FDA 510(k) Decisions During April, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K083672 04/13/2009 P.D SOFTWARE .DECIMAL, INC. DANIEL BENNETT
K090569 04/29/2009 MODIFICATION TO: ATTEST RAPID READOUT BIOLOGICAL INDICATOR, MODE 1292 3M COMPANY BRYAN BECKER
K090519 04/15/2009 VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 3M COMPANY KAREN O'MALLEY
K090460 04/14/2009 BONOS INJECT AAP BIOMATERIALS GMBH VOLKER STIRNAL
K083223 04/16/2009 RELION ULTIMA BLOOD GLUCOSE MONITORING SYSTEM, MODELS 70055-50, STRIPS (20 COUNT): 70973-01 ABBOTT DIABETES CARE INC. ARUL STERLIN
K083809 04/07/2009 CREATININE ABBOTT LABORATORIES LINDA MORRIS
K083111 04/16/2009 IMPELLA 5.0 CATHETER FAMILY ABIOMED, INC. WILLIAM BOLT
K090300 04/30/2009 MODIFICATION TO AUTOFUSER ACE MEDICAL US, LLC ANDREW LAMBORNE
K090057 04/08/2009 ON-CALL PLUS BLOOD GLUCOSE MONITORING SYSTEM ACON LABORATORIES CO. RICHARD LENART
K090031 04/16/2009 ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010 ACTHERM, INC. RICHARD HSIEH
K083539 04/03/2009 INFANT CARDIAC ARRAY ADVANCED IMAGING RESEARCH, INC. RAVI SRINIVASAN
K090299 04/24/2009 BIOLOX OPTION CERAMIC FEMORAL HEAD AND METHA XL HEADS AESCULAP IMPLANT SYSTEMS KATHY A RACOSKY
K090657 04/20/2009 MODIFICATION TO: S4 SPINAL SYSTEM AESCULAP IMPLANT SYSTEMS LISA M BOYLE
K090138 04/24/2009 MOBILECARE MONITOR, MODEL 2100 AFRAME DIGITAL, INC. DARREN REEVES
K082080 04/01/2009 ALCO TUBE PLUS ALCOTEST QUEBEC E.J. SMITH
K083848 04/14/2009 ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM ALMA LASERS LTD. TATIANA EPSTEIN
K090782 04/22/2009 NOVEL ALIF SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. MARY STANNERS
K090228 04/29/2009 ROC LUMBAR PLATING SYSTEM ALPHATEC SPINE, INC. KARLA SCHAFFNER
K090854 04/16/2009 ABT GLUCOSE CONTROL SOLUTION, MODEL 2120090 AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GROMLEY
K082333 04/02/2009 ASAP WOUND DRESSING GEL AMERICAN BIOTECH LABS JAMES S TURNER
K090663 04/09/2009 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC. STEPHANIE GEORGE
K090713 04/02/2009 ELEVATE PROLAPSE REPAIR SYSTEM WITH PC COATED INTEPRO LITE- APICAL AND POSTERIOR PROLAPSE REPAIR SYSTEM, ANTERIOR AND AP AMERICAN MEDICAL SYSTEMS, INC. DENISE THOMPSON
K090963 04/30/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 ANDON HEALTH CO.,LTD LIU YI
K090043 04/09/2009 AUTOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011F9 APEX BIOTECHNOLOGY CORP. THOMAS Y.S. SHEN
K083656 04/22/2009 APEX MEDICAL XT AUTO CPAP 9S-005200 APEX MEDICAL CORP. ALAN CHANG
K082325 04/21/2009 APEXUM ABLATOR APEXUM LTD. IDAN TOBIS
