FDA 510(k) Decisions During January, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K033022 11/21/2003 PROTEMP 3 GARANT 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K023640 01/24/2003 PICCOLO HDL TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K023642 01/24/2003 PICCOLO TOTAL CHOLESTEROL TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K023639 01/24/2003 PICCOLO TRIGLYCERIDES TEST SYSTEM ABAXIS, INC. DENNIS M BLEILE
K024239 01/13/2003 CHEMO DISPENSING PIN, MODEL 12495 ABBOTT LABORATORIES NICOHL R WILDING
K024126 01/14/2003 CLEAR OR BRAIDED CONTRAST MEDIA INJECTION LINE OR WITHOUT ROTATOR, CATH LAB KIT ABBOTT LABORATORIES NICOHL R WILDING
K030002 01/27/2003 LIFESHIELD PRIMARY IV SET CONV. PIN. CLAVE; LF LC 5000 PLUMSET-DUAL W/CONV PIN & CAP PORT; LIFESHIELD LF MACROBORE EXT. ABBOTT LABORATORIES NOCOHL R WILDING
K024067 01/15/2003 RHEUMATOID FACTOR (RF) ABBOTT LABORATORIES LINDA MORRIS
K030144 01/31/2003 MODIFICATION TO PENTRA 60 AND PENTRA 60C+ ABX DIAGNOSTICS TIM LAWTON
K024002 01/03/2003 PENTRA 80 ABX DIAGNOSTICS TIM LAWTON
K030031 01/28/2003 SOFT TISSUE ANCHORING WASHERS ACCU-SPEED, INCORPORATED ROBERT W SECOVICH
K020892 01/27/2003 ACIST GENTOO CONTRAST INJECTION SYSTEM ACIST MEDICAL SYSTEMS CARL M BEAURLINE
K023358 01/03/2003 USA SERIES DUR 8 ELITE, USA SERIES DUR 8, MODELS DUR 8E, DUR 8 ACMI CORPORATION TERRENCE SULLIVAN
K033041 11/21/2003 ACON QUIK-CHECK II HOME PREGNANCY TEST STRIP ACON LABORATORIES, INC. EDWARD TUNG
K032879 11/13/2003 NAVIGATOR I ADAPTIVE HEALTHCARE TECHNOLOGIES, INC. JOAN JOHNSON
K033401 11/20/2003 MODIFICATION TO RESQPOD CIRCULATORY ENHANCER ADVANCED CIRCULATORY SYSTEMS, INC. GARY SYRING
K023981 01/31/2003 AHL GENERIC GLASS IONOMER LUTING CEMENT ADVANCED HEALTHCARE LTD. BILL ETTINGER
K033597 11/25/2003 ATR 5000, LC 5000, IMPLANT SYSTEM ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. DANIELE POLI
K032481 11/04/2003 THERATEARS CONTACT LENS COMFORT DROPS ADVANCED VISION RESEARCH, INC. BEVERLEY D VENUTI
K023712 01/31/2003 ADVANTAGE MULTIPLE DRUGS OF ABUSE TEST ADVANTAGE DIAGNOSTICS CORP JANIS FREESTONE
K032849 11/21/2003 AERONEB GO NEBULIZER, MODEL AG-AG2000 AEROGEN, INC. NANCY E ISAAC
K023678 01/23/2003 DIMISIL SCAR GEL AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC. CATHERINE RIPLE
K033013 11/25/2003 MDIFICATION TO MEDIPRIME ALGOTEC SYSTEMS, LTD. ELI M ORBACH
K024292 01/09/2003 MODIFICATION TO POSITIVE TOUCH POWDER-FREE LATEX EXAMINATION GLOVES WITH PROTEIN AND CHEMOTHERAPY LABELING CLAIM ALLEGIANCE HEALTHCARE CORP. ERICA SETHI
K024120 01/15/2003 MODIFICATION TO TEMNO BIOPSY NEEDLES ALLEGIANCE HEALTHCARE CORP. SHARON NICHOLS
