FDA 510(k) Decisions During November, 2001  

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
K013206 11/16/2001 TINA-QUANT APOLIPOPROTEIN B VER.2 ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K013207 11/13/2001 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
K013440 11/16/2001 ISOBAR SPINAL SYSTEM SCIEN'TX USA INC. JOANNA DROEGE
K013444 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


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