K082846 04/03/2009 APK SPO2 PULSE OXIMETER SENSOR APK TECHNOLOGY CO., LTD DIANA HONG
K083278 04/08/2009 AVC A/H5N1 FLU TEST ARBOR VITA CORPORTATION LINDA ALLISTER
K082951 04/08/2009 IMMERSION HYDROBATH ARJO HOSPITAL EQUIPMENT AB TRACI GIOVENCO
K083799 04/16/2009 TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K083007 04/08/2009 PROWICK ARTHREX, INC. SALLY FOUST
K090323 04/01/2009 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ASCENT HEALTHCARE SOLUTIONS KATIE BRAY
K083871 04/15/2009 ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE ASTRA TECH, INC. BETSY A BROWN
K090130 04/02/2009 ATMOS S041 WOUND ATMOS INC. CARL ALLETTO
K090121 04/15/2009 PRE-FILLED CATHETER INFLATION SYRINGE AVAIL MEDICAL PRODUCTS, INC. PATRICIA A GOEREE
K090905 04/27/2009 ADDEASE 20MM BINARY CONNECTOR WITH 17 GA. NEEDLE B. BRAUN MEDICAL, INC. ANGELA J CARAVELLA
K090603 04/22/2009 BARCO 5MP MAMMO, MODEL MDMG-5221 BARCO NV ALBERT XTHONA
K090732 04/20/2009 NIO COLOR 3MP AND MDNC-3121 BARCO NV LIEVEN DE WANDEL
K082251 04/08/2009 SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 BECKMAN COULTER, INC. MARINE BOYAJIAN
K083466 04/03/2009 MD2000A VITAL SIGN MONITOR, MODEL MD2000A BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. DIANA HONG
K090873 04/10/2009 I OPEN 0.5T BEIJING WANDONG MEDICAL EQUIPMENT CO., LTD. WANG WEIMIN
K090999 04/15/2009 BIOCARDIA MORPH SHEATH GUIDE BIOCARDIA, INC. DAVID SNOW
K090759 04/01/2009 BIODRAIN STREAMWAY FLUID MANAGEMENT SYSTEM BIODRAIN MEDICAL, INC. CHAD RUWE
K090003 04/02/2009 ZETAJET BIOJECT, INC. KRIS RICHARD
K083595 04/14/2009 EZLASE BIOLASE TECHNOLOGY, INC. IOANA RIZOUI
K080561 04/10/2009 VIDAS CA 125 II ASSAY BIOMERIEUX, INC. SANDRA L PERREAND
K083779 04/03/2009 MAK OSS KNEE FEMORAL COMPONENTS BIOMET MANUFACTURING CORP. PATRICIA S BERES
K083782 04/03/2009 REGENEREX PATELLA COMPONENTS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K082793 04/02/2009 INTERGRO DBM BIOMET SPINE KATHLEEN IDEO
K083674 04/01/2009 PK-141 PATIENT CABLE BIOTRONIK, INC. JON BRUMBAUGH
K090607 04/22/2009 BLUE SKY BIO PLAN, VERSION .38 BLUE SKY BIO, LLC ALBERT ZICKMANN
K090297 04/14/2009 BLUESHINE GOLD SERIES BLUESHINE SRL CHIARA RICCI
K083374 04/22/2009 WALLFLEX BILIARY RX PARTIALLY-COVERED STENT SYSTEM BOSTON SCIENTIFIC CORP. MARYBETH GAMBER
K083627 04/07/2009 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 BOSTON SCIENTIFIC CORPORATION MARYBETH GAMBER
K083483 04/08/2009 BRAINLAB HIP UNLIMITED, CI HIP UNLIMITED BRAINLAB AG MICHAEL HOTTNER
K083310 04/01/2009 SPINE & TRAUMA ICT BRAINLAB AG RAINER BIRKENBACH
K090743 04/03/2009 YIELD MINI DOPPLER SYSTEM BRONCUS TECHNOLOGIES, INC. NANCY ISAAC
