FDA 510(k) Applications Received During May, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K031281 05/01/2003 ERGO SRS 3D LINE USA, INC. NADER SALEHI
K031631 05/27/2003 STEREOTACTIC BODY FRAME, MODEL COD. 70-1A 3D LINE USA, INC. NADER SALEHI
K031438 05/06/2003 ACUMED SMALL BONE LOCKING ROD SYSTEM II ACUMED LLC ED BOEHMER
K031588 05/21/2003 CELLSEARCH EPITHELIAL CELL ENRICHMENT KIT; CELLSPOTTER SYSTEM ADVANCED DIAGNOSTIC SYSTEMS DEBRA J RASMUSSEN
K031216 05/06/2003 MONOPLUS POLY-P-DIOXANONE MONOFILAMENT ABSORBABLE SURGICAL SUTURE AESCULAP GEORG KELLER
K031303 05/06/2003 AESCULAP-MIETHKE SHUNT SYSTEM GRAVITY ASSISTED VALVE (GAV) AESCULAP, INC. MATTHEW M HULL
K031286 05/06/2003 SAFIL AND SAFIL QUICK SYNTHETIC ABSORBABLE SURGICAL SUTURE AESCULAP, INC. GEORG KELLER
K031579 05/21/2003 INSTAREAD LITHIUM SYSTEM AKERS LABORATORIES, INC. ERIKA B AMMIRATI
K031497 05/13/2003 AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST AMEDICA BIOTECH, INC. JEFF CHEN
K031501 05/15/2003 EASYGLUCO, MODEL IGM0002 AMERICAN HEALTHCARE INC. EDWARD LETCO
K031394 05/05/2003 AMERICAN SYRINGE COMPANY 1CC AND 3CC SYRINGE AMERICAN SYRINGE COMPANY DAVID M GARVIN
K031271 05/12/2003 ONE-STEP PREGNANCY TEST AMERISOURCE PHARMACAL, INC. FRAN WHITE
K031233 05/06/2003 ANDIODYNAMICS, INC. ELVS PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K031626 05/28/2003 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K031385 05/08/2003 ANZAI AZ-733 RESPIRATORY GATING SYSTEM ANZAI MEDICAL CO, LTD. T. WHIT ATHEY
K031523 05/16/2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K031553 05/19/2003 SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES ARCADIA MEDICAL CORPORATION ARTHUR WARD
K031029 05/13/2003 ARTHROCARE BIPOLAR ELECTROSURGERY SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K031503 05/28/2003 AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER AVITA CORPORATION JENNIFER REICH
K031434 05/27/2003 BAWMED E-Z BAG RESUSCITATOR BAWMED UK BARBARA WOODS
K031431 05/27/2003 BAWMED RESCUE MASK BAWMED UK BARBARA WOODS
K031676 05/30/2003 HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q BAXTER HEALTHCARE CORP. DAVID E CURTIN
K031566 05/21/2003 SYNDEO PCA SYRINGE PUMP, MODEL 2L3113 BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K031393 05/05/2003 BAYER ADVIA CENTAUR CA 19-9 ASSAY BAYER HEALTHCARE, LLC KENNETH T EDDS
K031644 05/29/2003 BAYER ADVIA CHEMISTRY SPECIAL CHEMISTRY CONTROL BAYER HEALTHCARE, LLC ANDRES HOLLE
K031560 05/19/2003 BAYER RAPIDLAB 1200 SYSTEM BAYER HEALTHCARE, LLC MARY E GRAY
K031682 05/30/2003 LIPOPROTEIN CALIBRATOR BAYER HEALTHCARE, LLC KENNETH T EDDS
K031429 05/08/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-MEROPENEM 0.25-16 UG/ML BD DIAGNOSTIC SYSTEMS KATHRYN B POWERS
K031606 05/22/2003 ACCESS IMMUNOASSAY SYSTEM RUBELLA IGG ASSAY BECKMAN COULTER, INC. LYNN WEIST
K031506 05/14/2003 ACCESS IMMUNOASSAY SYSTEM TOXO IGM II ASSAY BECKMAN COULTER, INC. LYNN WEIST
K031530 05/15/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN-8-512 UG/ML BECTON DICKINSON & CO. MONICA EVELYN GIGUERE
K031200 05/28/2003 MODIFICATION TO BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO. CYNTHIA LACATENA
K031589 05/22/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NITROFURANTOIN GRAM POSITIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K031679 05/30/2003 BD PHONENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. BRADFORD SPRING
K031478 05/12/2003 MICROHEATER BELMONT INSTRUMENT CORP. URAIWAN P LABADINI
K031375 05/22/2003 BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 BESMED HEALTH BUSINESS CORP. DR. JEN KE MIN
