FDA 510(k) Decisions During October, 2003  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K032099 10/27/2003 SWISS MASTER LIGHT (EMS SA) ELECTRO MEDICAL SYSTEMS CYNTHIA J M. NOLTE
K031263 10/07/2003 3M LIQUID BANDAGE, MODEL 120-LB 3M COMPANY ANNA E MCRIGHT
K031012 10/16/2003 ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO, MODEL 1294; ATTEST RAPID READOUT BIOLOGICAL INDICATOR FOR EO TEST PACK 3M COMPANY CYNTHIA LAMARUCCIOLA
K032499 10/30/2003 A & D MEDICAL LIFESOURCE UA-704 DIGITAL BLOOD PRESSURE MONITORS A & D ENGINEERING, INC. JERRY WANG
K032458 10/06/2003 ABBOTT ARCHITECT ESTRADIOL CALIBRATORS; ABBOTT IMX ESTRADIOL CALIBRATOR; ABBOTT IMX ESTRADIOL MODE 1 CALIBRATOR; ABBOTT ABBOTT LABORATORIES DENISE FARMER
K032929 10/22/2003 MODIFICATION TO:XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 14819, 14820, 14821, 14822, 14822 ABBOTT VASCULAR INC. JOANNA KUSKOWSKI
K032956 10/10/2003 ACCUSONIC A-SCAN MODEL, 24-4000 ACCUTOME, INC. JEFFREY L WRIGHT
K032661 10/14/2003 ACON QUICK-CHECK II HOME PREGNANCY TEST DEVICE (CASSETTE) ACON LABORATORIES, INC. EDWARD TUNG
K033254 10/22/2003 FORTE GAMMA CAMERA SYSTEM ADAC LABORATORIES JOY M SACMAR
K032724 10/09/2003 PINNACLE3 RADIATION THERAPY PLANNING SYSTEM ADAC LABORATORIES RANDY VADER
K032220 10/24/2003 ADEPT 1064/532 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K032218 10/24/2003 ADEPT 1064/532/755 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K032221 10/24/2003 ADEPT 1064/755 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K032034 10/03/2003 ANS AXXESS PERCUTANEOUS LEAD ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K032751 10/06/2003 MODIFICATION TO RENEW LEAD EXTENSION ADVANCED NEUROMODULATION SYSTEMS DANIELLE ALARCON
K032349 10/03/2003 PLACER ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K032736 10/03/2003 HEART 2006 AEROTEL MEDICAL SYSTEMS (1998) LTD. GEORGE MYERS
K032210 10/02/2003 ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM ALARA, INC. DIANE M KING
K032801 10/17/2003 MODIFIED BROWNE PACKAGING AND LABEL STEAM PROCESS INDICATOR ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K030279 10/03/2003 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. MOIRA BARTON
K033311 10/29/2003 ALOKA SSD-5000 V5.0 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K030421 10/23/2003 ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM ALSIUS CORP. KENNETH A COLLINS
K031497 10/17/2003 AMEDICA DRUG SCREEN MDMA-BAR-BZO-MTD-TCA TEST AMEDICA BIOTECH, INC. JEFF CHEN
K031501 10/16/2003 EASYGLUCO, MODEL IGM0002 AMERICAN HEALTHCARE INC. EDWARD LETCO
K032789 10/09/2003 REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P1, MODEL BX10468, REPLACEMENT PUMP HEAD DOOR ASSEMBLY, P2, MODEL BX10469 AMERICAN I.V. PRODUCTS, INC. GREGORY FALK
