FDA 510(k) Applications Received During January, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K033576 11/13/2003 LIFESHIELD LATEX-FREE PRIMARY IV PUMP SET DISTAL MICROBORE PATIENT LINE, CONVERTIBLE PIN, 72 INCH, WITH 2 PRESSURE ABBOTT LABORATORIES PATRICIA MELERSKI
K030002 01/02/2003 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
K033537 11/10/2003 SELFX XPERT BILIARY STENT, MODELS EX8L2005, EX8L3005, EX8L4005, EX8L2006, EX8L3006, EX8L4006, EX8S2005, AND EX8S3005 ABBOTT LABORATORIES JOANNA KUSKOWSKI
K030144 01/15/2003 MODIFICATION TO PENTRA 60 AND PENTRA 60C+ ABX DIAGNOSTICS TIM LAWTON
K030261 01/24/2003 BATTERY, RECHARGEABLE ACCESS BATTERY, INC. ALEXANDER B HENDERSON
K030031 01/03/2003 SOFT TISSUE ANCHORING WASHERS ACCU-SPEED, INCORPORATED ROBERT W SECOVICH
K033503 11/05/2003 RFS VACUUM GAUGE SCAVENGING CIRCUIT ACCUTRON, INC. ROBERT N CLARK
K033639 11/20/2003 ACUMED LOWER EXTREMITY CONGRUENT PLATE SYSTEM ACUMED LLC ED BOEHMER
K033735 11/28/2003 VANTAGE PRO ATTENUATION CORRECTION DEVICE ADAC LABORATORIES CHARLENE BRUMBAUGH
K030092 01/10/2003 COMPLETE BRAND MULTI-PURPOSE SOLUTION ADVANCED MEDICAL OPTICS, INC. PAUL J NOWACKI
K030118 01/13/2003 RAPID PROGRAMMAR ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K030004 01/02/2003 0.55% ORTH-PHTHALALDEHYDE SOLUTION ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKAR
K033597 11/14/2003 ATR 5000, LC 5000, IMPLANT SYSTEM ADVANCED TECHNOLOGY RESEARCH (A.T.R.) S.R.L. DANIELE POLI
K030109 01/13/2003 ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. MOIRA BARTON
K030026 01/03/2003 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. MOIRA BARTON
K030279 01/27/2003 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL CORP. MOIRA BARTON
K030187 01/21/2003 REPROCESSED ELECTROPHYSIOLOGY CATHETER ALLIANCE MEDICAL, INC. MOIRA BARTON
K030161 01/16/2003 SUPERBOND AMERICAN DENT-ALL, INC. PHILIP HACOPIANS
K033636 11/19/2003 AMS LARGE PORE POLYPROPYLENE MESH AMERICAN MEDICAL SYSTEMS, INC. ELSA A LINKE
K030123 01/14/2003 BIOARC SP SLING KIT AMERICAN MEDICAL SYSTEMS, INC. MARK MCINTYRE
K030222 01/22/2003 NX SYSTEM AMERICAN TELECARE, INC. PETE PLUCINAK
K030059 01/07/2003 PORTABLE RO+ MODEL MROS09 AMERIWATER BRIAN R BOWMAN
K030275 01/27/2003 MB SYSTEM, BIOENERGY LIGHT THERAPY AMEST CORP. JOHN IEST
K030120 01/13/2003 AMSURE FOLEY CATHETER AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K030293 01/28/2003 AMSURE RED RUBBER URETHRAL CATHETER AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K033722 11/26/2003 APAPORE BONE GRAFT SUBSTITUTE APATECH LTD. BARRY SALL
K033533 11/10/2003 POWDER FREE LATEX EXAMINATION GLOVES APL INTERNATIONAL INCORPORATED LIMITED LEE SON HONG
K033531 11/10/2003 POWDERED LATEX EXAMINATION GLOVES APL INTERNATIONAL INCORPORATED LIMITED LEE SON HONG
K033720 11/26/2003 ARI COLD SPRAY ARI RON ARKIN