K031374 05/22/2003 BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 BESMED HEALTH BUSINESS CORP. DR. JEN KE MIN
K031043 05/05/2003 D-10 HEMOGLOBIN A1C BIO-RAD LABORATORIES, INC. JACKIE BUCKLEY
K031427 05/21/2003 ELECTRO NEUROMUSCULAR STIMULATOR, MODEL BMLS03-1 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K031410 05/13/2003 VITEK 2 GRAM POSITIVE LINEZOLID FOR STREPTOCOCCUS PNEUMONIAE BIOMERIEUX, INC. NANCY WEAVER
K031454 05/07/2003 ACUMEN SURGICAL NAVIGATION SYSTEM BIOMET, INC. KRISTINE C ARNOLD
K031527 05/21/2003 MODIFICATION TO CAVERMAP SURGICAL AID BLUE TORCH MEDICAL TECHNOLOGIES FREDERICK TOBIA
K031538 05/30/2003 ENDOVIVE INITIAL PLACEMENT PEG KIT, DIRECT PEJ KIT, AND PEG SAFETY KIT BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K031466 05/14/2003 IQMARK DIGITAL HOLTER BRENTWOOD MEDICAL TECHNOLOGY CORP. RUOMEI ZHANG
K031447 05/07/2003 CANON, DIGITAL RADIOGRAPHY, MODEL CXDI-50G CANON INC. SHEILA DRISCOLL
K031633 05/27/2003 CANON INC., DIGITAL RADIOGRAPHY, MODEL CXDI-40C CANON U.S.A., INC. SHEILA DRISCOLL
K031629 05/27/2003 CANON NON-MYDRIATIC RETINAL CAMERA, MODEL CR-DGI CANON U.S.A., INC. SHEILA DRISCOLL
K031468 05/09/2003 TEMPORARY TITANIUM ANEURYSM CLIP CARDINAL HEALTH LANCE MACRCONI
K031363 05/05/2003 QCA (VERSION 3.1) CELL ANALYSIS, INC. JOEL HERM
K031511 05/14/2003 DYNESYS SPINAL SYSTEM CENTERPULSE SPINE-TECH, INC. ANGELA BYLAND
K031116 05/20/2003 VECTRA (INTELECT) EPR ULTRASOUND CHATTANOOGA GROUP MICK DAVIS
K031077 05/20/2003 VECTRA EPR SYSTEM AND INTELECT EPR SYSTEM CHATTANOOGA GROUP CHERYL L BAGWELL
K031521 05/28/2003 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K031522 05/28/2003 SOLO-CARE PLUS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K031416 05/05/2003 CLEARMEDICAL/CRITIKON BLOOD PRESSURE CUFF; CLEARMEDICAL/WELCH ALLYN BLOOD PRESSURE CUFF CLEAR MEDICAL, INC. LANE ABENROTH
K031536 05/16/2003 BRAIN COIL, MODEL 9900GE-64 CLINICAL MR SOLUTIONS, LLC RALPH S HASHOIAN
K031618 05/28/2003 COMFORT VARIOUS OF STANDING WHEELCHAIR, HERO 2 COMFORT ORTHOPEDIC CO. LTD. ERIC H.C. LEE
K031621 05/28/2003 HERO 1, MODEL LY-ESB220 COMFORT ORTHOPEDIC CO. LTD. ERIC H.C. LEE
K031323 05/12/2003 DBT, DYNAMIC BUBBLE TRAP CONVERGENZA AG CHRISTIE DEWITT
K031494 05/13/2003 DOC'S BEST WHITE COPPER CEMENT COOLEY & COOLEY, LTD. M. JOYCE HEINRICH
K031208 05/20/2003 REAADS IGM ANTI-B2GPI TEST KIT, MODEL 038-001 CORGENIX, INC. NANCI DEXTER
K031482 05/12/2003 CRYOSTAR SYSTEM, COMPRISING: A) CRYOSTAR CONSOLE, B) CRYOSTAR 1MM CRYOPROBE, C) CRYOSTAR 2MM CRYOPROBE, D) CONVENIENCE CRYOMEDICAL INSTRUEMTS LTD. GARETH COPPING
K031651 05/30/2003 MODIFICATION TO CERASORB ORTHO CURASAN AG ROLF KAUFMANN
K031327 05/08/2003 VERICOR CVP DIAGNOSTICS, INC. T. WHIT ATHEY
K031488 05/13/2003 CYNOSURE APOGEE-TKS II DERMATOLOGICAL LASER CYNOSURE, INC. GEORGE CHO
K031389 05/06/2003 CYNOSURE SMART 2940D ER:YAG LASER CYNOSURE, INC. GEORGE CHO
K031440 05/06/2003 SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER CYNOSURE, INC. GEORGE CHO
K031512 05/14/2003 EMIT II PLUS COCAINE METABOLITE ASSAY DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K031377 05/01/2003 SYSMEX AUTOMATED COAGULATION ANALYZER CA500 SERIES (CA-510, -520, -530, -540. -550, AND -560 DADE BEHRING, INC. RADAMES RIESGO
K031636 05/30/2003 CS100 INTRA-AORTIC BALLOON PUMP, MODEL 0998-00-3013-XX DATASCOPE CORP. SUSAN MANDY
K031569 05/20/2003 DATASCOPE CA 40 8FR. IABS, MODEL 0684-00-04XX DATASCOPE CORP. JOANN TAYLOR
K031653 05/29/2003 DATEX-OHMEDA HMEF 750 DATEX-OHMEDA JOEL C KENT
K031479 05/08/2003 AMBULATORY BLOOD PRESSURE (ABP) 92506 REPORT MANAGEMENT SYSTEM (RMS), MODEL 92506 DATEX-OHMEDA, INC. AL VAN HOUDT
