FDA 510(k) Decisions During February, 2002  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K014142 02/28/2002 UNITE BONDING ADHESIVE 3M UNITEK L. MARLYN SCHEFF
K012472 02/15/2002 A & D MEDICAL LIFESOURCE UA-781, UA781PC, & UA-781T DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC. JERRY WANG
K021233 12/09/2002 AAP CANNULATED SCREWS AAP IMPLANTATE AG CHRISTIAN ABEL
K014201 02/25/2002 AARON REUSABLE ELECTROSURGICAL ELECTRODE AARON MEDICAL INDUSTRIES RICHARD A KOZLOFF
K023397 12/16/2002 ABBOTT ARCHITECT FOLATE ABBOTT LABORATORIES MARGARET PROCHNIAK
K024084 12/31/2002 ABBOTT PLUM A+ INFUSION PUMP, MODEL 12391 ABBOTT LABORATORIES FRANK POKROP
K023807 12/26/2002 MODIFICATION TO ALKP ABBOTT LABORATORIES LINDA MORRIS
K012975 02/28/2002 SOF-TACT DIABETES MANAGEMENT SYSYEM; SOF-TACT BLOOD GLUCOSE TEST STRIP; PRECISION CONTROL SOLUTIONS ABBOTT LABORATORIES JANET S CONNOLLY
K014203 02/28/2002 ABX MICROS 60 HEMATOLOGY ANALYZER ABX DIAGNOSTICS TOM M PHILLIPS
K022854 12/30/2002 ACELL UBM HYDRATED WOUND DRESSING ACELL, INC PATSY J TRISLER
K021637 12/19/2002 ACELL UBM LYOPHILIZED WOUND DRESSING ACELL, INC PATSY J TRISER
K013511 02/01/2002 XENALIGHT MODELS # AX9125 (100-120V~); # AX9225 (220-240V~) ACULUX, INC. KIM MARSH
K012691 12/20/2002 MONSOON CRITICAL CARE JET VENTILATOR AND ACCESSORIES ACUTRONIC MEDICAL SYSTEMS AG TERRY TORZALA
K014185 02/13/2002 AOS CANNULATED BONE SCREW SYSTEM ADVANCED ORTHOPAEDIC SOLUTIONS, INC. PAUL DONER
K994055 02/13/2002 STERRAD CYCLESURE BIOLOGICAL INDICATOR ADVANCED STERILIZATION PRODUCTS KEVIN CORRIGAN
K013778 02/07/2002 PEACE OF MIND HOME DRUG TEST ADVANTAGE DIAGNOSTICS CORP. JANIS FREESTONE
K012694 02/04/2002 REPROCESSED USED DISPOSABLE ARTHROSCOPIC BLADES AND BURS ADVEN MEDICAL MARK W ALDANA
K012675 02/12/2002 REPROCESSED USED DISPOSABLE SEQUENTIAL COMPRESSION SLEEVES/WRAPS ADVEN MEDICAL MARK W ALDANA
K012676 02/04/2002 REPROCESSED USED, DISPOSABLE BLADES, BURS, BITS AND TAPS ADVEN MEDICAL MARK W ALDANA
K023788 12/13/2002 COLUMBUS (CR) TOTAL KNEE SYSTEM AESCULAP, INC. JOYCE KILROY
K023411 12/19/2002 STEELEX STERNUM SET AESCULAP, INC. GEORG KELLER
K014144 02/07/2002 EXTORAL/TESCERA GLAZING RESIN, MODEL T-1804 AFP IMAGING CORP. DAVID VOZICK
K013946 02/27/2002 FLEX 10 ACCESSORY FOR THE AFX MICROWAVE ABLATION SYSTEM AFX, INC. NANCY NORRIS
K023212 12/13/2002 AG GARMENTS CONDUCTIVE ELECTRODES, MODELS 100-104 SLEEVES,110-114 GLOVES,120-124 SOCKS,130-132 PANELS AG GARMENTS ATHENA SHUDDE
K013893 02/01/2002 SCANX AIR TECHNIQUES, INC. JOSEPH CAREY
K023264 12/19/2002 MEDLEY SYRINGE PUMP MODULE SYSTEM, MODEL 8110 ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K022693 12/09/2002 INSTANT-VIEW TCA URINE TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K023936 12/20/2002 MODIFICATION TO MEDIPRIME ALGOTEC SYSTEMS, LTD. ELI M ORBACH