K090853 04/07/2009 YIELD TISSUE SAMPLER BRONCUS TECHNOLOGIES, INC. NANCY ISAAC
K090134 04/21/2009 INTRAVENOUS POWER INJECTOR EXTENSION SET C.R. BARD, INC. SCOTT PEASE
K091017 04/29/2009 CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM, MODEL FG-000001 CARDICA, INC. KIMBERLEE LEON
K090872 04/21/2009 MODIFICATION TO CARDICA C-PORT XA DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. KIMBERLEE LEON
K090014 04/09/2009 CAREMATE SPHYGMOMANOMETER WITH STETHOSCOPE CAREMATE MEDICAL DEVICE CO., LTD XIAOMING HONG
K090318 04/06/2009 CARESTREAM DRX-1 SYSTEM CARESTREAM HEALTH, INC. CHRISTINE EHMANN
K090013 04/21/2009 CHEMPAQ XBC ANALYZER CHEMPAQ A/S LONE HOFFENSETS
K083216 04/14/2009 CIBA VISION (NELFILCON A) ONE-DAY SOFT CONTACT LENSES CIBA VISION CORPORATION MARTINA HEIM
K082038 04/28/2009 CLARUS VIDEO AIRWAY ENDOSCOPE, MODELS 30000-V AND 30003-V CLARUS MEDICAL, LLC. THOMAS BARTHEL
K083554 04/21/2009 CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 CLINIQA CORPORATION DAWN GAST
K090217 04/23/2009 BONEE NEEDLE FOR BLADDER INJECTIONS, MODELSNBI035, NBI070 COLOPLAST A/S SURESH GHAL
K083351 04/24/2009 PROABLE PULSE OXIMETER, MODEL MD-600P, TRAVELER OXIMETER, MODEL MD-650P AND PALM PULSE OXIMETER, MODEL MD-680P COMDEK INDUSTRIAL CORP. Y.S. KUO
K083482 04/02/2009 COOK VASCULAR VITAL-JECT POWER INJECTABLE SAFETY INFUSION SET COOK VASCULAR INC. JIM FERGUSON, JR.
K090822 04/27/2009 ADVANCE 14RX RAPID EXCHANGE PTA BALLOON CATHETER COOK, INC. NATHAN SIMON
K090624 04/02/2009 COOK MREYE EMBOLIZATION COILS COOK, INC. SUSANNE GALIN
K090303 04/30/2009 XTEND-ST NUCLEUS REMOVAL SYSTEM, MODEL 9004 CORESPINE TECHNOLOGIES, LLC BRITT K NORTON
K091084 04/29/2009 MAXIM MENSTRUAL TAMPONS & ORGANYC MENSTRUAL TAMPONS COTTON HIGH TECH SL ELENA GOMEZ
K090352 04/03/2009 TAPERGUARD ENDOTRACHEAL TUBES, TAPERGUARD EVAC ENDOTRACHEAL TUBES COVIDIEN TED KUHN
K083350 04/21/2009 TENS/NMES/FES STIMULATING ELECTRODE COVIDIEN LP WEI ZHAO
K083519 04/10/2009 AUTOSUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES FRANK GIANELLI
K083693 04/02/2009 PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. KIM BLOOM
K090049 04/20/2009 ATLAS IMPLANT SYSTEM- MINI PLUS COWELLMEDI CO., LTD JUNG BAE BANG
K090618 04/14/2009 CYNOSURE SMARTCOOL FAMILY COLD AIR DEVICE: SMARTCOOL, SMARTCOOL 6 AND CRYO C CYNOSURE, INC. GEORGE CHO
K083586 04/29/2009 I-FIX SYSTEM DENTIS CO. LTD. JUNG BAE BANG
K083841 04/14/2009 ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K090669 04/03/2009 RIGIDFIX BIOCRYL CROSS PIN KITS DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K090799 04/22/2009 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K090695 04/23/2009 DINKLER SURGICAL SKULL CLAMP, MODEL 0308 DINKLER SURGICAL DEVICES, INC. CHARLES E DINKLER III