K031361 05/08/2003 CADD HIGH-VOLUME ADMINISTRATION SETS WITH FLOWSTOP DELTEC, INC. LISA STONE
K031615 05/27/2003 SLED CURING LIGHT SYSTEM DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K031461 05/08/2003 CARRIER TIPS DENTSPLY INTL. P. JEFFREY LEHN
K031635 05/28/2003 DEPUY ACROMED VBR SYSTEM DEPUY ACROMED LISA GILMAN
K031495 05/14/2003 PINNACLE DUOFIX HA ACETABULAR CUP PROSTHESIS DEPUY ORTHOPAEDICS, INC. KARLA A HAM
K031159 05/27/2003 CALIBRATING MATERIAL, CALIBRATING STANDARDS DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K031401 05/05/2003 FIXION DYNAMIC HIP SCREW SYSTEM (FIXION DHS) DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K031465 05/13/2003 MODEL 2100 PULSE OXIMETER DOLPHIN MEDICAL INC. JON WERNER
K031400 05/05/2003 FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K031571 05/22/2003 EMPOWERCTA INJECTOR SYSTEM, MODELS 9930 & 9910 & 9825 E-Z-EM, INC. STEVEN HARTMAN
K031423 05/06/2003 EBI P148 SPINAL FIXATION SYSTEM EBI, L.P. JON CAPARETTA
K031424 05/06/2003 EBI SPINELINK SPINAL FIXATION SYSTEM EBI, L.P. BARRY SANDS
K031645 05/28/2003 EBI XFIX DFS SYSTEM EBI, L.P. ART KAUFMAN
K031267 05/12/2003 STERICHEK BICARB PH REAGENT STRIPS ENVIRONMENTAL TEST SYSTEMS, INC. DAVID A MORRIS
K031227 05/06/2003 LORDEX POWER TRACTION EQUIPMENT EVER PROSPEROUS INSTRUMENT INC JOHN BOREN
K031430 05/06/2003 CEMEX SYSTEM FAST EXACTECH, INC. GARY J MILLER
K031500 05/16/2003 EXCEL PRIMARY SOLUTION SET EXELINT INTL. CO. ARMAND HAMID
K031307 05/06/2003 FERRIS POLYMEM SILVER WOUND DRESSING FERRIS MFG. CORP. THEODORE THORSEN
K031660 05/28/2003 FERRIS POLYMEM STERILE BREAST PAD FERRIS MFG. CORP. THEODORE R THORSEN
K031067 05/30/2003 FEMTEX JUNIOR/SLENDER REGULAR OPEN-END TAMPONS FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB
K031378 05/01/2003 FRESENIUS ULTRAFLUX HEMODIALYZER FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K031674 05/30/2003 MODIFICATION TO FRIALIT-2 DENTAL IMPLANT SYSTEM FRIADENT GMBH CAROL PATTERSON
K031396 05/02/2003 ADVANTAGE WORKSTATION PASTING 1.1 GE MEDICAL SYSTEMS LARRY A KROGER
K031637 05/28/2003 INNOVA 3100 GE MEDICAL SYSTEMS LARRY KROGER
K031561 05/19/2003 CARDIOSOFT/CASE CARDIAC TESTING SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DAVID WAHLIG
K031376 05/01/2003 DINAMAP PRO 1000 V3 MONITOR, MODEL 1100 SERIES GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K031209 05/08/2003 GE 1.5T 8 CHANNEL TORSO COIL GE MEDICAL SYSTEMS, INC. LARRY KROGER
K031663 05/29/2003 GE VIVID 7, MODEL FC0003XX GENERAL ELECTRIC CO. ALLEN SCHUH
K031554 05/28/2003 S-1150 PLEUR-EVAC SAHARA PLUS CONTINUOUS REINFUSION AUTOTRANSFUSION SYSTEM GENZYME BIOSURGERY DENISE LIMA
K031647 05/27/2003 BIOSIGN SSI BIOLOGICAL TEST PACK WITH INSTANT READOUT INTEGRATOR GETINGE USA, INC KARLA BYRNE
K031225 05/01/2003 TIMESH ALSO KNOWN AS TIMESH-TC, MODELS 6000001 & 6000004 GFE MEDIZINTECHNIK GMBH JOHN E SAWYER
K031360 05/01/2003 GI SUPPLY BILIARY STENT GI SUPPLY ROB WHALEN
K031581 05/20/2003 NON-STERILE POWDER FREE, LATEX EXAMINATION GLOVES, POLYMER COATED WHITE COLOR, WITH PROTEIN LABELING, CONTAINS 50 MICROG GREEN PROSPECT SDN BHD JANNA P TUCKER
K031580 05/20/2003 NON-STERILE, POWDER-FREE, BLUE COLOR NITRILE EXAMINATION GLOVE GREEN PROSPECT SDN BHD JANNA P TUCKER
K031446 05/09/2003 JABES ELECTRONIC STETHOSCOPE GS TECHNOLOGY CO., LTD. DANIEL KAMM
K031678 05/30/2003 HI-TORQUE BALANCE INIVERSAL GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING GUIDANT CORP. BRUCE CERWIN
K031398 05/05/2003 IS-1 HEMOSTASIS VALVE, MODEL 6799 GUIDANT CORP. COLLEEN MCCARTER BLOOM
