FDA 510(k) Applications Received During February, 2003

FDA 510(k) Number Submission Date Device Name Applicant Contact
K033996 12/24/2003 HERMES 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K033974 12/22/2003 HERMES BOND 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K030480 02/13/2003 L600 HAIR REMOVAL A&M TECHNOLOGY PASCAL DANET
K030513 02/19/2003 CELL-DYN 1800 SYSTEM ABBOTT LABORATORIES JOHN DEAN
K033845 12/11/2003 PRECISION XCEED DIABETES MONITORING SYSTEM ABBOTT LABORATORIES TRACEY H WIELINSKI
K033909 12/17/2003 WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES JOANNA KUSKOWSKI
K034057 12/30/2003 LACRYTEST ADIATEC SA JOEL LESSER
K033749 12/01/2003 TITANIUM CANNULATED INTERFERENCE SCREW ADVANCED BIOMATERIALS PATRICK JANIN
K030461 02/12/2003 A127 LEAD EXTENSION ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K033757 12/09/2003 MTS MULTIPROGRAM TRIAL STIMULATOR SYSTEM ADVANCED NEUROMODULATION SYSTEMS KATRYNA WARREN
K030429 02/10/2003 STERRAD 200 STERILIZER ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K030367 02/04/2003 COLUMBUS (PS) AESCULAP, INC. JOYCE KILROY
K030556 02/21/2003 STEELEX ELECTRODE SET AESCULAP, INC. GEORG KELLER
K030647 02/28/2003 EVA DIGITAL DENTAL X-RAY SYSTEM AFP IMAGING CORP. MARY MCNAMARA-CCULLINANE
K030459 02/11/2003 MEDLEY SYSTEM WITH MEDICATION MANAGEMENT SYSTEM (MMS) ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K030430 02/10/2003 POLY STAT SERUM/URINE HCG TEST ALIDEX, INC. HELEN LANDICHO
K030421 02/10/2003 ALSIUS COOLGARD 3000 & ALSIUS CATHETER SYSTEM ALSIUS CORP. KENNETH A COLLINS
K033768 12/03/2003 ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE ALTUS MEDICAL, INC. KATHY MAYNOR
K033990 12/26/2003 ALVEOLUS INC. TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. HOWARD L SCHRAYER
K030594 02/25/2003 I-125 RAPID STRAND, MODEL 7000 AMERSHAM HEALTH SUBHASH PATEL
K030518 02/19/2003 AMERITEK SURE-POINT TRACKER SYSTEM AMERTEK MEDICAL, INC. GREG WIITA
K030415 02/07/2003 ANGIODYNAMICS, INC. MORPHEUS PICC AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K030642 02/28/2003 DEFLECTING URETERAL ACCESS SHEATH APPLIED MEDICAL RESOURCES CORP. ANIL BHALANI
K030553 02/21/2003 ARKIT HBA1C ARKRAY, INC. GARY M HAIGHT
K030551 02/21/2003 ARTHROCARE CONTROLLER (SYSTEM 2000 AND 8000); ARTHROCARE PATIENT CABLE; FOOT CONTROL; POWER CORD; WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K030638 02/28/2003 DURAMAX .035 BILIARY STENT SYSTEM, MODELS DML0718-80, DML0718-135, DML0818-80, DML0818-135, DML0918-80, DML0918-135, DML AVANTEC VASCULAR CORP. JAMES M SHY
K030622 02/27/2003 AXIOM BIOLASER LLLT SERIES-1 AXIOM USA. INC JAMES J GIBSON
K030396 02/06/2003 OMNI~NEB; OMNI~MAX B & B MEDICAL TECHNOLOGIES, INC. STEPHEN W BRIGGS
K034066 12/31/2003 B.BRAUN PREMIXED DIALYSATE B. BRAUN MEDICAL, INC. PATRICIA D WILSON
K033952 12/22/2003 PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. AMY SMITH
K033997 12/24/2003 SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 BACCHUS VASCULAR, INC. LISA CAPARRA
K033859 12/11/2003 BARCOVIEW MGD 521M DIGITAL MAMMOGRAPHY DISPLAY BARCO NV BARCOVIEW FRANK FERGUSON