K030245 01/24/2003 NITRILE EXAMINATION GLOVES, POWDER FREE, POLYMER COATED, PURPLE COLOR ARISTA LATINDO INDUSTRIAL, LTD. P.T. LINGA SUMARTA
K030258 01/24/2003 FIRST RESPONSE PREGNANCY TEST ARMKEL, LLC. STEPHEN C KOLAKOWSKY
K033637 11/19/2003 MEDICAL IMAGE DIGITIZER, MODEL 2908 ARRAY CORP. TAKASHI INAMI
K030096 01/10/2003 VIDEO ARTHROSCOPE, MODELS AR-3050-30, AR-3050T-30, AR-3050-70, AR-3051-30, AR-3052-30, AR3030AN, AR-3030AS, AR3030AW ARTHREX, INC. SALLY FOUST
K033584 11/13/2003 ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K030108 01/13/2003 ARTHROCARE ENT COBLATOR SURGERY SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K033718 11/26/2003 MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE ARTHROTEK, INC. PATRICIA SANDBORN BERES
K030163 01/16/2003 ASEPTICO VCT VERSATILE COMMAND TECHNOLOGY MODEL AEU-925 ASEPTICO, INC. GRANT RAMALEY
K033532 11/10/2003 ASIA PACIFIC LATEX SDN. BHD. POLYMER COATED POWDER FREE LATEX EXAMINATION GLOVES ASIA PACIFIC LATEX SDN BHD LEE SON HONG
K033530 11/10/2003 ASIA PACIFIC LATEX SDN. BHD. POWDER FREE LATEX EXAMINATION GLOVES ASIA PACIFIC LATEX SDN BHD LEE SON HONG
K030267 01/27/2003 EEG MONITOR WITH BIS, MODEL A-2000 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K030339 01/31/2003 CAUTERY TIP CLEANER, MODEL-TC-100 ASPEN SURGICAL PRODUCTS, INC. DEBBIE DALY
K030137 01/14/2003 MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-358S6, MMT-358M6, MMT-358L6, MMT-358S9, MMT-358M9, AND MMT-358L9 AVAIL MEDICAL PRODUCTS, INC. COURTLAND IMEL
K030149 01/15/2003 MEDTRONIC MINIMED SOF-SITE INFUSION SET, MODELS MMT-359S6, MMT-359M6, MMT-359L6, MMT-359S9, MMT-359M9, AND MMT-359L9 AVAIL MEDICAL PRODUCTS, INC. CARROLL COUNCILMAN
K030062 01/07/2003 ADMIRAL .035 DILATATION CATHETER, MODELS ADL0720-80,ADL0720-135,ADL0820-80, ADL0820-135,ADL0920-80,ADL0920-135,ADL1020-0 AVANTEC VASCULAR CORP. JAMES M SHY
K030230 01/22/2003 AVITA BPM1 SERIES (WRIST TYPE) BLOOD PRESSURE METER (OR MONITOR) AVITA CORPORATION JENNIFER REICH
K033606 11/17/2003 ABBOTT AXSYM B-TYPE NATRIURETIC PEPTIDE (BNP) MICROPARTICLE ENZYME IMMUNOASSAY (MEIA) TEST AXIS-SHIELD DIAGNOSTICS, LTD. JUDITH FINLAYSON, PH.D.
K033527 11/07/2003 INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER B. BRAUN MEDICAL, INC. AMY SMITH
K033575 11/12/2003 ONE.CLICK NEEDLE B. BRAUN MEDICAL, INC. JENNIFER A KOSOY
K030135 01/14/2003 SAFETY INTRODUCER NEEDLE B. BRAUN MEDICAL, INC. AMY K SMITH
K033723 11/26/2003 DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES BAODING GUANZHONG GLOVE CO., LTD. HUAN-CHUNG LI
K033653 11/21/2003 VENTURI PHACO PACK BAUSCH & LOMB, INC. DENNIS POZZO
K030099 01/10/2003 BAXTER ARENA HEMODIALYSIS DELIVERY SYSTEM, MODEL 1571278000 BAXTER HEALTHCARE CORP. ROBERT L WILKINSON
K033643 11/20/2003 CO2 CALIBRATOR/DILUENT BAYER HEALTHCARE, DIAGNOSTICS DIVISION KENNETH T EDDS, PH.D.