K023613 01/23/2003 AX200 AUTOMATIC X-RAY FILM PROCESSOR, MODEL 6586.036 ALPHATEK CORP. PAUL M KUPSCO
K032744 11/13/2003 ALVEOLUS INC., TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. HOWARD L SCHRAYER
K033345 11/19/2003 AN5150 AND AN7150 DIGITAL RADIOLOGY SYSTEMS ANALOGIC CORP. MARVIN ROSENBAUM
K033443 11/19/2003 SPEEDLYSER INFUSION CATHETER KIT ANGIODYNAMICS, INC. TERI JUCKETT
K023213 01/16/2003 RDH-2000 ANODIA SYSTEMS THAD OVERMYER
K031385 11/10/2003 ANZAI AZ-733 RESPIRATORY GATING SYSTEM ANZAI MEDICAL CO, LTD. T. WHIT ATHEY
K033333 11/14/2003 SINGLE USE 3-LUMEN BALLOON CATHETER, MODELS B-230Q-A AND B-230Q-B AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K024056 01/17/2003 SURESET 3.0 ML RESERVOIR, MODEL 24-103 APPLIED DIABETES RESEARCH, INCORPORATED JAMES BARLEY
K031553 11/18/2003 SILICONE FOAM CUFF TRACHEOSTOMY TUBES, SILICONE CUFFLESS NEONATAL AND PEDIATRIC TRACHEOSTOMY TUBES ARCADIA MEDICAL CORPORATION ARTHUR WARD
K023609 01/17/2003 SILVERLON ADHESIVE STRIP ARGENTUM INTERNATIONAL LLC. BART FLICK
K023612 01/24/2003 SILVERLON CONTACT WOUND DRESSING ARGENTUM INTERNATIONAL LLC. BART FLICK
K031153 11/25/2003 MONITOR, MODEL HSM-00200; PROBE, MODEL HSP-05065; JACKET, MODEL HSJ-05065 ARROW INTL., INC. WILLIAM G MCLAIN
K031666 11/18/2003 ARTHREX FIBERWIRE BUTTON REPAIR KIT, MODEL AR-8920DS/AR-8921DS ARTHREX, INC. ANN WATERHOUSE
K033584 11/28/2003 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K032160 11/17/2003 ARTELON SURGICAL SUTURE ARTIMPLANT AB RUSS PAGANO
DEN020001 01/31/2003 BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL HOWARD M HOLSTEIN
K010514 01/31/2003 BREASTVIEW VISUAL MAPPING SYSTEM ASSURANCE MEDICAL HOWARD M HOLSTEIN
K023004 01/28/2003 "LFRE" INDIRECT LARYNGOSCOPE ASTRALITE CORP. DORIAN SWARTZ
K023686 01/29/2003 AURORA MR-GUIDED INTERVENTIONAL SYSTEM AURORA IMAGING TECHNOLOGY, INC. ALAN OSLAN
K023653 01/17/2003 MAXONE IV FLUID/BLOOD WARMER, MODEL 102 AUTOMATIC MEDICAL TECHNOLOGIES, INC. CINDY MARTIN
K023934 01/23/2003 RAPID THERMAL EXCHANGE SYSTEM AVACORE TECHNOLOGIES, INC. CRAIG COOMBS
K024018 01/17/2003 AVANT GUARDIAN 101 AVANT MEDICAL CORPORATION JOHN B SLATE
K033015 11/25/2003 AXIOM BIOLASER LLLT SERIES-3 AXIOM USA. INC JIM GIBSON
K022602 01/23/2003 DRX3000 AXIOM USA. INC JIM GIBSON
K024236 01/17/2003 ULTRASOUND SCANNER, TYPE 2400 B-K MEDICAL A/S VILLY BRAENDER
K023533 01/17/2003 BARCO MEDIS 5MP2 AURA BARCO NV FRANK FERGUSON
K031646 11/14/2003 BAUSCH & LOMB MULTI-PURPOSE SOLUTION NRC03 BAUSCH & LOMB, INC. PAUL G STAPLETON
K031676 11/20/2003 HOMECHOICE APD SET WITH LINEO CONNECTOR, MODELS 5C4469Q, 5C4468Q, 5C4531Q, 5C8302Q, 5C4599Q BAXTER HEALTHCARE CORP. DAVID E CURTIN
K024234 01/23/2003 ASCENSIA GLUCOFACTS; ASCENSIA GLUCOFACTS PROFESSIONAL BAYER CORP. GEORGE M TANCOS
