SDN. BHD LEOW K HOOI
K090830 03/26/2009 LABORIE INJETAK ADJUSTABLE TIP NEEDLE, FLEXIBLE TIP AND RIDGID TIP LABORIE MEDICAL TECHNOLOGIES, LTD. BARBARA MORNET
K090815 03/25/2009 PERCUTANEOUS DISCECTOMY SYSTEM LAURIMED LLC SEVRINA CIUCCI
K090633 03/09/2009 LENSAR LASER SYSTEM LENSAR, INC. SHIRLEY MCGARVEY
K090879 03/31/2009 INSUFLOW CO2IONSHIELD LEXION MEDICAL, LLC. BERNARD HORWATH
K090865 03/30/2009 LIFE SPINE FACET SCREW SPINAL SYSTEM LIFE SPINE MURALI AUDIPUDY
K090766 03/23/2009 LIFEGUARD BACKTRACK B90 BREATH ALCOHOL TESTER LIFELOC TECHNOLOGIES, INC. MARK LARY
K090774 03/23/2009 LIGHTLAS SELECTOR LIGHTMED CORP. ANITA CHEN
K090844 03/27/2009 BUPRENORPHINE ENZYME IMMUNOASSAY WITH NORBUPRENORPHINE CALIBRATORS AND CONTROLS Lin-Zhi International, Inc. MARIE LIN
K090802 03/24/2009 TIGRT MLC, TIGRT DMLC LINATECH, LLC JONATHAN YAO
K090893 03/31/2009 TIGRT TPS LINATECH, LLC JONATHAN YAO
K090835 03/27/2009 CONMED LINVATEC BIO MINI-REVO SUTURE ANCHOR, MODEL C6170CR LINVATEC CORP. JOY LOVETT
K090763 03/23/2009 RESTORIS MULTICOMPARTMENTAL KNEE (MCK) SYSTEM MAKO SURGICAL CORPORATION WILLIAM F TAPIA
K090555 03/02/2009 PLEGIOX CARDIOPLEGIA HEAT EXCHANGER WITH SOFTLINE COATING, MODEL BIO-CHX 30 MAQUET CARDIOPULMONARY AG FRANK MOEHRKE
K090689 03/16/2009 QUADROX-I SMALL ADULT WITH AND WITHOUT INTERGRATED ARTERIAL FILTER WITH SOFTLINE COATING, MODELS HMO 50000, HMO 51000 MAQUET CARDIOPULMONARY AG INGRID RICHTER
K090690 03/16/2009 VENOUS SOFTBAG RESERVOIRS WITH SOFTLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K090662 03/12/2009 MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP MASIMO CORPORATION MARGUERITE THOMLINSON
K090637 03/10/2009 CARDIO-WRAP MAST BIOSURGERY USA INC. KENNETH K KLEINHENZ
K090734 03/19/2009 EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTES MEDICA CORP. Photios Makris
K090834 03/27/2009 EPICARDIA 5000 MEDICOMP, INC. SUSAN D GOLDSTEIN-FALK
K090707 03/17/2009 TALOS INTERVERTEBRAL BODY FUSION DEVICE MEDITECH ADVISORS, LLC JANET M WEBB
K090568 03/03/2009 MEDLINE NITRILE EXAM GLOVES W/ALOE -GREEN MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K090780 03/23/2009 MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE MEDTRADE PRODUCTS LTD. JONATHAN RANFIELD
K090721 03/18/2009 CARDIOBLATE MAPS SURGICAL MAPPING, ABLATION, PACING AND SENSING DEVICE, MODEL 49205 Medtronic PETER LIU
K090659 03/12/2009 ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND GUIDE CATHETERS FOR LEFT HEART DELIVERY MEDTRONIC INC. BRUCE BACKLUND
K090869 03/31/2009 MIRCSP (MINIMALLY INVASIVE RETROGRADE CORONARY SINUS PERFUSION) MANUAL INFLATE CANNULA, MODEL 94113TD MEDTRONIC PERFUSION SYSTEMS JESSICA SIXBERRY
K090740 03/20/2009 MODIFICATION TO: TSRH SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LILA JOE
K090714 03/18/2009 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK MELISA LANSKY
K090833 03/26/2009 SEGMENT MEDVISO EINAR HEIBERG