K033941 12/19/2003 MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK BAUSCH & LOMB, INC. DENNIS POZZO
K030452 02/11/2003 BAYER LIGAND PLUS 1, 2, 3 CONTROLS BAYER DIAGNOSTICS CORP. KENNETH T EDDS
K033791 12/23/2003 BAYER SPECIFIC PROTEIN REFERENCE SERUM BAYER HEALTHCARE, LLC ANDRES HOLLE
K030407 02/07/2003 ADVISOR, MODEL 9200 BCI, INC. DONALD ALEXANDER
K030573 02/24/2003 BD VACUTAINER PUSH BUTTON BLOOD COLLECTION SET, MODELS 367338, 367344, 367336, 367342, 367335, 367341 BD VACUTAINER SYSTEMS PREANALYICAL SOLUTIONS M. WENDY BALLESTEROS
K033781 12/04/2003 BEBIG ISOSEED I-125 BEBIG ISOTOPEN-UND MEDIZINTECHNIK GMBH SVEN LANGER
K030606 02/25/2003 COULTER LH 750 BODY FLUIDS APPLICATION BECKMAN COULTER, INC. STAN SUGRUE
K030408 02/07/2003 CYTO-STAT TETRACHROME CD45-FIT/CD4-PE/CD3-PC5 MONOCLONAL ANTIBODY REAGENT, CYTO-STAT TETRACHROM CD45-FITC/CD56-PE/CD19-A BECKMAN COULTER, INC. STAN SUGRUE
K033784 12/04/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML BECTON DICKINSON & CO. KATHRYN BABKA POWERS
K033907 12/17/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TRIMETHOPRIM-SULFAMETHOXAZOLE 0.5/9.5 - 16/304 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K033889 12/16/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE BECTON, DICKINSON & CO. DAVID STREETT
K030579 02/24/2003 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-NALIDIXIC ACID - 2-32 UG/ML BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K033861 12/12/2003 BD PROBETEC ET LEGIONELLA PNEUMOPHILA (LP) AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. COLLEEN A KISTLER
K033771 12/03/2003 BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR BIO-DETEK, INC. ROBERT MORSE
K033924 12/18/2003 LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K033761 12/08/2003 GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K033792 12/05/2003 BILOK ST SCREW BIOCOMPOSITES LTD. J. STEPHEN BRATT
K030463 02/12/2003 MODIFICATION TO THE MAESTRO SYSTEM BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K030348 02/03/2003 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 02/20/2003 LASERSMILE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K030523 02/19/2003 WATERLASE BIOLASE TECHNOLOGY, INC. IOANA M RIZOIU
K030394 02/05/2003 FLUID SAMPLE RETRIEVAL SYSTEM BIOMED PERSONAL METABOLIC AND NUTRITIONAL TESTING SUSAN B FENTRESS
K033838 12/10/2003 TITANIUM TOGGLE BUTTON(S) BIOMET MANUFACTURING, INC. TRACY J BICKEL
K030555 02/21/2003 GPS PLATELET SEPARATION KIT WITH ANTICOAGULANT ACD-A BIOMET, INC. LONNIE WITHAM
K033871 12/12/2003 IM TOTAL FEMUR BIOMET, INC. PATRICIA SANDBORN BERES
K030446 02/11/2003 REPICCI LOCKED KEEL TIBIAL BEARING BIOMET, INC. TRACY J BICKEL
K030501 02/19/2003 X-SERIES INTEGRAL LATERALIZED HIP COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K030388 02/05/2003 IMPACT SUTURE ANCHOR. MODEL 433510 BIONX IMPLANTS, LTD. TUIJA ANNALA
K033862 12/12/2003 BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR WITHOUT SAFETY STRING LOCK BIOTEQUE CORP. WILLIAM LEE
