FDA 510(k) Decisions During November, 2009  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K093169 11/12/2009 SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) A PLUS INTERNATIONAL, INC. SOLOMON CHEN
K092687 11/23/2009 VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER A PLUS MEDICAL THOMAS LOESCHER
K082534 11/02/2009 ETEST VORICONAZOLE 0.002-32 UG/ML AB BIOMERIEUX ANETTE ENGELHARDT
K090730 11/13/2009 AKITA JET ACTIVAERO AMERICA, INC. PAUL DRYDEN
K092503 11/19/2009 RADAR VASCULAR COMPRESSION DEVICES ADVANCED VASCULAR DYNAMICS MATTHEW SEMLER
K092166 11/23/2009 S. AUREUS/CNS PNA FISH, MODEL KT005 ADVANDX, INC. PAULA E BULGER
K092669 11/06/2009 DX-D IMAGING PACKAGE AGFA HEALTHCARE N.V. JEFFERY A JEDLICKA
K093488 11/20/2009 ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K092568 11/17/2009 SPARTAN S3 FACET SYSTEM AMENDIA, INC. RICHARD JANSEN
K092826 11/12/2009 ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL AMERICAN BIOTECH LABS MIRIAM PROVOST
K092735 11/09/2009 GREENLIGHT XPS LASER SYSTEM AMERICAN MEDICAL SYSTEMS, INC. DARLENE-CROCKET BILLIG
K093387 11/27/2009 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 ANDON HEALTH CO.,LTD LIU YI
K093296 11/05/2009 ALEXIS LAPAROSCOPIC SYSTEM APPLIED MEDICAL RESOURCES CORP. FRANS VANDENBROEK
K091653 11/02/2009 ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K092104 11/24/2009 ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM ARKRAY FACTORY USA, INC. HAMID IDRISSI
K092133 11/05/2009 ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N ARTHROCARE CORP. VALERIE DEFIESTA-NG
K092440 11/05/2009 ASCENSION CANNULATED SCREW SYSTEM ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K092597 11/12/2009 CENTROS CHRONIC HEMODIALYSIS CATHETER SET ASH ACCESS TECHNOLOGY, INC. ROLAND WINGER
K093187 11/05/2009 MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM AVANTIS MEDICAL SYSTEMS, INC. ELAINE APLAON
K092959 11/27/2009 AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 AVITA CORPORATION JENNIFER REICH
K092313 11/04/2009 PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM B. BRAUN MEDICAL, INC. SUSAN OLINGER
K092487 11/10/2009 HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K083757 11/18/2009 BPZ02 MULTIPURPOSE SOLUTION BAUSCH & LOMB, INC. GLENN A DAVIES, O.D.
K092877 11/17/2009 INDISCAL ASPIRATION DEVICE AND ACCESSORIES BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K091724 11/13/2009 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY BECTON DICKINSON & CO. SABA MODJARRAD
K091730 11/13/2009 BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. SABA MODJARRAD
K091272 11/10/2009 BESMED JET NEBULIZER BOTTLE SET BESMED HEALTH BUSINESS CORP. KE-MIN JEN
K092549 11/16/2009 OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P BIO MEDICAL TECHNOLOGIES CO., LTD CATHRYN CAMBRIA
K091248 11/30/2009 MAXEMS, MODELS 1000 AND 2000 BIO PROTECH, INC. JUDY BURTON
K092732 11/25/2009 PROPENCIL ESU PENCIL BIO PROTECH, INC. KEVIN HAN
K092761 11/24/2009 PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C BIO PROTECH, INC. JUDY BURTON
K093224 11/09/2009 DENSICHECK PLUS BIOMERIEUX, INC. JOLYN TENLLADO
K092341 11/30/2009 LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION BIOMET 3I, INC. JOSE E CABRERA
K091914 11/06/2009 OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION BIONOSTICS, INC. MINNA RANNIKKO
K093032 11/13/2009 TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET BIOSITE INCORPORATED MARA CALER
K091815 11/16/2009 SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 BIOTEST MEDICAL CORP. DIANE MANDELL HORWITZ