K090710 03/18/2009 MERCURY CPAP MERCURY MEDICAL PAUL DRYDEN
K090700 03/17/2009 IMMUNOCARD STAT CAMPY, MODEL 751530 MERIDIAN BIOSCIENCE, INC. Michelle L Smith
K090870 03/30/2009 ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY MICRO THERAPEUTICS, INC. TOM DAUGHTERS
K090810 03/25/2009 THERMO SCIENTIFIC CYTO-CAL COUNT TUBES MICROGENICS CORP. LISA CHARTER
K090891 03/30/2009 MICROPLEX COIL SYSTEM-COSMOS MICROVENTION, INC. Naomi Gong
K090670 03/13/2009 MIDMARK M3 ULTRAFAST AUTOMATIC STERILIZER MIDMARK CORP. GARY BENNING
K090668 03/13/2009 VISION TOOLS MILLENSYS CHRISTINE NICHOLS
K090608 03/06/2009 MINTA RYAN RF THERMOCOUPLE ELECTRODE (RYAN-50, 100, 150 AND 200), MINTA INTERMEDIATE CABLE (RYAN-C, -R, -B) MINTA MEDICAL LIMITED ANDREW EDWARDS
K090792 03/24/2009 MITAKA UNIARM MITAKA KOHKI CO., LTD. MAXWELL STURGIS
K090809 03/25/2009 MPS ACACIA POWER INJECTABLE INFUSION SET MPS ACACIA FERGIE FERGUSON
K090553 03/02/2009 NAVISCAN PEMFLEX SOLO II HIGH RESOLUTION PET SCANNER NAVISCAN, INC. HEATHER JALISI
K090825 03/26/2009 SQ IS SYSTEM NEOBIOTECH CO., LTD. EUGENE BANG
K090885 03/31/2009 NEPHROS, INC., DSU DUAL STAGE ULTRAFILTER NEPHROS, INC. VIKKI M O'CONNOR
K090811 03/25/2009 INSPIRA HD, MODEL: NL1000 NEUROLOGICA CORPORATION DONALD D FICKETT
K090866 03/31/2009 NEUROCALM MODEL 1 AND 2 NEUROMED DEVICES, INC ROBERT SEIPLE
K090552 03/02/2009 UROCARE NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K090888 03/31/2009 NEWPORT HT70 FAMILY OF VENTILATORS NEWPORT MEDICAL INSTRUMENTS, INC. DANA RODRIGUEZ
K090630 03/09/2009 NOBEL BIOCARE ENDOSSEOUS IMPLANTS (MAXILLOFACIAL INDICATION) NOBEL BIOCARE AB HERBERT CRANE
K090807 03/25/2009 REGIONAL OXIMETER SYSTEM, MODEL 7600 NONIN MEDICAL, INC. LORI M ROTH
K090546 03/02/2009 MODIFICATION TO NORDICICE SOFTWARE NORDICIMAGINGLAB AS CHANDANA G BHANDARI
K090661 03/12/2009 NES REPROCESSED VARICOSE VEIN RF CATHETER Northeast Scientific, Inc. CRAIG ALLMENDINGER
K090731 03/19/2009 NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD NovaBone Products, LLC DAVID M GAISSER
K090706 03/17/2009 ONCENTRA SIMULATION 2.3 NUCLETRON CORPORATION ELAINE COLBY
K090626 03/09/2009 ENDOSERTER OCULAR SYSTEMS, INC. KURT WEBER
K090725 03/19/2009 OCULUS MICROCYN WOUND GEL OCULUS INNOVATIVE SCIENCES, INC. ANTIOINETTE DOUGLAS
K090697 03/17/2009 MODIFICATION TO: GIRAFFE AND PANDA WARMER OHMEDA MEDICAL AGATA SMIEJA
K090609 03/06/2009 OKMETER MATCH BLOOD GLUCOSE MONITORING SYSTEM OK BIOTECH CO., LTD. Ke-Min Jen
K090845 03/27/2009 APEX ARC HIP STEM OMNI LIFE SCIENCE, INC. WILLIAM MCCALLUM
K090819 03/25/2009 ONTEX TAMPON (UNSCENTED) ONTEX INTERNATIONAL NV NEAL KOBER
K090705 03/17/2009 BALANCED KNEE SYSTEM ULTRACONGRUENT TIBIAL INSERT ORTHO DEVELOPMENT CORP. JOHANNE YOUNG
K090587 03/04/2009 STARLIGHT ORTHOMERICA PRODUCTS, INC. ALAN T SANDIFER
K090666 03/13/2009 PEDIPLATES ORTHOPEDIATRICS, CORP. GARY BARNETT
K090754 03/20/2009 LIPOCONTROL OSYRIS MEDICAL BLANDINE BOUVET
