| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K013491 |
11/19/2001 |
HSG CATHETER SET, 5F MODEL RGS0947, HSG CATHETER SET, 7F, MODEL R65-948 |
A & A MEDICAL, INC. |
JAY MANSOUR |
| K013437 |
11/19/2001 |
SF SH CATHETER, MODEL R65-945 |
A & A MEDICAL, INC. |
JAY MANSOUR |
| K013393 |
11/09/2001 |
HEPARIN COATED MINIATURE CENTRIFUGAL BYPASS PUMP SYSTEM;MODEL #CP-1H |
A-MED SYSTEMS, INC. |
CYNTHIA G ROYSTER |
| K012824 |
11/09/2001 |
ACON BAR ONE STEP BARBITURATES TEST STRIP, ACON BAR ONE STEP BARBITURATES TEST DEVICE |
ACON LABORATORIES, INC. |
EDWARD TUNG |
| K011994 |
11/08/2001 |
ACRYDERM SILVER ANTTIMICROBIAL WOUND GEL MODEL# A-002101 |
ACRYMED, INC. |
BRUCE GIBBINS |
| K012655 |
11/07/2001 |
CONGRUENT BONE PLATE SYSTEM |
ACUMED, INC. |
SHARI JEFFERS |
| K013521 |
11/07/2001 |
GEMINI IMAGING SYSTEM |
ADAC LABORATORIES |
COLEEN A COLEMAN |
| K013496 |
11/06/2001 |
MODIFICATION TO SKYLIGHT IMAGING SYSTEM |
ADAC LABORATORIES |
DAVID KOLESAR |
| K013291 |
11/14/2001 |
ALTAIR MODEL, DEI SYSTEM (DIFFRACTIVE ENERGY IMAGING SYSTEM) |
ADVANCED DIAGNOSTICS, INC. |
STEVE HESLER |
| K011556 |
11/16/2001 |
MACS HMA ANTERIOR SPINAL STABILIZATION SYSTEM |
AESCULAP, INC. |
LISA M MILLINGTON |
| K012750 |
11/14/2001 |
ADC PEDIATRIC |
AGFA CORP. |
T. WHIT ATHEY |
| K012941 |
11/29/2001 |
DRYSTAR, MODEL 4500M |
AGFA CORP. |
T. WHIT ATHEY |
| K013087 |
11/13/2001 |
SINGLE DOSE DISPENSING PIN, MODEL 2201 |
ALARIS MEDICAL SYSTEMS, INC. |
RENEE L FLUET |
| K002937 |
11/05/2001 |
TST CONTROL INTEGRATOR FOR STEAM STERILIZERS |
ALBERT BROWNE LTD. |
CYNTHIA J.M. NOLTE |
| K011192 |
11/26/2001 |
COMPRESSIBLE LIMB SLEEVE |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K012605 |
11/07/2001 |
REPROCESSED ATHROSCOPICS BURS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K012603 |
11/07/2001 |
REPROCESSED AUTOSUTURE UNIPOLAR LAPAROSCOPIC/ENDOSCOPIC INSTRUMENTS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K012652 |
11/08/2001 |
REPROCESSED DYONICS ARTHROSCOPIC BURS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K012635 |
11/07/2001 |
REPROCESSED STRYKER ARTHROSCOPIC SHAVERS |
ALLIANCE MEDICAL CORP. |
DON SELVEY |
| K012611 |
11/07/2001 |
REPROCESSED DYONICS ARTHROSCOPIC SHAVERS |
ALLIANCE MEDICAL, INC. |
DON SELVEY |
| K012630 |
11/09/2001 |
REPROCESSED LINVATEC ARTHROSCOPIC BURS |
ALLIANCE MEDICAL, INC. |
DON SELVEY |
| K012613 |
11/07/2001 |
REPROCSSED LINVATEC SHAVERS |
ALLIANCE MEDICAL, INC. |
DON SELVEY |
| K012484 |
11/30/2001 |
AMEDITECH IMMUTEST DRUG SCREEN AMPHETAMINE |
AMEDITECH, INC. |
JOHN WU |
| K012585 |
11/16/2001 |
AMEDITECH IMMUTEST DRUG SCREEN METHAMPHETAMINE |
AMEDITECH, INC. |
JOHN WU |
| K012483 |
11/30/2001 |
AMEDITECH IMMUTEST DRUG SCREEN OPIATES |
AMEDITECH, INC. |
JOHN WU |
| K012582 |
11/30/2001 |
AMEDITECH IMMUTEST DRUG SCREEN PCP |
AMEDITECH, INC. |
JOHN WU |
| K012164 |
11/20/2001 |
'RAPIDONE'-METHADONE TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K013180 |
11/26/2001 |
RAPIDONE-ECSTASY TEST |
AMERICAN BIO MEDICA CORP. |
HENRY WELLS |
| K012304 |
11/01/2001 |
ADC 656 ELECTRONIC STETHOSCOPE |
AMERICAN DIAGNOSTIC CORP. |
MARC BLITSTEIN |
| K013604 |
11/13/2001 |
MODIFICATION TO: ULTRALON (R) POWDER FREE LATEX SURGICAL GLOVES |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
| K013603 |
11/13/2001 |
MODIFICATION TO:MICRO TOUCH (R) POWDER FREE LATEX SURGICAL GLOVES , MODEL STYLE 65 |
ANSELL HEALTHCARE PRODUCTS, INC. |
JAMES R CHATTERTON |
| K012918 |
11/27/2001 |
APEX MODULAR ALUMINA FEMORAL HEAD |
APEX SURGICAL, LLC. |
EDWARD J CHEAL |
| K012429 |
11/06/2001 |
SURESET INFUSION SET, MODEL 8023 |
APPLIED DIABETES RESEARCH, INCORPORATED |
CHARLES H KYPER |
| K013463 |
11/15/2001 |
ARTHROCARE ARTHRO WANDS, ENETEC EVAC PLASMA WAND |
ARTHROCARE CORP. |
BRUCE PROTHRO |
| K012872 |
11/20/2001 |
RESORBABLE SCREW ANCHOR |
ARTHROTEK, INC. |
SARA B SHULTZ |
| K013682 |
11/28/2001 |
MODIFICATION TO BASIC DENTAL IMPLANT SYSTEM |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
DAN BLACKLOCK |
| K013232 |
11/20/2001 |
CYBERCASES BY BAUSCH & LOMB |
BAUSCH & LOMB, INC. |
KIM S DEVITTO |
| K012873 |
11/19/2001 |
DOCUMENTING LASER SLIT LAMP, DP 2010 |
BAUSCH & LOMB, INC. |
PENNI L PANNELL |
| K011796 |
11/01/2001 |
RENU MULTIPLUS NO RUB MULTI-PURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
