FDA 510(k) Decisions During November, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K023033 11/26/2002 ALLGRAD WASH (HERPES BUFFERED WASHING MEDIUM) INTL., INC. MICHAEL D CECCHI
K022973 11/22/2002 ADHESIVE 14 AB ARDENT CLYDE E INGERSOLL
K022975 11/22/2002 ETCHING 15 AB ARDENT CLYDE E INGERSOLL
K022972 11/22/2002 MICROFILL 13 AB ARDENT CLYDE E INGERSOLL
K022971 11/25/2002 MICROHYBRID 11 AB ARDENT CLYDE E INGERSOLL
K022974 11/22/2002 MICROHYBRID 12 AB ARDENT CLYDE E INGERSOLL
K023772 11/22/2002 KINETDX PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM ACUSON CORP. BOB LEIKER
K023711 11/21/2002 DIGITAL THERMOMETER CLASSIC TYPE AND FLEXIBLE TYPE ACUTE IDEAS CO. LTD. ALBERT CHEN
K011618 11/15/2002 CALGITROL AG SILVER ALGINATE WOUND DRESSING ADRI GEORGE H SCHERR
K023418 11/06/2002 HEARTONE EVENT RECORDER AND TRANSMITTER AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K022672 11/08/2002 COLUMBUS TOTAL KNEE SYSTEM (CR) AESCULAP, INC. JOYCE KILROY
K022829 11/05/2002 INSTANT-VIEW LH OVULATION PREDICTING TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K022501 11/13/2002 INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K022915 11/29/2002 INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K023425 11/06/2002 DRAPES WITH ABSORBENT REINFORCEMENT ALLEGIANCE HEALTHCARE CORP. SHARON NICHOLS
K022954 11/06/2002 AMEDICA DRUG SCREEN COCAINE TEST AMEDICA BIOTECH, INC. JEFF CHEN
K023047 11/06/2002 AMEDICA DRUG SCREEN OPIATES TEST AMEDICA BIOTECH, INC. JEFF CHEN
K022955 11/06/2002 AMEDICA DRUG SCREEN THC TEST AMEDICA BIOTECH, INC. JEFF CHEN
K022729 11/14/2002 VENTED CEMENT RESTRICTOR AMEDICA CORP. ASHOK C KHANDKAR
K023126 11/18/2002 AMEDITECH IMMUTEST HCG PREGANCY TEST AMEDITECH, INC. JOHN WU
K023516 11/19/2002 MONARC SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. DAVID WORRELL
K022970 11/22/2002 AMICAS LIGHT BEAM WORKSTATION, MODEL 1.0 AMICAS, INC. PATRICE NEDELEC
K023153 11/13/2002 MICRO-TOUCH NEXT STEP POWDER FREE MEDICAL EXAMINATION GLOVES WITH ALOE AND GLYCEROL ANSELL HEALTHCARE PRODUCTS, INC. JAMES R CHATTERTON
K022572 11/08/2002 NITRI GRIP POWDERED NITRILE EXAMINATION GLOVES AR ALLIANCE HEALTHCARE SDN. BHD. CHUA C CHUAN
K021434 11/07/2002 ARTHREX FIBERWIRE IN USP SIZES ARTHREX, INC. ANN WATERHOUSE
K022892 11/25/2002 ASCENSION SILLICONE MCP ASCENSION ORTHOPEDICS, INC. ROBERT M WOLFARTH
K021767 11/19/2002 ASSUFIL ASSUT EUROPE S.P.A. LUCIO IMPROTA
K023631 11/07/2002 ASTRA TECH DENTAL IMPLANTS-CERAMIC ABUTMENTS ASTRA TECH, INC. BRUCE R MANNING
K023604 11/27/2002 MODIFICATION TO RADIAL HEAD IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE FOCHT
K022681 11/01/2002 AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST (DEVICE OR CASSETTE) AZOG, INC. AZUBUIKE OGALA
K022680 11/01/2002 AZOG, INC. HCG ONE-STEP URINE PREGNANCY TEST STRIP (DIPSTICK) AZOG, INC. AZUBUIKE OGALA
K023457 11/01/2002 ULTRASOUND SCANNER, TYPE 1101 B-K MEDICAL A/S VILLY BRAENDER
K022760 11/18/2002 MILLENNIUM MICROSURGICAL SYSTEM BAUSCH & LOMB, INC. DENNIS POZZO
K021615 11/18/2002 BAXTER ACCURA SYSTEM, MODEL 5M5660 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K023584 11/20/2002 ASCENSIA DEX 2 DIABETES CARE SYSTEM BAYER CORP. GEORGE M TANCROS
K022329 11/27/2002 CA 125 II ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K022178 11/12/2002 CA 15-3 ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K023184 11/18/2002 ETHANOL ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K023075 11/25/2002 BD VACUTAINER PLUS SST SERUM SEPARATOR TUBE BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS JING ZHANG