K024102 12/18/2002 DENTAL POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K013479 02/11/2002 COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. PAUL J NOWACKI
K014202 02/20/2002 COMPLETE BRAND MULTI-PURPOSE SOLUTION ALLERGAN, INC. PAUL J NOWACKI
K023996 12/18/2002 ALOKA SSD-3500 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K023299 12/11/2002 ALPHA MIRAGE TOP TIGHTENING SPINAL SYSTEM ALPHATEC MFG., INC. ELLEN A HICKS
K023104 12/16/2002 AMEDICA DRUG SCREEN AMPHETAMINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K023101 12/16/2002 AMEDICA DRUG SCREEN METHAPHETAMINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K023109 12/16/2002 AMEDICA DRUG SCREEN PHENCYCLIDINE TEST AMEDICA BIOTECH, INC. Jeff Chen
K023229 12/13/2002 S.O.F.T. PADDLE (SPECIAL OPTIMIZED FULL COMPRESSION TRAY), MODEL SFT-PDLE AMERICAN MAMMOGRAPHICS, INC. ADRIAN PALMER
K023276 12/09/2002 AMSINO TRACHEOSTOMY CARE TRAY AMSINO INTERNATIONAL, INC. DEAN R GAUF
K023161 12/10/2002 SMARTSTEP SYSTEM ANDANTE MEDICAL DEVICE, LTD. ORLY MAOR
K023173 12/18/2002 ANDREWS INTRODUCER, MODEL ASI01 ANDREWS SURGICAL INNOVATIONS, LTD. EMMET ANDREWS
K014005 02/15/2002 APPLE MEDICAL MOBIUS ELASTIC RETRACTOR APPLE MEDICAL CORP. JOHN C PULFORD
K014047 02/28/2002 APPLIED GELPORT LAPAROSCOPIC HAND ACCESS DEVICE APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K023769 12/30/2002 PREPARE ADMINISTRATION SET APPRO HEALTHCARE, INC. JOHN R SEMLER
K013614 02/01/2002 TROJAN CRYSTAL CLEAR LIQUID ARMKEL LLC STEPHEN C KOLAKOWSKY
K023405 12/16/2002 TROJAN MINT TINGLE BRAND LATEX CONDOMS ARMKEL, LLC. STEPHEN C KOLAKOWSKY
K023986 12/17/2002 ARTHREX OPES ELECTRODES AND ACCESSORIES ARTHREX, INC. ANN WATERHOUSE
K023119 12/18/2002 BI-CORTICAL BIO POST AND WASHER, MODEL AR-1367B ARTHREX, INC. ANN WATERHOUSE
K023777 12/11/2002 ARTHRONET BLACKLINE 2 AND 3 PIECE ARTHROSCOPIC BLADES, MODELS 123, 133, 153, 163, 173 AND 183 ARTHRONET MEDICAL, INC. CAROLINA SCHABER
K013940 02/26/2002 LASER SYSTEM YELLOWSTAR ASCLEPION-MEDITEC AG WILLIAM KELLEY
K020304 02/14/2002 DISPOSABLE LIGHT HANDLE AND ADAPTOR ASPEN SURGICAL PRODUCTS, INC. ROY MELLING
K011273 02/20/2002 SI ASCOPE ASTRON CLINICA LIMITED E.J. Smith
K012487 02/21/2002 SPHYGMOCOR PX MODEL SCOR-PX ATCOR MEDICAL PTY. LTD KIRSTEN PAULSON
K020683 12/17/2002 ISOROD PD-103 IMPLANT, MODEL ATI-PD-103 ATI MEDICAL, INC. MICHAEL WIENHOLT
K023108 12/03/2002 STERIPACK STERILE DISPOSABLE SYRINGE & STERILE DISPOSABLE INSULIN SYRINGE ATLANTIC PRODUCTS, INC. MAHBUBUR RAHMAN
K014102 02/21/2002 PROVOX HME CASSETTE, MODEL 7240; PROVOX ADHESIVE, MODEL 7251 ATOS MEDICAL AB EDDY ABERG