K090171 04/30/2009 COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D E-WOO TECHNOLOGY VINCENT LEE
K083623 04/15/2009 CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 EDWARDS LIFESCIENCES, LLC. ERICA WALTERS
K083191 04/10/2009 DETLOGIX ANNULOPLASTY RING, MODEL: 5100 EDWARDS LIFESCIENCES, LLC. MARTIN A KAUFMAN
K090064 04/09/2009 EMINENT SPINE INTERBODY FUSION SYSTEM EMINENT SPINE DAVE FREEHILL
K083381 04/15/2009 EUROIMMUN ANTI-DSDNA-NCX ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K082130 04/07/2009 EUROIMMUN ANTI-PR3-HN-HR ELISA (IGG) EUROIMMUN US INC KATHRYN KOHL
K090728 04/16/2009 HYPERGLIDE OCCLUSION BALLOON SYSTEM EV3 INC. JASON K LYON
K083793 04/27/2009 STEERABLE GUIDE CATHETER EVALVE INC KARUNA VELUSAMY
K090764 04/21/2009 NOVATION CFS PRESS-FIT AND CEMENTED STEMS EXACTECH, INC. TARA R PATTERSON
K083508 04/28/2009 SWABCAP EXCELSIOR MEDICAL CORP. ROSHANA AHMED
K090801 04/08/2009 ELECTRONIC HOUSE CALL EXPRESS MD SOLUTIONS, LLC CHRIS DOHERTY
K082934 04/23/2009 EXTREMITY MEDICAL MIDFOOT SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K083889 04/23/2009 FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY FOTONA D.D. STOJAN TROST
K090116 04/22/2009 FUJINON COLONOSCOPE FOR DOUBLE BALLOON ENTERSCOPY SYSTEM MODEL, EC-450B15 FUJINON, INC. MASAYUKI OOYATSU
K090892 04/30/2009 GE DATEX-OHMEDA S/5 ADU CARESTATION GE HEALTHCARE FINLAND OY ADRIENNE LENZ
K083098 04/01/2009 NAVIGATOR APPLICATIONS SUITE GE HEALTHCARE FINLAND OY ADRIENNE LENZ
K090702 04/15/2009 MODIFICATION TO DASH 2500 PATIENT MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DAVID WAHLIG
K090638 04/29/2009 GENADYNE A4-XLR8 WOUND VACUUM SYSTEM GENADYNE BIOTECHNOLOGIES, INC. CHIEN-MING GOH
K083509 04/24/2009 LIFEGLOBAL HUMAN SERUM ALBUMIN LG HSA GENX INTL., INC. MICHAEL D CECCHI
K072500 04/21/2009 ONE STEP HCG URINE/SERUM TEST GUANGZHOU WONDFO BIOTECH CO., LTD. HOWARD MANN
K090814 04/20/2009 MODIFICATION TO GYRUS ACMI INVISIO ICN, MODELS ICN-0564 AND ICN-0565 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K090249 04/03/2009 MODIFICATION TO: MICRO-INDUCTION 1000 SYSTEM HARBINGER MEDICAL, INC. HAROLD HOIUM
K090237 04/17/2009 HG II FIXTURE SYSTEM HIOSSEN INC. MINJOO KIM
K083534 04/13/2009 LIFEBED NETWORK PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. NANCY GERTLAR
K090074 04/22/2009 HYGIA HEALTH SERVICES REPROCESSED COMPRESSION SLEEVES / FOOT CUFFS HYGIA HEALTH SERVICES, INC. JEROME JAMES