K093303 11/20/2009 SCOUTPRO 7F LONG CATHETERS BIOTRONIK, INC. JON BRUMBAUGH
K092009 11/06/2009 MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 BOSTON SCIENTIFIC CORPORATION JENNIFER KIMBALL
K093423 11/17/2009 LUNGPOINT PROCEDURE PLANNING BRONCUS TECHNOLOGIES, INC. NANCY ISAAC
K092191 11/25/2009 EXILIS, MODEL 5000 BTL INDUSTRIES LTD RICHARD VINCINS
K092090 11/30/2009 ERBELIFT HAND PUMP AND FLEXIBLE PROBE BYRNE MEDICAL INC. CHRIS HIERHOLZER
K092429 11/19/2009 ENDOGATOR BYRNE MEDICAL, INC. DON BYRNE
K092607 11/20/2009 AJUST ADJUSTABLE SINGLE INCISION SLING C.R. BARD, INC. JOHN C KNORPP
K090739 11/10/2009 BARD SACROCOLPOPEXY GRAFT C.R. BARD, INC. TERRI MORRIS
K093068 11/10/2009 FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US C.R. BARD, INC. CINDY MOSS
K083273 11/19/2009 MICRODOT XTRA CAMBRIDGE SENSORS LIMITED WARREN REEVES
K090915 11/18/2009 STERILE WATER FOR INHALATION FLEX BAG, USP CARDINAL HEALTH, INC. KIMBERLY SOUTHWELL
K093521 11/25/2009 GDXPRO CARL ZEISS MEDITEC INC JUDY A BRIMACOMBE
K090584 11/24/2009 INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS CARL ZEISS SURGICAL GMBH MARK W SHEEHAN
K092868 11/20/2009 CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 CELLAVISION AB CONSTANCE G BUNDY
K092384 11/04/2009 LIQUICORD CENTRIX, INC. ROGER MASTRONY
K093134 11/27/2009 CERNER CAREAWARE IBUS CERNER CORP. SHELLEY S LOOBY
K091531 11/02/2009 CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER CHOICE SPINE, LLP G.TODD HAWKINS
K080459 11/17/2009 CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH CATHY CAMBRIA
K092362 11/02/2009 SLEEPWEAVER NASAL CPAP MASK CIRCADIANCE LLC DAVID GROLL
K092619 11/13/2009 ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER CIVCO JAMES LEONG
K090326 11/25/2009 RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS CLARITY MEDICAL SYSTEMS GARY A SEEGER
K093184 11/06/2009 ENVOY GUIDING CATHETERS CODMAN & SHURTLEFF, INC. KATHRYN LAROSE
K083770 11/23/2009 COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM COLOPLAST A/S JANELL A COLLEY
K092160 11/27/2009 POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES COMFORT RUBBER GLOVES IND. SDN. BHD. TAN KENG BENG
K093389 11/17/2009 CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK COMPUTERIZED SCREENING, INC. SAM KUMAR
K092298 11/05/2009 MODIFICATION TO MODIFIED HD GUIDE CATHETER CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K092954 11/06/2009 CADSTREAM VERSION 5 CONFIRMA, INC. BRENT LEWIS
K092359 11/02/2009 ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A COOK IRELAND LTD TRACY MORIARTY
K092730 11/20/2009 COSMEDENT BRUSHABLE COMPOSITE COSMEDENT, INC. JAMES L SANDRIK
K092364 11/03/2009 MODEL 220 PATIENT MAGNET CYBERONICS, INC. KAREN STUEBER
K092473 11/25/2009 EXPEDIUM SPINE SYSTEM DEPUY SPINE,INC LISA GILMAN
K092317 11/02/2009 DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM DEROYAL INDUSTRIES, INC. GRACIE GREENWAY
K091309 11/05/2009 REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX DGIMED ORTHO, INC SCOTT YOUNGSTROM
K092113 11/13/2009 STA - FREE PS CALIBRATOR DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K091382 11/16/2009 KRYPTONITE BONE CEMENT DOCTORS RESEARCH GROUP, INC. JUSTIN EGGLETON
K092999 11/24/2009 NBP CUFF DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K092670 11/19/2009 BIODRIVE MICRO SCREW SYSTEM EBI,LLC D/B/A BIOMET TRAUMA SHIKHA GOLA
K092997 11/10/2009 ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 EDAN INSTRUMENTS, INC. WILLIAM STERN