K030102 01/10/2003 ADVIA CENTAUR AND ACS:180 LIQUID CARDIAC MARKERS 1, 2, 3 BAYER HEALTHCARE, LLC KENNETH T EDDS
K030169 01/17/2003 SETPOINT CHEMISTRY CALIBRATOR BAYER HEALTHCARE, LLC KENNETH T EDDS
K030091 01/10/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - NORFLOXACIN 0.25 - 16 UG/ML BD DIAGNOSTIC SYSTEMS KATHRYN BABKA POWERS
K030012 01/02/2003 CK-MB AND CK-MB CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 386371 AND 386372 BECKMAN COULTER, INC. BRENT TABER
K030291 01/28/2003 COULTER ACT 5DIFF AUTOLOADER (AL) BECKMAN COULTER, INC. LOURDES COBA
K033603 11/17/2003 INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999 BECKMAN COULTER, INC. VALYNDA MACHEN
K033500 11/05/2003 BD CAREFLOW CENTRAL VENOUS CATHETER BECTON DICKINSON & CO. LESLIE WOOD
K033560 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTAZIDIME 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON DICKINSON & CO. KATHRYN BABKA POWERS
K033558 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AZTREONAM 0.5-64 UG/ML-GRAM-NEGATIVE ID/AST OR AST ONLY PHOENIX PANELS BECTON, DICKINSON & CO. BRADFORD SPRING
K033557 11/12/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TICARCILLIN/CLAVULANATE-GRAM NEGATIVE BECTON, DICKINSON & CO. MICHELLE B BANDY
K030266 01/27/2003 CEM-OSTETIC BONE; CEMO-10G, CEMO-20G, CEMO-30G, CEMO-40G, CEMO-60G, CEM0-XXGC; CEMO-XYZ202005P, CEMO-XYZ20210P, CEMO-XYZ BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K030075 01/08/2003 NITRILE POWDER-FREE MEDICAL EXAMINATION GLOVE (BLUE) (TEXTURED AND NON-TEXTURED) BEST MANUFACTURING COMPANY-DISTRIBUTION CENTER DAVID C YOUNG
K030182 01/17/2003 LIQUICHEK D-DIMER CONTROL, MODEL 356, 357 BIO-RAD ELIZABETH PLATT
K030076 01/08/2003 PROFESSIONAL BLOOD SAMPLE RETRIEVAL SYSTEM BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING SUSAN B FENTRESS
K033627 11/19/2003 Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEM BIOMEDIX, INC. JUDY S CHEN
K030328 01/31/2003 VIDAS D-DIMER NEW (DD2) ASSAY, MODEL 30 442 BIOMERIEUX, INC. SANDRA PERREAND
K030048 01/06/2003 HA PMI FEMORAL HIP STEM BIOMET ORTHOPEDICS, INC. PATRICIA BERES
K033489 11/04/2003 AGC TOTAL KNEE SYSTEM KNEE, ASCENT TOTAL KNEE SYSTEM, MAXIM COMPLETE KNEE SYSTEM, MAXIM ACCEL KNEE SYSTEM ALSO KNOWN BIOMET, INC. PATRICIA SANDBORN BERES
K033611 11/17/2003 CALCIGEN -NAP BONE VOID FILLER BIOMET, INC. MARY L VERSTYNEN
K030178 01/17/2003 CALCIGEN PSI BONE GRAFT SUBSTITUTE BIOMET, INC. MARY VERSTYNEN
K033519 11/07/2003 CANNULATED ARTHRORIVET AND CANNULATED RC ARTHRORIVET BIOMET, INC. GARY BAKER
K033506 11/05/2003 COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE BIOMET, INC. TRACY J BICKEL