K021699 12/16/2002 AUTOLENS CLEANING AND DISINFECTING UNIT AUTOLENS INC. RICHARD E LIPPMAN
K021859 12/02/2002 WRIST IMPLANT AVANTA ORTHOPAEDICS, INC. LOUISE M FOCHT
K023160 12/20/2002 DRX5000 AXIOM USA. INC JIM GIBSON
K022640 12/02/2002 SOLERA MAGNUM THROMBECTOMY CATHETER, 55 CM, MODEL BAC SMG 007 055 & SOLERA MAGNUM THROMBECTOMY CATHETER, 110 CM BACCHUS VASCULAR, INC. GREGORY J MATHISON
K013635 02/11/2002 TRELLIS INFUSION SYSTEM (10CM INFUSION LENGTH); TRELLIS INFUSION SYSTEM (20CM INFUSION LENGTH) BACCHUS VASCULAR, INC. GREG MATHISON
K023514 12/02/2002 TRELLIS RESERVE INFUSION SYSTEM (140CM CATHETER LENGTH, 10CM INFUSION LENGTH) BACCHUS VASCULAR, INC. GREGORY J MATHISON
K022773 12/13/2002 BARCO MEDIS 2MP1NT MEDICAL DIAGNOSTIC DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K023341 12/23/2002 CORNIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K023340 12/23/2002 CORONIS 1MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV FRANK FERGUSOPN
K023322 12/23/2002 CORONIS 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV FRANK FERGUSON
K023339 12/23/2002 IMAGETILE BARCO NV FRANK FERGUSON
K014174 02/22/2002 HARVEY PV DRY STERILIZER, MODEL # ST127325; ST127320; ST127320-33 BARNSTEAD/THERMOLYNE CORP. MIA M WARE
K013562 12/12/2002 AURORA SYSTEM 1000 SERIES HOME SELF-CARE SINGLE PATIENT DELIVERY SYSTEM; MODELS- SYS 1000, L3 WITH N100 ARM, 4B SOFTWARE BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K022288 12/17/2002 COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEM BAYER CORP. KENNETH T EDDS
K023841 12/24/2002 AMMONIA ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K012357 02/28/2002 CA 15-3 ASSAY FOR THE ADVIA CENTAUR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K022177 12/17/2002 PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K023334 12/31/2002 BMC CATHETER CONNECTOR CABLE, MODEL RFP-101 BAYLIS MEDICAL CO., INC. AMANDA HARTLEY
K013904 02/12/2002 BMC RADIO FREQUENCY PERFORATION GENERATOR, MODELS RFP-100-115 AND RFP-100-230 BAYLIS MEDICAL CO., INC. KRIS SHAH
K013919 02/22/2002 TORFLEX TRANSSEPTAL GUIDING SHEATH BAYLIS MEDICAL CO., INC. KRIS SHAH
K013862 02/21/2002 BCI 1621 OXIMETRY DATA MANAGEMENT PROGRAM BCI, INC. DONALD ALEXANDER
K013719 02/05/2002 BECKER BAND CRANIAL REMOLDING ORTHOSIS BECKER ORTHOPEDIC APPLIANCE CO. JAMES H CAMPBELL
K023597 12/11/2002 ACCESS OV MONITOR IMMUNOENZYMETRIC ASSAY BECKMAN COULTER, INC. MARA CALER
K023480 12/20/2002 ACCESS TOTAL BHCG BECKMAN COULTER, INC. DENISE THOMPSON
K023369 12/09/2002 ACCESS TOTAL T4 ASSAY BECKMAN COULTER, INC. DENISE THOMPSON
K014173 02/15/2002 SYNCHRON SYSTEMS SALICYLATE REAGENT AND CALIBRATOR BECKMAN COULTER, INC. MARY BETH TANG