K031459 05/13/2003 RAPIDO CUT-AWAY CUTTER GUIDANT CORP. SHAH HILALI
K031505 05/15/2003 RAPIDO CUT-AWAY GUIDING CATHETER GUIDANT CORPORATION SHAH M HILALI
K031387 05/05/2003 ISOLETTE INFANT INCUBATOR, MODEL C2000E HILL-ROM MANUFACTURING, INC. MONICA FERRANTE
K031432 05/12/2003 KLEIN SURGICAL INFILTRATION PUMP, MODEL KIP-II HK SURGICAL, INC. SALLY M BOWDON
K031435 05/06/2003 BONESOURCE BVF HOWMEDICA OSTEONICS DEBRA BING
K031480 05/13/2003 GLOBAL MODULAR REPLACEMENT SYSTEM PEDIATRIC TIBIAL BEARING COMPONENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K031657 05/28/2003 STRYKER SPINE OASYS BONE SCREW HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K031383 05/08/2003 MODEL 780 HUDSON RESPIRATORY CARE, INC. CHARLES MIERKIEWICZ
K031388 05/08/2003 MODIFICATION TO HYPOGUARD ADVANCE BLOOD GLUCOSE MONITORING SYSTEM HYPOGUARD USA, INC. BRUCE A MACFARLANE
K031167 05/05/2003 HIGH PRECISION BODY WEIGHT MONITOR WITH BODY FAT INDEX IDT TECHNOLOGY LIMITED STEPHEN LI
K031490 05/12/2003 RUBELLACOL IMMUNOSTICS, INC. JEFFREY FLEISHMAN
K031475 05/13/2003 OSSEOTITE NT CERTAIN IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K031449 05/08/2003 MODIFICATION TO THE TRABECULAR METAL GLENOID - BIGLIANI/FLATOW THE COMPLETE SHOULDER SOLUTION IMPLEX CORP. ROBERT A POGGIE
K031462 05/08/2003 THE NEXGEN KNEE SYSTEM UNCEMENTED COMPONENTS IMPLEX CORP. MARCI HALEVI
K031106 05/14/2003 IMTEC SENDAX MDI AND MDI PLUS ENDOSSEOUS IMPLANT, MODELS OB-XX, SH-XX, MOB-22, MSH-XX IMTEC CORP. J. BRAD VANCE
K031450 05/12/2003 QUANTA PLEX ENA PROFILE 6 INOVA DIAGNOSTICS, INC. BRYS C MYERS
K031086 05/01/2003 CAMINO SINGLE PARAMETER MONITOR, MODEL SPM-1 INTEGRA NEURO SCIENCES NANCY A MATHEWSON
K031583 05/21/2003 MODIFICATION TO IVS INTRODUCER SET, MODEL 1003 INTEGRATED VASCULAR SYSTEMS, INC. SUSAN TURNER
K031051 05/08/2003 SMARTEP-ASSR, MODEL M811007 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K031639 05/27/2003 INTERMED ZOOM COLPOSCOPE INTERMED GROUP, INC. GEORGE GARAMY, JR.
K031399 05/08/2003 INTERGRO DBM INTERPORE CROSS INTL. MARK LOAR
K031322 05/06/2003 INTRA-LOCK HYDROXYAPATITE COATED IMPLANTS INTRA-LOCK INTERNATIONAL JEFFERY SAKOFF
K031473 05/09/2003 RATIONAL IMAGING PACS INTUITIVE IMAGING INFORMATICS, LLC DONALD MUNDT
K031665 05/29/2003 IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS IRIDEX CORP. JOHN JOSSY
K031204 05/29/2003 DENTAPORT ZX J. MORITA USA, INC. KEITH A BARRITT
K031342 05/12/2003 JASON MARINE ALL TERRAIN ELECTRIC WHEELCHAIR, MODEL SEEKER II JASON MARINE ENTERPRISES, INC. BRIAN GAGNON
K031544 05/16/2003 HEATER COOLER UNIT, MODEL HCU 30 JOSTRA AB LE ANN LATHAM
K031457 05/19/2003 ENDOMAT LC PUMP, MODEL 20 3303 20 KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K031485 05/14/2003 RINSPIRATION SYSTEM KERBEROS PROXIMAL SOLUTIONS TOM MASON
K031484 05/12/2003 STAND OUT KERR CORP. COLLEEN BOSWELL
K031444 05/08/2003 OPTIBOND FL KERR DENTAL MATERIALS CENTER COLLEEN BOSWELL
K031419 05/05/2003 GRI-FLEX, MODELS 1000ML, 500ML, 250ML, 100ML LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K031540 05/16/2003 APEX ELECTRIC HANDPIECE SYSTEM LARES RESEARCH, INC. JOHN DAHLGREN
K031282 05/21/2003 OPTILOCK IMPLANTABLE ACCESS PORT, MODEL 1700-05 LEMAITRE VASCULAR, INC. BRIAN K KEOGH
K031250 05/12/2003 DBC PRESS ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K031060 05/12/2003 NANO TECH AND SUPER NANO ACUPUNCTURE NEEDLES LHASA MEDICAL, INC. KYUNG P RIIHIMAKI
K031472 05/09/2003 ONE TOUCH BASIC/PROFILE/ONE TOUCH II TEST STRIPS LIFESCAN, INC. FRANK PERALTA
K031425 05/09/2003 GENTLEWAVES LED PHOTOMODULATION DEVICE LIGHT BIOSCIENCE, LLC ROBERT T HANDREN, JR.