K030120 10/29/2003 AMSURE FOLEY CATHETER AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K023885 10/21/2003 COMBI-SCREEN, MODELS 10SL AND 11SL ANALYTICON BIOTECHNOLOGIES AG DANIEL KAMM
K032257 10/16/2003 MODEL IR 1200 INSULIN PUMP ANIMAS CORP. MICHAEL J ANDREWS
K031523 10/01/2003 OLYMPUS ULTRASONIC SURGICAL SYSTEM AOMORI OLYMPUS CO., LTD. TINA STEFFANIE-OAK
K033099 10/16/2003 ADR THINSET INFUSION SET MODEL, 23-106, 23-109, 43-106, 43-109 APPLIED DIABETES RESEARCH, INCORPORATED JIM BARLEY
K032889 10/02/2003 OPTICAL SEPARATOR APPLIED MEDICAL RESOURCES CHERYL BLAKE
K033024 10/24/2003 MODIFICATION TO SUTURE CLINCH APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K032962 10/29/2003 AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE ARROW INTL., INC. ELIZABETH PRICE
K032098 10/07/2003 ARTHREX BIO-COMPRESSION SCREW, SMALL, ARTHREX BIO-COMPRESSION SCREW, LARGE, MODELS AR-5024B, AR-5025B ARTHREX, INC. ANN WATERHOUSE
K033257 10/30/2003 ARTHROCARE ENT PLASMA WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K032072 10/01/2003 LACTOSORB L15 SCREW ANCHOR WITH LACTOCARBONATE SUTURE ARTHROTEK, INC. TRACY J BICKEL
K032686 10/22/2003 ASCENSION MODULAR RADIAL HEAD ASCENSION ORTHOPEDICS, INC. PETER STRZEPA
K031503 10/24/2003 AVITA TS8/TS9 SERIES IR EAR/FOREHEAD THERMOMETER AVITA CORPORATION JENNIFER REICH
K032144 10/01/2003 PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. AMY SMITH
K032655 10/06/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-CEFTRIAXONE 0.5-64 UG/ML BECTON, DICKINSON & CO. KATHRYN B POWERS
K033126 10/29/2003 MONARCH 21 PENILE PLETHYSMOGRAPH SYSTEM BEHAVIORAL TECHNOLOGY, INC. SUSAN E OLSEN
K031909 10/07/2003 BETEC RETRACTABLE SAFETY SYRINGE (5ML) BETEC MEDICAL SCIENCE CO., LTD. JENNIFER REICH
K032166 10/21/2003 BINAX NOW RSV TEST, MODEL 430-000 AND BINAX NOW NASOPHARYNGEAL SWAB ACCESSORY PACK, MODEL 400-065 BINAX, INC. PAMELA ANGELL
K031838 10/30/2003 PROFUSION BONE VOID FILLER KIT BIOGENERATION BERNARD F GRISONI
K032351 10/21/2003 THE MAESTRO SYSTEM 3.0MM DIAMETER IMPLANT BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON D GREER
K030348 10/21/2003 BIOPURE PORTABLE RO SYSTEM,BIOPURE 4400 SERIES RO SYSTEM, BIOPURE 8400 SERIES RO SYSTEM,BIOPURE WATER PURFICATION PRETRE BIOLAB EQUIPMENT CANADA LTD. JERRY PONIKVAR
K030539 10/10/2003 LASERSMILE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K030394 10/27/2003 FLUID SAMPLE RETRIEVAL SYSTEM BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING SUSAN B FENTRESS
K032766 10/31/2003 VITEK 2 GRAM POSITIVE LINEZOLID BIOMERIEUX, INC. NANCY WEAVER
K032738 10/31/2003 VITEK 2 GRAM POSITIVE QUINUPRISTIN/DALFOPRISTIN BIOMERIEUX, INC. NANCY WEAVER
K032711 10/31/2003 VITEK GRAM NEGATIVE GATIFLOXACIN BIOMERIEUX, INC. NANCY WEAVER