K090682 11/19/2009 EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 EDWARDS LIFESCIENCES SERVICES GMBH NEIL R ARMSTRONG
K092741 11/10/2009 COLOR LCD MONITOR, MODEL RADIFORCE MX241W EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K090796 11/25/2009 MULTI-BITE HOT BIOPSY FORCEPS ENDO-THERAPEUTICS, INC. MARK R WADDELL
K092400 11/06/2009 ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 ENDOGASTRIC SOLUTIONS, INC. STEVE HOFFMAN
K091607 11/02/2009 ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE ETEX CORP. CHRISTOPHER KLACZYK
K091824 11/27/2009 ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 ETHICON ENDO-SURGERY, INC. GLENDA MARSH
K093236 11/10/2009 ETHICON ENDO-SURGERYOPTICAL DILATOR ETHICON ENDO-SURGERY, INC. RENEE ROWE
K091657 11/19/2009 IMMUNOSCAN CCPLUS EURO-DIAGNOSTICA AB ANNIKA ANDERSSON
K093286 11/13/2009 POWERCROSS .018 OTW PTA DILATION CATHETER EV3 INC SARA BAKKER
K093301 11/06/2009 TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM EV3 INC BRENDA JOHNSON
K092271 11/17/2009 GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 GE HEALTHCARE NICOLE LANDREVILLE
K093348 11/25/2009 3.0T 16 CHANNEL HEAD NECK SPINE COIL GE HEALTHCARE COILS (USA INSTRUMENTS INC.) ELIZABETH MATHEW
K092231 11/24/2009 GEBDI TRIBOS 501 GEBDI DENTAL-PRODUCTS GMBH THOMAS BISKUPSKI
K092146 11/16/2009 XTEND ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K091367 11/05/2009 GDS-DCS GUIDED DELIVERY SYSTEMS BONNIE MCINERNEY
K091643 11/02/2009 POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD FOO KHON PU
K092072 11/04/2009 POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE GX CORPORATION SDN BHD FOO KHON PU
K092163 11/16/2009 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB HEALTH & LIFE CO., LTD. SARAH SU
K093352 11/24/2009 HG III FIXTURE SYSTEM HIOSSEN INC. PATRICK LIM
K092406 11/04/2009 ABG II MODULAR HIP STEM HOWMEDICA OSTEONICS CORP. ESTELA CELI
K092178 11/20/2009 AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS HOWMEDICA OSTEONICS CORP. MELISSA A MATARESE
K091061 11/13/2009 IMPLICITGUIDE SURGICAL SUTURE SYSTEM IMPLICITCARE, LLC STEVE REITZLER
K091963 11/06/2009 VIGILANT EEG MONITOR, VIGILANT 2.0 INFINITE BIOMEDICAL TECHNOLOGIES, LLC MANAN HATHI
K091157 11/17/2009 GLUCO LAB AUTO CODING, MODEL IGM-0022 INFOPIA CO., LTD PRISCILLA CHUNG
K090804 11/05/2009 NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD INNOMED TECHNOLOGIES INC./RESPCARE INC. LINDA MAGILL
K093564 11/25/2009 SVED WOUND TREATMENT SYSTEM INNOVATIVE THERAPIES, INC. JUDITH HARBOUR
K091743 11/02/2009 SEC VBR INNVOTEC SURGICAL, INC. JUSTIN EGGLETON
K091874 11/18/2009 INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 INOMED MEDIZINTECHNIK GMBH YOLANDA SMITH
K093399 11/19/2009 PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 INRAD MELISSA LALOMIA
K093256 11/17/2009 SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 INRAD MELISSA LALOMIA
K092591 11/20/2009 ORTHOPANTOMOGRAPH OP30 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY JOUNI ONNELA
K092395 11/19/2009 OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM INTEGRA LIFESCIENCES CORP. DONNA MILLISKY
K091468 11/20/2009 IVD TECHNOLOGIES ACHRAB TEST KIT IVD TECHNOLOGIES GARY LEHNUS
K090925 11/23/2009 MULTIPLE (APEX LOCATOR), MODEL RCM-7 J. MORITA USA, INC. KEITH A BARRITT
K091686 11/13/2009 LEFORTE NEUROSYSTEM BONE SCREW JEIL MEDICAL CORPORATION SHIN KUK YOO
K092640 11/06/2009 CASPIAN SPINAL SYSTEM K2M, INC. RICHARD W WOODS
K092446 11/03/2009 INTRA LUX HEAD 3 LDSY KALTENBACH & VOIGT GMBH & CO. CLAUDIA ORTIZ
K092797 11/19/2009 ACUTE AND CHRONIC CATHETER REPAIR KIT KENDALL DANIEL CAMPION