K031443 05/08/2003 LSI SOLUTIONS SUTURE QUICK LOAD PRODUCTS LSI SOLUTIONS CHRISTOPHER A KLACZYK
K031594 05/21/2003 BAK'SNAP DUOPRO SAFETY SYRING (DUOPROSS) SAFETY'TRAY ALLERGY SAFETY SYRINGE TRAY M.K. MEDITECH CO. LTD. ROSINA ROBINSON
K031445 05/07/2003 MAINLINE MAXIE HCG URINE PREGNANCY TEST MAINLINE TECHNOLOGY, INC. MARTHA MAZUREK
K031339 05/06/2003 OPTIBOLUS MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS ELLIS ROGERS
K031463 05/08/2003 MARINA MEDICAL SILICONE PESSARY MARINA MEDICAL INSTRUMENTS, INC. JAY MANSOUR
K031330 05/05/2003 MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES MASIMO CORP. JAMES J CRONIN
K031614 05/23/2003 MEDELA PUMP IN STYLE ADVANCED BREAST PUMP MEDELA, INC. CHRISTOPHER L PETERSON
K031364 05/05/2003 MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K031392 05/08/2003 MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K031441 05/08/2003 URICHEMTRAK LIQUID ASSAYED URINE CONTROL MEDICAL ANALYSIS SYSTEMS, INC. PENNY M LAYMAN
K031442 05/19/2003 PBN GUIDEWIRES MEDICAL DEVICE TECHNOLOGIES, INC. KARL SWARTZ
K031084 05/01/2003 SOLAR GI SYSTEM MEDICAL MEASUREMENT SYSTEMS,B.V. KARIN OGINK-SOMHORST
K031486 05/14/2003 BLASTFREEZE AND BLASTTHAW MEDICULT A/S RONALD G LEONARDI
K031351 05/01/2003 FLEX-NECK PD CATHETER, INFANT MEDIGROUP, INC. JOHN A NAVIS
K031617 05/29/2003 MEDIPLUS SINGLE USE LOWER GI MANOMETRY CATHETER MEDIPLUS LTD. NORMAN F ESTRIN
K031552 05/19/2003 MYCOLOR 202 DIAGNOSTIC ULTRASOUND SYSTEM AND TRANSDUCERS MEDISON AMERICA, INC. BOB DEPALMA
K031321 05/16/2003 LIQUISHIELD LIQUID BANDAGE, MODEL LSB 0001 MEDLOGIC GLOBAL LIMITED MEL LONGHURST
K031037 05/06/2003 EOPA ELONGATED ONE-PIECE ARTERIAL CANNULA AND GUIDEWIRE MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K031655 05/28/2003 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD W TREHARNE, PHD
K031533 05/16/2003 VANTAGE ANTERIOR FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K031518 05/15/2003 EOPA CAP ELONGATED ONE-PIECE ARTERIAL CANNULA WITH PRESSURE MONITORING LINE, MODELS 774XX, 775XX, 776XX, 777XX, 788XX, MEDTRONIC VASCULAR DAWN STENSTROM
K031510 05/14/2003 NIM-SPINE MEDTRONIC XOMED MARTIN SARGENT
K031369 05/05/2003 MERCATOR HEALTHCARE MALE LATEX CONDOM MERCATOR HEALTHCARE LTD. ELI J CARTER
K031411 05/05/2003 MINI STATCO2 CO2 DETECTOR, MODEL 10-55371 MERCURY MEDICAL WAYNE GLOVER
K031390 05/21/2003 MEDTRONIC MINIMED PARADIGM INSULIN PUMP, MODEL MMT-712 MINIMED, INC. MIRIELLE MENGOTTO
K031519 05/19/2003 CUFFLOK ANCHOR MITEK WORLDWIDE RUTH C FORSTADT
K031406 05/20/2003 EXOJET TISSUE MANAGEMENT SYSTEM MITEK WORLDWIDE SERGIO J GADALETA
K031514 05/15/2003 MODIFICATION TO TRUPEAK PEAK FLOW METER MONAGHAN MEDICAL CORP. JAMES A COCHIE
K031492 05/20/2003 MOSSMED DUAL INTERMITTENT ASPIRATOR MOSS MEDICAL PRODUCTS GERALD MOSS
K031627 05/27/2003 NANO-TICROWN NANO-WRITE CORP. KENNETH E KNAPP
K031173 05/08/2003 NEEDLETECH GUIDEWIRE INTRODUCER NEEDLE, MODELS 40021, 40069, 40053, 40042 & 40013 NEEDLETECH PRODUCTS, INC. RICK TRIPP
K031073 05/05/2003 PERIOGLAS PLUS - SETTABLE BONE GRAFT SUBSTITUTE NOVABONE PRODUCTS, LLC DAVID M GAISSER
K031349 05/01/2003 OTP 1.2 NUCLETRON CORP. LISA DIMMICK
K031158 05/14/2003 SWIFT 2.0, MODEL 132.001 NUCLETRON CORP. LISA DIMMICK
K031477 05/14/2003 HYDROGENICS 2.0 60 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS OCULAR SCIENCES, INC. RICHARD E LIPPMAN