K030354 02/03/2003 BISCOVER LIQUID POLISH KIT, BISCOVER LIQUID POLISH AND BISCOVER VISCOSITY MODIFIER BISCO, INC. STEPHEN D SMITH
K030585 02/24/2003 SCULPTING RESIN BISCO, INC. STEPHEN SMITH
K033980 12/29/2003 BLACKSTONE ASCENT POCT SYSTEM HOOKS (SYSTEM MODIFICATION) BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030595 02/25/2003 BLACKSTONE FUSION ANTERIOR CERVICAL PLATING SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030581 02/24/2003 BLACKSTONE SPINAL FIXATION SYSTEM LATERAL OFFSET (SYSTEM MODIFICATION) BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K030349 02/03/2003 HEALTHOMETER PROFESSIONAL BODY FAT MONITOR AND SCALE, MODELS BFM 940, BFM 945 & BFM 960 BONSO ELECTRONICS INTERNATIONAL INC. RUSS PAGANO
K030645 02/28/2003 BOSTON SCIENTIFIC EXPRESS BILIARY LD UNMOUNTED STENT BOSTON SCIENTIFIC CORP. TODD KORNMANN
K034068 12/31/2003 CONTOUR SE MICROSPHERES BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K030503 02/19/2003 MODIFICATION TO CONTOUR POLARIS URETERAL STENT BOSTON SCIENTIFIC CORP. DONNA M GARDNER
K030617 02/26/2003 PT2 GUIDE WIRE AND ADDWIRE EXTENSION WIRE BOSTON SCIENTIFIC SCIMED, INC. ANNE V ROSSI
K030475 02/13/2003 GDC STRETCH RESISTANT DETACHABLE COIL BOSTON SCIENTIFIC, TARGET JAMES LEATHLEY
K030489 02/14/2003 BRM2 BRAIN MONITOR BRAINZ INSTRUMENTS LTD. CHRIS MANDER
K030460 02/12/2003 MODIFICATION TO BRENNEN BIOSYNTHETIC SURGICAL MESH MATRIX BRENNEN MEDICAL, INC. KENNETH B HERLAND
K033829 12/15/2003 BRUNO ELECTRA-RIDE III STAIRWAY ELEVATOR SYSTEM, MODEL CRE-2100 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD KELLER
K033752 12/01/2003 BRUNO ELECTRA-RIDE STAIRWAY ELEVATOR SYSTEM. MODEL SRE-1540 BRUNO INDEPENDENT LIVING AIDS, INC. RICHARD A KELLER
K030438 02/11/2003 BARD AQUAGUIDE URETERAL CONDUIT C.R. BARD, INC. FRAN HARRISON
K033936 12/19/2003 BARD ELIMINATOR PET BALLOON DILATORS C.R. BARD, INC. MICHAEL A PATZ
K033814 12/09/2003 BARD SOFT MESH, MODELS 0117001, 0117002, 0117003, 0117004, 0117005, 0117006, 0117007 C.R. BARD, INC. SUZANNE LASCALZA
K030442 02/11/2003 CATHETER REPAIR KIT WITH REPLACEMENT CONNECTOR, MODEL 5587000 C.R. BARD, INC. RAMON RICART
K034020 12/24/2003 GROSHONG NXT PICC CATHETERS C.R. BARD, INC. PEGGY KEIFFER
K033778 12/05/2003 MODIFICATION TO BARD AQUAGUIDE URETERAL CONDUIT C.R. BARD, INC. FRAN HARRISON
K034065 12/29/2003 MODIFICATION TO X-PORT DUO PORT C.R. BARD, INC. ANGELA BRADY
K030627 02/27/2003 ORBITER PV DIAGNOSTIC ELECTRODE CATHETER, MODELS 320100 & 320110 C.R. BARD, INC. DEBORAH HERRINGTON
K034019 12/24/2003 POLY PER-Q-CATH PICC CATHETERS C.R. BARD, INC. MICHAELA RIVKOWICH
K030387 02/05/2003 C.T.M. MOBILITY SCOOTER, MODEL HS-890 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K030451 02/11/2003 CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K030398 02/06/2003 CARDIACASSIST TRANSSEPTAL CANNULA SET, MODEL 5132-6221 CARDIAC ASSIST, INC. TIM KRAUSKOPF
K033789 12/04/2003 LATEX POWDER-FREE EXAMINATION GLOVES WITH COATING CARDINAL HEALTH ERICA SETHI
K033905 12/17/2003 PROTEGRITY STEILE LATEX SURGICAL GLOVES WITH COATING CARDINAL HEALTH ERICA SETHI
K030357 02/03/2003 QUANTIX/OR DEVICE CARDIOSONIX, LTD. AHAVA STEIN