K022133 12/10/2002 BD DIRECTIGEN EZ RSV KIT BECTON DICKINSON & CO. COLLEEN A KISTLER
K024109 12/30/2002 BD ULTRA-FINE III PEN NEEDLE BECTON DICKINSON & CO. JOHN A SCHALGO
K013971 02/01/2002 BD VACUTAINER SAFETY COAGULATION TUBE BECTON DICKINSON & CO. KEITH SMITH
K023219 12/06/2002 BECTON DICKINSON DIABETES SOFTWARE BECTON DICKINSON & CO. JOHN SCHALAGO
K023858 12/20/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K023527 12/23/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN - 0.25-16 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K023634 12/24/2002 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-GENTAMICIN GN (0.25-16UG/ML) BECTON, DICKINSON & CO. MICHELLE B BANDY
K013668 02/04/2002 BERCHTOLD ELEKTROTOM 106 HITT BERCHTOLD CORP. MARIKA ANDERSON
K010185 12/30/2002 6.0 X 5.7MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K022660 12/19/2002 BIOCHECK MYOGLOBIN ELISA, MODEL BC-1117 BIOCHECK, INC. ROBIN J HELLEN
K022995 12/02/2002 COLLATEK HYDROGEL BIOCORE MEDICAL TECHNOLOGIES, INC. AJAY KUMAR
K023089 12/16/2002 GELSPHERES EMBOLIC AGENT BIOCURE, INC. JOHN GREENBAUM
K013148 02/28/2002 BIOGENEX MONOCLONAL ANTI-ESTROGEN RECEPTOR(CLONE ER88) BIOGENEX LABORATORIES GURVINDER S NANDA
K013908 02/12/2002 WATERLASE MILLENNIUM BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K023063 12/13/2002 COMPREHENSIVE HUMERAL FRACTURE SYSTEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K023188 12/11/2002 PRESS-FIT HEAD RESURFACING DEVICE BIOMET ORTHOPEDICS, INC. PATRICIA SANDBORN BERES
K020264 02/08/2002 REPICCI II UNICONDYLAR KNEE SYSTEM BIOMET ORTHOPEDICS, INC. DALENE T BINKLEY
K013923 02/25/2002 TITANIUM RETROGRADE FEMORAL NAIL - 13 MM DIAMETER BIOMET ORTHOPEDICS, INC. LONNIE WITHAM
K022952 12/02/2002 MODULAR HEAD BONE SCREW BIOMET, INC. KACY ARNOLD
K024037 12/30/2002 NARROW ASCENT INTERLOK FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K011569 02/22/2002 BIOSORBFX O/M 2.0/2/4 SYSTEM BIONX IMPLANTS, INC. TUIJA ANNALA
K020088 02/08/2002 MODIFICATION OF THE BIOPLATE ZIP CRANIOTOMY FIXATION SYSTEM BIOPLATE, INC. CAROL E JONES
K023810 12/04/2002 MODIFICATION TO BIOPLATE RIGID FIXATION BONE PLATING SYSTEM FOR CRANIOMAXILLOFACIAL SURGERY BIOPLATE, INC. JUDY SOKUA
K013803 02/13/2002 FLOWGUARD DEVICE BIOSONIX LTD. AHAVA STEIN
K020164 02/12/2002 E-SCAN XQ BIOSOUND ESAOTE, INC. COLLEEN DENSMORE
K023803 12/11/2002 MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS BIOTRONIK, INC. Jon Brumbaugh
K013885 02/01/2002 BLACKSTONE SPINAL FIXATION SYSTEM POSTERIOR HOOKS BLACKSTONE MEDICAL, INC. ALAN LOMBARDO
K014169 02/06/2002 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS BOB J. JOHNSON & ASSOC., INC ROBERT SNYDER
K014187 02/06/2002 AUTOVAC ORTHOPEDIC AUTOTRANSFUSION SYSTEM BOEHRINGER LABORATORIES JOHN KARPOWICZ