K031380 05/05/2003 OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA1C CALIBRATOR, (CATOLOG NUMBER ODC3032) OLYMPUS AMERICA, INC. MICHAEL CAMPBELL
K031648 05/29/2003 VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V OLYMPUS OPTICAL CO., LTD. TINA STEFFANIE-OAK
K031607 05/28/2003 ORION DIAGNOSTICA QUIKREAD CRP KIT AND QUIKREAD CRP CONTROL ORION DIAGNOSTICA, DIV. ORION CORP. ANNIKKA RANTAMA
K031474 05/21/2003 SC TOTAL HIP SYSTEM ORTHOPEDIC ALLIANCE LLC ROGER WILLIAMS
K031471 05/19/2003 ORIA SPINAL CLIP SYSTEM, LATERAL INTERMEDIATE CONNECTOR, MODEL AL01 ORTHOTEC, L.L.C. PATRICK BERTRANOU
K031452 05/19/2003 ORIA SPINAL CLIP SYSTEM, SACRAL CONNECTOR, MODELS CA03 AND AO03 ORTHOTEC, L.L.C. PATRICK BERTRANOU
K031164 05/20/2003 PACING LEAD ADAPTORS, BIPOLAR, MODELS ILINK-BIS, ILINK-BLV OSCOR INC. MILA DOCKOCIL
K031155 05/28/2003 OSTEOMED SUBTALAR IMPLANT SYSTEM OSTEOMED L.P. DAWN T HOLDEMAN
K031205 05/14/2003 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K031103 05/14/2003 PASCO MIC AND MIC/ID PANELS (ERTAPENEM) PASCO LABORATORIES, INC. LINDA K DILLON
K031625 05/29/2003 POWDER-FREE BARRIER-PRO CO-POLYMER EXAMINATION GLOVE, WHITE (NON-COLORED), AND GREEN COLORED PERUSAHAAN GETAH ASAS SDN BHD JAMES F LOGAN
K031591 05/27/2003 POWDER-FREE NITRILE PATIENT EXAMINATION GLOVE, WHITE (NON-COLORED), BLUE AND GREEN COLORED PERUSAHAAN GETAH ASAS SDN BHD JAMES F LOGAN
K031404 05/08/2003 DIGNITY OPHTHALMIC SURGICAL SYSTEM PHACOR INC., A SANTEN COMPANY JEFF B PAUL
K031422 05/06/2003 PHILIPS PAGE WRITER TRIM SERIES CARDIOGRAPH INCLUDING I, II, III, MODELS 860286, 860287, 860288, 860289, 860290, 860291 PHILIPS MEDICAL SYSTEMS SONGHUA ZHANG
K031535 05/19/2003 PHILIPS EASYDIAGNOST ELEVA PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN T HARMER
K031403 05/05/2003 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.1 PHILIPS MEDICAL SYSTEMS, INC. DAVID OSBORN
K031481 05/12/2003 THE PHILIPS INTELLIVUE MP60, MP70, AND MP90 PATIENT MONITORS, RELEASE A.20 PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH HAUKE SCHIK
K031451 05/15/2003 XTRACXL PLUS EXCIMER LASER SYSTEM, MODEL AL7000 PHOTO MEDEX, INC. BOB ROSE
K031539 05/16/2003 HEMOGLOBIN A1C REAGENT SET POINTE SCIENTIFIC, INC. WILLIAM F WALTERS
K031622 05/23/2003 WALLACE DUAL LUMEN OOCYTE RETRIEVAL SETS PORTEX LTD. STEVE OGILVIE
K031630 05/27/2003 BIFURCATED ALLERGY SKIN TESTING NEEDLE PRECISION MEDICAL PRODUCTS, INC. RONALD D WOLFE
K031680 05/30/2003 SPECTRAPULSE PRIMARY TECHNOLOGY, LLC. STEPHEN ALMEIDA
K031409 05/05/2003 URINARY CATHETERS PROMEDIC, INC. PAUL DRYDEN
K031662 05/28/2003 PRESSURE WIRE SENSOR, MODELS 12004/12304 RADI MEDICAL SYSTEMS AB MATS GRANLUND
K031562 05/21/2003 RAMSOFT PACS, MODEL 3.0 RAMSOFT, INC. LUCIAN POPESCU
K031344 05/01/2003 RANFAC GOLDENBERG SNARECOIL SOFT TISSUE BIOPSY (GSS) NEEDLE RANFAC CORP. ANNETTE M FAGNANT
K031565 05/20/2003 XPECT INFLUENZA A/B REMEL INC MARY ANN SILVIUS
K031559 05/29/2003 RENU MEDICAL REPORCESSED COMPRESSIBLE LIMB SLEEVES RENU MEDICAL, INC. L. BRUCE PIERSON
K031047 05/22/2003 MIRAGE VISTA MASK RESMED LTD. ROGER KOTTER
K031656 05/30/2003 BIPAP HARMONY VENTILATORY SUPPORT SYSTEM RESPIRONICS, INC. ZITA A YURKO
K031460 05/08/2003 MODIFICATION TO REMSTAR AUTO CPAP SYSTEM RESPIRONICS, INC. ZITA A YURKO