K030433 02/10/2003 STRATUSOCT WITH RNFL NORMATIVE DATABASE CARL ZEISS MEDITEC INC R. MICHAEL CROMPTON
K030538 02/20/2003 AMERICAN CATHETER, MODEL W3 CATHETER LLC. JOHN C DEVANNEY
K030524 02/19/2003 CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMEN CD LEYCOM BV T. LOPES
K030403 02/06/2003 CEFAR REHAB 2 AND REHAB 2 PRO CEFAR MEDICAL AB CONSTANCE G BUNDY
K033799 12/05/2003 CLINICAL LASETTE P-200 CELL ROBOTICS, INC. LINDA A BLAIR
K033840 12/10/2003 CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB CONSTANCE G BUNDY
K030533 02/14/2003 ACCUNATE ONE-STEP,ACCUNATE ONE-STEP CASSETTE, ACCUNATE-CHOICE, ACCUNATE HOME PREGNANCY TEST CENOGENICS CORP. NITZ KATZ
K030373 02/04/2003 ALLOCLASSIC ZWEYMUELLER SL/SLL FEMORAL STEM CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K033943 12/23/2003 ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K033810 12/08/2003 NATURAL-KNEE II UNICOMPARTMENTAL KNEE SYSTEM CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K033679 12/05/2003 COPSIOS BONE VOID FILLER (BVF) CENTERPULSE SPINE-TECH, INC. TIM MILLER
K030522 02/19/2003 AOSEPT CLEAR CARE CLEANING AND DISINFECTING SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K033919 12/18/2003 CIBA VISION (LOTRAFILCON B) SPHERICAL, TORIC, MULTIFOCAL AND TORIC MULTIFOCAL DESIGNS CIBA VISION CORPORATION ALICIA M PLESNARSKI
K030528 02/19/2003 ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) CLINICAL DATA WYNN STOCKING
K033983 12/23/2003 VITALAB IRON REAGENT CLINICAL DATA, INC. WYNN STOCKING
K034000 12/24/2003 VITALAB TRIGLYCERIDES REAGENT AND VITALAB CALIBRATOR CLINICAL DATA, INC. WYNN STOCKING
K030566 02/24/2003 LINICAL PROTEIN 3 CALIBRATION VERIFIERS LEVELS A-E FOR THE OLYMPUS AU SERIES CHEMISTRY IMMUNO ANALYZERS CLINIQA CORPORATION CAROL RUGGIERO
K033910 12/17/2003 OLYMPUS URINE CALIBRATOR CLINIQA CORPORATION CAROL RUGGIERO
K030636 02/28/2003 C-PORT CLINISURG VASCULAR PRODUCTS, LLC DONALD F HULTS
K030462 02/12/2003 COBE REVOLUTION CENTRIFUGAL BLOOD PUMP WITH PC, MODEL 050300700 COBE CARDIOVASCULAR, INC. CHARLES COPPERBERG
K033729 12/02/2003 COLLAGEN DENTAL WOUND DRESSINGS COLLAGEN MATRIX, INC. PEGGY HANSEN
K030464 02/12/2003 GEM, MODEL 004110 COLLINS MEDICAL, INC. DONALD HENTON
K033869 12/12/2003 CONTREET FOAM CAVITY DRESSING WITH SILVER, MODEL 9628 (2X4 IN.) COLOPLAST CORP. ELIZABETH BOOTS
K033760 12/02/2003 ONE COAT SE BOND COLTENE/WHALEDENT INC. HENRY J VOGELSTEIN
K030355 02/03/2003 COMFORT POWERED WHEELCHAIR, CONQUEROR LY-EB 202 COMFORT ORTHOPEDIC CO. LTD. KE-MIN JEN
K030356 02/03/2003 COMFORT POWERED WHEELCHAIR, TRAVELLER LY-EB 103 COMFORT ORTHOPEDIC CO. LTD. KE-MIN JEN
K030578 02/24/2003 BIPOLAR GRASPER AND BIPOLAR SCISSORS FOR THE ZEUS MICROWRIST SURGICAL SYSTEM COMPUTER MOTION, INC. CATHY STUPAK
K030476 02/13/2003 MODIFIED CONCENTRIC RETRIEVER, MODEL 90037 CONCENTRIC MEDICAL, INC. KEVIN F MACDONALD
K034039 12/29/2003 SIS PLASTIC SURGERY MATRIX COOK BIOTECH, INC. MARK BLEYER
K030441 02/11/2003 SYDNEY IVF BLASTOCYST CRYOPRESERVATION KIT AND SYDNEY IVF BLASTOCYST THAW KIT COOK OB/GYN BRENDA DAVIS