K023147 12/12/2002 ANALOG MULTIPLEXED CABLE TELEMETRY (AMT) ELECTROMYOGRAPH, MODELS AMT-16, AMT-8 & AMT-4 BORTEC BIOMEDICAL, LTD. CARL YOUNGMAN
K020283 02/11/2002 BACK-UP MEIER STEERABLE GUIDEWIRE BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K023870 12/20/2002 FLEXIMA BILIARY CATHETER BOSTON SCIENTIFIC/MEDI-TECH NICHOLAS CONDAKES
K023489 12/16/2002 QUICKTOX MULTIPLE DRUG DIPCARD BRANAN MEDICAL CORP. CHIA HER
K013717 02/06/2002 BRENTWOOD REAL TIME ST AND ARRHYTHMIA ANALYSIS SOFTWARE LIBRARY BRENTWOOD MEDICAL TECHNOLOGY CORP. RUOMEI ZHANG
K023961 12/24/2002 SCOUT BOSS BURKE, INC. DUWAYNE E KRAMER JR.
K023374 12/18/2002 GROSHONG NXT DUAL LUMEN PICC CATHETERS C.R. BARD, INC. PEGGY KEIFFER
K023193 12/20/2002 CANDELA GENTLE YAG LASER SYSTEM CANDELA CORP. William McGrail
K013748 02/11/2002 CANDELA SCLERO LONG PULSE LASER (AKA VBEAM) CANDELA CORP. L NELSON
K013825 02/15/2002 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE NELSON
K020197 02/21/2002 MODIFICATION TO DATACAPTOR CAPSULE TECHNOLOGIE DANIEL KAMM
K013879 02/01/2002 TM2000, MODEL 1 CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K024058 12/30/2002 MODIFICATION TO CARDEON AEGIS CATHETER CARDEON CORP. JANE BEGGS
K012241 02/01/2002 CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION, MODEL CN1001 CARDIONET, INC DONALD V CANAL
K020018 02/21/2002 MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE CARDIOPULMONARY CORP. JOHN LAVIOLA
K022584 12/30/2002 CARDIOTECH ANTIBOTIC HYDROGEL WOUND DRESSING CARDIOTECH INTL. ANDREW M REED
K014028 02/08/2002 CARESIDE APTT CARESIDE HEMOTOLOGY, INC. KENNETH B ASARCH
K023466 12/13/2002 TULIP ALGINATE IMPRESSION MATERIAL CAVEX HOLLAND B.V. RICHARD WOORTMAN
K011147 02/15/2002 CAVITAT ULTRASOUND BONE DENSITOMETER (CAVITAT) CAVITAT MEDICAL TECHNOLOGIES, INC. LARRY R PILOT
K023328 12/12/2002 REINFORCED ABSORBABLE SYNTHETIC SURGICAL MESH CENTER FOR BIOMATERIALS AND ADVANCED TECHNOLOGIES MELISSA MAHALL
K020132 02/26/2002 CHASE CARDIOVASCULAR PATCH KIT CHASE MEDICAL, INC. DAVE HERNON
K023347 12/06/2002 VITAL STIM CHATTANOOGA GROUP CHERYL BAGWELL
K013342 02/15/2002 EXCELSIOR TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. CHAY MEDICAL, LLC. STEPHEN C PEARSON
K023370 12/24/2002 CHEETAH I.V.D.S., MODEL 2002P CHEETAH MEDICAL INC. ARAVA HACOHEN
K023732 12/10/2002 CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR CIBA VISION CORPORATION TERRINA WILDER
K020193 02/28/2002 OCULAR SCIENCES, INC. BIOMEDICS UV ASPHERE (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS CL MCINTOSH RICHARD E LIPPMAN
K012601 02/06/2002 CLEARMEDICAL/AIRCAST VENAFLOW CALF CUFF, CLEARMEDICAL AIRCAST XL VENAFLOW CALF CUFF, CLEARMEDICAL/AIRCAST VENAFLOW THIGH CLEAR MEDICAL, INC. RICHARD RADFORD