K023093 11/25/2002 ACCESS HYPERSENSITIVE HTSH ASSAY BECKMAN COULTER, INC. DENISE THOMPSON
K023048 11/07/2002 MODIFICATION TO SYNCHRON SYSTEMS BENZODIAZEPINE REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K023301 11/12/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON DICKINSON & CO. MONICA E GIGUERE
K023331 11/25/2002 BD VACUTAINER SST II PLUS TUBES BECTON DICKINSON & CO. JING ZHANG
K023444 11/12/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-AMIKACIN-0.5-64 UG/ML BECTON, DICKINSON & CO. BRADFORD SPRING
K022645 11/05/2002 CURAD BEIERSDORF AG DANIEL J DILLON
K023521 11/19/2002 EASY LIFE BERKLINE CORP. DAVID POPKIN
K011518 11/15/2002 VITALSAT SERIES BETA BIOMED SERVICES, INC. E J SMITH
K023473 11/20/2002 SONOREAL 3D BIO MEDI COM COLLEEN DENSMORE
K020003 11/07/2002 ELECTROCARDIOGRAPH (ECG) ELECTRODE, NON-STERILE BIO PROTECH, INC. JANNA P TUCKER
K021551 11/01/2002 STIMULAN - CALCIUM SULFATE BONE VOID FILLER KIT BIOCOMPOSITES LTD. J. STEPHEN BRATT
K022925 11/19/2002 ELECTRO-NERVE STIMULATOR TENS MODEL BMLS02-10 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K022841 11/19/2002 ELECTRO-NERVE STIMULATOR TENS, MODEL BMLS02-9 BIOMEDICAL LIFE SYSTEMS, INC. RICHARD SAXON
K023357 11/06/2002 ARCPM 1050 RESIN-HIPS BIOMET ORTHOPEDICS, INC. TRACY J BICKEL
K023409 11/08/2002 HA X-SERIES BI-METRIC HIP FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K023034 11/14/2002 CARDIOTOUCH-3000 BIONET COMPANY LTD JAY MANSOUR
K022769 11/13/2002 LIFESCAN ONETOUCH ULTRA CONTROL SOLUTION BIONOSTICS, INC. KATHLEEN STORRO
K023665 11/22/2002 MODIFICATION TO BIOPLATE RIGID BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. CAROL E JONES
K022986 11/19/2002 THE BIOPLATE BATTERY POWERED DRILL BIOPLATE, INC. BRUCE F MACKLER
K021397 11/22/2002 EMBOSPHERE MICROSPHERES AND EMBOGOLD MICROSPHERES FOR USE IN UTERINE FIBROID EMBOLIZATION BIOSPHERE MEDICAL, INC. SHIELA HEMEON-HEYER
K022674 11/06/2002 BIRD AVEA VENTILATOR BIRD PRODUCTS CORP. JEFFREY K SHAPIRO
K023498 11/13/2002 MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K021846 11/22/2002 804SIII; 804W; LIBRA TENS; 410; S-TENS II BODY CLOCK HEALTH CARE LTD JONATHAN BASH
K022731 11/14/2002 V TENS PLUS BODY CLOCK HEALTH CARE LTD JONATHAN BASH
K023337 11/18/2002 CRE PULMONARY BALLOON DILATATION CATHETER, MODELS K00550300, M00550310, M00550320, M00550330, M00550340, M00550350 BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K022059 11/13/2002 MICROVASIVE PULMONARY GUIDEWIRE BOSTON SCIENTIFIC CORP. JAMES D MCMAHON
K023681 11/26/2002 RENEGADE STC 18 MICROCATHETER BOSTON SCIENTIFIC CORP. CHRISTINE M CAMERON
K022860 11/21/2002 ATLANTIS PV IMAGING CATHETER, MODEL 36456 BOSTON SCIENTIFIC, TARGET IRENE JAWORSKI
K023344 11/06/2002 INDWELLING FECAL MANAGEMENT SYSTEM-NON-STERILE BOWEL MANAGEMENT SYSTEMS, LLC CHAD A COBERLY
K022236 11/27/2002 RECOVERY FILTER SYSTEM, MODEL RF-048F C.R. BARD, INC. KAY FULLER
K023750 11/22/2002 CANNON DIGITAL RADIOGRAPHY MODEL CXDI-40G CANON U.S.A., INC. SHEILA DRISCOLL
K023586 11/05/2002 DR-ER VERFSION OF CANON X-RAY DIGITAL CAMERAS CANON U.S.A., INC. SHIELA DRISCOLL
K023816 11/26/2002 CANON FULL AUTO TONOMETER TX-F CANON, INC.-UTSUNOMIYA OPTICAL PRODUCTS OPERATION SHEILA DRISCOLL
K023431 11/13/2002 QUANTIX/ND DEVICE CARDIOSONIX, LTD. AHAVA STEIN
K023747 11/15/2002 PHASEAL CARMEL PHARMA AB. KJELL ANDREASSON
K023106 11/05/2002 PROMOTOR CERES FERTILITY, INC. GRACE HOLLAND
K023671 11/25/2002 AQUEOUS ACRYLIC DISPERSION 28% W/W CHX TECHNOLOGIES, INC. ROSS PERRY