K031684 10/30/2003 TOPKIN WOUND DRESSING BIOMET MERCK GMBH THOMAS KIEWITT
K032819 10/20/2003 GLUCOSE CONTROL SOLUTION FOR CHDIAGNOSTICS SENOVA, CHDIGNOSTICS SENOVA BLOOD GLUCOSE TEST SYSTEM BIONOSTICS, INC. KATHLEEN STORRO
K033217 10/31/2003 PHERON PTA CATHETER BIOTRONIK, INC. JON BRUMBAUGH
K032700 10/09/2003 BLACKSTONE SURGICAL TITANIUM MESH SYSTEM ANGLED END RINGS BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K032930 10/23/2003 ULTRAFLEX ESOPHAGEAL NG STENT SYSTEM BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K032712 10/02/2003 VAXCEL PLUS CHRONIC DIALYSIS CATHETER BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K033010 10/10/2003 BRM2 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. CHRIS MANDER
K031928 10/24/2003 BRAUN THERMOSCAN PRO 4000 SERIES (PROFESSIONAL USE ENVIRONMENT); BRAUN THERMOSCAN IRT 4000 SERIES (HOME USE ENVIRONMENT) BRAUN GMBH FRED SCHLADOR
K030627 10/23/2003 ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 C.R. BARD, INC. DEBORAH HERRINGTON
K032918 10/06/2003 C.T.M. MOBILITY SCOOTER, MODEL HS-235 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K032919 10/15/2003 C.T.M. MOBILITY SCOOTER, MODEL HS-250 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K033172 10/30/2003 CANDELA GENTLEYAG FAMILY OF LASER SYSTEMS CANDELA CORP. LORRAINE CALZETTA-PATROVIC
K032388 10/31/2003 BONE CEMENT RADIO-OPACIFIER CARDINAL HEALTH SHARON NICHOLS
K031301 10/15/2003 ESTEEM STERILE POLYISOPRENE SURGICAL GLOVES WITH COATING CARDINAL HEALTH ERICA SETHI
K033037 10/31/2003 MODIFICATION TO GLOBALCARDIO CARDIOCOMM SOLUTIONS, INC. JANET WAINMAN
K031840 10/10/2003 CAREMATIX WELLNESS SYSTEM CAREMATIX INC. DANIEL KAMM
K032348 10/24/2003 CONVERGE RETI-LOCK MULTI-HOLE REINFORCEMENT CUP CENTERPULSE ORTHOPEDICS, INC. ROBERT M WOLFARTH
K030923 10/03/2003 EPSILON DURASUL CONSTRAINED ACETABULAR LINER CENTERPULSE ORTHOPEDICS, INC. ROBERT M WOLFARTH
K031567 10/02/2003 3D INVIVO BY CSIST CHUNG-SHAN INSTITUTE OF SCIENCE AND TECHNOLOGY CARL ALLETTO
K032978 10/20/2003 MODIFICATION TO CIBA VISION CENTURION SES SPIKERATOME CIBA VISION CORPORATION PENNY NORTHCUTT
K033162 10/10/2003 LINICAL CHEMISTRY CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K032074 10/21/2003 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON ANALYZERS CLINIQA CORPORATION CAROL RUGGIERO
K030910 10/10/2003 CLUED UP MULTIPURPOSE SOLUTION- NO RUB CLUED UP LIMITED JENNY KOKSHUN
K032698 10/23/2003 COAPT ENDOTINE MIDFACE-ST 4.5 DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K032770 10/08/2003 ENDOTINE FOREHEAD DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K032100 10/02/2003 I-BEAM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K032223 10/15/2003 COOK VASCULAR PERFECTA ELECTROSURGICAL DISSECTION SYSTEM ERGONOMIC INTERMITTENT ACTIVATION SWITCH COOK VASCULAR, INC. THOMAS J KARDOS