K024017 01/30/2003 BAYER ADVIA CENTAUR HER-2/NEU ASSAY BAYER CORP. KENNETH T EDDS
K023840 01/07/2003 ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 BAYER DIAGNOSTICS CORP. ANDRES HOLLE
K033007 11/14/2003 BAYER ADVIA DIGOXIN ASSAY FOR THE INTEGRATED MODULE SYSTEM BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K030102 01/24/2003 ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 BAYER HEALTHCARE, LLC KENNETH T EDDS
K030169 01/31/2003 SETPOINT CHEMISTRY CALIBRATOR BAYER HEALTHCARE, LLC KENNETH T EDDS
K030012 01/17/2003 CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 BECKMAN COULTER, INC. BRENT TABER
K023764 01/28/2003 UNICEL DXI 800 ACCESS IMMUNOASSAY SYSTEM, MODEL 973100 BECKMAN COULTER, INC. LYNN WEIST
K024112 01/09/2003 BD INSULIN SYRINGE BECTON DICKINSON & CO. JOHN A SCHALAGO
K033350 11/18/2003 BD VACUTAINER SAFETY-LOK ADMINISTRATION SET WITH FILTER BECTON DICKINSON & CO. M. WENDY BALLESTEROS
K023568 01/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM BECTON, DICKINSON & CO. MONICA E GIGUERE
K023895 01/08/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CIPROFLOXACIN GN BECTON, DICKINSON & CO. MICHELLE B BANDY
K024152 01/31/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - RIFAMPIN 0.25-32 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K023703 01/30/2003 BI-OSTETIC BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K022622 01/09/2003 CEM-OSTETIC, MODELS CEMO-020O, CEMO-05P, CEMO-10P, CEMO-20P, AND CEMO-30P BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K031375 11/20/2003 BESMED VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, BE-560/BE-580 BESMED HEALTH BUSINESS CORP. DR. JEN KE MIN
K031374 11/28/2003 BESMED VARIOUS MODELS OF TENS, BE-550/BE-660 BESMED HEALTH BUSINESS CORP. DR. JEN KE MIN
K023705 01/29/2003 BICON TRANSITIONAL IMPLANT (BTI) SYSTEM BICON, INC. VINCENT J MORGAN
K024222 01/15/2003 LIQUICHEK ANA CONTROL CENTROMERE PATTERN, POSITIVE, CATALOG #112 BIO-RAD YVETTE LLOYD
K024221 01/15/2003 LIQUICHEK ANA CONTROL HOMOGENEOUS PATTERN CONTROL, POSOTIVE, CATALOG #118 BIO-RAD YVETTE LLOYD
K024230 01/15/2003 LIQUICHEK ANA CONTROL SET, POSITIVE: HOMOGENEOUS, SPECKLED, CENTROMERE AND NUCLEOLAR PATTERNS, CATALOG #131 BIO-RAD YVETTE LLOYD
K024229 01/15/2003 LIQUICHEK ANA CONTROL, NUCLEOLAR PATTERN, POSITIVE, CATALOG #111 BIO-RAD YVETTE LLOYD
K024217 01/15/2003 LIQUICHEK ANA CONTROL, SPECKLED PATTERN, POSITIVE, CATALOG #108 BIO-RAD YVETTE LLOYD
K024227 01/15/2003 LIQUICHEK ANTI-MITOCHONDRIAL CONTROL, POSITIVE, CATALOG #127 BIO-RAD YVETTE LLOYD
K024231 01/13/2003 LIQUICHEK ANTI-MITOTIC SPINDLE PATTERN CONTROL, POSITIVE, CATALOG #118 BIO-RAD YVETTE LLOYD