K091192 11/02/2009 KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX KENSEY NASH CORP. ALYSSA SCHWARTZ
K092167 11/02/2009 KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 KIMBERLY-CLARK CORP. THOMAS KOZMA
K082399 11/05/2009 PECTUS STRUT KOROS USA, INC. TIBOR KOROS
K092499 11/20/2009 LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) LAGLOVE (M) SDN. BHD. G BASKARAN
K092498 11/20/2009 LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) LAGLOVE (M) SDN. BHD. G. BASKARAN
K092656 11/24/2009 LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM LANX, INC. ANDREW LAMBORNE
K092153 11/20/2009 SKYLINE 55, MODEL VER 1 LARSEN & TOUBRO LIMITED SHAILESH BHOSALE
K091568 11/05/2009 LH-75 PHOTOTHERAPY SYSTEM LERNER MEDICAL DEVICES, INC. ZAFIRIOS F GOURGOULIATOS
K093499 11/23/2009 HAIRMAX LASERCOMB LEXINGTON INTERNATIONAL, LLC CHERITA JAMES
K091625 11/03/2009 EPICARE-DUO LASER SYSTEM LIGHT AGE, INC. ELIZABETH REDDINGTON
K091754 11/13/2009 LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 LUNE GROUP LTD. MORRIS WAXLER
K091241 11/06/2009 MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER MASIMO CORPORATION MARGUERITE THOMLINSON
K091263 11/19/2009 ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) MATERIALISE N.V. KARL VON BERGE
K083123 11/24/2009 MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES MEDART A/S OLAV BALLE-PETERSON
K093309 11/24/2009 PRO-LINE CT (BASIC TRAY) MODEL MR28036101 MEDCOMP (MEDICAL COMPONENTS) JEAN CALLOW
K092737 11/17/2009 EASYRA MG REAGENT, MODEL 10220 MEDICA CORP. PHOTIOS MAKRIS
K092239 11/17/2009 ROSA SURGICAL DEVICE, MODEL ROSA 1.1 MEDTECH S.A. BERTIN NAHUM
K090780 11/20/2009 MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE MEDTRADE PRODUCTS LTD. JONATHAN RANFIELD
K091795 11/20/2009 MEDTRADE PRODUCTS CELOX TRAUMA GAUZE MEDTRADE PRODUCTS LTD. JONATHAN RANFIELD
K091813 11/17/2009 INTREPID SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK MIKE SCOTT
K093160 11/05/2009 HEADWAY 21 MICROCATHETER, MODEL: MC212150S MICROVENTION, INC. NAOMI GONG
K092702 11/20/2009 MICRUS MICROCATHETER, MODEL COURIER 270 MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K083754 11/20/2009 MINI LAP ELECTROCAUTERY INSTRUMENTS MINI LAP TECHNOLOGIES INC. JOSEPH AZARY
K093337 11/17/2009 VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM NANOSPHERE, INC GREGORY SHIPP
K093366 11/24/2009 NMI PICC II NAVILYST MEDICAL, INC. LORRAINE HANLEY
K090888 11/18/2009 NEWPORT HT70 FAMILY OF VENTILATORS NEWPORT MEDICAL INSTRUMENTS, INC. DANA RODRIGUEZ
K092899 11/10/2009 OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 NINGBO XINGAOYI MAGNETISM CO., LTD. JIANG MOWEN
K092246 11/12/2009 NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 NIPRO MEDICAL CORPORATION JESSICA OSWALD
K092501 11/12/2009 LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL NOVOCOL, INC. STEVE RUDOLPH
K093451 11/20/2009 OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP OMNIGUIDE, INC. DOUGLAS W WOODRUFF
K092522 11/20/2009 ACU007S ONCOLOGY SYSTEMS, INC. JENNIFER WILLIAMS
K092374 11/17/2009 OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN OPHTHALMIC IMAGING SYSTEMS ANDREA AMBROSE
K090195 11/20/2009 PALOMAR LUX1540 HANDPIECE PALOMAR MEDICAL TECHNOLOGIES, INC. SHARON TIMBERLAKE
K093307 11/06/2009 ASEPT PLEURAL DRAINAGE SYSTEM PFM MEDICAL, INC SALVADORE PALOMARES, RAC
K092050 11/20/2009 IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 PHADIA AB MARTIN MANN
K091862 11/20/2009 NESSI SPACER PHARMACARIBE PAUL DRYDEN