K031610 05/22/2003 REX MEDICAL CLEANER ROTATIONAL THROMBECTOMY SYSTEM REX MEDICAL SUSAN D GOLDSTEIN-FALK
K031299 05/01/2003 ELECSYS LH CALSET II ROCHE DIAGNOSTICS CORP. THERESA M AMBROSE
K031650 05/28/2003 FERRITIN GENERATION 2 ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K031407 05/05/2003 ROSS EMBRACE ENTERAL PUMP ROSS PRODUCT DIV. ABBOTT LABORATORIES DANIEL HAMILTON
K031094 05/06/2003 FLUID FILLED TEETHERS ROYAL KING INFANT PRODUCTS CO. LTD. DALBIR SINGH KHURANA
K031574 05/20/2003 SQUEEZE-EASE MAMMOGRAPHY CUSHION S & S X-RAY PRODUCTS, INC. SUSAN D GOLDSTEIN-FALK
K031359 05/01/2003 S-MONOVETTE EDTA K2-GEL SARSTEDT, INC. PETER RUMSWINKEL
K031236 05/21/2003 AUTO-BAND LIGATOR SCANDIMED. A.S. KRISTIAN K JENSEN
K031238 05/21/2003 VARICES NEEDLE SCANDIMED. A.S. COURTNEY SMITH
K031534 05/16/2003 CYCLASE ACTIVATING PTH (CAP) IMMUNORADIOMETRIC (IRMA) ASSAY KIT, MODEL 3KG001 SCANTIBODIES LABORATORY, INC. RICHARD LENART
K031643 05/27/2003 SPIROTEL, MODEL 29-1020 SDI DIAGNOSTICS, INC. MICHAEL J BOYLE
K031381 05/09/2003 UCR SPINAL SYSTEM, LAMINAR HOOKS, PEDICLE HOOKS, AND INSTRUMENTS SEASPINE DIANA SMITH
K031370 05/29/2003 SHINMED MODE SW-988 UNTRASONIC NEBULIZER SHINING WORLD HEALTH CARE CO., LTD. JEN KE-MIN
K031467 05/20/2003 GLASIONOMER FX-II SHOFU DENTAL CORP. ROBERT NOBLE
K031433 05/08/2003 SIEMENS INFINITY MODULAR MONITORS, MODELS SC 7000, SC 9000XL AND SC 8000 WITH VF3 MODIFICATIONS SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K031340 05/08/2003 SIEMENS INFINITY MODULAR MONITORS, MODELS SC 8000, SC 7000 AND SC 9000XL, WITH SCIO SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K031455 05/12/2003 CONKLUSION PEDICLE SCREW SYSTEM SIGNUS MEDICAL LLC. THOMAS HOGHAUG
K031546 05/21/2003 RAINBOW GT-4A PAIN RELIEF MACHINE SINO-US INFORMATION, INC YITANG SHENG
K031154 05/28/2003 SINTEA BIOTECH SCHANZ SCREW, MODEL TFX.SS.XX.X SINTEA BIOTECH, INC. MARIANNE GRUNWALDT
K031584 05/21/2003 SIROTORQUE L SIRONA DENTAL SYSTEMS GMBH MARY MCNAMARA-CULLINANE
K031379 05/01/2003 DYONICS VISION 325Z DV3-CCD HERMES READY CAMERA SYSTEM, MODEL 7209531 SMITH & NEPHEW, INC. JANICE HASELTON
K031605 05/22/2003 INTELIJET FLUID MANAGEMENT SYSTEM HERMES-READY SMITH & NEPHEW, INC. JANICE HASELTON
K031675 05/30/2003 SMITH & NEPHEW DYONICS ELECTROBLADE RESECTOR SMITH & NEPHEW, INC. KAREN PROVENCHER
K031499 05/16/2003 DIOBEAM 830 SOFT-CORE TEXAS, INC. ROY MARTIN
K031586 05/21/2003 CORRESTORE PATCH SYSTEM SOMANETICS CORP. RONALD A WIDMAN
K031436 05/21/2003 MEDISCOPE SOMETECH CORPORATION KI CHEOL HAN
K031222 05/08/2003 SCANLUBE SONOTECH, INC. MARGARET J LARSON
K031097 05/06/2003 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM MODES SPV, SPVA, SPVB SOPHYSA SA JACQUELINE E MASSE
K032152 05/28/2003 BENCO ADMIX SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
K031318 05/29/2003 TRAXIS CEMENT RESTRICTOR SPINAL CONCEPTS, INC. LISA PETERSON
K031543 05/16/2003 STARCAST DENTAL ALLOYS STAR REFINING PRECIOUS METALS SOUTH AFRICA YOLANDA SMITH
K031576 05/20/2003 SPARTAN ORTHOPAEDIC WRIST BRACE, MODEL SCT-1 SURGITECH, INC. CHRISTOPHER CROWELL
K031609 05/27/2003 SWISS ORTHOPEDIC SOLUTIONS, INC., SMALL FRAGMENT LOCKING PLATE SYSTEM SWISS ORTHOPEDIC SOLUTIONS INC BOB BENNETT
K031476 05/09/2003 FILL-IN SYBRON DENTAL SPECIALTIES, INC. COLLEEN BOSWELL
K031664 05/29/2003 ELEMENTS OBTURATION UNIT SYBRON ENDO/ANALYTIC COLLEEN BOSWELL