K030047 01/06/2003 FREEDOM CONSTRAINED LINERS BIOMET, INC. MAX T HEBEL
K030055 01/06/2003 MALLORY/HEAD TOTAL HIP SYSTEM; HA MALLORY/HEAD TOTAL HIP SYSTEM; BI-METRIC FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K030086 01/09/2003 PALACOS R BONE CEMENT WITH GENTAMICIN BIOMET, INC. LONNIE WITHAM
K030332 01/31/2003 MODIFICATION TO BIONICARE STIMULATOR SYSTEM, MODEL BIO-1000 BIONICARE MEDICAL TECHNOLOGIES, INC. KENT HOFFMAN
K030051 01/06/2003 VERSABOARD, MODEL 7040 BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K030088 01/10/2003 TRIAGE CARDIAC CALIBRATION VERIFICATION CONTROLS, TRIAGE CARDIO PROFILER CALIBRATION VERFICICATION CONTROLS BIOSITE INCORPORATED JEFFREY R DAHLEN
K030089 01/10/2003 TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS BIOSITE INCORPORATED JEFFREY R DAHLEN
K030286 01/28/2003 TRIAGE CARDIO PROFILER/TRIAGE CARDIAC PANEL BIOSITE INCORPORATED JEFFREY R DAHLEN
K033613 11/17/2003 MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER BIOTRONIK, INC. Jon Brumbaugh
K030192 01/21/2003 DUET SYSTEM BIOVIEW LTD. ORLY MAOR
K033521 11/07/2003 BISBLOCK BISCO, INC. BENJAMIN LICHTENWALNER
K033585 11/13/2003 DIAPEX BISCO, INC. BENJAMIN LICHTENWALNER
K033472 11/03/2003 TESCERA U-BAR AND BARRELS BISCO, INC. BENJAMIN LICHTENWALNER
K033702 11/25/2003 BLACKSTONE PEEK VERTEBRAL BODY REPLACEMENT SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030197 01/21/2003 BLACKSTONE POSTERIOR CERVICAL SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030241 01/23/2003 MODIFICATION TO BLACKSTONE SPINAL FIXATION SYSTEM BLACKSTONE MEDICAL, INC. DEAN CIPORKIN
K033717 11/26/2003 TRANSET FRACTURE FIXATION SYSTEM BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K030107 01/13/2003 100MM WALLSTENT RX BILIARY ENDOPROSTHESIS, MODELS M00569800 8MM, M00569810 10MM BOSTON SCIENTIFIC CORP. JENNIFER JOHNSON
K033742 11/28/2003 BOSTON SCIENTIFIC V-18 CONTROL WIRE BOSTON SCIENTIFIC CORP. DEBORAH THOMAS
K030083 01/09/2003 VAXCEL WITH PASV PORT BOSTON SCIENTIFIC CORP. JODI LYNN GREENIZEN
K030113 01/13/2003 MONITECT OXYCODONE DRUG SCREEN CASSETTE TEST, MODEL MC 23, FASTECT OXYCODONE DRUG SCREEN DIPSTICK TEST, MODEL MD23 BRANAN MEDICAL CORP. RAPHAEL WONG
K030172 01/17/2003 SMALL HIGH SPEED MOTOR DRILL SYSTEM BRASSELER USA I, L.P. ANTHONY V ROSE
K033695 11/25/2003 IRRIGATION CHANNEL TUBING, MODEL 100135 BYRNE MEDICAL, INC. J. HARVEY KNAUSS
K033497 11/05/2003 BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. AYMEE R BERRY
K033719 11/26/2003 BARD TIGERTAIL URETERAL CATHETER C.R. BARD, INC. FRANCES HARRISON
K033562 11/12/2003 FASTRAC GASTRIC ACCESS PORT KIT C.R. BARD, INC. THOMAS HIRTE, P.E.