K091176 11/13/2009 PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 PHILIPS MEDICAL SYSTEMS PAUL SCHRADER
K091927 11/03/2009 INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN ANDREAS SUCHI
K091031 11/17/2009 PIONEER SURGICAL NANOSS BVF-E PIONEER SURGICAL TECHNOLOGY DAVID J COLLETTE
K091965 11/24/2009 POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED PLATINUM GLOVE INDUSTRIES SDN.BHD. SO SOON CHEAW
K091053 11/20/2009 PROPARAFLU+ASSAY PRODESSE, INC. KAREN HARRINGTON
K092040 11/18/2009 PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 R4 VASCULAR, INC. LAURIE LEWANDOWSKI
K093089 11/13/2009 MAGNUM NAIL ROBERT REID INC. KAREN WARDEN
K092168 11/16/2009 ELECSYS HCG+B CALCHECK 5 ROCHE DIAGNOSTICS SARAH BAUMANN
K092320 11/03/2009 ELECSYS PRECICONTROL THYROAB ROCHE DIAGNOSTICS SARAH BAUMANN
K092888 11/10/2009 ELECSYS TOXO IGG CALCHECK 5 ROCHE DIAGNOSTICS CORP. JANE E PHILLIPS
K092858 11/10/2009 SAFERSONIC SONOGRAPHY COVER SAFERSONIC MEDIZINPRODUKTE GMBH KEVIN WALLS
K093253 11/12/2009 AMID STAPLER SAFESTITCH LLC STEWART DAVIS
K092685 11/24/2009 PNEUMOTHERML, MODEL: 5800 SALTER LABS TERRY NEWTON
K093453 11/30/2009 MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM SCHICK TECHNOLOGIES, INC. HOWARD FIDEL
K093512 11/20/2009 ENCOR BREAST BIOPSY SYSTEM SENORX, INC. EBEN GORDON
K093359 11/27/2009 1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 SHANGHAI LITTLE DOCTOR CO. LIMITED JANUSUN WANG
K093100 11/24/2009 REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) SHENZHEN COMFORT TECHNOLOGY CO., LTD. JEAN ASQUITH
K091664 11/16/2009 GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C SHENZHEN GSD TECH. CO., LTD. DIANA HONG
K090578 11/06/2009 SHIMADZU COLLIMATOR R-30H SHIMADZU CORP. DON KARLE
K092993 11/20/2009 ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL SIEMENS HEALTHCARE DIAGNOSTICS CLARE SANTULLI
K092401 11/17/2009 SINEXUS SINUS STENT GEN 2, MODEL 1999-25 SINEXUS, INC. AMY CONUEL
K091714 11/18/2009 ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 SKYFINE INC. LIMITED MICHAEL LEE
K092386 11/03/2009 R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS SMITH & NEPHEW, INC. MEGAN BEVILL
K092657 11/04/2009 EPIFUSE CATHETER CONNECTOR, MODEL: 4909E SMITHS MEDICAL ASD, INC. CINDY ENGELHARDT
K092463 11/05/2009 SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM SORIN GROUP DEUTSCHLAND GMBH ROSINA ROBINSON
K093501 11/24/2009 ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION SPACELABS MEDICAL INC. DAVID GERAGHTY
K092378 11/02/2009 SPECTRANETICS VISISHEATH DILATOR SHEATH SPECTRANETICS CORP. CHERYL HASTINGS
K092659 11/17/2009 SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 SPINAL USA JEFFREY JOHNSON
K093170 11/04/2009 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART FRANCK PENNESI
K092420 11/19/2009 KRD1 PEDICLE SCREW SYSTEM SPINEFRONTIER, INC. JOHN SULLIVAN
K092464 11/09/2009 SPINEOLOGY FACET SCREW SPINEOLOGY, INC. KAREN ROCHE
K091865 11/13/2009 SPORT-ELEC BODY CONTROL SYSTEM SPORT-ELEC KIMBERLY JONES
K093130 11/04/2009 ENGAGE TR INTRODUCER ST. JUDE MEDICAL LINH PHAM
K092368 11/03/2009 REPROCESSED PULSE OXIMETER SENSORS STERILMED, INC. GARRETT AHLBORG
K092490 11/04/2009 AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 STERIS CORPORATION ROBERT F SULLIVAN
K092434 11/10/2009 STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM STERNGOLD LEE CLERMONT
K093408 11/12/2009 V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE NISHITH DESAI
K093410 11/12/2009 AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE FRANK GIANELLI
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