K090189 04/10/2009 ANTIMICROBIAL CLAVE, MODELS AG CLAVE, AG MICROCLAVE ICU MEDICAL, INC TRACY BEST
K082806 04/06/2009 SPINNING SPIROS, MODEL CH-2000 ICU MEDICAL, INC TRACY BEST
K083215 04/08/2009 INCISIVE FAMILY OF INPULSE ND:YAG LASERS INCISIVE, LLC. ANN WORDEN
K090506 04/20/2009 MAYFIELD INFINITY XR2 SKULL CLAMP, MODEL A-2114 INTEGRA LIFESCIENCES CORPORATION HELDER A SOUSA
K082470 04/03/2009 SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA INTER-MED, INC. GEORGE HORVAT
K083861 04/09/2009 TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE INTERACOUSTICS AS HANNE NIELSEN
K090192 04/24/2009 BILI BLUE F20T12/BBY AND F40T12/BBY INTERLECTRIC CORP. KEN C FRAZIER
K090070 04/22/2009 INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEM INVUITY, INC. KIT CARIQUITAN
K083058 04/15/2009 IBA PROTON THERAPY SYSTEM - PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K090087 04/07/2009 MRIDIUM 3860 MRI INFUSION PUMP/MONITORING SYSTEM IRADIMED CORPORATION FRANCIS X CASEY
K083590 04/17/2009 ISKRA MEDICAL GREEN IRF PRESTIGE ISKRA MEDICAL, D.O.O. MOJCA VALJAVEC
K090701 04/29/2009 EMPRESS DIRECT IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K082698 04/21/2009 ALEUTIAN IBF SYSTEM K2M, INC. RICHARD WOODS
K090292 04/03/2009 PREMISE MODIFIED KERR CORP. WENDY GARMAN
K083815 04/20/2009 LANX FUSION SYSTEM LANX, INC. ALAN BURKHOLDER
K083581 04/07/2009 LANX SPINAL FIXATION SYSTEM LANX, INC. ANDREW LAMBORNE
K090316 04/07/2009 MODIFICATION TO: LANX ANTERIOR CERVICAL PLATE SYSTEM LANX, INC. ANDREW LAMBORNE
K083203 04/28/2009 HELIOS II Q-SWITCHED ND:YAG LASER SYSTEM LASEROPTEK CO. LTD. PHILLIP CHEON
K090186 04/10/2009 CONMED LINVATEC PALADIN, PRELOADED WITH TWO #2 HI-FI SUTURES LINVATEC CORP. JOY LOVETT
K090475 04/16/2009 VALIDATE CM2 CALIBRATION VERIFICATION / LINEARITY TEST SET, MODEL 402 MAINE STANDARDS CO. HOLLY CRESSMAN
K090147 04/22/2009 BLOOD MONITORING UNIT, MODEL BMU 40 MAQUET CARDIOPULMONARY AG ANASTASIA MUELLER
K083794 04/21/2009 MECC SET WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K083622 04/02/2009 LNCS OXIMETRY SENSORS MASIMO CORPORATION MARGUERITE THOMLINSON
K090411 04/07/2009 FREEDOM METAL BACKED TIBIAL COMPONENT MAXX ORTHOPEDICS, INC. MARY MCNAMARA-CULLINANE
K083116 04/07/2009 VERSAFIT CUP DOUBLE MOBILITY SYSTEM MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K090053 04/23/2009 APTUS 2.0 RADIAL HEAD SYSTEM MEDARTIS AG KEVIN THOMAS
K090714 04/17/2009 VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK MELISA LANSKY
K090063 04/22/2009 MERETE LOCKING BONE PLATE SYSTEM MERETE MEDICAL, INC. JORG MIETZNER