K090631 03/09/2009 PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G QUASS
K090829 03/26/2009 PARI PEP S PARI RESPIRATORY EQUIPMENT, INC. MICHAEL JUDGE
K090597 03/05/2009 FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH PASCAL CO., INC. VINCENT M TENTARELLI
K090752 03/20/2009 PENUMBRA SYSTEM (PENNUMBRA REPERFUSION CATHETER 054), MODEL PSC054; (PENUMBRA SEPARATOR 054), MODEL PSS054 PENUMBRA, INC. LOUISE MUSANTE
K090846 03/30/2009 GSP INSTRUMENT AND GSP NEONATAL HTSH KIT PERKINELMER, INC. KAY A TAYLOR
K090590 03/04/2009 VERADIUS, MODEL 718-130 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K090625 03/09/2009 WIRELESS PORTABLE DETECTOR FD-W17 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K090808 03/25/2009 PINNACLE3 SMARTARC PHILIPS MEDICAL SYSTEMS, INC. JILL KAEDER
K090733 03/19/2009 PMT HALO SYSTEM PMT CORP. ERIC CAILLE
K090703 03/17/2009 POLY-CHEM 90 GLUCOSE POLYMEDCO, INC. HELEN LANDICHO
K090781 03/23/2009 HELIO2 BLENDER PRECISION MEDICAL, INC. JAMES PARKER
K090848 03/30/2009 PREMIER STERILE SALINE WOUND WASH, MODELS 210 ML, WWM PREMIER BRANDS OF AMERICA, INC. MACK CAUTHEN
K090805 03/25/2009 V10, THREE WHEEL SCOOTER, MODEL SC610V, V10, THREE WHEEL SCOOTER, MODEL SC610VPS, V10, FOUR WHEEL SCOOTER, MODEL SC710 PRIDE MOBILITY PRODUCTS CORP. THOMAS J SCHAPPERT
K090641 03/10/2009 CURIOS PROGENTIX ORTHOBIOLOGY B.V. YVONNE P BOVELL
K090639 03/10/2009 EXELO2, MODEL 4010 QUANTEL DERMA GMBH MICHAEL JOHNSON
K090762 03/23/2009 LEDA QUANTEL DERMA GMBH DIETMAR FISCHER
K090585 03/04/2009 NEOSALUS CREAM QUINNOVA PHARMACEUTICALS SHAHBAZ KHAN
K090750 03/20/2009 RT300-SL, MODEL FA100052; RT300-SLSA, MODEL FA104581 RESTORATIVE THERAPIES INC. ANDREW BARRISKILL
K090776 03/23/2009 MEGAPULSE LASER SYSTEM AND FIBERS RICHARD WOLF MEDICAL INSTRUMENTS CORP. RON HASELHORST
K090541 03/02/2009 ELECSYS PRECICONTROL UNIVERSAL Roche Diagnostics GAIL SAUERS
K090806 03/25/2009 SAFI-GEL DAILY DISPOSABLE (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS, SAFI-GEL DAILY DISPOSABLE TORIC ( METHAFILCON SAFILENS, S.R.L. JOHN M SZABOCSIK
K090742 03/20/2009 DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL LTX240AA01-A SAMSUNG MOBILE DISPLAY CO., LTD VINCENT LEE
K090601 03/05/2009 FSC 2 SCHOELLY IMAGING, INC. F. DAVID ROTHKOPF
K090800 03/24/2009 VS-100 ILLUMINATION AND IMAGING SYSTEM SCHOELLY IMAGING, INC. KEN SPECTOR
K090823 03/26/2009 THERAFORM BILAYER SEWON CELLONTECH CO., LTD. EUGENE BANG
K090812 03/25/2009 THERAFORM STANDARD/SHEET SEWON CELLONTECH CO., LTD. JUNG BAE BANG
K090722 03/19/2009 SHAPE-HF CARDIOPULMONARY EXERCISE TESTING SYSTEM SHAPE MEDICAL SYSTEMS, INC CLARENCE JOHNSON
K090691 03/16/2009 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) SHIJIAZHUANG BENESTAR PLASTIC CO., LTD CHU XIAOAN
K090578 03/03/2009 SHIMADZU COLLIMATOR R-30H SHIMADZU CORP. DON KARLE
K090686 03/16/2009 SIC BREVETTI S.R.L. DEVICE FOR STERNAL SYNTHESIS SIC BREVETTI S.R.L. ROSINA ROBINSON