K024225 01/15/2003 LIQUICHEK ANTI-NDNA CONTROL, POSITIVE, CATALOG #119 BIO-RAD YVETTE LLOYD
K024223 01/13/2003 LIQUICHEK ANTI-RNP CONTROL, POSITIVE, CATALOG #116 BIO-RAD YVETTE LLOYD
K024226 01/10/2003 LIQUICHEK ANTI-SCL-70 CONTROL, POSITIVE, CATALOG #116 BIO-RAD YVETTE LLOYD
K024219 01/15/2003 LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115 BIO-RAD YVETTE LLOYD
K024224 01/15/2003 LIQUICHEK ANTI-SMOOTH MUSCLE CONTROL, POSITIVE, CATALOG #129 BIO-RAD YVETTE LLOYD
K024218 01/17/2003 LIQUICHEK ANTI-SS-A CONTROL, POSITIVE, CATALOG #114 BIO-RAD YVETTE LLOYD
K024232 01/17/2003 LIQUICHEK ANTI-SS-B CONTROL, POSITIVE, CATALOG #113 BIO-RAD YVETTE LLOYD
K024220 01/17/2003 LIQUICHEK AUTOIMMUNE NEGATIVE CONTROL, CATALOG #130 BIO-RAD YVETTE LLOYD
K032874 11/24/2003 HBA SPERM-HYALURONAN BINDING ASSAY BIOCOAT, INC. JAMES B JOHNSTON
K020586 01/24/2003 GOOD LUBRICATIONS BIOFILM, INC. ROBERT L DE ARMOND
K032425 11/05/2003 INVISIJECT RESUSABLE AUTO-INJECTOR BIOGEN MICHAEL POIRIER
K024088 01/02/2003 CERALAS D 980 LASER SYSTEM WITH ENDO LASER VEIN SYSTEM KIT, MODEL: D15 AND D25 BIOLITEC, INC. JONATHAN S KAHAN
K032788 11/04/2003 VITEK 2 GRAM NEGATIVE GATIFLOXACIN BIOMERIEUX, INC. NANCY WEAVER
K032861 11/12/2003 VITEK 2 GRAM NEGATIVE MOXIFLOXACIN BIOMERIEUX, INC. NANCY WEAVER
K032286 11/20/2003 CALCIGEN PSI BONE GRAFT SUBSTITUTE BIOMET ORTHOPEDICS, INC. TRACY J BICKEL
K024086 01/09/2003 PROPELLER HEAD SMALL CANNULATED SCREW SYSTEM BIOMET ORTHOPEDICS, INC. KACY ARNOLD
K032895 11/20/2003 BI-ANGULAR SHOULDER SYSTEM BIOMET, INC. PATRICIA S BERES
K021992 01/14/2003 DHS DISPOSABLE HOOD SYSTEM BIOMET, INC. KACY ARNOLD
K030047 01/23/2003 FREEDOM CONSTRAINED LINERS BIOMET, INC. MAX T HEBEL
K033233 11/05/2003 LACTOSORB TIBIAL L-15 SCREW AND WASHER BIOMET, INC. PATRICIA SANDBORN BERES
K023546 01/17/2003 MAXIM ACCEL KNEE SYSTEM BIOMET, INC. TRACY J BICKEL
K024022 01/23/2003 OSTEO-CABLE SLEEVE BIOMET, INC. KACY ARNOLD
K020863 01/09/2003 CARTO XP AND QWIKMAP EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. WILLIAM WELCH
K030088 01/17/2003 TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS BIOSITE INCORPORATED JEFFREY R DAHLEN
K030089 01/23/2003 TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS BIOSITE INCORPORATED JEFFREY R DAHLEN
K032992 11/21/2003 UNIMARK HOME PREGNANCY TEST DEVICE BIOTECH ATLANTIC, INC. FRANCIS L DENG
K022360 01/27/2003 ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA 3000 BATTERY (TYPE 2); NK-11 POWER SUPP. BIOTRONIK, INC. JON BRUMBAUGH
K033320 11/19/2003 SCOUT PRO BIOTRONIK, INC. JON BRUMBAUGH
K032597 11/04/2003 BISCEM GI BISCO, INC. KATHY JOUNG
K024165 01/10/2003 DUAL-LUMEN CATHETER BISTECH, INC. PAMELA PAPINEAU