K012621 02/06/2002 CLEARMEDICAL/HENTLEIGH DEEP VEIN THROMBOSIS (DVT) GARMENT CLEAR MEDICAL, INC. RICHARD RADFORD
K012616 02/06/2002 CLEARMEDICAL/HUNTLEIGH FOOT GARMENTS; MODELS FG200/LRG (LARGE), FG200/STD (STANDARD), FG100/SM (SMALL), FG100-R (REGULAR CLEAR MEDICAL, INC. RICHARD RADFORD
K012606 02/06/2002 CLEARMEDICAL/KENDALL KNEE-HIGH SCD SLEEVES, CLEARMEDICAL/KENDALL THIGH-HIGH SCD SLEEVES, MEDIUM,SMALL, LARGE CLEAR MEDICAL, INC. RICHARD RADFORD
K012612 02/06/2002 CLEARMEDICAL/NOVAMEDIX AVI FOOT COVER, PAIR, REGULAR & LARGE SIZE CLEAR MEDICAL, INC. RICHARD RADFORD
K013863 02/19/2002 CRYSTAL MONITOR MODEL 16 CLEVELAND MEDICAL DEVICES, INC. ROBERT N SCHMIDT
K014048 02/11/2002 CLINICON UNIVERSAL WAVEGUIDE HANDPIECE AND FIBER TIPS CLINICON CORP. SEAN M CURRY
K023661 12/06/2002 LINICAL RF-CRP CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K014063 02/07/2002 TASK FORCE MONITOR 3040 CNSYSTEMS MEDIZINTECHNIK GMBH CHRISTIAN WAGNER
K023125 12/18/2002 COALESCENT U-CLIP- AND ACCESSORIES COALESCENT SURGICAL MICHAEL A DANIEL
K023922 12/20/2002 COAPT SYSTEMS ENDOTINE DEVICE, MODEL CFD-101-00197 COAPT SYSTEMS, INC. SHELLEY TRIMM
K011835 02/12/2002 COBE REVOLUTION COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K023581 12/02/2002 COMFORT AGILE SCOOTER, LY-EW303 COMFORT ORTHOPEDIC CO. LTD. JEN KE-MIN
K023655 12/13/2002 ENHANCE HTF MEDIUM WITH HEPES CONCEPTION TECHNOLOGIES GRACE HOLLAND
K023717 12/13/2002 SPERM WASH MEDIUM WITH GENTAMICIN CONCEPTION TECHNOLOGIES JOHN CORCORAN
K023731 12/24/2002 QUICKCHECK LIQUID CHEMISTRY CONTROL (ASSAYED AND UNASSAYED), LEVELS 1, 2, AND 3 CONSOLIDATED TECHNOLOGY CANDICE BETZ
K023349 12/24/2002 CONTAFLEX GM3 58% (ACOFILCON A) SPHERICAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, LATHE-CUT) CONTAMAC LTD. MARTIN DALSING
K013216 02/27/2002 DIODENT DENTAL LASER SYSTEM CONTINUUM ELECTRO-OPTICS, INC. RONALD KOHLHARDT
K014160 02/08/2002 PGD-PRE-IMPLANTATION GENETIC DIAGNOSTIC PIPETTES (BIOPSY PIPETTES) COOK UROLOGICAL, INC. DEBBIE SCHMITT
K023353 12/20/2002 SYDNEY IVF HYALURONIDASE COOK UROLOGICAL, INC. DEBBIE SCHMITT
K013241 02/21/2002 ARNDT EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. HEIDI MASTEN
K013252 02/21/2002 PATIL EMERGENCY CRICOTHYROTOMY CATHETER SET COOK, INC. HEIDI MASTEN
K023379 12/11/2002 COOPERSURGICAL EMBRYO TRANSFER CATHETER, COOPERSURGICAL ASSISTED REPRODUCTION CATHETER COOPER SURGICAL JOSEPH M AZARY
K023383 12/13/2002 COOPERSURGICAL INTRAUTERINE INSEMINATION CATHETER COOPER SURGICAL JOSEPH M AZARY
K023382 12/20/2002 COOPERSURGICAL MALLEABLE SYTLET COOPER SURGICAL JOSEPH M AZARY
K023384 12/13/2002 COOPERSURGICAL TRIAL TRANSFER CATHETER COOPER SURGICAL JOSEPH M AZARY