K031966 10/16/2003 ENK FIBEROPTIC ATOMIZER SET COOK, INC. JENNIFER J BOSLEY
K032426 10/31/2003 GUNHTER TULIP VENA CAVA MREYE FILTER AND RETRIEVAL SET COOK, INC. JENNIFER J BOSLEY
K032931 10/22/2003 PTA BALLOON CATHETER COOK, INC. KAREN BRADBURN
K032737 10/02/2003 CORDIS POWERFLEX EXTREME PTA BALLOON CATHETER, CORDIS POWERFLEX PLUS PTA BALLOON CATHETER, CORDIS POWERFLEX P3 PTA CORDIS EUROPA N.V. KAREN WILK
K032868 10/14/2003 REAADS II ANTI-CARDIOLIPIN IGG SEMI-QUANTITATIVE TEST KIT, MODEL 11139 CORGENIX, INC. NANCI DEXTER
K032186 10/14/2003 AUTOALIGN CORTECHS LABS, INC. ALLAN GREEN
K030737 10/10/2003 OMEGA WHOLE-CORTEX MFG SYSTEM, MODELS OMEGA 151, OMEGA 275 CTF SYSTEMS (2001), INC. DARYL WISDAHL
K032565 10/22/2003 CYNOSURE PHOTOGENICA VL CYNOSURE, INC. GEORGE CHO
K031389 10/01/2003 CYNOSURE SMART 2940D ER:YAG LASER CYNOSURE, INC. GEORGE CHO
K031125 10/09/2003 CYNOSURE SMART FILE ND:YAG LASERS CYNOSURE, INC. GEORGE CHO
K031440 10/01/2003 SMART CO2 (SMART US 20D, SMART CLINIC) SURGICAL LASER CYNOSURE, INC. GEORGE CHO
K032798 10/30/2003 DIMENSION AUTOMATED HDL CHOLESTEROL (AHDL) FLEX REAGENT CARTRIDGE (DF48A) CATALOG # DF48A DADE BEHRING, INC. ANDREA M TASKER
K032574 10/06/2003 DIMENSION DRUG CALIBRATOR II, MODEL DC49C DADE BEHRING, INC. RICHARD M VAUGHT
K032564 10/31/2003 DIMENSION N-ACETYLPROCAINAMIDE (NAPA) FLEX REAGENT CARTRIDGE METHOD, MODEL DF111 DADE BEHRING, INC. RICHARD M VAUGHT
K032573 10/31/2003 DIMENSION PROCAINAMIDE (PROC) FLEX REAGENT CARTRIDGE METHOD, MODEL DF110 DADE BEHRING, INC. RICHARD M VAUGHT
K013452 10/31/2003 DANMAR PRODUCTS CRANIAL ADJUSTIVE PROSTHESIS DANMAR PRODUCTS, INC. KAREN A LINDNER
K031760 10/10/2003 VIEWPOINT TELEMETRY SYSTEM DATASCOPE CORP. SUSAN E MANDY
K033078 10/29/2003 DATEX OHMEDA S/5 WEB VIEWER AND S/5 POCKET VIEWER WITH L-WEB03 SOFTWARE DATEX-OHMEDA JOEL KENT
K023366 10/07/2003 DATEX-OHMEDA 7900 VENTILATOR ENHANCEMENTS DATEX-OHMEDA, INC. MICHAEL A CHILBERT
K031074 10/15/2003 DIGITAL AMBULATORY ECG (HOLTER) RECORDER DATRIX LAUREN M LUHMANN
K023509 10/30/2003 DBB-05 HEMODIALYSIS DELIVERY SYSTEM DAVITA CLINICAL RESEARCH (TRRI) TRACY L GRAY
K032195 10/07/2003 DENTAURUM GLASTEC DENTAL ORTHODONTIC CEMENT DENTAURUM JAN A DOORSCHODT
K032320 10/01/2003 APPOLLO 3 ALLOY DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K032904 10/14/2003 ACUCAM CONCEPT IV FWT, MODEL 110-0185G1 DENTSPLY INTL. JOHN R MILLER
K024133 10/01/2003 CLS-2000 UNIT DENTSPLY INTL. P. JEFFERY LEHN
K032687 10/06/2003 ACE NANCY NAIL DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K031408 10/15/2003 DEROYAL POLY-REINFORCED SURGICAL GOWNS (STERILE, NON-STERILE) DEROYAL AUDREY DANIELS