PAUL G STAPLETON |
| K011963 |
11/20/2001 |
ADVIA 1650 GLUCOSE HEXOKINASE 11 ASSAY |
BAYER CORP. |
KENNETH T EDDS |
| K013073 |
11/08/2001 |
INSYTE, ANGIOCATH, INSYTE AUTOGUARD, ANGIOCATH AUTOGUARD, AUTOGUARD PRO, INTIMA AND SAF-T-INTIMA INTRAVASCULAR CATHETERS |
BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. |
LESLIE WOOD |
| K012746 |
11/14/2001 |
ICE BATON |
BEHIVE LTD |
MARY MCNAMARA-CULLINANE |
| K010607 |
11/28/2001 |
MED-RX IRRIGATION SET, MODEL 10-3001, 10-3002, 10-4000, 10-4001 |
BENLAN, INC. |
BILL LIM |
| K012521 |
11/30/2001 |
BINAX NOW STREPTOCOCCUS PNEUMONIAE TEST |
BINAX, INC. |
PAMELA ANGELL |
| K012829 |
11/02/2001 |
STRIPMAX 1210 URINE CHEMISTRY ANALYZER, URIMATE REAGENT STRIP FOR URINALYSIS |
BIOCARE CORP. |
BRUCE A MACFARLAND |
| K012798 |
11/16/2001 |
INTEX SCREW |
BIOMET, INC. |
DALENE T BINKLEY |
| K011328 |
11/21/2001 |
CARDIO CARE EKG-2000 12-CHANNEL ELECTROCARDIOGRAPH |
BIONET COMPANY LTD |
MIN SOO HAN |
| K013546 |
11/21/2001 |
MODIFICATION TO: 1.5 BONE FIXATION KIT, MODELS BXS6114, BXS6214 |
BIONX IMPLANTS, INC. |
TUIJA ANNALA |
| K012908 |
11/28/2001 |
BIOPLATE RESORBABLE BONE SCREW |
BIOPLATE, INC. |
ERIC V HOHENSTEIN |
| K012910 |
11/20/2001 |
THE BIOPLATE MANDIBLE FIXATION SYSTEM |
BIOPLATE, INC. |
BRUCE F MACKLER |
| K013083 |
11/21/2001 |
CARTO XP EP NAVIGATION SYSTEM |
BIOSENSE WEBSTER, INC. |
AMY WALTERS |
| K011909 |
11/28/2001 |
ULTRA-THIN SDS BALLOON DILATATION CATHETER |
BOSTON SCIENTIFIC CORP. |
JENNIFER BOLTON |
| K012752 |
11/15/2001 |
WALLSTENT RX BILIARY ENDOPROSTHESES, MODELS 6961-6972 INCLUSIVE |
BOSTON SCIENTIFIC CORP. |
KATHLEEN MORAHAN |
| K013124 |
11/07/2001 |
MODIFICATION TO SCOOPER DRUG/ADULTERATION TEST CUP |
BRANAN MEDICAL CORP. |
RAPHAEL WONG |
| K013565 |
11/21/2001 |
CARDIAC DIAGNOSTIC SYSTEM, MODEL CH2000 |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K013564 |
11/21/2001 |
MODIFICATION TO HEARTWAVE ALTERNANS PROCESSING SYSTEM, MODEL APS |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K012197 |
11/16/2001 |
POWERHEART CARDIAC RHYTHM MODULE |
CARDIAC SCIENCE, INC. |
Sew-Wah Tay |
| K011439 |
11/02/2001 |
MODIFICATION TO BIOZ.COM HEMODYNAMIC MONITOR |
CARDIODYNAMICS INTERNATIONAL CORP. |
BRIAN PARK |
| K011861 |
11/06/2001 |
BERNOULLI VENTILATOR MANAGEMENT SYSTEM |
CARDIOPULMONARY CORP. |
JOHN LAVIOLA |
| K013402 |
11/14/2001 |
VISULAS 532S |
CARL ZEISS, INC. |
KENNETH M NICOLL |
| K013472 |
11/28/2001 |
TOTAL O2 |
CHAD THERAPEUTICS, INC. |
KEVIN MCCULLOH |
| K012951 |
11/09/2001 |
APN-2 USA SERIES FLEXIBLE CHOLEDOCHOSCOPE |
CIRCON VIDEO |
WAYNE B STERNER |
| K012925 |
11/07/2001 |
DUR-8, MODELS DUR-8 |
CIRCON VIDEO |
WAYNE STERNER |
| K012929 |
11/19/2001 |
FLEXIBLE PEDIATRIC CYSTOURETEROSCOPE, MODEL AUR- 735 |
CIRCON VIDEO |
WAYNE STERNER |
| K012942 |
11/05/2001 |
THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 |
CIRCULATORY TECHNOLOGY, INC. |
YEHUDA TAMARI |
| K013332 |
11/20/2001 |
LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A=E FOR BECKMAN COULTER IMMAGE |
CLINIQA CORPORATION |
CAROL RUGGIERO |
| K013480 |
11/16/2001 |
COBE SMARXT OPTIMIN SURFACE MODIFIED HOLLOW FIBER MEMBRANE OXYGENATOR |
COBE CARDIOVASCULAR, INC. |
SHAWN RIEDEL |
| K012763 |
11/15/2001 |
SORIN BIOMEDICA SMART BCD VANGUARD,SURFACE MODIFIED BLOOD CARDIOPLEGIA SYSTEM |
COBE CARDIOVASCULAR, INC. |
LYNNE LEONARD |
| K010601 |
11/16/2001 |
FANELLI BILIARY STENT |
COOK, INC. |
LISA HOPKINS |
| K011812 |
11/08/2001 |
SPECTRUM VENTRICULAR CATHETER |
COOK, INC. |
APRIL LAVENDER |
| K013581 |
11/28/2001 |
CORDIS AVIATOR PERIPHERAL DILATATION CATHETER |
CORDIS, A JOHNSON & JOHNSON CO. |
CHUCK RYAN |
| K012563 |
11/02/2001 |
DEEP GRAY |
CORTECHS LABS, INC. |
JEFFREY M ANDERS |
| K013274 |
11/16/2001 |
MONO-DOX, SYNTHETIC ABSORBABLE POLYDIOXANONE SURGICAL SUTURE,STERILE |
CP MEDICAL |
MARY ANN GREENAWALT |
| K012790 |
11/16/2001 |
CYNOSURE PHOTOGENICA ER |
CYNOSURE, INC. |
GEORGE CHO |
| K012806 |
11/19/2001 |
CYNOSURE PHOTOGENICA VL |
CYNOSURE, INC. |
GEORGE CHO |
| K013114 |
11/09/2001 |
BCS SYSTEM |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K011852 |
11/15/2001 |
DIMENSION HAIC ASSAY, MODEL DF105 |
DADE BEHRING, INC. |
Cathy Craft |
| K013126 |
11/09/2001 |
N LP(A) STANDARD SY |