K090148 04/13/2009 PROGUIDE CHRONIC DIALYSIS CATHETER MERIT MEDICAL SYSTEMS, INC. SUSAN CHRISTENSEN
K090357 04/10/2009 HYDROFRAME (HES) MICROVENTION, INC. FLORIN TRUUVERT
K083659 04/16/2009 SILVER WOUND PAD MILLIKEN & CO. MARY MCNAMARA-CULLINANE
K081527 04/01/2009 LIGHT DIAGNOSTICS HSV 1/2 TYPING DFA KIT MILLIPORE CORPORATION ALISHA VU
K083467 04/23/2009 REBOUND HRDV MINNESOTA MEDICAL DEVELOPMENT, INC. STEVE NUSS
K090809 04/28/2009 MPS ACACIA POWER INJECTABLE INFUSION SET MPS ACACIA FERGIE FERGUSON
K083112 04/29/2009 PRIMADO NAKANISHI, INC. KEITH A BARRITT
K090218 04/15/2009 MD213MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR MODEL, L218TJ NEC DISPLAY SOLUTIONS, LTD. ANGUS HSU
K090215 04/15/2009 MD213MG 21.3 DIAGNOSTIC IMAGING LCD MONITOR - L218TL NEC DISPLAY SOLUTIONS, LTD. ANGUS HSU
K082223 04/21/2009 NEUTROLUMENPN SYSTEM, MODEL 1000 NEUROLUMEN, LLC SHELLY HENRY
K090178 04/24/2009 ATTRIUS, MODEL PET150A6001, ATTRIUS L, MODEL PET150A8001, TRUESIGHT, MODEL NSP-P6C, TRUESIGHT, MODEL NSP-P8 NEUSOFT POSITRON MEDICAL SYSTEMS CO., LTD SUN YAN
K090731 04/15/2009 NOVABONE POROUS - SYNTHETIC BONE GRAFT SCAFFOLD NOVABONE PRODUCTS, LLC DAVID M GAISSER
K090176 04/27/2009 NUVASIVE ADJUSTABLE VERTEBRAL BODY REPLACEMENT SYSTEM NUVASIVE, INC. HAN FAN
K090697 04/16/2009 MODIFICATION TO: GIRAFFE AND PANDA WARMER OHMEDA MEDICAL AGATA SMIEJA
K081770 04/02/2009 BLACK WIDOW ANTERIOR BUTTRESS PLATE OMNI SURGICAL, L.P. JOSHUA KAUFMAN
K072732 04/15/2009 ORTHO T. CRUZI ELISA TEST SYSTEM ORTHO-CLINICAL DIAGNOSTICS, INC. ANDREA J CASPER
K091121 04/28/2009 ORTHOSTAT ORTHOCON, INC. KENNETH A COLLINS
K090666 04/24/2009 PEDIPLATES ORTHOPEDIATRICS, CORP. GARY BARNETT
K083012 04/09/2009 PAPCONE OTTO BOCK PUR LIFE SCIENCE GMBH CHRISTIAN SCHULTE
K080950 04/02/2009 STIWELL MED4 OTTO BOCK, AUSTRIA GMBH WILLIAM F JACKSON
K090631 04/16/2009 PAJUNK DISPOSABLE BALLOONS AND BALLOON SYSTEMS PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN G QUASS
K082759 04/10/2009 ELIA CENP IMMUNOASSAY, ELIA U1RNP IMMUNOASSAY, ELIA SM IMMUNOASSAY, ELIA RO IMMUNOASSAY PHADIA US INC. MARTIN R MANN
K090808 04/03/2009 PINNACLE3 SMARTARC PHILIPS MEDICAL SYSTEMS, INC. JILL KAEDER
K083284 04/08/2009 PIEZOSURGERY MEDICAL PIEZOSURGERY SRL ROGER GRAY
K090222 04/28/2009 PIONEER LUMBAR PLATE SYSTEM PIONEER SURGICAL TECHNOLOGY JONATHAN M GILBERT
K090253 04/08/2009 ANGIOJET ULTRA DVX THROMBECTOMY SET, MODEL 106552-001, ANGIOJET ULTRA XPEEDIOR THROMBECTOMY SET, MODEL 105040-001 POSSIS MEDICAL, INC. DOUG ATKINS
K083695 04/28/2009 TRAXODENT PREMIER DENTAL PRODUCTS CO. VINCENT D'ALESSANDRO
K090805 04/03/2009 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