K090594 03/05/2009 DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN A DRAY-LYONS
K090745 03/20/2009 ARTIS ZEE / ZEEGOS WITH SW VC14 SIEMENS MEDICAL SOLUTIONS USA, INC. GARY JOHNSON
K090683 03/16/2009 SYNGO RT THERAPIST CONNECT SIEMENS MEDICAL SOLUTIONS USA, INC. CHRISTINE DUNBAR
K090656 03/12/2009 INTERTAN CHS LIMITED COLLAPSE SET SCREW SMITH & NEPHEW, INC. SHEREEN MYERS
K090562 03/02/2009 SMITH & NEPHEW INSTRUMENT TRAYS SMITH & NEPHEW, INC. JULIE ACKER
K090675 03/13/2009 SMITH & NEPHEW, INC. VLP FOOT PLATING, SCREW SYSTEM AND ACCESSORIES SMITH & NEPHEW, INC. Jahanvi Agnihotri
K090858 03/30/2009 PARIETEX MONOFILAMENT POLYESTER MESH SOFRADIM PRODUCTION ANGELA BUNN
K090580 03/03/2009 THERMAGE THERMACOOL NXT SYSTEM AND ACCESSORIES SOLTA MEDICAL, INC. HEATHER MACFALLS
K090684 03/16/2009 AVANTE LEUCITE BLOCKS SOMERSET DENTAL PRODUCTS, INC. CINDY SALTER
K090655 03/11/2009 PORTABLE X-RAY SYSTEM, MODEL POWERMAX 1260 SOURCE-RAY, INC. RAY MANEZ
K090556 03/02/2009 SPACELABS ELANCE VITAL SIGNS MONITORING SYSTEM AND CENTRAL MONITOR SOFTWARE SPACELABS HEALTHCARE MEDICAL EQUIPMENT (SUZHOU) CO THOMAS KROENKE
K090820 03/26/2009 TRIA HAIR REMOVAL LASER SYSTEM SPECTRAGENICS, INC. TOBIN C ISLAND
K090887 03/31/2009 ORIO-C CERVICAL, ORIO-TL TLIF, ORIO-PL PLIF, ORIO-AL ALIF INTERVEDRTEBRAL BODY FUSION CAGES SPINECRAFT J.D. WEBB
K090650 03/11/2009 SPSMEDICAL VAPORIZED HYDROGEN PEROXIDE CHEMICAL INDICATORS SPS MEDICAL SUPPLY CORP. GARY J SOCOLA
K090613 03/06/2009 CPS AIM SL SLITTABLE INNER CATHETERS, MODELS DS2N021-59, DS2N022-59, DS2NO23-59, DS2N024-65, DS2N024-65, DS2N021-65, DS2 ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI COLLEEN CANAN
K090567 03/03/2009 ORTHODONTIC CERAMIC BRACKET STAR DENTECH KOREA., CORP BRANDON CHOI
K090816 03/25/2009 STRYKER SPINE AVS PL PEEK SPACERS STRYKER CORP. VIKKI M O'CONNOR
K090542 03/02/2009 SUN-RAIN ULTRASONIC THERAPY MODELS, SU-300, SU-400, SU-500, SU-600, SU-700, SU-800, SU-900 SUN-RAIN SYSTEM CORP. JEN KE-MIN
K090839 03/27/2009 MODIFICATION TO SYNTEC-TAICHUN NON-STERILE BONE PLATE AND SCREW IMPLANTS SYNTEC SCIENTIFIC CORP. CAROL CHANG
K090605 03/06/2009 CLAMPFIX SYNTHES (USA) JASON LIPMAN
K090658 03/12/2009 SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL SYNTHES (USA) JILL R YELTON
K090549 03/02/2009 SYNTHES SYNAPSE TRANSCONNECTOR SYNTHES SPINE STACEY BONNELL
K090551 03/02/2009 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD CHU XIAOAN
K090831 03/26/2009 TANTHERA-T35 TANTHERA, INC. NATHAN A BEAVER, ESQ
K090698 03/17/2009 CAPIOX BUBBLE TRAP WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS GARRY A COURTNEY
K090878 03/31/2009 MODIFICATION TO TERUMO'S TENDERFLOW PEDIATRIC VENOUS RETURN CANNULAE (X-COATING) TERUMO CARDIOVASCULAR SYSTEMS CORP. CHRISTINA THOMAS
K090753 03/20/2009 THERATEST EL-ANTI-CCP/2 THERATEST LABORATORIES, INC. MARIUS TEODORESCU
K090760 03/23/2009 THERATEST EL-ANTI-TPO AND THERATEST EL-ANTI-THYROGLOBULIN, MODEL 104-119, 103-120 THERATEST LABORATORIES, INC. GABRIELLA LAKOS
K090856 03/30/2009 JOURNEY (OR RPSP), JOURNEY CUBIC (OR SUPRA OR TP02) THYSSENKRUPP CETECO SRL FEDELE FABRIZIO
K090582 03/04/2009 CALCANEAL FRACTURE PLATE SYSTEM TORNIER, INC. BRAHIM HADRI
K090564 03/02/2009 TRULY INFRARED EAR THERMOMETER, MODEL TET-350, TET-360, TET-370 TRULY INSTRUMENT LIMITED YANG JIAN-HAO
K090636 03/10/2009 TSO3 OZONE STERILIZER, MODEL 125L TSO3 INC. CHARLES O HANCOCK
K090886 03/31/2009 RTX 3371 TUNSTALL HEALTHCARE NIELS OLE ANDERSON
K090783 03/23/2009 TUTTNAUER ELARA-11 PRE-VACUUM TABLETOP AUTOCLAVE TUTTNAUER USA CO. LTD. THEODORE SULLIVAN
K090629 03/09/2009 EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMS TYSON BIORESEARCH, INC. WEN-HAI TSAI
K090841 03/27/2009 ADDPLUS ULRICH GMBH & CO. KG MERLE SYMES
K090861 03/30/2009 MAMBO, MODEL CS 18XX-XX ULRICH GMBH & CO. KG MERLE SYMES
K090828 03/26/2009 NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVES ULTRAWIN SDN BHD MAH SIEW HOE
K090612 03/06/2009 BENACEL UNICARE BIOMEDICAL STAN YANG
K090840 03/27/2009 VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN. VENTLAB CORP. JAMES A COCHIE
K090749 03/20/2009 ROOGRAPH EVO, MODEL 9307XY11Z1, ROTOGRAPH EVO D, MODEL 9307XY1191 VILLA SISTEMI MEDICALI S.P.A. PAOLO C SANTIN
K090679 03/16/2009 VESSELINK MICROVASCULAR ANASTOMOTIC COUPLER SYSTEM VIOPTIX, INC. GRACE HOLLAND
K090649 03/11/2009 VRAD PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM SOFTWARE VIRTUAL RADIOLOGIC CORPORATION KIMBERLY TOKACH
K090644 03/10/2009 VITABLOCS, MODEL VX55-**** VITA ZAHNFABRIK H. RAUTER GMBH & CO. ELIZABETH WOLFSEN
K090832 03/26/2009 RAPID-I VITROLIFE SWEDEN AB KJELL KJORK
K090843 03/27/2009 AMARIS GINGIVA OPAQUER VOCO GMBH M. TH. PLAUMANN
K090817 03/25/2009 IONOLUX VOCO GMBH M.TH. PLAUMANN
K090548 03/02/2009 CONTRA-ANGLE HANDPIECE KOMET OS30 W & H DENTALWERK BUERMOOS GMBH JOHANN GEORG SCHARL
K090692 03/16/2009 ORTHOLOC 2.0/2.4 PLATE SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. FRED W BOWMAN
K090857 03/30/2009 VALOR ANKLE FUSION NAIL SYSTEM WRIGHT MEDICAL TECHNOLOGY, INC. KELLEN HILLS
K090778 03/23/2009 MTA PROTECTIVE SHEET XYLOS CORPORATION JOYCE ELKINS
K090880 03/31/2009 XYLOS POROUS SURGICAL MESH XYLOS CORPORATION JOYCE ELKINS
K090724 03/19/2009 OR-LIGHT YPERION TECHNOLOGY PASCAL DANET
K090620 03/09/2009 QUIKCLOT INTEVENTIONAL, MODEL P/N 182 Z-MEDICA CORPORATION RONALD E PETERSON
K090723 03/09/2009 HEX-LOCK SHORT ABUTMENT, MODEL SA341, SA342, SA451, SA452, SA561, SA562 SHORT HEALING CAP, MODEL SAHEAL4, SAHEAL5, ZIMMER DENTAL INC. WILLIAM FISHER
K090596 03/05/2009 ZIMMER NATURAL NAIL SYSTEM STAINLESS STEEL TIBIAL NAIL & STAINLESS PIRIFORMIS FOSSA AND GREATER TROCHANTER ANTEGRADE FEM ZIMMER, INC. DANIEL J WILLIMAN
K090736 03/19/2009 POWER INFUSER, MODEL M100B-3A ZOLL MEDICAL CORPORATION EILEEN M BOYLE


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