K022687 11/19/2002 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K022610 11/05/2002 CLARUS STRAIGHT FIRING LASER FIBER, MODEL 1150, CLARUS SIDE FIRING LASER FIBER, MODEL 1160 CLARUS MEDICAL, LLC. TOM BARTHEL
K023095 11/15/2002 HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. CATHY STUPAK
K023504 11/13/2002 MODIFICATION TO ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K022798 11/19/2002 CERVIVE ANTERIOR CERVICAL PLATING SYSTEM, MODEL NUMBER 157.XXX SERIES CATALOGUE NUMBERS CORIN U.S.A. JOEL K BATTS
K020920 11/05/2002 COZART RAPISCAN ORAL FLUID DRUG TEST - OPIATE/METHADONE COZART BIOSCIENCE LTD. ROBERTO LIDDI
K023518 11/08/2002 ECAT LSO PET/CT 16 CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K023768 11/25/2002 ECAT PET/CT; ECAT LSO PET/CT; ECAT LSO PET/CT 16 CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K021444 11/20/2002 CYNOSURE PHOTOGENICA SV CYNOSURE, INC. GEORGE CHO
K023309 11/01/2002 CONTROL PLASMA N DADE BEHRING, INC. DONNA A WOLF
K023312 11/01/2002 CONTROL PLASMA P DADE BEHRING, INC. DONNA A WOLF
K022977 11/27/2002 STRATUS CS D-DIMER CALPAK CALIBRATOR, MODEL CDDMR-C DADE BEHRING, INC. RICHARD M VAUGHT
K023641 11/27/2002 DATEX-OHMEDA HMEF MINI DATEX-OHMEDA JOEL C KENT
K022740 11/14/2002 DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02 & L-CICU02A SOFTWARE DATEX-OHMEDA JOEL C KENT
K023497 11/04/2002 DATEX-OHMEDA S/5 WEB VIEWER WITH L-6WV02 SOFTWARE DATEX-OHMEDA JOEL C KENT
K023029 11/25/2002 DEMETECH SILK NONABSORBABLE SUTURE DEMETECH CORP. LUIS ARGUELLO
K023697 11/06/2002 STERI-MATE STERILIZABLE HANDPIECE DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K023438 11/13/2002 MODIFICATION TO MONARCH SPINE SYSTEM DEPUY ACROMED LISA GILMAN
K023453 11/13/2002 DEPUY SUMMIT FX CEMENTED HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. CHERYL HASTINGS
K021732 11/04/2002 DHF 0.2 HEMOCONCENTRATOR: DIDECO NEWBORN-INFANT HEMONCENTRATION; DHR 0.6 HEMOCONCENTRATOR: DIDECO PEDIATRIC/SMALL ADULT DIDECO S.P.A. BARRY SALL
K023110 11/22/2002 CEDARS-SINAI MOTION CORRECTION (MOCO) SOFTWARE, MODEL 111005 DIGIRAD CORP. COREY STEWART
K023437 11/14/2002 FIXION INTERLOCKING PROXIMAL FEMUR INTRAMEDULLARY NAILING SYSTEM (FIXION PF NAILING SYSTEM), FIXION INTRAMEDULLARY NAIL DISCO-O-TECH MEDICAL TECHNOLOGIES, LTD. YAEL RUBIN
K014218 11/07/2002 OSI MEDICAL DIGITAL DOLPHIN 3000 PULSE OXIMETER; DIGITAL DOLPHIN REUSABLE OPTICAL SENSOR, MODEL 210' DOLPHIN MEDICAL INC. JON WERNER
K023434 11/14/2002 DOREX SPECTRUM 9000MB THERMOGRAPHY SYSTEM DOREX, INC. MEL KUTAS
K021240 11/08/2002 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-200M/HD-200 EIKON HEALTHCARE DEVICE CORP. JEN KE-MIN
K021239 11/08/2002 EIKON AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL HD-400M EIKON HEALTHCARE DEVICE CORP. JEN KE-MIN
K022464 11/21/2002 EQUILASE SYSTEM EQUILASERS, INC RICHARD C SAM
K023812 11/29/2002 NESSY (OMEGA) DISPOSABLE SPLIT RETURN ELECTRODES, MODELS P/N: 20193-084 AND P/N: 20193-085 ERBE USA, INC. JOHN TARTAL
K021112 11/22/2002 INSPIRATION VENTILATOR SYSTEM EVENT MEDICAL LTD MIKE GRIFFITHS
K023524 11/29/2002 EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES EVER-MORE LATEX PRODUCTS SDN BHD CHIA MENG CHENG
K023522 11/29/2002 EVER-MORE POWDER-FREE LATEX EXAMINATION GLOVES, BLUE COLOR EVER-MORE LATEX PRODUCTS SDN BHD CHIA MENG CHANG
K023523 11/29/2002 EVER-MORE POWDER-FREE POLYMER-COATED LATEX EXAMINATION GLOVES EVER-MORE LATEX PRODUCTS SDN BHD CHIA MENG CHENG
K023646 11/13/2002 EXATECH ACUMATCH INTEGRATED HIP SYSTEM C-SERIES CEMENTED FEMORAL STEM EXACTECH, INC. LISA SIMPSON