K030020 01/03/2003 HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER C.R. BARD, INC. GLENN NORTON
K030268 01/27/2003 NIAGARA TEMPORARY DUAL LUMEN CATHETERS; FLEXXICON II TEMPORARY DUAL LUMEN CATHETERS C.R. BARD, INC. GLENN NORTON
K030255 01/24/2003 SILICONE DUAL LUMEN RADPICC CATHETERS C.R. BARD, INC. PEGGY KEIFFER
K030277 01/27/2003 SOFT-CELL DUAL LUMEN CATHETERS C.R. BARD, INC. GLENN NORTON
K033624 11/18/2003 PACS SOFTWARE SOLUTION 2003 CANON U.S.A., INC. SEAN M CURRY
K030175 01/17/2003 2 BASIC CAPINTEC, INC. MARY ANNE DELL
K030141 01/15/2003 MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100 CARDIOVENTION, INC. TESSA YAMUT
K030216 01/21/2003 COLONCARE CARE PRODUCTS, INC. HUBERT POTOTSCHNIG
K030259 01/24/2003 AMATOMICAL SHOULDER WITH REMOVABLE HEAD CENTERPLUS ORTHOPEDICS, INC AUDREY SWEARINGEN
K033634 11/19/2003 EPSILON METASUL 32MM ACETABULAR INSERTS, STANDARD AND HOODED CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K033664 11/21/2003 MODIFICATION TO ALLOCLASSIC ZWEYMULLER SL OFFSET FEMORAL STEM CENTERPULSE ORTHOPEDICS, INC. JEAN ASQUITH
K033679 11/24/2003 COPSIOS BONE VOID FILLER (BVF) CENTERPULSE SPINE-TECH, INC. TIM MILLER
K030060 01/07/2003 SPINEMED CERT HEALTH SCIENCES, LLC LYNETTE HOWARD
K033514 11/06/2003 CODA CX1 MOTION ANALYSIS SYSTEM CHARNWOOD DYNAMICS LTD. DAVID L MITCHELSON
K033608 11/17/2003 AQUIFY MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K033701 11/25/2003 FOCUS DAILIES, FOCUS DAILIES TORIC AND FOCUS DAILIES PROGRESSIVES ONE-DAY SOFT CONTACT LENSES CIBA VISION CORPORATION ALICIA M PLESNARSKI
K033579 11/13/2003 REPROCESSED MULTIPLE CLIP APPLIERS CLEAR MEDICAL, INC. MIKE KOVACS
K033578 11/13/2003 REPROCESSED RELOADABLE CUTTERS, STAPLERS, AND APPLIERS CLEAR MEDICAL, INC. MIKE KOVACS
K033593 11/13/2003 REPROCESSED SINGLE USE DEVICES BIOPSY FORCEPS CLEAR MEDICAL, INC. MIKE KOVACS
K033592 11/13/2003 REPROCESSED SURGICAL SCISSORS AND GRASPERS CLEAR MEDICAL, INC. MIKE KOVACS
K033591 11/13/2003 REPROCESSED TROCARS CLEAR MEDICAL, INC. MIKE KOVACS
K030167 01/16/2003 MIERU (ETAFILCON A) DAILY WEAR CONTACT LENS CLEAR AND VISIBILITY TINT, WITH UV BLOCKER CLEARLAB PTE LTD. MARTIN DALSING
K030074 01/08/2003 LINICAL IMMUNOLOGY CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER SYNCHRON CX SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K030150 01/15/2003 LINICAL PROTEIN 5 CALIBRATION VERIFIERS LEVELS A-E FOR BECKMAN COULTER ARRAY AND IMMAGE PROTEIN SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K033488 11/04/2003 CMI MAGNETOCARDIOGRAPH CMI CARDIOMAG IMAGING INC STEVEN KARR
K033524 11/07/2003 COAPT ENDOTINE CHIN 3.5 DEVICE COAPT SYSTEMS, INC. LORI DONDIEGO
