FDA 510(k) Applications Received During August, 2009

FDA 510(k) Number Submission Date Device Name Applicant Contact
K092638 08/27/2009 FREESTYLE BLOOD GLUCOSE TEST STRIPS, MODELS 100-COUNT: 12401-01, 12101-21, 12101-22, 12101-23 ABBOTT DIABETES CARE INC. ARUL STERLIN
K092602 08/25/2009 FREESTYLE LITE BLOOD GLUCOSE TEST STRIPS, MODELS 100 COUNT: 70827-22, 70827-23, 50 COUNT, 70819-20, 70822-22 ABBOTT DIABETES CARE INC. ARUL STERLIN
K092594 08/24/2009 ACE SURGICAL SECURE- MINI LOCATOR IMPLANT SYSTEM, MODEL 09-2702-OX, 09-2703-OX, 09-2705-OX ACE SURGICAL SUPPLY CO., INC. J.EDWARD CARCHIDI
K092371 08/05/2009 SWIFT-LOCK ANCHOR, MODEL 1192 ADVANCED NEUROMODULATION SYSTEMS PENNY HOUSTON
K092622 08/26/2009 STERRAD 100NX STERILIZER EXPRESS CYCLE ADVANCED STERILIZATION PRODUCTS NANCY CHU
K092503 08/14/2009 RADAR VASCULAR COMPRESSION DEVICES ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
K092655 08/28/2009 C. ALBICANS PNA FISH ADVANDX, INC. PAULA E BULGER
K092393 08/05/2009 EK/P. AERUGINOSA PNA FISH ADVANDX, INC. PAULA E BULGER
K092669 08/31/2009 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. JEFFERY A JEDLICKA
K092628 08/27/2009 ENTERAL FEEDING TUBE AND ACCESSORIES, FEEDING TUBE EXTENSION SET ALAN REID PAUL DRYDEN
K092427 08/31/2009 SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) ALBERT DAVYDOV DDS PC PROFESSIONAL ALBERT DAVYDOV
K092635 08/27/2009 ALCATEL-LUCENT TELEHEATH MANAGER ALCATEL-LUCENT CANADA INC. ALEX GIOSA
K092568 08/20/2009 SPARTAN S3 FACET SYSTEM AMENDIA, INC. RICHARD JANSEN
K092588 08/24/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5910,KD-5911, KD-5918 ANDON HEALTH CO.,LTD LIU YI
K092510 08/17/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7901, KD-7905, KD-7911 ANDON HEALTH CO.,LTD LIU YI
K092327 08/04/2009 MICRO-TOUCH NITRA FREE ANSELL HEALTHCARE PRODUCTS LLC CYNTHIA A INGRAM
K092539 08/19/2009 SEAMFREE APEX DENTAL MATERIALS, INC. CHRIS KULTON
K092472 08/12/2009 NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT ASCEND EAGLE, INC. JANNA TUCKER
K092440 08/10/2009 ASCENSION CANNULATED SCREW SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K092425 08/07/2009 REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 ASCENT HEALTHCARE SOLUTIONS AMANDA BABCOCK
K092597 08/24/2009 CENTROS CHRONIC HEMODIALYSIS CATHETER SET ASH ACCESS TECHNOLOGY, INC. ROLAND WINGER
K092593 08/24/2009 PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) ATOS MEDICAL AB FERENC DAHNER
K092313 08/24/2009 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B. BRAUN MEDICAL, INC. SUSAN OLINGER
K092487 08/13/2009 HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K092328 08/04/2009 MED-SEG, MODEL BTMS 1000 BARTRON MEDICAL IMAGING, INC. ZVI LADIN
K092318 08/04/2009 BAXJECT II HI-FLOW NEEDLELESS TRANSFER DEVICE BAXTER HEALTHCARE CORPORATION VALERIE FOLLOWELL
K092337 08/04/2009 PAIN MANAGEMENT OPTIMA, MODEL PMO21-100-05, PMO20-100-10CS, PMO20-145-10CS BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K092505 08/14/2009 BECKMAN COULTER FERRITIN REAGENT, MODEL: OSR61203 BECKMAN COULTER, INC. CATRIONA NEILAN