K023479 11/26/2002 "FEMTEX" TAMPONS AND OTHER PRIVATE LABEL PLASTIC APPLICATOR TAMPONS; CONSUMER PACKAGES AND BULK PACKAGES FIRST QUALITY HYGIENIC, INC. ROBERT J STAAB
K022838 11/25/2002 FOTONA DUALIS ER:YAG/KTP LASER SYSTEM FOTONA D.D. MOJCA VALJAVEC
K022839 11/25/2002 FOTONA DUALIS PLUS ND:YAG LASER SYSTEM FOTONA D.D. MOJCA VALJAVEC
K022837 11/25/2002 FOTONA TANDEM LASER SYSTEM FOTONA D.D. MOJCA VALJAVEC
K021060 11/13/2002 FRESENIUS ICARE MONITORING SYSTEM FRESENIUS MEDICAL CARE NORTH AMERICA NICHOLE RIEK
K023557 11/07/2002 CENTRICITY PACS PLUS GE MEDICAL SYSTEMS SCOTT EVANS
K023442 11/05/2002 EXTRA LARGE BODY COIL GE MEDICAL SYSTEMS LARRY KROGER
K023178 11/26/2002 INNOVA 4100 GE MEDICAL SYSTEMS, INC. LARRY A KROGER, PH.D
K021470 11/14/2002 SEER LIGHT COMPACT DIGITAL HOLTER RECORDER GENERAL ELECTRIC MEDICAL SYSTEMS INFORMATION TECHN LISA LEE MICHELS
K022989 11/25/2002 RADLITE TISSUE RETRACTOR SYSTEM GENZYME BIOSURGERY KAREN K SYLVIA
K022934 11/14/2002 SILENTFLOW 2 EXHALATION SYSTEM, MODEL WM 23650 GOTTLIEB WEINMANN GERAETE FUER MEDIZIN UND ARBEITS ECKHARDT ALBERS
K023627 11/12/2002 ESSEX ENDOSCOPE, MODEL SXD-1000 GUIDANT CORP. ANNE SCHLAGENHAFT
K023629 11/12/2002 ESSEX DISSECTION CANNULA, MODEL SXD-1100, ESSEX DISSECTION TIP, MODEL SXD-1200 GUIDANT CORPORATION, CARDIAC SURGERY ANNE SCHALEGENHAFT
K023492 11/13/2002 EVEREST BIPOLAR CUTTING FORCEPS AND GYRUS BIPOLAR CUTTING FORCEPS GYRUS MEDICAL, INC. FREDERICK G MADES
K023493 11/13/2002 PK ZIP WING CUTTING DISSECTOR GYRUS MEDICAL, INC. FREDERICK G MADES
K022671 11/18/2002 FREEFORM BLUE POWDERFREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD TITO ALDAPE
K023298 11/04/2002 HEMCON BANDAGE HEMCON, INC. JAMES F HENSEL
K023398 11/08/2002 HOLOGIC QDR X-RAY BONE DENSITOMETER, MODELS 1000, 2000, 4500, DELPHI, DISCOVERY HOLOGIC, INC. RICHARD L FOLLETT
K020703 11/13/2002 SCORPIO CR AND PS CO CR FEMORAL COMPONENTS WITH TITANIUM PLASMA SPRAY COATING HOWMEDICA OSTEONICS CORP. MARGARET F CROWN
K022799 11/21/2002 TRIDENT SCREW HOLE PLUG AND TRIDENT BONE SPIKE HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K022800 11/25/2002 VISIQUANT ANTI-NUCLEAR ANTIBODY TEST SYSTEM HYPERION, INC. RADHA GOOLABSINGH
K023252 11/22/2002 RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020 ICN BIOMEDICALS, INC. CHARLES C.F. YU
K022817 11/22/2002 COOLTOUCH ND:YAG LASER SYSTEM, MODEL COOLTOUCH, COOLTOUCH-II ND:YAG LASER SYSTEM, MODEL COOLTOUCH-II ICN PHARMACEUTICALS, INC. EDWARD F SMITH
K022821 11/15/2002 ARAGON WIRING SYSTEM WIRE CARTRIDGE, MODELS I0007 WIRE CARTRIDGE, 22 GAUGE, I0008 WIRE CARTRIDGE, 24 GAUGE, I0009 WIRE E IDEATRICS, INC. JAMES W HELLER
K023159 11/12/2002 MIDAS TOUCH BLUE LATEX EXAMINATION GLOVES - POEDER FREE INDUSTRIAL CLOTHINGS, LTD. UMAIR AHMED
K022504 11/18/2002 IDI-STREP B ASSAY INFECTIO DIAGNOSTIC, INC. JUDI SMITH
K021867 11/19/2002 INSOUND XT SERIES HEARING AID INSOUND MEDICAL INC. SUSAN WHICHARD
K021789 11/20/2002 QUICKLAB RSV INTEGRATED BIOTECHNOLOGY CORP. SALLY A BOOTH
K022159 11/07/2002 PISTON SYRINGE & HYPODERMIC NEEDLE INTERNATIONAL MEDSURG CONNECTION MICHELE H VOVOLKA
K023585 11/21/2002 FLOSTAR NEEDLELESS CONNECTOR, MODEL FS3000 INTRAVASCULAR INCORPORATED STEVE APERAVICH
K022574 11/12/2002 INTUITIVE SURGICAL ENDOSCOPIC INSTRUMENT CONTROL SYSTEM & ENDOSCOPIC INSTRUMENTS, MODEL DA VINCI ISI 1000/1200 INTUITIVE SURGICAL, INC. USHA S KREADEN
K023589 11/19/2002 STORM TDX POWER WHEELCHAIR INVACARE CORP. RAE ANN FARROW
K022931 11/04/2002 HYALURONIDASE SOLUTION IRVINE SCIENTIFIC SALES CO., INC. WENDELL LEE