K033903 12/17/2003 MODIFICATION TO INTRACYTOPLASMIC SPERM INJECTION (ISCI), MICRO-INJECTION PIPETTES, HOLDING PIPETTES, DENUDING PIPETTES, COOK UROLOGICAL, INC. BRENDA DAVIS
K033904 12/17/2003 PRE-IMPLANTATION GENETIC DIAGNOSIS PIPETTES (BIOPSY PIPETTES) COOK UROLOGICAL, INC. BRENDA DAVIS
K033875 12/16/2003 ATB ALL-TERRAIN BALLOON PTA DILATATION CATHETER COOK, INC. KAREN BRADBURN
K033843 12/10/2003 SPECTRUM CENTRAL VENOUS CATHETER WITH OR WITHOUT HYDROPHILIC COATING COOK, INC. JENNIFER BOSLEY, MBA
K030409 02/07/2003 SMART NITINOL STENT ENDOSCOPIC BILIARY SYSTEM CORDIS CORP. SAM MIRZA
K034050 12/30/2003 CORDIS OPTEASE VENA CAVA FILTER, MODELS 466-F220A AND 466-F220B; RETRIEVABLE CATHETER, MODEL 466-C220F CORDIS CORPORATION DONNA MARSHALL
K034013 12/24/2003 REAADS DSDNA QUANTITATIVE TEST KIT, MODEL 022-001 CORGENIX, INC. NANCI DEXTER
K033743 12/19/2003 COZART EIA AMPHETAMINES ORAL FLUID MICROPLATE KIT COZART BIOSCIENCE LTD. ROBERTO LIDDI
K030351 02/03/2003 STAINLESS STEEL SURGICAL SUTURE, NON-ABSORBABLE CP MEDICAL MARY ANN GREENAWALT
K030532 02/19/2003 CPCA2000 COUNTERPULSATION SYSTEM CPCA2000 INC ROD SHIPMAN
K033912 12/17/2003 CRADLE PACS CRADLE TECHNOLOGY CORP. JEN KE-MIN
K030613 02/26/2003 VITAL SIGNS MONITOR W/ARRHYTHMIA DETECTION AND ST ANALYSIS, MODEL 8100 CRITICARE SYSTEMS, INC. ALEX KAPLAN
K034030 12/29/2003 APOGEE ELITE CYNOSURE, INC. GEORGE CHO
K033176 12/29/2003 TRISTAR AESTHETIC WORKSTATION LASER CYNOSURE, INC. GEORGE CHO
K033809 12/08/2003 DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D DADE BEHRING, INC. RICHARD M VAUGHT
K033948 12/29/2003 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS (GEMIFLOXACIN) DADE BEHRING, INC. CYNTHIA VAN DUKER
K033940 12/29/2003 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) DADE BEHRING, INC. CYNTHIA VAN DUKER
K033908 12/17/2003 N HIGH SENSITIVITY CRP DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K033865 12/24/2003 IDEIA PCE CHLAMYDIA DAKOCYTOMATION LTD JENNIE OATES
K033896 12/16/2003 DEFIBTECH AED WITH ATTENUATED DEFIBRILLATION/MONITORING PADS, MODELS DDU-100 WITH DDP-200P DEFIBTECH, LLC JOHN L ROGERS
K030546 02/20/2003 CRP (II) CALIBRATORS DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K030545 02/20/2003 CRP-LATEX (II)X2 SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K030644 02/28/2003 CONTEC DUO, CONTEC LC, CONTEC LCR DENTAURUM JAN W A DOORSCHODT
K030641 02/28/2003 CONTEC LIGHT DENTAURUM JAN W A. DOORSCHODT
K030508 02/19/2003 DEPILASE TRIO LASE LASER SYSTEM DEPILASE GROUP LTD. MARIO LUCA RUSSO
K030510 02/19/2003 DEPILASE TWIN YAG LASER SYSTEM DEPILASE GROUP LTD. MARIO LUCA RUSSO
K030506 02/19/2003 DEPILASE YAG LASE PLUS LASER SYSTEM DEPILASE GROUP LTD. MARIO LUCA RUSSO
K033878 12/15/2003 ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM DEPUY ACE RHONDA MYER
K033806 12/08/2003 ACE PROXIMAL HUMERAL NAIL SYSTEM DEPUY ACE RHONDA MYER
K030383 02/05/2003 MODIFICATION TO MOSS MIAMI SPINAL SYSTEM POLYAXIAL SCREWS DEPUY ACROMED LISA GILMAN
K033893 12/16/2003 SPECTRUM MODULAR SYSTEM DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN, J.D.