K033641 11/20/2003 SMARXT VVR4000I PLUS FILTERED HARDSHELL VENOUS RESERVOIR, MODEL 439914800 COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K033729 11/28/2003 COLLAGEN DENTAL WOUND DRESSINGS COLLAGEN MATRIX, INC. PEGGY HANSEN
K030017 01/02/2003 CHUMP COLOURS 'N MOTION VICTOR R BOX
K033515 11/06/2003 HUBERPRO SAFETY HUBER INFUSION SET COMMAND MEDICAL PRODUCTS JOYCE VYTLACIL
K030240 01/23/2003 MODIFICATION TO HERMES OPERATING ROOM CONTROL CENTER COMPUTER MOTION, INC. CATHY STUPAK
K033736 11/28/2003 MERCI RETRIEVER, MODELS 90065, 90066 CONCENTRIC MEDICAL, INC. KEVIN F MACDONALD
K030117 01/13/2003 ENHANCE SPERM FREEZE CONCEPTION TECHNOLOGY, INC. GRACE HOLLAND
K030116 01/13/2003 ENHANCE-S PLUS H CONCEPTION TECHNOLOGY, INC. GRACE HOLLAND
K033594 11/13/2003 OPTIMUM GP (OXYGEN PERMEABLE) DAILY WEAR CONTACT LENSES CONTAMAC LTD. MARTIN DALSING
K030056 01/06/2003 WORRY-REMOVER IRRIGATOR CORISEN GROUP, LTD. WEI N ZUO
K033743 11/28/2003 COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT COZART BIOSCIENCE LTD. ROBERTO LIDDI
K030234 01/23/2003 COZART EIA COCAINE ORAL FLIUD KIT COZART BIOSCIENCE LTD. ROBERTO LIDDI
K030303 01/29/2003 FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE AND CCT.2 CARDIAC CARDIAC CRYOABLATION CRYOCONSOLE CRYOCATH TECHNOLOGIES, INC. JEAN-PIERRE DESMARAIS
K033484 11/04/2003 HUMAN HEART VALVE, CRYOVALVE SG CRYOLIFE, INC. DAVID M FRONK
K030281 01/27/2003 CRYOTRON 2 CRYOTHERAPY DEVICE CRYONIC MEDICAL NORTH AMERICA SANDRA WILLIAMSON
K033622 11/18/2003 POLARCATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. KIM TOMPKINS
K030338 01/31/2003 ICLEAR PHOTOTHERAPY SYSTEM, MODEL FGCM0002 CURELIGHT LTD JONATHAN S KAHAN
K033518 11/07/2003 LOTUS PULMONARY FUNCTION FILTER, MODELS CPF 101, CPF 102, CPF 103 CUSTOM PLASTIC PRODUCTS JIM BARLEY
K030340 01/31/2003 AUTOLOGEL PROCESS CENTRIFUGE, MODEL B4360 (100-103, 100-129) CYTOMEDIX CARELYN P FYLLING
K033525 11/07/2003 DIMENSION MICROALBUMIN (MALB) FLEX REAGENT CARTRIDGE METHOD, CALIBRATOR, MODELS DF114, DC114 DADE BEHRING, INC. RICHARD M VAUGHT
K033482 11/04/2003 MICROSCAN SYNERGIES PLUS GRAM NEGATIVE MIC/COMBO PANELS WITH AMPICILLIN (0.25-128 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K033487 11/04/2003 STRATUS CS ACUTE CARE TROPONIN I TESTPAK, MODEL CCTNI DADE BEHRING, INC. GEORGE M PLUMMER
K033713 11/26/2003 URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A DADE BEHRING, INC. ANDREA M TASKER
K030307 01/29/2003 DAVOL ARTHROVENT OUTFLOW TUBING DAVOL, INC. LUCINDA L FOX
K033550 11/12/2003 DXL CALSCAN DEMETECH AB JOAKIM ARWIDSON
K033697 11/25/2003 POWER LED DENTAL PRODUCTS OF USA, INC. GEORGE ECHEVERRI
K030133 01/14/2003 SOLARA SERIES COMPRISED OF THE SOLARA HIGH SPEED DENTAL HANDPIECE AND THE SOLARA PLUS HIGH SPEED DENTAL HANDPIECE DENTALEZ GROUP WILLIAM GUSCOTT