K023616 11/04/2002 PHYSIOLOGICAL MONITOR, MODEL 3000 (SERIES) IVY BIOMEDICAL SYSTEMS, INC. DICK LISTRO
K022900 11/14/2002 BUTLER GUM VARI-CLEAN POWER TOOTHBRUSHES JOHN O. BUTLER CO. KEVIN G YOST
K022916 11/21/2002 BLOOD PRESSURE MONITOR SMARTLOGIC, MODELS KP-6210 AND KP-6211 K-JUMP HEALTH CO., LTD. JONATHAN S KAHAN
K021467 11/04/2002 AUTOCON II 400 ELECTROSURGICAL GENERATOR KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K022853 11/25/2002 ENDOTACK KARL STORZ ENDOSCOPY-AMERICA, INC. JAMES A LEE
K022057 11/22/2002 KG MEDIX DISPOSABLE SYRING, 1,3,5,10, 20, 30, 50 ML'S,KG MEDIX KYUNG GI MEDICAL IND. CO., LTD BYUNG DOO JEE
K022686 11/25/2002 LAP SURGICAL SYSTEMS MULTIPLE INSTRUMENT GUIDE LAP SURGICAL SYSTEMS, LLC DONALD WENNER
K022708 11/12/2002 KLARITY LARSON PRODUCTS, INC. PETER M LARSON
K023503 11/14/2002 SKINTACT ECG ELECTRODE LEONHARD LANG GMBH ELAINE DUNCAN
K022827 11/22/2002 ULTRAFIX KNOTLESS MINIMITE SUTURE ANCHOR LINVATEC CORP. LAURA D SENEFF
K021565 11/14/2002 LUTHER SAFETY HUBER NEEDLE SET LUTHER RESEARCH PARTNERS GREY HOLLAND
K023352 11/22/2002 VALIDATE CHEM 9 CALIBRATION VERIFICATION TEST SET, MODEL 109 MAINE STANDARDS CO. CHRISTINE BEACH
K023054 11/13/2002 JIA CHEN ACUPUNCTURE NEEDLE, FOR SINGLE USE MANDALA HEALTH CARE, LLC DASHIMA DOVCHIN
K022719 11/13/2002 PHYSICAL MONITORING REGISTRATION UNIT MARYROSE CUSIMANO, PH.D./PHIL REASTON MARYROSE CUSIMANO
K023236 11/12/2002 SENSICARE -C SYNTHETIC POLYISOPRENE POWDER-FREE SURGICAL GLOVES MAXXIM MEDICAL ROY E MOSER
K023390 11/26/2002 MY BREAST FRIEND, BREAST SELF-EXAM PAD MBF SALES, LLC EDUARDO MARCH
K021247 11/08/2002 PNEUMOPERITONEUM INSUFFLATION NEEDLE MECTRA LABS, INC. CHARLES E ALLGOOD
K022982 11/15/2002 MED-LOGICS MICROKERATOME BLADE, MODEL 7050CLB MED-LOGICS, INC. MARK MOYER
K022948 11/04/2002 VAGINAL SPECULUM, MODEL 5555S, 5555M, OR 5555L MEDICAL ACTION INDUSTRIES, INC. SHARON SUESS GRAHAM
K023573 11/21/2002 WIZAIR COMPRESSION SYSTEM MEDICAL COMPRESSION SYSTEMS (D.B.N.) LTD. SARIT GELBART
K022712 11/12/2002 HAND DRILL, MODEL 11-9901-7 MEDICAL DESIGN LLC. PAUL JOHN AXT
K022751 11/04/2002 REPROCESSED USED DISPOSABLE HOT AND COLD BIOPSY FORCEPS MEDICAL DEVICE SERVICES MARK ALDANA
K022753 11/14/2002 REPROCESSES USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS MEDICAL DEVICE SERVICES MARK ALDANA
K023432 11/04/2002 MEDLINE ASEP PLUS SURGICAL DRAPES MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K023538 11/01/2002 TIMEX ACCUCURVE TALKING 30 SECOND THERMOMTER MEDPORT, INC. FRAN WHITE
K023596 11/08/2002 MEDRAD 8-RECEIVER PHASED ARRAY NEUROVASCULAR COIL MEDRAD, INC. JIM FERGUSON
K011471 11/08/2002 BILITEC 2000, POLYGRAM '98 PH TESTING APPLICATION (INCL.BILE), OPTICAL FIBER PROBER MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TOVE KJAER
K014269 11/21/2002 POLYGRAM NET ELECTROGASTROGRAPHY APPLICATION SOFTWARE, MODEL 9043S0151; POLYGRAF ID, MODEL 9043G0102 MEDTRONIC FUNCTIONAL DIAGNOSTICS A/S TOVE KJAER
K013913 11/15/2002 PERCUSURGE GUARDWIRE PLUS TEMPORARY OCCLUSION AND ASPIRATION SYSTEM MEDTRONIC PERCUSURGE, INC. MATTHEW J MOON
K023570 11/19/2002 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K023555 11/22/2002 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE
K021980 11/19/2002 HIP MODULE FOR THE STEALTHSTATION SYSTEM MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES VICTORIA G RENDON
K023402 11/06/2002 8F LAUNCHER GUIDE CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K021576 11/04/2002 MERCURY MEDICAL STATCO2 END TIDAL CO2 DETECTOR, MODEL 10-55370 MERCURY MEDICAL RONALD RUPENSKI