K090239 04/16/2009 PROGASTRO CD ASSAY PRODESSE, INC. KRISTINE SCHRAUFNAGEL
K090464 04/23/2009 BLACK NITRILE EXAMINATION GLOVES, POWDER FREE, NON STERILE PT MAHAKARYA INTI BUANA AZMAN ISMAIL
K083931 04/27/2009 SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE QUANTUM CO., LTD. LIJUAN WANG
K090585 04/02/2009 NEOSALUS CREAM QUINNOVA PHARMACEUTICALS SHAHBAZ KHAN
K082091 04/15/2009 TRI T-STAT REAGENT ASSAY (DRIED FORM) MODEL 25107-00 REAMETRIX INC. STEVE KUNITAKE
K082782 04/02/2009 REPLICATION MEDICAL VESSEL GUARD REPLICATION MEDICAL INC MARCOS VELEZ-DURAN
K090244 04/13/2009 SWIFT FX RESMED LTD. DAVID D'CRUZ
K083901 04/15/2009 NAVI ROOT S-DENTI CO., LTD. KEVIN WALLS
K080243 04/07/2009 PORTABLE OXYGEN UNIT SCA900 SAN CHEONG CO. LTD. JUNG BAE BANG
K090059 04/30/2009 IMAGO C21 DIAGNOSTIC ULTRASOUND SYSTEM SASET (CHENGDU) INC. DONG CHYUAN LIN
K082309 04/09/2009 CAMBRIA SEASPINE, INC. JEFF BRITTAN
K082085 04/17/2009 CAPILLARYS IMMUNOTYPING, MODEL 2100 SEBIA KAREN ANDERSON
K082388 04/14/2009 MINICAP IMMUNOTYPING, MODEL: 2300 SEBIA KAREN ANDERSON
K083349 04/10/2009 BLOOD TRANSFUSION SET SHAN DONG WEI GAO GROUP MEDICAL POLYMER PRODUCTS DIANA HONG
K090131 04/27/2009 DS N95 SURGICAL MASKS AND FLAT SURGICAL SHANGHAI DASHENG HEALTH PRODUCTS MAGGIE ZHONG
K090912 04/15/2009 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM, MODEL DP-6900 SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD TAN CHUANBIN
K083386 04/02/2009 ADVIA CHEMISTRY CALCIUM_2 (CA_2) METHOD, MODELS P/M 02189699 (40 ML FILL), P/N 02189915 (70 ML FILL) SIEMENS HEALTHCARE DIAGNOSTICS CAROL BIANCA
K090236 04/27/2009 DIMENSION VISTA AFP FLEX REAGENT CARTRIDGE, MODEL 6454 SIEMENS HEALTHCARE DIAGNOSTICS JANET M FOSE
K090594 04/29/2009 DIMENSION VISTA IMMUNOGLOBULIN A FLEX REAGENT CARTRIDGE (IGA), AND DIMENSION VISTA IMMUNOGLOBULIN M FLEX REAGENT CARTRID SIEMENS HEALTHCARE DIAGNOSTICS KATHLEEN A DRAY-LYONS
K090038 04/28/2009 SYNGO BREVIS SIEMENS MEDICAL SOLUTIONS USA INC. JUDITH CAMPBELL
K083524 04/01/2009 SYNGO DUAL ENERGY WITH EXTENDED FUNATIONALLY SIEMENS MEDICAL SOLUTIONS USA, INC. CORRINE MCLEOD
K083569 04/01/2009 SURGYBONE SILFRADENT S.R.L. CLAUDE D BERTHOIN
K082679 04/07/2009 LAKI HAND FIXATION SYSTEM, MODEL TFX.3X.06.X SINTEA BIOTECH, INC. DANIELLE WERNIKOWSKI
K082479 04/24/2009 SKLAR SURGICAL GOWN SKLAR CORP. NATALYA VALERIO
K083787 04/15/2009 BCI WW1000 PULSE OXIMETER, MODEL WW1000 SMITHS MEDICAL PM, INC. DONALD ALEXANDER
K083705 04/09/2009 BCI WW1020 PULSE OXIMETER, MODEL WW1020 SMITHS MEDICAL PM, INC. DONALD ALEXANDER
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