K032881 10/10/2003 IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE
K031465 10/10/2003 MODEL 2100 PULSE OXIMETER DOLPHIN MEDICAL INC. JON WERNER
K032947 10/17/2003 NELLCOR COMPATIBLE DOLPHIN 2000 Y OXIMETRY SENSOR, MODEL 2210 DOLPHIN MEDICAL INC. BILL CURNAN
K033305 10/31/2003 INFINITY MULTIVIEW INFINITY TELEMETRY SYSTEM DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K024072 10/06/2003 DUCKWORTH & KENT LTD LENS DELIVERY SYSTEM DUCKWORTH & KENT, LTD. MARTIN LOCK
K031329 10/22/2003 DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY) DYNATRONICS CORP. RON HATCH
K031732 10/15/2003 EBI ACUMEN SURGICAL NAVIGATION SYSTEM EBI, L.P. JON CAPAROTTA
K032587 10/02/2003 EDWARDS PERIPHERAL DILATATION CATHETER EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K031769 10/14/2003 E-STRIP EEMSO, INC. LARRY R PILOT
K033214 10/14/2003 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K032996 10/23/2003 ELEKTA SYNERGY SYSTEM ELEKTA ONCOLOGY SYSTEMS, LTD. PETER STEGAGNO
K032616 10/02/2003 DISPOSABLE POWDER FREE VINYL SYNTHETIC EXAM GLOVES ELITE INTERNATIONAL, INC. BOBBY LING
K024361 10/09/2003 EM PROBE, EM PAD EM PROBE INC. GLEN A GORDON
K032105 10/30/2003 ENDOHELIX ENDARTERECTOMY DEVICE ENDARX, INC. SCOTT ADAMS
K033211 10/30/2003 ENSITE SYSTEM ENDOCARDIAL SOLUTIONS, INC. KAREN J MCKELVEY
K031066 10/17/2003 VIEWMATE ULTRASOUND IMAGING SYSTEM EP MEDSYSTEMS JOHN J TALARICO
K024023 10/01/2003 ESSEX HIGH PRESSURE (HP) OCD AND ESSEX ESCORT PNEUMATIC CONSERVER ESSEX MEDICAL SYSTEMS PLUS SUSAN D GOLDSTEIN-FALK
K032632 10/22/2003 REMOTE ACCESS PERFUSION CANNULA LEFT AXILLARY 21 FRENCH ESTECH, INC. ARTHUR BERTOLERO
K032307 10/24/2003 CAP BONE SUBSTITUTE MATERIAL ETEX CORP. KRISTINE CANAVAN
K032676 10/30/2003 ENDOPATH BLADELESS TROCAR, ENDOPATH BLUNT TIP TROCAR, ENDOPATH DILATING TIP TROCAR ETHICON ENDO-SURGERY, INC. ELIZABETH MILLER
K030472 10/09/2003 MAMMOTOME BIOPSY SYSTEM PROBE & HOUSING, MAMMOTOME HAND-HELD SYSTEM ETHICON ENDO-SURGERY, INC. MICHAEL J CRADER
K032420 10/22/2003 MODIFIED COATED VICRYL PLUS ANTIBACTERIAL (POLYGLACTIN 910) SYNTHETIC ABSORBABLE SUTURE ETHICON, INC. REY LIBROJO
K031195 10/10/2003 CUF-COVER (TM) ETHOX CORP. DANIEL KAMM
K032580 10/22/2003 PROTEGE GPS SELF-EXPANDING NITINOL STENT AND DELIVERY SYSTEM EV3 INC GLEN D SMYTHE
K033140 10/29/2003 NEUROMUSCULAR ELECTRICAL STIMULATOR, MODEL EV-807P EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOR
K023209 10/10/2003 INSIGHT MILLENNIUM III FASSTECH LEE BRODY
K031307 10/22/2003 FERRIS POLYMEM SILVER WOUND DRESSING FERRIS MFG. CORP. THEODORE THORSEN
K023723 10/23/2003 FINOMETER NONINVASIVE HEMODYNAMIC MONITOR, MODEL 1 FMS, FINAPRES MEDICAL SYSTEMS BV CHRISTINE EMANUEL