K022768 11/13/2002 AMT POLYAXIAL PEDICLE SCREW MICRON PRECISION ENGINEERING, INC. FRANK E BAILEY
K022903 11/27/2002 CHILLBUSTER MICROTEK MEDICAL, INC. THOMAS BONNER
K023426 11/21/2002 TRX VERTICAL POSITIONER MOTION CONCEPTS DAVID CIOLFE
K020540 11/01/2002 REGENECARE WOUND GEL MPM MEDICAL, INC. PAUL R MILLER
K023413 11/08/2002 MODIFICATION TO NEOTHERMIA'S EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORP. SHERRIE COVAL-GOLDSMITH
K022597 11/01/2002 K-FIX NEWDEAL S.A. NORMAN F ESTRIN
K023562 11/13/2002 MODIFICATION TO CLASSIC GREAT TOE IMPLANT NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K023206 11/08/2002 SPERM CRYOPROTEC NIDACON INTERNATIONAL AB DANIEL KAMM
K013694 11/19/2002 NIDEK ADVANCED VISION INFORMATION SYSTEM (NAVIS) NIDEK, INC. CAROL PATTERSON
K022746 11/22/2002 STAT PROFILE CRITICAL CARE XPRESS ANALYZER NOVA BIOMEDICAL CORP. PAUL W MACDONALD
K023283 11/13/2002 1075LD HUSH-SLUSH O.R. SOLUTIONS, INC. STEVE HANNES
K023282 11/13/2002 ORS-3000LD O.R. SOLUTIONS, INC. STEVE HANNES
K022777 11/19/2002 MANUAL TOUCHE SYSTEM ONUX MEDICAL, INC. RUTHANN DEPIETRO
K021679 11/19/2002 ORIA SPINAL CLIP SYSTEM ORTHOTEC, L.L.C. PATRICK BERTRANOU
K022047 11/04/2002 PHLEBOTEST 2000 OSBORN MEDICAL CORP. BILL DAVIS
K022779 11/20/2002 OTI UNICONDULAR INTERPOSITIONAL SPACER OSTEOIMPLANT TECHNOLOGY, INC. SAM SON
K022887 11/26/2002 INTERPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM OSTEOMED CORP. DAWN T HOLDEMAN
K022886 11/25/2002 METATARSOPHALANGEAL FLEXIBLE STABILIZING ROD SYSTEM OSTEOMED CORP. DAWN T HOLDEMAN
K023433 11/13/2002 VARELISA CARDIOLIPIN ANTIBODIES SCREEN, MODELS 15848 AND 15896 PHARMACIA DIAGNOSTICS GMBH & CO. KG MICHAEL LINSS
K023698 11/19/2002 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE E.O PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K023674 11/29/2002 PHILIPS DRUG CALCULATOR SOFTWARE PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K020715 11/08/2002 PHILIPS M5066A AND M5068A PHILIPS MEDICAL SYSTEMS TAMARA YOUNT
K023749 11/19/2002 THE M3810A PHILIPS TELEMONITORING SYSTEM WITH M3812B TELESTATION (M310A/12B) PHILIPS MEDICAL SYSTEMS J.P. OUELLETTE
K022899 11/22/2002 PHILIPS INTEGRIS ALLURA FLAT DETECTOR RELEASE 1.0 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K023268 11/15/2002 PHOENIX ISE STANDARD A,B AND C FOR ROCHE/AVL SYSTEMS PHOENIX DIAGNOSTICS, INC. RAM NUNNA
K022539 11/19/2002 PHFW-10 PIHSIANG MACHINERY MFG. CO. LTD. CHRIS TINSLEY
K022594 11/01/2002 PLAYTEX BREAST PUMP PLAYTEX PRODUCTS, INC. PAUL A SIRACUSA
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K022675 11/07/2002 PRIME-DENT AUTOMIX DUAL CURE CORE BUILD UP MATERIAL PRIME DENTAL MANUFACTURING, INC. ROLANDO MARASIGAN
K022868 11/08/2002 PRIMAGARD SURGICAL EQUIPMENT DRAPES PRIMELINE MEDICAL PRODUCTS, INC. BRENDA LEE
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K023266 11/08/2002 PRIMAGARD SURGICAL GOWNS PRIMELINE MEDICAL PRODUCTS, INC. DAVID POWER
K022634 11/06/2002 CO-AXIAL INTRODUCER NEEDLE PROMEX, INC. JOSEPH L MARK
K011005 11/01/2002 PURE WATER SOLUTIONS CENTRAL WATER SYSTEM FOR HEMODIALYSIS PURE WATER SOLUTIONS, INC. JOHN BOWER
K023008 11/13/2002 UNIVERSAL SYSTEM, MODEL QV-800 QUANTUM MEDICAL IMAGING, LLC. MARK CAMIRAND
K023003 11/20/2002 IMAGECHECKER-CT WORKSTATION R2 TECHNOLOGY, INC. KATHY O'SHAUGHNESSY
K022682 11/05/2002 RANDOX C-REACTIVE PROTEIN CALIBRATOR RANDOX LABORATORIES, LTD. PAULINE ARMSTRONG
K021897 11/26/2002 RANDOX HAEMOGLOBIN A1C RANDOX LABORATORIES, LTD. P ARMSTRONG
K023244 11/27/2002 MIRAGE FULL FACE MASK SERIES 2 RESMED LTD. ROGER KOTTER
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K023306 11/27/2002 MIRAGE FULL FACE MASK SERIES 2 RESMED LTD. ROGER KOTTER
K023350 11/06/2002 ESPRIT VENTILATOR WITH RESPIRATORY MECHANICS RESPIRONICS CALIFORNIA, INC. MARY FUNK
K023296 11/25/2002 COBAS INTEGRA ONLINE DAT II COCAINE II ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K020883 11/29/2002 ELECSYS PROBNP CALCHECK ROCHE DIAGNOSTICS CORP. SHERRI L COENEN
K022516 11/19/2002 ELECSYS PROBNP IMMUNOASSAY ROCHE DIAGNOSTICS CORP. ROBERT A GREGG
K023601 11/19/2002 RUBICOR ENCAPSULE BREAST BIOPSY DEVICE, MODEL 30086 RUBICOR MEDICAL, INC. ROBERT J CHIN
K022861 11/26/2002 SAFETOUCH RUSIN MEDICAL DEVICES JAMES D RUSIN
K023199 11/04/2002 CERANUM 50 SB LUCIUS, INC. DAE-KYU CHANG
K023200 11/04/2002 CERANUM 76 SB LUCIUS, INC. DAE-KYU CHANG
K023197 11/05/2002 CERANUM 82 SB LUCIUS, INC. DAE-KYU CHANG
K023198 11/01/2002 CERANUM 90 SB LUCIUS, INC. DAE-KYU CHANG
K023196 11/01/2002 LUCIUS 76 SB LUCIUS, INC. DAE-KYU CHANG
K023569 11/04/2002 SIEMENS MULTIVIEW WORKSTATION MODIFICATIONS SIEMENS MEDICAL SOLUTIONS USA, INC. PENELOPE H GRECO
K022036 11/05/2002 SIEMENS VIRTUAL SIMULATION (VSIM) SIEMENS MEDICAL SOLUTIONS USA, INC. SEAN M CURRY
K023720 11/20/2002 SONOLINE ANTARES ULTRASOUND SYSTEM SIEMENS MEDICAL SOLUTIONS USA, INC. JUDI HOFFMAN
K023571 11/20/2002 6 CHANNEL BODY COIL SIEMENS MEDICAL SYSTEMS, INC. JAMIE YIEH
K023687 11/22/2002 SOMATOM EMOTION 6 CT SYSTEMS SIEMENS MEDICAL SYSTEMS, INC. PRAVEEN NADKARNI
K023155 11/25/2002 ALOCLAIR ORAL RINSE SINCLAIR PHARMACEUTICALS, LTD. DENISE SWIFT
K021585 11/13/2002 STELLAR SERIES SURGICAL LIGHTS WITH HERMES SKYTRON, DIV. THE KMW GROUP, INC. KARI OGREEN
K023680 11/19/2002 BIOBUCK CEMENT RESTRICTOR SMITH & NEPHEW, INC. DAVID HENLEY
K023417 11/07/2002 SURETAC III, MODELS 7209900, 7209901 SMITH & NEPHEW, INC. JASON BILOBRAM
K023066 11/25/2002 DRILL GUIDE ATTACHMENT (PN 3105 DG) OF THE SODEM HIGH SPEED SYSTEM (PNEUMATIC) SODEM SYSTEMS CAROLE BURNIER
K023636 11/22/2002 BLOCKING TRAY SOUTHEASTERN RADIATION PRODUCTS, INC. RICHARD SWEAT
K023647 11/27/2002 CADENCE PEEK CEMEENT RESTRICTOR SPINAL CONCEPTS, INC. AUDREY SWEARINGEN
K023644 11/25/2002 MODIFICATION TO INCOMPASS SPINAL FIXATION SYSTEM SPINAL CONCEPTS, INC. AUDREY SWEARINGEN
K022644 11/06/2002 RETRO REPAIR KIT, MODEL PRRK5 SPIRE BIOMEDICAL, INC. DONALD FICKETT
K023635 11/18/2002 SRI/SURGICAL EXPRESS SP REUSABLE SURGICAL GOWN SRI/SURGICAL EXPRESS, INC. JACK A HAMILTON
K023765 11/29/2002 STELLARTECH COAGULATION SYSTEM (MODELS 1100C-115 & 1100C-230) STELLARTECH RESEARCH CORP. JAMES R SANTOS
K022843 11/01/2002 GAYHEART CORNEAL EXCISION DEVICE STEPHENS INSTRUMENTS ARCHANA JOHNSON
K022835 11/01/2002 STEPHENS DISPOSABLE FORCEPS STEPHENS INSTRUMENTS ARCHANA JOHNSON
K022842 11/01/2002 STEPHENS DISPOSABLE HOOKS STEPHENS INSTRUMENTS ARCHALA JOHNSON
K022840 11/01/2002 STEPHENS DISPOSABLE SCISSORS STEPHENS INSTRUMENTS ARCHANA JOHNSON
K022836 11/01/2002 STEPHENS DISPOSABLE SPECULUM STEPHENS INSTRUMENTS ARCHANA JOHNSON
K021363 11/27/2002 ENDOVASCULAR GUIDE WIRE STEREOTAXIS, INC. GARY RAUVOLA
K023622 11/21/2002 STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35 STOCKERT INSTRUMENTE GMBH LYNNE LEONARD
K022309 11/08/2002 STRYKER POWERED WHEELED STRETCHER STRYKER CORP. LYNETTE GABRIEL
K014050 11/13/2002 HEX-LOCK TEMPORARY ABUTMENT SULZER DENTAL, INC. SEAN HARIRI
K014140 11/18/2002 RENAX HEMODIALYSIS BLOOD TUBING SET; SUNDER HEMODIALYSIS BLOOD TUBING SET SUNDER BIOMEDICAL TECH. CO., LTD. TONY HUNG