K023907 12/18/2002 CORDIS MAXI LD LARGE DIAMETER BALLOON DILATATION CATHETER, CORDIS MAXI LD PTA BALLOON DILATION CATHETER CORDIS CORP. DONNA MARSHALL
K020052 02/11/2002 SMART NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K011239 02/14/2002 GINDA GUARD COSMEDENT, INC. MICHAEL O'MALLEY
K013975 02/22/2002 CP-SLEEVE CP MEDICAL MARY ANN GREENWALT
K020107 02/07/2002 SMARTEPIL CYNOSURE, INC. GEORGE CHO
K023327 12/02/2002 CYNOVAD ZIRKON CYNOVAD NAOUM ARAJ
K020249 02/06/2002 MICROSCAN PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MEROPENEM (0.12-32 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020185 02/06/2002 MICROSCAN RAPID/S PLUS GRAM-NEGATIVE MIC COMBO PANELS WITH GENTAMICIN (0.12-32 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020209 02/06/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMIKACIN (0.25-128 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020328 02/19/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH CEFUROXIME (1-64 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K023361 12/16/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH GATIFLOXACIN (0.004-16 UG/ML) DADE BEHRING, INC. CYNTHIA VAN DUKER
K020246 02/06/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH IMIPENEM (0.25, 1-32 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K023541 12/13/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH MOXIFLOXACIN (0.004-16UG/ML) DADE BEHRING, INC. CYNTHIA VAN DUKER
K020182 02/06/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH NETILMICIN (0.12-32 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020173 02/06/2002 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TETRACYCLINE (0.12-128 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020168 02/06/2002 MICROSCAN SYNERGIS PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH TOBRAMYCIN (0.12-32 UG/ML) DADE BEHRING, INC. MAUREEN MENDE
K020023 02/28/2002 DAKO MONOCLONAL MOUSE ANTI-HUMAN PROGESTERONE RECEPTOR, CLONE PGR 636, ANTIBODY FOR IMMUNOENZYMATIC STAINING DAKO CORP. GRETCHEN M MURRAY
K011540 02/06/2002 VIEWPOINT CENTRAL MONITORING SYSTEM, MODEL 0998-00-0187-07 DATASCOPE CORP. SUSAN E MANDY
K014249 02/19/2002 JETPOLISHER DELDENT LTD. ALAN EDEL
K014252 02/19/2002 JETSTREAM DELDENT LTD. ALAN EDEL
K022284 12/10/2002 SNORE-AID MAX DENTAL IMAGINEERS, LLC WILLIAM A BELFER
K020412 02/22/2002 DEPILASE TWIN LASE LASER SYSTEM DEPILASE GROUP LTD. MARIO RUSSO
K020463 02/27/2002 DEPILASE YAG LASE PLUS LASER SYSTEM DEPILASE GROUP LTD. MARIO LUCA RUSSO
K023115 12/18/2002 ACE VERSANAIL DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN, J.D.
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