K031953 10/22/2003 WEST NILE VIRUS ELISA IGG, MODEL EL0300G FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K031952 10/22/2003 WEST NILE VIRUS IGM CAPTURE ELISA, MODEL EL0300M FOCUS TECHNOLOGIES, INC. MICHAEL J WAGNER
K032302 10/02/2003 XIVE TG ABUTMENTS FRIADENT GMBH CAROL PATTERSON
K032750 10/02/2003 MODIFICATION TO: XIVE 3.0 DENTAL IMPLANT SYSTEM, MULTIPLE FRIANDENT GMBH CAROL PATTERSON
K032290 10/10/2003 FUKUDA DENSHI DYNASCOPE MODEL DS-7100 SERIES PORTABLE PATIENT MONITOR FUKUDA DENSHI USA, INC. LARRY D WALKER
K033209 10/31/2003 FUKUDA DENSHI MODEL FF SONIC UF-750XT FUKUDA DENSHI USA, INC. LARRY D WALKER
K032289 10/20/2003 FIT CHECKER II GC AMERICA, INC. TERRY L JORITZ
K032656 10/30/2003 GE LOGIQ 9 ULTRASOUND BT03/IQ, MODEL 2375600-X GE MED. SYSTEMS ULTRASOUND & PRIM. CARE DIAG.,LLC ALLEN SCHUH
K032577 10/10/2003 MODIFICATION TO: MAC-LAB/CARDIOLAB EP/COMBOLAB SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA L MICHELS
K032513 10/30/2003 T-WAVE ALTERNANS (TWA) ALGORITHM OPTION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES DAVID WAHLIG
K033244 10/16/2003 DIGITAL FLUOROSCOPIC IMAGING SYSTEM, MODEL INNOVA 4100 WITH TILT TABLE OPTION GE MEDICAL SYSTEMS, INC. LARRY A KROGER
K032915 10/30/2003 ADVANTAGE 4D OPTION GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K032795 10/08/2003 GE 0.7T SIGNA OPENSPEED WITH EXCITE MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K033168 10/10/2003 GE 0.2T SIGNA PROFILE/I MR SYSTEM GENERAL ELECTRIC CO. LARRY A KROGER
K032974 10/21/2003 GE LOGIQ 5 PRO OR EXPERT GENERAL ELECTRIC CO. ALLEN SCHUH
K032477 10/22/2003 GE LOGIQ BOOK GENERAL ELECTRIC CO. ALLEN SCHUH
K033139 10/23/2003 GE MARLIN ULTRASOUND GENERAL ELECTRIC CO. ALLEN SCHUH
K032620 10/10/2003 GE VOLUSON 730 PRO/EXPERT BT03 ULTRASOUND SYSTEM GENERAL ELECTRIC CO. ALLEN SCHUH
K032002 10/30/2003 FERTELL FEMALE FERTILITY TEST GENOSIS, INC. SHARON A SEGAL
K032723 10/01/2003 BIOSIGN STEAM-24 BIOLOGICAL INDICATOR GETINGE USA, INC KARLA BYRNE
K032405 10/29/2003 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K032385 10/30/2003 GLOBAL PRESS-FIT STEM GLOBAL MEDICAL CO. J.D. WEBB
K032608 10/21/2003 GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETER GONOTEC GESELLSCHAFT FUER MESS-UND REGELTECHNIK MB THOMAS BOCK
K031446 10/31/2003 JABES ELECTRONIC STETHOSCOPE GS TECHNOLOGY CO., LTD. DANIEL KAMM
K032530 10/23/2003 MODIFICATION TO OMNILINK .035 BILIARY STENT SYSTEM GUIDANT CORPORATION MICHELLE GROSSMAN
K022679 10/22/2003 RAPHAEL HAMILTON MEDICAL AG DAVID THOMPSON
K032705 10/01/2003 DISTAL RADIUS FRACTURE REPAIR SYSTEM HAND INNOVATIONS, INC. AL WEISENBORN
K033125 10/30/2003 HANDIVIPP HANDINOR USA, INC. BARBARA CHIPONIS
K031439 10/02/2003 ALGINATE IMPRESSION MATERIAL III (FAST & REGULAR) HARRY J. BOSWORTH CO. MILDRED M GOLDSTEIN
K032913 10/02/2003 HL888 AF HEALTH & LIFE CO., LTD. PAUL HUNG