K031489 05/21/2003 PITANGA SYNERON MEDICAL LTD. AMIR WALDMAN
K031171 05/05/2003 DISPOSABLE POWDERED VINYL SYNTHETIC EXAM GLOVES SYNMERTEX CO, LTD ALBERT LING
K031677 05/30/2003 SYNTHES (USA) CALVICLE HOOK PLATE SYNTHES (USA) BONNIE J SMITH
K031555 05/19/2003 SYNTHES (USA) COMPARTMENTAL PRESSURE MONITORING SYSTEM SYNTHES (USA) LISA M BOYLE
K031428 05/12/2003 SYNTHES (USA) LARGE EXTERNAL FIXATION CLAMPS-MR SAFE SYNTHES (USA) BONNIE J SMITH
K031508 05/14/2003 SYNTHES (USA) STERNAL RECONSTRUCTION SYSTEM SYNTHES (USA) LISA M BOYLE
K031573 05/22/2003 SYNTHES 3.5 MM LOW PROFILE PELVIC RECONSTRUCTION PLATE SYNTHES (USA) BONNIE J SMITH
K031654 05/28/2003 SYNTHES RESORBABLE CRANIAL CLAMP, (MODIFIED) SYNTHES (USA) BONNIE SMITH
K031453 05/08/2003 TERUMO SURGUARD 2 SAFETY NEEDLE TERUMO MEDICAL CORP. BARBARA SMITH
K031563 05/28/2003 BINDAZYME CLQ CIC EIA KIT THE BINDING SITE, LTD. JAY H GELLER
K031046 05/08/2003 THERMACOOL TC SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K031469 05/09/2003 AQUILION SUPER 4 MULTISLICE CT SCANNER, MODEL TSX-101A/7 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K031545 05/20/2003 SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATE TREK DIAGNOSTIC SYSTEMS, INC. CYNTHIA C KNAPP
K031470 05/09/2003 PURITAN BENNETT, GOODKNIGHT 420 EVOLUTION, MODEL M-113903-US TYCO HEALTHCARE NANCY JAMES BONDS
K031595 05/21/2003 U & I AMERICA SPINAL HOOK SYSTEM U&I CORP., AMERICA PATRICK MOORE
K031366 05/05/2003 PREMIER 9000 8 CHANNEL PHASED ARRAY CTL SPINE COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K031365 05/05/2003 PRIMA III TOTALSENSE TORSO COIL USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K031502 05/20/2003 USFILTER BICARBONATE MIXING AND DISPENSING (BICARB) SYSTEM USFILTER EDWARD L ARMSTRONG
K031611 05/27/2003 P4-FITNESS VALMED CORP. GUY POITOUT
K031524 05/16/2003 GAMMAMED PLUS 3/24 HDR REMOTE AFTERLOADER VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K031641 05/27/2003 VASCULAR ARCHITECTS ASPIRE COVERED STENT AND 718 DELIVERY SYSTEM VASCULAR ARCHITECTS, INC. PHYLLIS ELSON
K031413 05/05/2003 VIGORMIST COMPRESSOR NEBULIZER VEGA TECHNOLOGIES, INC. JOSEPH LU
K031515 05/22/2003 SPIROPRO SPO2 VIASYS HEALTHCARE GMBH EARL DRAPER
K031194 05/01/2003 SPIROSOFT VIASYS HEALTHCARE GMBH EARL DRAPER
K031448 05/15/2003 RSV (RADIOLOGY SYSTEM VISIODENT VISIODENT SA CLAUDE D BERTHOIN
K031556 05/21/2003 VIVATHERM THEMPERATURE MEASUREMENT SYSTEM VIVANT MEDICAL, INC. STEVEN KIM
K031550 05/16/2003 REUSABLE MULTIPLE-PATIENT LIFESHIRT WITH VIVOLOGIC ANALYSIS SOFTWARE VIVOMETRICS, INC. HOWARD M HOLSTEIN
K031551 05/22/2003 NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONTROLLER-D) VYTERIS, INC. GEORGE M BASKINGER
K031548 05/20/2003 LED HEADLIGHT WELCH ALLYN, INC. DAVID KLEMENTOWSKI
K031549 05/20/2003 SOLID STATE LAMP [LED] HEADLIGHT WELCH ALLYN, INC. DAVID KLEMENTOWSKI
K031402 05/20/2003 PERFECTA FEMORAL STEM WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K031384 05/01/2003 MULTIPLE PRIVATE LABELED, NON-STERILE, POWDER-FREE, POLYURETHANE WHITE COLOR, EXAMINATION GLOVES (INTACTA POLYURETHANE G YTY INDUSTRY (MANJUNG) SDN. BHD. JANNA P TUCKER
K031517 05/22/2003 ZARGIS ACOUSTIC CARDIOSCAN ZARGIS MEDICAL CORP. SHAHRAM HEJAZI


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact