| 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. |
ARAVA HACOHEN |
| 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 |
| K023416 |
11/08/2002 |
MODIFICATION TO VKS KNEE SYSTEM |
PLUS ORTHOPEDICS |
LOUISE FOCHT |
| K023558 |
11/15/2002 |
PTS PANELS LIPID PANEL TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| 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 |
| K023117 |
11/08/2002 |
PRIMAGARD SURGICAL GOWNS |
PRIMELINE MEDICAL PRODUCTS, INC. |
BRANDA LEE |
| 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 |
| K023284 |
11/27/2002 |
MIRAGE FULL FACE MASK SERIES 2 |
RESMED LTD. |
ROGER KOTTER |
| 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 |