K032839 10/10/2003 HL888BA HEALTH & LIFE CO., LTD. PAUL HUNG
K032695 10/02/2003 HL888BF HEALTH & LIFE CO., LTD. PAUL HUNG
K032837 10/10/2003 HL888BM HEALTH & LIFE CO., LTD. PAUL HUNG
K033043 10/10/2003 MODIFICATION TO HL168 HEALTH & LIFE CO., LTD. PAUL HUNG
K030998 10/10/2003 MEDRELIEF SE SERIES, MODELS SE-50, SE-100, SE-200, SE-300 HEALTHONICS, INC. JAMES W KRONBERG
K032337 10/21/2003 HEMEDEX CRANIAL BOLT MODELS, 3601, 3602 HEMEDEX INCORPORATED DEBBIE IAMPIETRO
K032772 10/08/2003 MODIFICATION TO WATCHCHILD OBSTETRICAL PATIENT DATA MANAGEMENT SYSTEM (ALSO REFERRED TO AS) THE WATCHCHILD SYSTEM HILL-ROM MANUFACTURING, INC. CINDY L CROSBY
K033248 10/20/2003 HITACHI CB MERCURAY DENTAL CONE-BEAM X-RAY SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K032985 10/21/2003 GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM HMD BIOMEDICAL, INC. JEFFREY FLEISHMAN
K032546 10/16/2003 HOLOGIC DR IMAGEPRO HOLOGIC, INC. DANIEL F PHELAN
K023000 10/29/2003 HOME CARE VARIOUS MODELS OF POWERED MUSCLE STIMULATOR, HT-329M SERIES HOME CARE TECHNOLOGY CO., LTD. SHU-CHEN CHENG
K032300 10/09/2003 ACCOLADE-J HIP STEM SERIES HOWMEDICA OSTEONICS CORP. LORRAINE MONTEMURRO
K032581 10/09/2003 GLOBAL MODULAR REPLACEMENT SYSTEM ANTEVERTED PROMIMAL FEMORAL COMPONENT HOWMEDICA OSTEONICS CORP. MARGARET F CROWE
K032523 10/22/2003 T2 NAILING SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K032898 10/09/2003 T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K031873 10/07/2003 I-STAT CARDIAC MARKERS CONTROL LEVEL 1, 2, AND 3; CARDIAC MARKERS CALIBRATION VERIFICATION CONTROL SET I-STAT CORPORATION GREGORY W SHIPP
K032324 10/02/2003 ECHOENCODER ICARDIOGRAM, INCORPORATED JAMES LOEHR
K033283 10/27/2003 CENTRA VIEW DEVICE LINK SYSTEM ICU DATASYSTEMS, INC. SAMUEL W COONS
K032527 10/31/2003 HEDROCEL VERTEBRAL BODY REPLACEMENT IMPLEX CORP. MARCI HALEVI
K032344 10/02/2003 THE HEDROCEL TRABECULAR METAL RECONSTRUCTION SYSTEM MODEL 10-330 IMPLEX CORP. MARCI HALEVI
K033194 10/30/2003 INION CPS BABY 1.5 BIOABSORBABLE SYSTEM INION LTD. HANNA MARTTILA
K030081 10/06/2003 CSF400 AND CSF600 INMED LTDA. JAY MANSOUR
K032140 10/02/2003 5.0 X 5MM ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP. HOWARD M HOLSTEIN
K032704 10/24/2003 INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30 INNOVATECH SURGICAL INC. MICHAEL J MCGOWAN
K032703 10/24/2003 INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10 INNOVATECH SURGICAL INC. MICHAEL J MCGOWAN
K032145 10/31/2003 AUDICOR UPGRADE SYSTEM INOVISE MEDICAL, INC. STEVE HESLER
K032419 10/24/2003 QUANTEX D-DIMER INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K032817 10/06/2003 EXTERNAL DRAINAGE SET INTEGRA NEUROSCIENCES IMPLANTS S.A. JUDITH E O'GRADY
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