DADE BEHRING, INC. |
REBECCA S AYASH |
| K012885 |
11/08/2001 |
NEUROMOVE NM900 |
DAN MED, INC. |
THOMAS SANDGAARD |
| K013326 |
11/02/2001 |
MODIFICATION TO: DATASCOPE 8FR. POLYIMIDE ALT B IAB, 25CC, 34CC, 40CC, DATASCOPE INSERTION KIT FOR 8 FR, POLYIMIDE ALT B |
DATASCOPE CORP. |
JOANN WOLF |
| K012531 |
11/02/2001 |
DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION, N-DISXXXX |
DATEX-OHMEDA |
JOEL KENT |
| K013049 |
11/29/2001 |
NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE |
DENNIS R. BAILEY, DDS |
DENNIS R BAILEY |
| K012720 |
11/08/2001 |
TULSA CONTRA ANGLES |
DENTSPLY INTL. |
P. JEFFREY LEHN |
| K012773 |
11/16/2001 |
DISCOVERY FACET SCREW FIXATION SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K013441 |
11/16/2001 |
ISOLA POLYAXIAL WASHER |
DEPUY ACROMED |
LISA GILMAN |
| K013382 |
11/07/2001 |
MODIFICATION TO: STACKABLE CAGE SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K013222 |
11/07/2001 |
SUMMIT OCCIPITO-CERVICO- THORACIC (OCT) SPINAL SYSTEM |
DEPUY ACROMED |
KAREN F JURCZAK |
| K012738 |
11/14/2001 |
SYMPHONY GRAFT DELIVERY SYSTEM (GDS) |
DEPUY ACROMED |
KAREN F JURCZAK |
| K012916 |
11/27/2001 |
FRONTIER ANTERIOR SCOLIOSIS SYSTEM |
DEPUY ACROMED, INC. |
LISA GILMAN |
| K011048 |
11/13/2001 |
BSM BONE SUBSTITUTE MATERIAL |
DEPUY ORTHOPAEDICS, INC. |
LYNNETTE WHITAKER |
| K013350 |
11/07/2001 |
MODIFICATION TO DEPUY C-STEM SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K013503 |
11/16/2001 |
MODIFICATION TO: STERILE COLLES CLASSIC FIXATOR |
DEPUY ORTHOPAEDICS, INC. |
MARCIA J ARENTZ |
| K013566 |
11/20/2001 |
IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 |
DIAGNOSTIC PRODUCTS CORP. |
EDWARD M LEVINE |
| K011586 |
11/16/2001 |
IRMA SL BLOOD ANALYSIS SYSTEM GL CARTRIDGE |
DIAMETRICS MEDICAL, INC. |
NANCY RING |
| K013499 |
11/16/2001 |
DIOMED 15 PLUS AND DIOMED 30PLUS LASERS |
DIOMED, INC. |
MARY MCNAMARA-CULLINANE |
| K013782 |
11/20/2001 |
DISETRONIC PENFINE INSULIN INJECTION PEN NEEDLE |
DISETRONIC MEDICAL SYSTEMS |
DAVID E CHADWICK |
| K011322 |
11/19/2001 |
DORNIER SAPPHIREERBIUM HANDPIECE, DORNIER SAPPHIRESPOT HANDPIECE |
DORNIER MEDTECH AMERICA, INC. |
BRIAN WALSH |
| K012917 |
11/28/2001 |
DYNAREX UMBILICAL CORD LAMP, MODELS 6833 AND 6833-B |
DYNAREX CORP. |
JOHN GAGLIARDI |
| K012516 |
11/27/2001 |
EBI SPINELINK - II SPINAL FIXATION SYSTEM |
EBI, L.P. |
PATRICIA M FLOOD |
| K013540 |
11/20/2001 |
EBI XFIX ACCESS PELVIC FIXATOR |
EBI, L.P. |
MICHAEL TAGGART |
| K013378 |
11/08/2001 |
EBI XFIX DFS SYSTEM |
EBI, L.P. |
MICHAEL T TAGGART |
| K013631 |
11/20/2001 |
EFILM VIDEO |
EFILM MEDICAL, INC. |
JOSEPH A THOMAS |
| K013152 |
11/09/2001 |
ATAC PAK DIRECT HDL REAGENT AND ATAC DIRECT HDL CALIBRATOR KITS |
ELAN HOLDINGS, INC. |
WYNN STOCKING |
| K013255 |
11/07/2001 |
SURGITRON 120 IEC (ALSO KNOWN AS SURGITRON 4.0 DUAL RF |
ELLMAN INTL., INC. |
FRANK LIN |
| K013431 |
11/15/2001 |
PASS SPINAL SYSTEM |
ENCORE ORTHOPEDICS, INC. |
JOANNA DROEGE |
| K013403 |
11/14/2001 |
TRI-FIX SPINAL FIXATION SYSTEM |
ENDIUS, INC. |
SUSAN FINNERAN |
| K012725 |
11/08/2001 |
TISSUE GRASPING FORCEPS, SCISSORS, CLAMPS AND DISSECTORS FOR LAPAROSCOPIC SURGERIES |
ENDO-THERAPEUTICS, INC. |
TODD ADKISSON |
| K012977 |
11/02/2001 |
VARICES INJECTION NEEDLE |
ENDO-THERAPEUTICS, INC. |
TODD ADKISSON |
| K001121 |
11/29/2001 |
OXYGEN APPLIED SYMPTOM IMPROVEMENT SYSTEM (OASIS) |
ENGINEERED MEDICAL TECHNOLOGY, INC. |
DON SCHMIELEY |
| K012920 |
11/28/2001 |
MOLDED CRANIAL HELMET |
FAIRVIEW ORTHOPEDIC LABORATORY |
ROSS C D'EMANUELE |
| K011174 |
11/07/2001 |
PARADIGM-FONTONA PEROVSKITE ND: YAP LASER SYSTEM AND ACCESSORIES |
FOTONA D.D. |
MOJCA VALJAVEC |
| K003957 |
11/01/2001 |
DIACLEAR ULTRAFILTER |
GAMBRO RENAL PRODUCTS |
SUZANNE DENNIS |
| K013481 |
11/02/2001 |
DUAL ENERGY AND TISSUE EQUALIZATION SOFTWARE OPTION |
GE MEDICAL SYSTEMS |
JODI PARKER |
| K013561 |
11/08/2001 |
LIGHTSPEED 4.0 CT SCANNER SYSTEM |
GE MEDICAL SYSTEMS |
LARRY A KROGER |
| K012875 |
11/20/2001 |
SIGNA OPENSPEED MAGNETIC RESONANCE SYSTEM |
GE MEDICAL SYSTEMS |
LARRY KROGER |
| K012718 |
11/13/2001 |
MODIFICATION TO COROMETRICS MODEL 120IS MATERNAL/FETAL MONITORING SYSTEM. |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
JOELLE NEIDER |
| K013731 |
11/27/2001 |
GIMMI ALPHA SINUSCOPES MODEL # E.8282.01/31/71 + E.8284.01/31/71; GIMMI ALPHA BRONCHOSCOPES MODEL # E.8189.00/01/02/03 |
GIMMI GMBH |
DAGMAR S MASER |
| K013136 |
11/26/2001 |
ANEURYSM CLIPS |
GISTLSTRASSE |
DIETER VON SEPPELIN |
| K013536 |
11/30/2001 |
EMTRAC; DELPHIN; SEMTRAC 2000 SET |
GYNETICS MEDICAL PRODUCTS NV |
GRACE HOLLAND |
| K013497 |
11/09/2001 |
FAS SET #4551 |
GYNETICS MEDICAL PRODUCTS NV |
GRACE HOLLAND |
| K013501 |
11/30/2001 |
IUI, MODEL 4220; SMOOZE, MODEL 4225, L; SEMINOR, MODEL 4502 A, B |
GYNETICS MEDICAL PRODUCTS NV |
GRACE HOLLAND |
| K012785 |
11/16/2001 |
TWINTRODE ELC 134 ELECTRODE |
HEALTH TRONICS SURGICAL SERVICES, INC. |
PETER WEIMAN |
| K013573 |
11/09/2001 |
CLIP PARTIAL PROSTHESIS-TITANIUM DRESDEN, MODEL 1002 250-257 |
HEINZ KURZ GMBH MEDIZINTECHNIK |
DAGMAR S MASER |
| K013709 |
11/16/2001 |
HILL-ROM PRIMAVIEW MONITOR SYSTEM |
HILL-ROM, INC. |
TIMOTHY M DAVIS |
| K012779 |
11/02/2001 |
ICONNECTION 3D |
HINNOVATION, INC. |
YI ISABELLE SUN |
| K012776 |
11/16/2001 |
DURACON CONSTRAINED POSTERIOR STABILIZED (PS) TIBIAL INSERT |
HOWMEDICA OSTEONICS CORP. |
MARGARET F CROWE |
| K013468 |
11/16/2001 |
LONG LENGTH DYAX NAIL |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K013524 |
11/14/2001 |
TROCHANTERIC DYAX NAIL SYSTEM |
HOWMEDICA OSTEONICS CORP. |
KAREN ARIEMMA |
| K013432 |
11/29/2001 |
IGG ANTI-NDNA FLUORESCENT TEST SYSTEM; MODEL # 3040G |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
| K013285 |
11/14/2001 |
RELISA MPO-ANCA TEST SYSTEM FOR ANTIBODIES TO MYELOPEROXIDASE, MODEL # 7096-15 |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
| K013283 |
11/14/2001 |
RELISA PR3-ANCA TEST SYSTEM FOR ANTIBODIES TO PROTEINASE 3, MODEL # 7096-16 |
IMMUNO CONCEPTS, INC. |
ERIC S HOY |
| K013531 |
11/07/2001 |
QWIKSIM VIRTUAL SIMULATION SYSTEM; VERSION 2.00 |
IMPAC MEDICAL SYSTEMS, INC. |
THOMAS H FARIS |
| K012964 |
11/09/2001 |
56MM CONDOM,MALE NATURAL RUBBER LATEX CONDOM |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
| K012962 |
11/09/2001 |
DOTTED CONDOM, MALE NATURAL RUBBER LATEX CONDOM |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
| K012664 |
11/09/2001 |
ULTRA THICK MALE LATEX CONDOM WITH SILICONE LUBRICANT |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
| K012665 |
11/09/2001 |
ULTRA THIN MALE LATEX CONDOM WITH SILICONE LUBRICANT |
INNOLATEX SDN. BHD |
CHANG AH-KAU |
| K011196 |
11/08/2001 |
IQUANTIFY, VERSION 1.0 |
INSIGHTFUL CORPORATION |
BRADLEY T WYMAN |
| K010989 |
11/07/2001 |
TELESCOPIC PLATE SPACER THORACOLUMBAR (TPS-TL) SPINAL, MODEL 8119, 8120, 8130, 8131 |
INTERPORE CROSS INTL. |
LYNN R RODARTI |
| K012833 |
11/16/2001 |
INTUITIVE SURGICAL BIPOLAR FORCEPS |
INTUITIVE SURGICAL, INC. |
MICHAEL YRAMATEGUI |
| K011479 |
11/30/2001 |
ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, ONE TOUCH ULTRA BLOOD GLUCOSE MONITORING SYSTEM |
INVERNESS MEDICAL INNOVATIONS, INC. |
CAROL A ADILETTO |
| K010739 |
11/06/2001 |
WATCH-PAT 100 |
ITAMAR MEDICAL (C.M.) 1997 LTD. |
GEORGE MYERS |
| K012877 |
11/21/2001 |
HIGH GOLD PALLADIUM FREE CERAMIC SOLDER |
IVOCLAR USA, INC. |
ANDERJEET GULATI |
| K012774 |
11/16/2001 |
JOSTRA ARTERIAL PERFUSION CANNULAE |
JOSTRA AG |
KATHLEEN JOHNSON |
| K012617 |
11/06/2001 |
JOSTRA ARTERIAL PERFUSION CANNULAE, MODEL A... |
JOSTRA AG |
KATHLEEN JOHNSON |
| K012492 |
11/02/2001 |
KADANCE 2000 |
KADA RESEARCH, INC. |
HARVEY KNAUSS |
| K012527 |
11/01/2001 |
KSEA SIALOENDOSCOPES AND ACCESSORIES |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
JAMES A LEE |
| K012815 |
11/13/2001 |
SAFESKIN HEALTHTOUCH POWDER-FREE EXAM GLOVE WITH VITAMIN E AND ALOE |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
| K012236 |
11/19/2001 |
STARS2000 POWER CANNULA |
KMI KOLSTER METHODS, INC. |
ALWIN H KOLSTER |
| K012830 |
11/20/2001 |
LERMAN & SON CRANIAL ORTHOSIS HELMET |
LERMAN & SON |
MAX LERMAN |
| K013117 |
11/29/2001 |
RESECTION ABLATOR |
LINVATEC CORP. |
LAURA D SENEFF |
| K012545 |
11/05/2001 |
ARAMIS DERMATLOGIC LASER |
LUMEDICS, LTD. |
JONATHAN S KAHAN |
| K013119 |
11/16/2001 |
VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
| K013265 |
11/20/2001 |
VALIDATE CHEM 7 CALIBRATION VERIFICATION TEST SET, MODEL 10007 |
MAINE STANDARDS CO. |
CHRISTINE BEACH |
| K012844 |
11/08/2001 |
MAROSIS PACS |
MAROTECH, INC |
CARL ALLETTO |
| K013443 |
11/29/2001 |
POWDERED LATEX MEDICAL MEDICAL EXAMINATION GLOVES WITH 150 MICROGRAMS OR LESS OF TOTAL WATER EXTRACTABLE PROTEIN PER DM2 |
MAXTER GLOVE MANUFACTURING SDN BHD |
STANLEY THAI |
| K013239 |
11/20/2001 |
COMFORTCARE COMPRESSION SUPPORT WITH MAGNETS COMFORTCARE MAGNETIC INSOLES |
MED GEN, INC. |
THEODORE BARASH |
| K012624 |
11/08/2001 |
REPROCESSED ARTHROSCOPIC BLADES, ARTHROSCOPIC SHAVERS, SHAVER BLADE, BLADE, LIMITED REUSE BLADE, ARTHROSCOPIC BURS |
MEDICAL INSTRUMENTS TECHNOLOGY, INC. |
JACK SPEER |
| K013627 |
11/16/2001 |
SONOACE SA-8000 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON AMERICA, INC. |
A. ROBERT DEPALMA |
| K012944 |
11/20/2001 |
POWER DRIVE |
MEDITEAM AB |
THOMAS STJERNKVIST |
| K013082 |
11/16/2001 |
MEDSTAR 100 INTERFERENTIAL STIMLATOR |
MEDNET SERVICES, INC. |
DAVID L MATHEWS |
| K013081 |
11/20/2001 |
MEDSTAR 150 |
MEDNET SERVICES, INC. |
DAVID L MATHEWS |
| K010579 |
11/21/2001 |
STENT SUPPORT GUIDE CATHETER |
MEDTRONIC VASCULAR |
FRED L BOUCHER |
| K012953 |
11/30/2001 |
GIOTTO IMAGE |
MEDX, INC. |
FLOYD R ROWAN |
| K013331 |
11/30/2001 |
LYMPHA PRESS PLUS DEVICE |
MEGO AFEK |
AHAVA STEIN |
| K013264 |
11/29/2001 |
MICRO STAMPING LIGATING CLIP |
MICRO STAMPING CORP. |
JOHN GAGLIARDI |
| K010771 |
11/27/2001 |
PERIOLASE ND:YAG DENTAL LASER SYSTEM |
MILLENNIUM DENTAL TECHNOLOGIES, INC. |
DAVID M HARRIS |
| K010366 |
11/28/2001 |
DISPOSABLE STORAGE CAP |
MOLDED PRODUCTS INC. |
ELISE JOHNSTON |
| K011070 |
11/07/2001 |
DRT4 LASER DOPPLER PERFUSION AND TEMPERATURE MONITOR |
MOOR INSTRUMENTS LTD. |
DAVID BOGGETT |
| K013602 |
11/20/2001 |
HNC-63-INT NEUROVASCULAR ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K013508 |
11/20/2001 |
HRH-127-ALLEGRA HEAD ARRAY COIL |
MRI DEVICES CORP. |
THOMAS SCHUBERT |
| K013399 |
11/13/2001 |
MODEL MES-9000/EMG SYSTEM |
MYOTRONICS-NOROMED, INC. |
FRAY ADIB |
| K012801 |
11/14/2001 |
N2000 BASE STATION, N2001 NURSE STATION |
NEPTEC DESIGN GROUP, LTD. |
CHARLES H KYPER |
| K012823 |
11/14/2001 |
MODIFICATION TO HANDMASTER |
NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS |
JONATHAN S HAHAN |
| K010819 |
11/08/2001 |
3CC NMT SAFETY SYRINGE |
NEW MEDICAL TECHNOLOGY LTD. |
MIKE MALANDRAKIS |
| K001879 |
11/20/2001 |
INFUSION IV SET |
NIRVI INTL. USA |
DARSHANA HATHI |
| K013133 |
11/13/2001 |
NORDIX INC RECHARGEABLE BATTERY PART NUMBER 2116 |
NORDIX, INC. |
MARIAN LISAK |
| K013185 |
11/28/2001 |
TCM ENDO III |
NOUVAG AG |
COLLEEN BOSWELL |
| K011652 |
11/07/2001 |
BODY FAT ANALYZER, MODEL HBF-306 |
OMRON HEALTHCARE, INC. |
OSAMU SHIRASAKI |
| K011536 |
11/14/2001 |
MICROSTREAM O2/CO2 ORAL NASAL FILTERLINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
| K013845 |
11/29/2001 |
MODIFICATION TO: MAC-LINE O2/CO2 ORAL NASAL CANNULA SAMPLE LINE |
ORIDION MEDICAL 1987 LTD. |
SANFORD BROWN |
| K012751 |
11/14/2001 |
HEALOS BONE GRAFT MATERIAL |
ORQUEST, INC. |
KRISTINE F LAHMAN |
| K013339 |
11/08/2001 |
PERMANENT PACING LEAD W/POLARIS COATED TIPS, VARIOUS MODELS |
Oscor Inc. |
MILA DOSKOCIL |
| K012626 |
11/02/2001 |
OSI MEDICAL DOLPHIN STAND-ALONE PULSE OXIMETER & DIGITAL DOLPHIN DISPOSABLE OPTICAL SENDOR |
OSI MEDICAL, INC. |
JON WERNER |
| K011043 |
11/30/2001 |
OSMETECH MICROBIAL ANALYSER-URINARY TRACT INFECTION DETECTOR (OMA-UTI) |
OSMETECH |
JOHN PLANT |
| K013362 |
11/13/2001 |
AUTOJECT 2 |
OWEN MUMFORD USA, INC. |
ROBERT SHAW |
| K011308 |
11/29/2001 |
MULTISTIM |
PAJUNK GMBH |
LYNETTE HOWARD |
| K012771 |
11/14/2001 |
TROCAR SLEEVE AND ACCESSORIES, MODELS 1287-XX-XX |
PAJUNK GMBH |
MARTIN HANGER |
| K013796 |
11/26/2001 |
LIVESURE METHADONE SCREEN TESTS |
PAN PROBE BIOTECH, INC. |
ALICE H YU |
| K012647 |
11/09/2001 |
TONOPORT V |
PAR MEDIZINTECHNIK GMBH |
LOTHAR ENGEL |
| K013489 |
11/29/2001 |
KP + LFM |
PDS HEALTHCARE PRODUCTS, INC. |
JIM LEWIS |
| K011899 |
11/06/2001 |
PF 5050 PRESSURE UNIT, MODEL PF 5050 |
PERIMED AB |
BJORN BAKKEN |
| K013470 |
11/14/2001 |
MODIFICATION TO M2376A DEVICELINK SYSTEM |
PHILIPS MEDICAL SYSTEMS, INC. |
MIKE HUDON |
| K013427 |
11/29/2001 |
MODIFICATION TO:PHILIPS M3000A/M3046A COMPACT PORTABLE PATIENT MONITOR, MODELS PHILIPS M3000A/M3046A |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
| K013199 |
11/28/2001 |
PHILIPS COMPONENT COMPACT MONITOR,MODEL M1275B, PHILIPS COMPENENT RACK, MODEL M1276B |
PHILIPS MEDICAL SYSTEMS, INC. |
DAVE OSBORN |
| K012987 |
11/07/2001 |
PHOENIX ELECTROLYTE CALIBRATION SET FOR THE MEDICAL EASYLYTE CALCIUM ANALYZER |
PHOENIX DIAGNOSTICS, INC. |
RAM NUNNA |
| K012846 |
11/20/2001 |
ZIPPY, MODEL I88WA |
PILLAR TECHNOLOGY, INC. |
CHRIS TINSLEY |
| K013220 |
11/20/2001 |
HD/HDT, PV/PVT (POLYMACON) SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY CAST-MOLDED LENS) |
POLY VUE TECHNOLGIES, INC. |
MARTIN DALSING |
| K013068 |
11/20/2001 |
BIOSCANNER 2000 |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K013203 |
11/16/2001 |
BIOSCANNER BEYOND GLUCOSE ANALYZER AND TEST STRIPS |
POLYMER TECHNOLOGY SYSTEMS, INC. |
MARGO ENRIGHT |
| K012670 |
11/09/2001 |
BOSS 2000-3 VACUUM ERECTION DEVICE |
POS-T-VAC, INC. |
DENNIS L BELL |
| K012672 |
11/09/2001 |
BOSS-2000-2 VACUUM ERECTION DEVICE |
POS-T-VAC, INC. |
DENNIS L BELL |
| K012794 |
11/05/2001 |
PRIME-DENT CHEMICAL CURE PIT & FISSURE SEALANT |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
| K012761 |
11/01/2001 |
PRIME-DENT VISIBLE LIGHT CURE PIT & FISSURE SEALANT |
PRIME DENTAL MANUFACTURING, INC. |
ROLANDO MARASIGAN |
| K011933 |
11/02/2001 |
GLYCOSAL II HBA 1C TEST |
PROVALIS DIAGNOSTICS LTD. |
THOMAS M TSAKERIS |
| K010868 |
11/06/2001 |
PSYCHEMEDICS RIA COCAINE ASSAY |
PSYCHEMEDICS CORP. |
THOMAS CAIRNS |
| K012498 |
11/01/2001 |
DYNAPULSE 500G (DP500G) BLLOD PRESSURE MONITORING SYSTEM |
PULSE METRIC, INC. |
ROBERT DUFFY |
| K012850 |
11/19/2001 |
RECORDING AND STIMULATING ELECTRODE |
RADIONICS, A DIVISION OF TYCO HEALTHCARE GROUP LP |
KEVIN J O'CONNELL |
| K013711 |
11/26/2001 |
BACTI-SWAB DRY |
REMEL CO. |
ROBERT E BOOTH |
| K011684 |
11/30/2001 |
INFLUENZA A/B RAPID TEST, CAT NO 2158 663 |
ROCHE DIAGNOSTICS CORP. |
LUANN OCHS |
| K013373 |
11/02/2001 |
OMNI C ANALYZER |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBETT |
| K012396 |
11/05/2001 |
ONTRAK TESTCARD 9 |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K013278 |
11/15/2001 |
TINA-QUANT APOLIPOPROTEIN A-1 VER.2 |
ROCHE DIAGNOSTICS CORP. |
HELEN TORNEY |
| K013207 |
11/13/2001 |
TINA-QUANT APOLIPOPROTEIN B VER.2 |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K013206 |
11/16/2001 |
TINA-QUANT APOLIPOPROTEIN B VER.2 |
ROCHE DIAGNOSTICS CORP. |
KAY A TAYLOR |
| K013249 |
11/16/2001 |
TINA-QUANT APOLIPOPROTEIN VER.2 |
ROCHE DIAGNOSTICS CORP. |
HELEN T TORNEY |
| K012361 |
11/29/2001 |
TINA-QUANT COMPLEMENT C3C TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
HELEN T TORNEY |
| K012359 |
11/29/2001 |
TINA-QUANT COMPLEMENT C4 TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
HELEN T TORNEY |
| K011122 |
11/16/2001 |
BALLPEN SPINAL NEEDLE W/WO INTRODUCER |
RUSCH INTL. |
JULIE A BEAUMONT |
| K010596 |
11/21/2001 |
RUSCH BRONCHUS BLOCKER KIT |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K011121 |
11/16/2001 |
RUSCH PERCUTANEOUS NEPHROSTOMY CATHETER SETS |
RUSCH INTL. |
JULIE A BEAUMONT |
| K013266 |
11/27/2001 |
RUSCH POLYFLEX STENT KIT |
RUSCH INTL. |
KARENANN J BROZOWSKI |
| K012767 |
11/01/2001 |
S & C HYDRO VINYL POLYSILOXANE IMPRESSION MATERIAL |
S & C POLYMER GMBH |
CHRISTIAN BOTTCHER |
| K013444 |
11/16/2001 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
JOANNA DROEGE |
| K013440 |
11/16/2001 |
ISOBAR SPINAL SYSTEM |
SCIEN'TX USA INC. |
JOANNA DROEGE |
| K012552 |
11/05/2001 |
SCITON IMAGE HAIR REMOVAL LASER |
SCITON, INC. |
PETER N ALLEN |
| K012546 |
11/02/2001 |
OPTIMA URS UNIVERSAL RADIOGRAPHIC SYSTEM |
SEDECAL USA, INC. |
DANIEL KAMM |
| K012819 |
11/16/2001 |
SEMPERMED DERMA PLUS, SIZES 5.5,6,6.5,7,7.5,8,8.5,9 |
SEMPERIT TECHNISCHE PRODUKTE GESELLSHAFT |
JAY MANSOUR |
| K012115 |
11/30/2001 |
SERIM BLOOD LEAK TEST STRIP-2 |
SERIM RESEARCH CORP. |
PATRICA RUPCHOCK |
| K013261 |
11/29/2001 |
MOTEX NITRILE EXAMINATION GLOVES POWDER-FREE |
SHANGHAI MOTEX HEALTHCARE CO., LTD. |
TONY T K CHENG |
| K011473 |
11/16/2001 |
SNAZZY2 |
SHOPRIDER INTL., INC. |
CHRIS TINSLEY |
| K013522 |
11/07/2001 |
SOMATOM P30 CT SYSTEMS |
SIEMENS MEDICAL SYSTEMS, INC. |
PRAVEEN NADKARNI |
| K013544 |
11/15/2001 |
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
| K013545 |
11/15/2001 |
SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221 |
SIGMA DIAGNOSTICS, INC. |
WILLIAM R GILBERT II |
| K013696 |
11/28/2001 |
SILMED NASAL SEPTAL BUTTON |
SILMED, INC. |
RAMA GUNDLAPALLI |
| K012517 |
11/01/2001 |
CEREC3 VITABLOCKS |
SIRONA DENTAL SYSTEMS GMBH |
SHEILA HEMEON-HEYER |
| K013306 |
11/02/2001 |
MINIME NASAL MASK, MODEL P/N 50220 |
SLEEPNET CORPORATION |
PAUL R CHIESA |
| K012853 |
11/16/2001 |
SMART GLOVE STERILE NITRILE EXAM GLOVE |
SMART GLOVE CORP. SDN BHD |
NG YEW SOON |
| K012856 |
11/16/2001 |
STERILE LATEX EXAMINATION GLOVES (POWDERED) WITH PROTEIN CLAIM LESS THAN 100UG/G |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K011985 |
11/02/2001 |
SMITH & NEPHEW PHOENIX 5.0 ALLOGRAFT ANCHOR KIT |
SMITH & NEPHEW, INC. |
TIM CRABTREE |
| K012724 |
11/08/2001 |
SMITH & NEPHEW VASCULAR VIDEOENDOSCOPE SYSTEM, MODEL 7209273 |
SMITH & NEPHEW, INC. |
JANICE HASELTON |
| K013469 |
11/20/2001 |
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
SOFLEX CONTACT LENS INDUSTRIES LTD. |
Kevin Walls |
| K013467 |
11/20/2001 |
TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC MULTIFOCAL CONTACT LENS FOR DAILY WEAR |
SOFLEX CONTACT LENS INDUSTRIES LTD. |
Kevin Walls |
| K011487 |
11/21/2001 |
CORRESTORE PATCH, MODELS 1.5P2, 2P3, 3P4; CORRESTORE SIZER, MODEL CRPS |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K013170 |
11/13/2001 |
SCANTAC MEMBRANE OR SCANTAC STRIP |
SONOTECH, INC. |
MARGARET J LARSON |
| K012753 |
11/13/2001 |
SORING GMBH SONOCA 180/190 |
SORING GMBH MEDIZINTECHNIK |
CARL ALLETTO |
| K013394 |
11/08/2001 |
LIFTLOC SAFETY INFUSION SET |
SPECIALIZED HEALTH PRODUCTS, INC. |
Mark Nelson |
| K012881 |
11/26/2001 |
C3 ANTERIOR CERVICAL PLATE SYSTEM |
SPINE VISION, INC |
DAVID W MULLIS, JR |
| K012880 |
11/16/2001 |
STERILE POWDER-FREE LATEX SURGICAL GLOVES (50 MICROGRAMS OR LESS) |
SSN GLOVES (M) SDN BHD |
CLINTON A TECK LEONG |
| K012896 |
11/16/2001 |
STERILE POWDERED LATEX SURGICAL GLOVES WITH PROTEIN LABELING CLAIM (200 MICROGRAMS OR LESS) |
SSN GLOVES (M) SDN BHD |
CLINTON A TECK LEONG |
| K013548 |
11/09/2001 |
STANDARD IMAGING IVB 1000 WELL CHAMBER |
STANDARD IMAGING, INC. |
RAYMOND RIDDLE |
| K012578 |
11/07/2001 |
REPROCESSED ENDOSCOPIC TROCAR |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K012571 |
11/07/2001 |
REPROCESSED HARMONIC |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K012598 |
11/07/2001 |
REPROCESSED LAPAROSCOPIC ELECTRIC INSTUMENTS |
STERILMED, INC. |
PATRICK F FLEISCHHACKER |
| K012682 |
11/08/2001 |
REPROCESSED LASER PROBE |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K012579 |
11/08/2001 |
REPROCESSED PHACO TIPS |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K012536 |
11/02/2001 |
REPROCESSED POWERED ARTHROSCOPIC ACCESSORIES |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K012679 |
11/08/2001 |
REPROCESSED RF ARTHROSCOPY PROBES |
STERILMED, INC. |
PATRICK FLEISCHHACKER |
| K011788 |
11/05/2001 |
EVERSTICK |
STICK TECH LTD. |
WILLIAM M TROETEL |
| K011799 |
11/05/2001 |
EVERSTICKNET |
STICK TECH LTD. |
WILLIAM M TROETEL |
| K013316 |
11/06/2001 |
SICKLE-CHEX |
STRECK LABORATORIES, INC. |
PAUL KITTELSON |
| K012991 |
11/29/2001 |
NEPTUNE WASTE MANAGEMENT STSTEM |
STRYKER INSTRUMENTS |
SUZANNE VELAZQUEZ |
| K013227 |
11/19/2001 |
SCREW VENT IMPLANT; TAPERED SCREW VENT IMPLANT |
SULZER DENTAL, INC. |
FOSTER BOOP |
| K012739 |
11/14/2001 |
CONVERGE ACETABULAR SYSTEM |
SULZER ORTHOPEDICS, INC. |
MITCHELL A DHORITY |
| K011195 |
11/06/2001 |
PRIZM BLADE (MORIA MODEL) LSK / MK8510LSK; PRIZM BLADE (MORIA MODEL) CB / MK8511CB |
SURGIN SURGICAL INSTRUMENTATION, INC. |
DON HAAR |
| K013526 |
11/15/2001 |
CAPIOX RX HARDSHELL RESERVOIR |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K012812 |
11/14/2001 |
CAROTID GUIDING SHEATH |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
| K013550 |
11/20/2001 |
CLIRANS E-SERIES DIALYZER |
TERUMO MEDICAL CORP. |
SANDI HARTKA |
| K012854 |
11/21/2001 |
RENAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
YUK-TING LEWIS |
| K012882 |
11/14/2001 |
BITEM ANGEL RELINE KIT, BITEM LABORATORY KIT, MODELS 120110, 120060 |
THERMOELASTIC TECHNOLOGIES, INC. |
ART WARD |
| K013324 |
11/29/2001 |
HPI SENSI GRIP STERILE POWDERED LATEX SURGICAL GLOVE,WITH LABELED PROTEIN CONTENT AND MADE FROM ALLOTEX AN ENZYME TREAT |
TILLOTSON HEALTHCARE CORP. |
F.W. PERRELLA |
| K013608 |
11/15/2001 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL DFP-8000D |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
DIANA THORSON |
| K013633 |
11/13/2001 |
SSA-770A, APLIO ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K013368 |
11/20/2001 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K013195 |
11/07/2001 |
HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP)MIC SUSCEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K012921 |
11/02/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K013075 |
11/26/2001 |
SENSITITRE HAEMOPHILUS/STREPTOCOCCUS PNEUMONIAE (HP) MIC PLATE |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K012818 |
11/20/2001 |
HELICAL COMPRESSION ANCHOR SYSTEM, CANNULATED SINGLE HELIX |
TRIAGE MEDICAL INC |
GREG H HOLLAND |
| K012817 |
11/20/2001 |
HELICAL COMPRESSION ANCHOR SYSTEM, NON-CANNULATED |
TRIAGE MEDICAL INC |
GREG HOLLAND |
| K011709 |
11/08/2001 |
UNI-GOLD STREP A TEST KIT |
TRINITY BIOTECH, PLC |
FIONA CAMPBELL |
| K012070 |
11/27/2001 |
ORALLITE COMPREHENSIVE EXAM TRAY |
TRYLON CORP. |
MARTIN L LONKY |
| K013372 |
11/09/2001 |
CLEARBLUE EASY EARLY RESULT PREGNANCY TEST |
UNIPATH LTD. |
STEVEN H ARMSTRONG |
| K012620 |
11/09/2001 |
SE-200 |
V.T.S.,INC. |
DENNIS L BELL |
| K012619 |
11/09/2001 |
VT-1 |
V.T.S.,INC. |
DENNIS L BELL |
| K012700 |
11/07/2001 |
VANGUARD REPROCESSED ENDOSCOPIC INSTRUMENTS |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K012698 |
11/09/2001 |
VANGUARD REPROCESSED PHACOEMULSIFICATION |
VANGUARD MEDICAL CONCEPTS, INC. |
MIKE SAMMON |
| K012544 |
11/15/2001 |
VASCULAR ARCHITECTS ASPIRE COVERED STENT AND CONTROLLED EXPANSION DELIVERY SYSTEM |
VASCULAR ARCHITECTS, INC. |
JEAN M CAILLOUETTE |
| K012662 |
11/09/2001 |
SE-100 VACUUM ERECTION DEVICE |
VTS, INC. |
DENNIS L BELL |
| K012639 |
11/09/2001 |
SE-300 VACUUM THERAPY SYSTEM |
VTS, INC. |
DENNIS L BELL |
| K013810 |
11/27/2001 |
CARDIOVASCULAR ARRAY |
W.L. GORE & ASSOCIATES,INC |
TRACEY D WOLF |
| K011175 |
11/01/2001 |
W.O.M. LASER U100 |
W.O.M. WORLD OF MEDICINE, GMBH |
MICHAEL MCGRAIL |
| K013557 |
11/16/2001 |
LACTOSORB CRANIOFACIAL ANCHOR-PUSH SCREW |
WALTER LORENZ SURGICAL, INC. |
TRACY J BICKEL |
| K012831 |
11/01/2001 |
BIO PORTADUR, ORDER-NO.:2017 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012826 |
11/01/2001 |
BIOPORTA G, MODEL 2052 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012841 |
11/20/2001 |
DUO PAL 6, ORDER-NO.: 2154 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012827 |
11/01/2001 |
PORTA AURIUM, MODEL 2067 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012834 |
11/01/2001 |
PORTA GEO TI MODEL #2004 |
WIELAND EDELMETALLE GMBH & CO. |
GEHARD POLZER |
| K012835 |
11/01/2001 |
PORTA MAXIMUM, MODEL# 2066 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012828 |
11/01/2001 |
PORTA SMK 82, MODEL 2032 |
WIELAND EDELMETALLE GMBH & CO. |
GERHARD POLZER |
| K012843 |
11/02/2001 |
PORTADUR P 2, MODEL #2031 |
WIELAND EDELMETALLE GMBH & CO. |
GEHARD POLZER |
| K013101 |
11/16/2001 |
WIENER LAB. AMILASA 405 CINETICA AA, WIENER LAB.AMILASA 405 CINETICA UNITEST,WIENER LAB.AMILASA CINETICA AA |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K013102 |
11/13/2001 |
WIENER LAB. FER-COLOR TRANSFERRINA, MODEL AUX. REAGENTS FOR 25 SAMPLES CAT. 1492002 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K013145 |
11/27/2001 |
WIENER LAB. GOT (AST) UV AA. WEINER LAB. GOT (AST) UV UNITEST, MODELS 10 * 20 ML CAT. NR. 1751302 AND 20 * 2 ML CAT NR. |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K013097 |
11/13/2001 |
WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K013095 |
11/16/2001 |
WIENER LAB.FOSFATEMIA UV, MODELS 1X100 ML CAT.N 1382321, 4X20 ML CAT.N 1009311 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K012326 |
11/08/2001 |
WIENER LAB.MG-COLOR AA, MODEL 2X50 ML CAT. N 1580001 |
WIENER LABORATORIES S.A.I.C. |
VIVIANA CETOLA |
| K011561 |
11/20/2001 |
SEREINE EXTRA STRENGTH DAILY CLEANER |
WILSA, INC. |
SALLY COOK |
| K012591 |
11/02/2001 |
ADVANCE UNICONDYLAR KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
EHAB M ESMAIL |
| K012147 |
11/02/2001 |
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE |
ZEVEX, INC. |
SUSAN P SCHMIDT |