K023721 01/10/2003 BONART ART-L2 LIGHT CURING UNIT BONART CO. LTD. ERIC L ONG
K032713 11/24/2003 BOSTON BIOMEDICA, INC. BORRELIA BURGDORFERI IGM AND IGG BOSTON BIOMEDICA, INC. PATRICIA E GARRETT
K033441 11/21/2003 BOSTON SCIENTIFIC 6F RUNWAY GUIDE CATHETER BOSTON SCIENTIFIC CORP. HEIDI M ERICKSON
K030083 01/28/2003 VAXCEL WITH PASV PORT BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K024048 01/06/2003 MODIFICATION TO BOSTON SCIENTIFIC EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM BOSTON SCIENTIFIC SCIMED, INC. TODD KORNMANN
K032940 11/20/2003 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDER FREE, STERILE) CONTAINING 50 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PE BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K032938 11/20/2003 BRIGHTWAY BRAND LATEX EXAMINATION GLOVE-(POWDERED, STERILE), CONTAINING 150 UGM OR LESS OF WATER EXTRACTABLE PROTEIN PER BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K033438 11/20/2003 BRUNO ELECTRA-RIDE ELITE, MODEL SRE-2000 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K021994 01/02/2003 BARD CONFORMEXX BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. AYMEE BERRY
K032521 11/14/2003 BARD DUAL LUMEN URETERAL CATHETER C.R. BARD, INC. FRANCES HARRISON
K030792 11/14/2003 BARD ENDOTRACHEAL TUBE, CUFFED C.R. BARD, INC. FRANCES E HARRISON
K022447 01/23/2003 BARD ER URETERAL STENT WITH SUTURE C.R. BARD, INC. DONNA J WILSON
K033245 11/06/2003 BARD ULTRAVIEW MULTIPLE BAND LIGATOR, MODEL 00700U C.R. BARD, INC. MICHAEL A PATZ
K033294 11/26/2003 HEMOSPLIT XK, HEMOSPLIT XK CATHETER, 16FR X 42 CM, KIT;16FR X 19 CM, KIT WITH MICROINTRODUCER C.R. BARD, INC. GLENN NORTON
K022951 01/27/2003 CANDELA GENTLE YAG LASER SYSTEM, VARIABLE PULSE YAG CANDELA CORP. LORRAINE NELSON
K022884 01/22/2003 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORAINE NELSON
K023728 01/07/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH ALOE VERA, GREEN COLOR CANOPUS MEDICAL SUPPLY CO., LTD. RUBY LIN
K023452 11/20/2003 OPUS-E DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES WITH NOPAL & VITAMIN E CANOPUS MEDICAL SUPPLY CO., LTD. RUBY LIN
K023689 01/17/2003 CG-500 PMP PERSONAL MEDICAL PHONE SYSTEM CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K023356 01/16/2003 KLOCK WATCH STYLE DIGITAL BLOOD PRESSURE MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K024365 01/15/2003 TM2005 PERSONAL MEDICAL PHONE CENTER CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K022929 01/27/2003 PEDIATRIC ATTENUATED DEFIBRILLATION ELECTRODES, MODEL 9730, POWEDERHEART AED, MODEL 9200/9210 CARDIAC SCIENCE, INC. JOHN CARLINE
K022008 01/29/2003 CARDIMA ABLATION SYSTEM CARDIMA, INC. ROBERT A CHIN
K032444 11/13/2003 NITRILE POWDER-FREE EXAMINATION GLOVES WITH LOTION COATING AND USE FOR CHEMOTHERAPY CARDINAL HEALTH ERICA SETHI
K023427 01/07/2003 CARDIASSIST COUNTERPULSATION SYSTEM, MODEL MARK 3000 CARDIOMEDICS, INC. GARY CLARK
K021694 01/08/2003 CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 CARDIOVENTION, INC. TESSA YAMUT
K021594 11/13/2003 COPC BAND CENTER FOR ORTHOTIC AND PROSTHETIC CARE,LLC JOSEPH TERPENNING
K023528 01/17/2003 NATURAL-KNEE II CEMENTED MODULAR TIBIAL BASEPLATE CENTERPLUS ORTHOPEDICS, INC MITCHELL A DHORITY
K023874 11/20/2003 SYSTEM 100 ULTRAFILTRATION CATHETER CHF SOLUTIONS, INC. AMY PETERSON
K033593 11/20/2003 REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS CLEAR MEDICAL, INC. MIKE KOVACS
K031042 11/03/2003 ATAC HEMOGLOBIN A1C REAGENT KIT CLINICAL DATA, INC. WYNN STOCKING
K024173 01/14/2003 CDS 3-PD HEMATOLOGY CONTROLS CLINICAL DIAGNOSTIC SOLUTIONS, INC. ANDREW C SWANSON
K022023 01/07/2003 COMPASS ESOPHAGEAL PRESSURE CATHETER, MODEL GIE-8500, COMPASS ANO-RECTAL PRESSURE CATHETER, MODEL GIA-8500 CLINICAL INNOVATIONS, INC. WILLIAM DEAN WALLACE
K030074 01/21/2003 LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K030150 01/28/2003 LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K022596 01/31/2003 BIO-CYBERNETIC CARDIO-DIAGNOSIS SYSTEM (BKD) CLOVER HI-TECH INC. CECILIA L YU
K024366 01/17/2003 COALESCENT SURGICAL U-CLIP AND ACCESSORIES COALESCENT SURGICAL MICHAEL A DANIEL
K023254 01/27/2003 SPEEDICATH COLOPLAST CORP. ELIZABETH BOOTS
K032662 11/03/2003 GUTTAFLOW COLTENE/WHALEDENT GMBH & CO. KG HENRY J VOGELSTEIN
K021176 01/21/2003 COMPUMEDICS SOMTE SYSTEM COMPUMEDICS LIMITED CONSTANCE G BUNDY
K024294 01/08/2003 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. CATHY STUPAK
K031007 11/14/2003 KWIKEZE MALE CONDOM APPLICATOR CONDAX LLC. ELI J CARTER
K033093 11/05/2003 ECHOCONNEX COMMUNICATOR CONNEXMD CURTIS LEBLEU
K024028 01/24/2003 SHARP VIEW IMAGE ENHANCEMENT SYSTEM CONTEXT VISION AB KENT STRANDLUND
K023850 01/22/2003 SYDNEY IVF EMBRYO BIOPSY MEDIUM COOK OB/GYN DEBBIE SCHMITT
K032869 11/19/2003 COOK CODA BALLOON CATHETER COOK, INC. THEODORE HEISE
K031494 11/12/2003 DOC'S BEST WHITE COPPER CEMENT COOLEY & COOLEY, LTD. M. JOYCE HEINRICH
K032873 11/07/2003 PROCLEAR COMPATIBLES MULTIFOCAL COOPER VISION, INC. LISA HAHN
K023930 01/22/2003 COOPERSURGICAL OOCYTE RECOVERY NEEDLES COOPERSURGICAL, INC. JOSEPH M AZARY
K024195 01/03/2003 MODIFICATION TO REAADS ANTI-PHOSPHATIDYLSERINE IGA SEMI-QUANTATIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K024196 01/03/2003 REEADS ANTI-PHOSPHATIDYLSERINE IGG/IGM SEMI-QUANTITATIVE TEST KIT CORGENIX, INC. NANCI DEXTER
K020745 01/02/2003 COSMED MICROQUARK COSMED S.R.L. ROBERT SCHIFF
K023710 01/17/2003 VISORB SWIFT CP MEDICAL MARY ANN GREENAWALT
K022807 01/29/2003 MELADINE NATURAL MELANIN ENHANCER, PRODUCT NUMBER CT81602AA CREATIVE TECHNOLOGIES, INC. ELIZABETH P NOBLE
K033431 11/20/2003 LSO PET/CT HIREZ AND LSO PET/CT 16 HIREZ CTI PET SYSTEMS, INC. WILLIAM SKREMSKY
K032383 11/28/2003 MULTICLEAR MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM CURELIGHT LTD JONATHAN S KAHAN
K032539 11/17/2003 CYNOSURE PHOTOGENICA SV LASER CYNOSURE, INC. GEORGE CHO
K032697 11/07/2003 DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) DADE BEHRING, INC. LORRAINE H PIESTRAK
K033482 11/26/2003 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K023141 01/16/2003 MODIFICATION TO STANDARD HUMAN PLASMA DADE BEHRING, INC. DONNA A WOLF
K022976 01/16/2003 STRATUS CS D-DIMER (DDMR) METHOD (TESTPAK & DILPAK), MODELS CDDMR & CDDMR-D DADE BEHRING, INC. RICHARD M VAUGHT
K033281 11/26/2003 DATEX OHMEDA S/5 NETWORK AND CENTRAL (ICENTRAL) '03 WITH L-NET03 SOFTWARE DATEX-OHMEDA JOEL KENT
K023459 01/13/2003 DATEX-OHMEDA S/5 ENTROPY MODULE, M-ENTROPY AND ACCESSORIES DATEX-OHMEDA JOEL KENT
K033144 11/13/2003 DEFIBTECH ELECTRODE ADAPTER, MODEL DAC-300 SERIES DEFIBTECH, LLC JOHN L ROGERS
K022221 01/30/2003 TRUFLOW LONG-TERM AND SHORT-TERM DUAL-LUMEN DIALYSIS CATHETERS DELTEC, INC. LISA STONE
K031793 11/13/2003 DENTATUS OSCIOMAT DENTATUS USA, LTD. RICHARD C LANZILLOTTO
K030644 11/21/2003 CONTEC DUO, CONTEC LC, CONTEC LCR DENTAURUM JAN W A DOORSCHODT
K023776 01/23/2003 XENO III DENTAL ADHESIVE DENTSPLY INTL. P. JEFFERY LEHN
K023835 01/29/2003 DEVEX MESH SYSTEM DEPUY ACROMED KAREN F JURCZAK
K024348 01/28/2003 MONARCH SPINE SYSTEM DEPUY ACROMED LISA GILMAN
K023804 01/23/2003 MOSS MIAMI SPINAL SYSTEM PIN NUT DEPUY ACROMED LISA GILMAN
K021478 11/18/2003 DELTA SHOULDER DEPUY, INC. JANET G JOHNSON
K033329 11/14/2003 DEPUY ACE UNIVERSAL AND TROCH ENTRY FEMORAL NAIL SYSTEMS DEPUY, INC. RHONDA MYER
K033057 11/20/2003 DEROYAL SURGICAL GOWNS, STERILE, NON-STERILE DEROYAL SHARON COOK
K033385 11/07/2003 DGH 55 HANDHELD PACHYMETER (PACHMATE) DGH TECHNOLOGY, INC. M. LUTHER DETWEILER
K023739 01/17/2003 GLUCOSE-SL-C ASSAY, MODEL 257-30 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K033061 11/07/2003 CALIBRATING MATERIAL, ISE ELECTROLYTE REFERENCE DIAMOND DIAGNOSTICS, INC. LINDA M STUNDTNER
K021338 01/07/2003 ACCULEAF DIREX SYSTEMS CORP. LARISA GERSHTEIN
K023535 01/17/2003 TRIPTER X-1 COMPACT DUET DIREX SYSTEMS CORP. LARISA GERSHTEIN
K023748 01/17/2003 FLASH-LITE II LED DENTAL CURING LIGHT DISCUS DENTAL, INC. GARY L HOLLAR
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