K033705 11/25/2003 BOBCAT PRO SCALER SYSTEM, MODEL G-130 DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K030111 01/13/2003 DIAMONDCOAT ULTRASONIC INSERTS DENTSPLY INTERNATIONAL P. JEFFERY LEHN
K033667 11/21/2003 CARRARA PRESS SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K033703 11/25/2003 IDEAL 1 ORTHODONTIC BRACKET ADHESIVE DENTSPLY INTL. P. JEFFERY LEHN
K033553 11/10/2003 PFZ PORCELAIN SYSTEM DENTSPLY INTL. P. JEFFERY LEHN
K030103 01/13/2003 SUMMIT OCT SPINAL SYSTEM MINIPOLYAXIAL SCREWS DEPUY ACROMED FRANK MASS
K030249 01/24/2003 SURGICAL TITANIUM MESH SYSTEM DEPUY ACROMED KAREN F JURCZAK
K033516 11/07/2003 DEPUY GLOBAL CAP HA RESURFACING SHOULDER HUMERAL HEADS DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K030122 01/14/2003 DEPUY SUMMIT BASIC PRESS-FIT HIP STEM DEPUY ORTHOPAEDICS, INC. CHERYL HASTINGS
K033563 11/12/2003 SMARTSET GHV GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K030035 01/03/2003 IRMA SL BLOOD ANALYSIS SYSTEM CR CARTRIDGE DIAMETRICS MEDICAL, INC. NANCY RING
K030154 01/16/2003 IDEAL: SYSTEM WITH INTEGRATED VENOUS AIR REMOVAL, CENTRIFUGAL BLOOD PUMP, PUMP BRACKET, ADULT MEMBRANE OXYGENATOR DIDECO S.P.A. BARRY SALL
K033714 11/26/2003 MVR 1200 PC: SORIN MONOLYTH VENOUS RESERVOIR 1200 PC WITH PHOSPHORYLCHOLINE COATING DIDECO S.P.A. BARRY SALL
K030085 01/09/2003 CARDIUS-1 AND CARDIS-2 DIGIRAD CORP. COREY STEWART
K033600 11/14/2003 INFINITY GAMMAXL Draeger Medical Systems, Inc. PENELOPE H GRECO
K033694 11/24/2003 INFINITY MODULAR MONITORS VF4 MODIFICATIONS Draeger Medical Systems, Inc. PENELOPE H GRECO
K033498 11/05/2003 NARKOMED 6400, MODEL NM6400 DRAEGER MEDICAL, INC. GALE E WINARSKY
K030136 01/14/2003 DRIP ALERT DRIP ALERT, INC. POLLY D HESEMAN
K030140 01/14/2003 DUOMED, SERIES 500, (MODELS ID 500, FL 500) DUOMED INC. CHARLES KOKINOS
K030058 01/07/2003 EARLYDETECT MENOPAUSE TEST FOR FSH EARLY DETECT, INC. PETER GEORGE
K033635 11/19/2003 MODIFICATION TO EBI XFIX VISION FIXATION SYSTEM EBI, L.P. FREDERIC TESTA
K030003 01/02/2003 ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR ELAN DIAGNOSTICS WYNN STOCKING
K030006 01/02/2003 ATAC PAK ALBUMIN REAGENT ELAN DIAGNOSTICS WYNN STOCKING
K030010 01/02/2003 ATAC PAK MAGNESIUM REAGENT ELAN DIAGNOSTICS WYNN STOCKING
K030015 01/02/2003 ATAC PAK PHOSPHORUS REAGENT ELAN DIAGNOSTICS WYNN STOCKING
K030014 01/02/2003 ATAC TOTAL BILIRUBIN REAGENT ELAN DIAGNOSTICS WYNN STOCKING
K030129 01/14/2003 MODIFICATION TO ENSITE 3000 SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. KAREN J MCKELVEY
K030297 01/28/2003 FLEXIBLE RUBBER ELECTRODES, MODELS: 1460265, 1460272, 1460274, 3444128, 3444129, 3444130 ENRAF-NONIUS B.V. RICK COELET
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K030311 01/30/2003 HEM-O-LOK XL CLIP WECK BRIAN YOUNG
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