K021925 11/08/2002 SUNPEX TECHNOLOGIES MODEL SE 01 SUNPEX TECHNOLOGY CO., LTD. LEONARD FRIER
K022643 11/05/2002 BLASTOMERE BIOPSY PIPETTE, MODELS H-55530 AND H-55540 SWEMED LAB INTERNATIONAL AB HOWARD M HOLSTEIN
K022784 11/13/2002 SYNTEX POWDER-FREE NITRILE EXAMINATION GLOVE, PURPLE COLOR SYNTEX HEALTHCARE PRODUCTS CO. LTD. TAN SWU CHOON
K013072 11/26/2002 CHRONOS TRICALCIUM PROSPHATE (CHRONOS TCP) SYNTHES THOMAS M MARGUIRE
K022791 11/13/2002 SYNTHES ANTERIOR TENSION BAND (ATB) SYSTEM SYNTHES (USA) VIKKI M HOFFMAN
K023675 11/26/2002 SYNTHES CERVIFIX/ AXON SYNTHES (USA) VIKKI M HOFFMAN
K022012 11/01/2002 SYNTHES LOW PROFILE NEURO SYSTEM SYNTHES (USA) MATTHEW M HULL
K023458 11/07/2002 TMD SAFETY SYRINGE (FA14 SERIES 10ML/FA15 SERIES 20ML) TAIJECT MEDICAL DEVICE CO., LTD. JIM-SON CHOU
K022652 11/21/2002 ALPHATRAC, MODEL A 205 TEFTEC CORP. THOMAS E FINCH III
K022783 11/19/2002 TL100 TENSMETER BLOOD PRESSURE MONITORING SYSTEM TENSYS MEDICAL, INC. STUART L GALLANT
K023056 11/26/2002 CIRCUIT TUBINGS WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORP. KAZUHITO INOUE
K022918 11/27/2002 ADAPTERS WITH X-COATING TERUMO CARDIOVASCULAR SYSTEMS CORPORATION KAZUHITO INOUE
K023767 11/29/2002 UES-30 ELECTROSURGICAL UNIT AND IT'S ASSOCIATED ACCESSORIES THE OLYMPUS OPTICAL CO. LAURA STORMS-TYLER
K021402 11/05/2002 THERMAGE THERMACOOL TC SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K022593 11/01/2002 THOMAS MEDICAL ELECTRODES THOMAS MEDICAL, INC. THOMAS J ZINNANTI
K023645 11/13/2002 SPI EASY DENTAL IMPLANT ABUTMENT THOMMEN MEDICAL, AG FLOYD G LARSON
K023606 11/19/2002 TILITE YG AND TILITE YGS TISPORT RICHARD S FORMAN
K023760 11/22/2002 CT CARDIAC FUNCTION ANALYSIS SOFTWARE, MODELS CSCF-001A AND CSCF-001B TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K023511 11/05/2002 EXCELART WITH PIANISSIMO XG/AG SPIN EDITION, MODEL MRT-1501/P3, P2 TOSHIBA AMERICA MEDICAL SYSTEMS, INC. MICHAELA MAHL
K022655 11/07/2002 TRIMEDYNE SIDE FIRING NEEDLE WITH VENT SHEATH TRIMEDYNE, INC. GLENN D YEIK
K023039 11/07/2002 BLOOD/SOLUTION ADMINISTRATION SET, MODEL 33.015 TUTA HEALTHCARE PTY LIMITED OMID SOURESRAFIL
K020886 11/01/2002 PURTIAN BENNETT, GOOD KNIGHT 420G MODEL M-113900-US; PURTAN BENNETT, GOODKNIGHT 420S MODEL M-113903-US TYCO HEALTHCARE NANCY MOUSTAFA ANKI
K023699 11/27/2002 CLEARBLUE EASY EARLY RESULT PREGNANCY TEST UNIPATH LTD. LOUISE ROBERTS
K020804 11/19/2002 AUTO SUTURE PREMIUM PLUS CEEA DISPOSABLE STAPLER UNITED STATES SURGICAL, A DIVISION OF TYCO HEALTHC SARAH HUBENY
K022007 11/04/2002 LIBERTY 5000 BREAST COIL WITH DISPOSABLE BIOPSY PLATES USA INSTRUMENTS, INC. CHRISTIE SHUMAKER
K023507 11/08/2002 MODIFICATION TO GELBFISH VASCULAR DILATORS VASCUMETRIX, LLC NICK RAIBLE
K020888 11/07/2002 FUNDUS AUTOIMAGER VISUAL PATHWAYS, INC. GERALD (GARY) F BUCK
K022021 11/01/2002 VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT VITAL SCIENTIFIC N.V. ISRAEL M STEIN
K021477 11/08/2002 PRECLUDE MVP DURA SUBSTITUTE W. L. GORE & ASSOCIATES, INC. TIMOTHY J RYNN
K023679 11/18/2002 GORE 3.0T TORSO ARRAY W.L. GORE & ASSOCIATES,INC TRACY WOLF
K023530 11/26/2002 HORIZON 38 (CLEAR) AND HORIZON 38 WESTINT (TINTED) WESTCON CONTACT LENS CO., INC. CAROL NOBLE
K022962 11/01/2002 WIENER LAB. BILIRRUBINA TOTAL AA WIENER LABORATORIES S.A.I.C. VIVIANA CETOLA
K022629 11/05/2002 WMT-TCP BONE GRAFT SUBSTITUTE WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
K023590 11/08/2002 POWDERED NATURAL AND/OR COLORED LATEX EXAM GLOVES YTY INDUSTRY (MANJUNG) SDN. BHD. JANNA P TUCKER


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