K092533 08/19/2009 FORCE FIBER BLUE ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES BEERE PRECISION MEDICAL INSTRUMENTS, KMEDIC, TELEF JOY VOIGT
K092652 08/28/2009 FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. LEI CHEN
K092620 08/26/2009 MD300C318 FINGERTIP PULSE OXIMETER BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. YAJING LI
K092549 08/19/2009 OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P BIO MEDICAL TECHNOLOGIES CO., LTD CATHRYN CAMBRIA
K092587 08/24/2009 BIOPLEX 2200 RUBELLA & CMV IGM KIT ON THE BIOPLEX 2200 MULTI ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES PATRICIA KLIMLEY
K092355 08/04/2009 MONOLISA ANTI-HAV EIA BIO-RAD LABORATORIES, INC. LINDA STASWICK
K092353 08/04/2009 MONOLISA ANTI-HAV IGM EIA BIO-RAD LABORATORIES, INC. LINDA STASWICK
K092333 08/04/2009 PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 BIOIMAGENE, INC. INDU P LAKSHMAN
K092454 08/12/2009 VITEK 2 YEAST VORICONAZOLE BIOMERIEUX, INC. NANCY WEAVER
K092341 08/12/2009 LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION BIOMET 3I, INC. JOSE E CABRERA
K092528 08/18/2009 BIOMET FORERUNNER LOCKING PLATE SYSTEM BIOMET TRAUMA (AKA EBI, LP) MARGARET CROWE
K092541 08/19/2009 INTERFACE BIOSTRUCTURES DAVE BALDING
K092624 08/26/2009 FIREBIRD SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K092666 08/31/2009 INZONE DETACHMENT SYSTEM, MODEL M00345100940, IZDS CONNECTING CABLE, MODEL M00345100250 BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K092455 08/12/2009 MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM BOSTON SCIENTIFIC CORPORATION SHANNON PETIT
K092383 08/05/2009 BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 BOVIE MEDICAL CORPORATION RICHARD KOZLOFF
K092429 08/07/2009 ENDOGATOR BYRNE MEDICAL, INC. DON BYRNE
K092607 08/25/2009 AJUST ADJUSTABLE SINGLE INCISION SLING C.R. BARD, INC. JOHN C KNORPP
K092483 08/13/2009 BARD PERMAFIX FIXATION SYSTEM, MODEL 0113012, 0113014, 0113016, 0116018 C.R. BARD, INC. KEVIN STEVENS
K092565 08/20/2009 DIGITAL RETINAL CAMERA CX-1 CANON COMPONENTS, INC. SHEILA DRISCOLL
K092616 08/26/2009 ASCENT BOND UNIVERSAL ADHESIVE SYSTEM, MODELS 006-00029, 006-00030, 006-00044, 006-00045 CAO GROUP, INC. ROBERT K LARSEN
K092484 08/13/2009 HELIOX LOW FLOW SENTRY BLENDER CARDINAL HEALTH 207, INC. MONTHER ABUSHABAN
K092384 08/05/2009 LIQUICORD CENTRIX, INC. ROGER MASTRONY
K092362 08/04/2009 SLEEPWEAVER NASAL CPAP MASK CIRCADIANCE LLC DAVID GROLL
K092619 08/26/2009 ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER CIVCO JAMES LEONG
K092437 08/07/2009 CODMAN STERILIZATION CONTAINERS CODMAN & SHURTLEFF, INC. PAUL AMARAL
K092608 08/25/2009 SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX COLLAGEN MATRIX, INC. PEGGY HANSEN
K092391 08/05/2009 MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED CONCORD MEDICAL PRODUCTS RANDALL FINCKE
K092441 08/10/2009 MODIFICATION TO: CONFORMIS IUNI UNICONDYLAR KNEE REPAIR SYSTEM CONFORMIS, INC. AMITA SHAH
K092414 08/07/2009 CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM CONMED CORPORATION SANDY COVELESKI
K092359 08/04/2009 ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A COOK IRELAND LTD TRACY MORIARTY
K092398 08/06/2009 HSV STRAW CRYO BIO SYSTEM DAVE BALDING
K092364 08/05/2009 MODEL 220 PATIENT MAGNET CYBERONICS, INC. KAREN STUEBER
K092319 08/04/2009 STAR VPS, MODEL 80014-01, FIRST QUATER, MODEL 90649, FIRST HALF, MODEL 89387 DANVILLE MATERIALS, INC. CRAIG BRUNS
K092547 08/19/2009 DENTIMAX DIGITAL X-RAY IMAGING SYSTEM SENSOR SIZE 1, 2, DENTIMAX USB CONTROL BOX DENTIMAX KORINA A AKHONDZADEH
K092614 08/26/2009 X-SMART EASY DENTSPLY INTERNTIONAL HELEN LEWIS
K092626 08/27/2009 MODIFICATION TO: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K092473 08/17/2009 EXPEDIUM SPINE SYSTEM DEPUY SPINE,INC LISA GILMAN
K092317 08/04/2009 DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM DEROYAL INDUSTRIES, INC. GRACIE GREENWAY
K092417 08/07/2009 INSIGHT ULTRASONIC INSERTS DISCUS DENTAL, LLC WINKIE WONG
K092479 08/13/2009 SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL DYN'R XAVIER ISNARD
K092488 08/13/2009 DYNAREX STERILE LUBRICATING JELLY DYNAREX CORPORATION DANIEL CONSAGA
K092589 08/24/2009 THERMOTEX PLATINUM SYSTEM EAS CONSULTING GROUP LLC EDUARDO MARCH
K092336 08/04/2009 C-THRU SPINAL SYSTEM EBI, L.P. VIVIAN KELLY
K092574 08/21/2009 ESL SPINAL SYSTEM EBI, L.P. VIVIAN KELLY
K092670 08/31/2009 BIODRIVE MICRO SCREW SYSTEM EBI,LLC D/B/A BIOMET TRAUMA SHIKHA GOLA
K092428 08/07/2009 BIO-OSS COLLAGEN ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER REICHERTZ
K092509 08/17/2009 EDWARDS LIFESCIENCES VENOUS RETURN CANNULAE EDWARDS LIFESCIENCES, LLC. KAREN JONES
K092330 08/04/2009 OC-SENSOR DIANA IFOB TEST EIKEN CHEMICAL CO., LTD.
K092613 08/26/2009 COLOR LCD MONITOR, MODEL RADIFORCE RS210 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K092331 08/11/2009 DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; ENCORE MEDICAL, L.P. TEFFANY HUTTO
K092400 08/06/2009 ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 ENDOGASTRIC SOLUTIONS, INC. STEVE HOFFMAN
K092418 08/06/2009 ENTRACARE GASTROSTOMY FEEDING TUBE ENTRACARE, LLC BRANDON CONVERSE
K092469 08/11/2009 O-SCAN MR SYSTEM ESAOTE S.P.A. ALLISON SCOTT
K092577 08/21/2009 ETHICON ENDO-SURGERY LINEAR CUTTER 55MM (NTLC55),SELECTABLE CARTRIDGE 55 / 75MM (SR55/75) ,LINEAR CUTTER 75MM (NTLC75) ETHICON ENDO-SURGERY, LLC ABHILASHA MUKHERJEE
K092590 08/24/2009 PDS PLATES ETHICON, INC. LESLIE YOUNG
K092495 08/24/2009 HYPERGLIDE OCCLUSION BALLOON SYSTEM, MODEL 104-4310, 104-4315 EV3 NEUROVASCULAR LAURIE E CARTWRIGHT
K092548 08/19/2009 EXTREMITY MEDICAL TRAPEZIUM PROSTHESIS EXTREMITY MEDICAL LLC JAMY GANNOE
K092297 08/05/2009 ELETONE CREAM FERNDALE PHARMA GROUP, INC. RICHARD A HAMER
K092579 08/25/2009 INTRAUTERINE INSEMINATION (IUI) CATHETER FERTILIGENT, LTD JOHN A STEEN
K092562 08/20/2009 MICROTARGETING STAR DRIVE SYSTEM, COMPONENTS FHC, INC. LEE D MARGOLIN
K092629 08/27/2009 SNM FIRMGRIP FLEXICATH LTD. TALI HAZAN
K092433 08/07/2009 DYSIS FORTH PHOTONICS HELLAS SA JUAN CARLOS SERNA
K092645 08/27/2009 FDI GLUCOSE CONTROL LEVELS 1, 2 AND 3 FUJIREBIO DIAGNOSTICS, INC. JOHN GORMLEY
K092369 08/05/2009 12SL ECG ANALYSIS PROGRAM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES JOE LUCAS
K092639 08/27/2009 INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP GE MEDICAL SYSTEMS SCS NICOLE LANDREVILLE
K092231 08/11/2009 GEBDI TRIBOS 501 GEBDI DENTAL-PRODUCTS GMBH THOMAS BISKUPSKI
K092576 08/21/2009 GEM HEART ONE/ONE+ GEM-MED S.L. WILSON TSENG
K092471 08/11/2009 MODEL SENTINELLA 102 GENERAL EQUIPMENT FOR MEDICAL IMAGING S.A SEVERINE MOINE
K092623 08/26/2009 F.A.S.T. SYSTEM SED AND CXD GENESIS MEDICAL INTERVENTIONAL, INC. ANNE WORDEN
K092513 08/17/2009 RAINBOW BLOCK GENOSS CO., LTD. EUNKYUNG SON
K092667 08/31/2009 GLOBAL DMSO BLASTOCYST VITRIFICATION KIT AND WARMING KIT GENX INTL., INC. MICHAEL D CECCHI
K092578 08/21/2009 LIFEGLOBAL PROTEIN SUPPLEMENT GENX INTL., INC. MICHAEL D CECCHI
K092633 08/27/2009 OSOM INFLUENZA A&B TEST , MODEL PN190 GENZYME CORPORATION FIL BUENVIAJE
K092421 08/31/2009 ALPHAHYSTEROSCOPE, FIBEROPTIC, OPERATIVE AND DIAGNOSTIC GIMMI GMBH KEN BLAKE
K092610 08/25/2009 MODIFICATION TO BEACON STABILIZATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K092546 08/19/2009 GMDASZ TENS ELECTRODES, MODELS CWN1005, DIA. 5CM, DWN2505, 5CMX5CM, CWN1007.DIA. 7CM, CWN2509,5CMX9CM GMDASZ MANUFACTURING CO., LTD CHARLIE MACK
K092373 08/05/2009 ICS CHARTR EP 200 GN OTOMETRICS DANIEL KAMM
K092493 08/14/2009 GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM GPC MEDICAL LTD VIKAS NARANG
K092571 08/21/2009 GYRUS ACMI BIOCOAG PROBE GYRUS ACMI, INC. LORRAINE CALZETTA
K092447 08/10/2009 DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K092514 08/17/2009 UPPERARM DIGITAL BLOOD PRESSURE MONITOR, MODEL: MB-300 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K092557 08/20/2009 DIGITAL THERMOMETER,HMCDT-002/KINETIK BRANDED DT1 SERIES HARVARD MEDICAL DEVICES LTD. MARTIN MA
K092558 08/20/2009 WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES HARVARD MEDICAL DEVICES LTD. MARTIN MA
K092650 08/27/2009 HEARTWAY POWER MOBILITY SCOOTER, S12 HEARTWAY MEDICAL PRODUCTS CO., LTD. KE MIN JEN
K092357 08/04/2009 CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2 HEMCON MEDICAL TECHNOLOGIES, INC. KEVIN HAWKINS
K092448 08/10/2009 HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 HIVOX BIOTEK, INC. KE-MIN JEN
K092405 08/06/2009 MAMMOSITE MULTI LUMEN HOLOGIC, INC. JENNIFER SULLIVAN
K092570 08/21/2009 ABX PENTRA TPU CAL, MODEL A11A01898 HORIBA ABX SAS CAROLINE FERRER
K092561 08/21/2009 REJUVENATE MODULAR STEM HOWMEDICA OSTEONICS CORP ESTELA CELI
K092406 08/06/2009 ABG II MODULAR HIP STEM HOWMEDICA OSTEONICS CORP. ESTELA CELI
K092419 08/06/2009 AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 3MM LOCKING INSERTS HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K092671 08/31/2009 VARIAX ELBOW SYSTEM LINE EXTENSION HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K092381 08/05/2009 IBALANCE AKRFX MEDIAL OPENING WEDGE TIBIAL SYSTEM, IFX MEDIAL PEEK IMPLANT AND ANCHOR, AKRFX INSTRUMENTATION IBALANCE MEDICAL, INC. JANICE M HOGAN
K092601 08/24/2009 IMMULISA ANCA SCREEN ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K092599 08/24/2009 IMMULISA MPO ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K092600 08/24/2009 IMMULISA PR3 ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K092545 08/19/2009 INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS LLC LARRY LEPLEY
K092544 08/19/2009 INSTRUMED VASCULAR CLAMPS INSTRUMED INTERNATIONAL, INC. MICHAEL MASSONG
K092591 08/24/2009 ORTHOPANTOMOGRAPH OP30 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY JOUNI ONNELA
K092395 08/05/2009 OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM INTEGRA LIFESCIENCES CORP. DONNA MILLISKY
K092388 08/05/2009 DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO INTEGRA LIFESCIENCES CORPORATION PETER ALLAN
K092409 08/12/2009 HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER INTERSURGICAL, INC. MICHAEL ZALEWSKI
K092451 08/27/2009 INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER INTERSURGICAL, INC. MICHAEL ZALEWSKI
K092361 08/04/2009 REEF HP 0.035" OTW PTA BALLOON DILATATION CATHETER INVATEC S.P.A. JOHN CLAY
K092352 08/04/2009 SCUBA BILIARY STENT SYSTEM INVATEC S.P.A. STEVE CAMP
K092349 08/04/2009 CLEARVIEW EXACT II INFLUENZA A & B TEST INVERNESS MEDICAL, INC. ANNE JEPSON
K092430 08/07/2009 1 ML FIXED NEEDLE, 3 ML LUER LOCK, 5 ML LUER LOCK, 10 ML LUER LOCK, 20 ML LUERL LOCK SAFETY SYRINGES INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K092413 08/07/2009 INVIROSNAP 50 AND 100 UNIT INSULIN SAFETY SYRINGES INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K092458 08/11/2009 PROXCELAN CS-131PRELOADED STRANDS, MODEL PL-1, PROXCELAN CS-131 PRELOADED STRANDS IN 18 GUAGE NEEDLES, MODEL PL-2 ISORAY MEDICAL, INC. FRED SWINDLER
K092432 08/07/2009 AUTOMOATIC BLOOD PRESSURE MONITOR, MODELS: EASY X 800 AND 900 (R/L) JAWON MEDICAL CO., LTD. H L JUNG
K092431 08/07/2009 BODY COMPOSITION ANALYZER, MODEL: IOI 353 JAWON MEDICAL CO., LTD. H L JUNG
K092326 08/04/2009 SMOOTHCOOL JEISYS MEDICAL, INC. KEVIN WALLS
K092634 08/27/2009 OBS DISPOSABLE ELECTROSURGICAL PENCILS, MODELS: OBS-DB, OBS-DR, OBS-DF JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO CHEN XI
K092335 08/04/2009 PEAK EXPIRATORY FLOW METER, KN-9710 K-JUMP HEALTH CO., LTD. JASON CHENG
K092640 08/27/2009 CASPIAN SPINAL SYSTEM K2M, INC. RICHARD W WOODS
K092474 08/13/2009 PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS K2M, INC. RICHARD W WOODS
K092446 08/10/2009 INTRA LUX HEAD 3 LDSY KALTENBACH & VOIGT GMBH & CO. CLAUDIA ORTIZ
K092281 08/04/2009 CLEARFIL MAJESTY POSTERIOR PLT KURARAY MEDICAL INC. KIYOYUKI ARIKAWA
K092344 08/04/2009 LAC-MAC INNERBLOC LR SURGICAL GOWNS LAC MAC, LTD. JEFFREY O STULL
K092499 08/14/2009 LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) LAGLOVE (M) SDN. BHD. G BASKARAN
K092498 08/14/2009 LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) LAGLOVE (M) SDN. BHD. G. BASKARAN
K092656 08/28/2009 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM LANX, INC. ANDREW LAMBORNE
K092536 08/19/2009 SPINAL FIXATION SYSTEM LANX, INC. JANICE M HOGAN
K092647 08/27/2009 LENSX 550 LASER SYSTEM LENSX LASERS, INC. JUDY GORDON
K092550 08/21/2009 TIGRT IVS LINATECH, LLC JONATHAN YAO
K092555 08/20/2009 UNO NARROW IMPLANT M.I.S. IMPLANTS TECHNOLOGIES LTD. IMAN KHORSHID
K092338 08/04/2009 MEDAX UNIPERSONALE SRL MEDAX UNIPERSONALE SRL FLAVIO TOMASSINI
K092653 08/28/2009 VERISUITE AND VERISUITE-PARTICLE, VERSION 1.8 MEDCOM GMBH STEFAN WALTER
K092347 08/17/2009 PRO-PICC CT MEDCOMP JEAN CALLOW
K092491 08/13/2009 MEDEFIL'S HEPARIN I.V. FLUSH SYRINGE 1 UNIT/ML; 10 UNITS/ML; AND 100 UNITS/ML IN VARIOUS FILL SIZES MEDEFIL, INC. PRADEEP AGGARWAL
K092506 08/17/2009 EASYRA GLU-H REAGENT, MODEL 10200 MEDICA CORP. PHOTIOS MAKRIS
K092284 08/07/2009 LIPISYSTEMS AQUAVAGE, MODELS AV2000 AND AV1200 MEDICAL DEVICE RESOURCE CORP. MELBOURNE KIMSEY
K092542 08/19/2009 M MEDISCITEC INC. KEVIN WALLS
K092564 08/20/2009 O-ARM IMAGING SYSTEM MEDTRONIC NAVIGATION, INC. (LITTLETON) SETH KUZDZAL
K092325 08/04/2009 MODIFICATION TO:CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. BRAD SHEALS
K092553 08/20/2009 TRU FLU, MODEL 751230 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K092343 08/04/2009 EN SNARE ENDOVASCULAR SNARE SYSTEM MERIT MEDICAL SYSTEMS, INC. GLENN NORTON
K092584 08/24/2009 LAPORT MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) PATRICK GAENSICKE
K092456 08/10/2009 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BS1-3C MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K092387 08/14/2009 MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM MINNTECH CORP. RICHARD M ORMSBEE
K092581 08/21/2009 MITS DICOM GATEWAY AND IMAGE MANAGER MITSMED MEDICAL INSTRUMENT TECHNOLOGY CO., LTD. KE-MIN JEN
K092566 08/20/2009 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM (RVNATSP) NANOSPHERE, INC GREGORY W SHIPP
K092477 08/12/2009 NEUROSENSE MONITORING SYSTEM, MODEL NS-701 NEUROWAVE SYSTEMS, INC. TRACIE CAPOZZIO
K092481 08/13/2009 HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 NEW AQUA LLC (DBA AQUA SYSTEMS) NEVIN RUDIE
K092527 08/18/2009 NEXUS INJECTION SITE, MODEL NIS-8 NEXUS MEDICAL, LLC HEATHER TURNER
K092382 08/05/2009 NEXUS PRESSURE RATED EXTENSION SETS NEXUS MEDICAL, LLC SUSAN CURRY
K092573 08/20/2009 NIHON KOHDEN QP-160AK EEG TREND PROGRAM NIHON KOHDEN AMERICA, INC. STEVE GEERDES
K092501 08/14/2009 LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL NOVOCOL, INC. STEVE RUDOLPH
K091386 08/03/2009 MICROFUSE DUAL RATE INFUSER NUMIA MEDICAL TECHNOLOGY, LLC ERIC FLACHBART
K092309 08/03/2009 SINGLE USE ELECTROSURGICAL KNIFE SERIES, MODEL KD-610L, KD-611L, KD-620LR, KD-630L, KF-640L OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
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