K033901 12/17/2003 MERLIN SPINE SYSTEM DEPUY SPINE,INC JENNIFER MOONEY
K033959 12/22/2003 LPS DEPUY, INC. DINA L WEISSMAN
K030365 02/04/2003 DEROYAL DRAPES, STERILE, NON-STERILE DEROYAL INDUSTRIES, INC. AUDREY DANIELS
K030364 02/04/2003 DEROYAL GOWNS, STERILE, NON-STERILE DEROYAL INDUSTRIES, INC. AUDREY DANIELS
K030477 02/13/2003 DIADEXUS PLAC TEST DIADEXUS, INC. ROBERT L WOLFERT
K034055 12/30/2003 IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I DIAGNOSTIC PRODUCTS CORP. EDWARD M LEVINE, PH.D.
K030366 02/04/2003 BICARD MIXING SYSTEM DIALYSIS SYSTEMS, INC. MARK VESLIGAJ
K034022 12/29/2003 UCLA AND CEMENT-ON ABUTMENTS AND ACCESSORIES DIAMODENT JEFF RASSOLI
K033987 12/23/2003 D735 MICRO 20 AND D736 MICRO 40 NEWBORN-INFANT ARTERIAL FILTERS DIDECO S.P.A. BARRY SALL
K034037 12/29/2003 SKY BONE EXPANDER SYSTEM DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. JONATHAN S KAHN
K033785 12/04/2003 PROACTIVE CARE PROPHYLAXIS PASTE WITH FLUORIDE DISCUS DENTAL, INC. VIVIAN LAI
K033892 12/16/2003 ULTRAFLEX INFUSION SET DISETRONIC MEDICAL SYSTEMS AG BERND HENNINGSEN
K033876 12/15/2003 DOLPHIN 2000 OXIMETRY SENSORS, MODELS 2020, 2040, 2060, 2070, 2321, 2323, 2341, 2342, 2343, 2344, 2220, 2260 AND 2422 DOLPHIN MEDICAL INC. BILL CURNAN
K030629 02/27/2003 DOLPHIN MEDICAL 2150 HANDHELD PULSE OXIMETER DOLPHIN MEDICAL INC. BILL CURNAN
K033957 12/22/2003 INFINITY MODULAR MONITORS VF4 MODIFICATIONS WITH SCIO, MODELS DELTA, DELTA XL, KAPPA, SC 8000, SC 7000, SC 9000XL DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K033807 12/08/2003 INFINITYEDICAL INFORMATION BUS (MIB/MIB II AND MIB DUO) PROTOCOL CONVERTER DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K030624 02/27/2003 MODIFICATION TO FABIUS GS ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K034067 12/31/2003 ZTI IMPLANTS SYSTEM, DRM IMPLANTS DRM RESEARCH LABORATORIES, INC. SAMUEL WAKNINE
K033950 12/29/2003 DORC VITRECTOMY LENSES, MODEL 1284 SERIES DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.) FRAN CARLETON
K030353 02/03/2003 MONOCANALICULAR STENTS, LACRIMAL INTUBATION SETS EAGLE VISION, INC. BILLY HANNAFORD
K033821 12/09/2003 KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY EASTMAN KODAK COMPANY STEPHEN SLAVENS
K033918 12/18/2003 EBI LACTOSORB GRAFT CONTAINMENT SYSTEM EBI, L.P. JON CAPAROTTA
K030372 02/04/2003 MODIFICATION TO EBI DYNAFIX DIAPHYSEAL CORRECTION SYSTEM EBI, L.P. FREDERIC TESTA
K030363 02/04/2003 ORG@NIZER, MODEL VERSION 3.0 EBIT SANITA, S.P.A. COLLEEN DENSMORE
K030630 02/27/2003 EDWARDS DIRECTIONAL CATHETER EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K033795 12/05/2003 PLASMACURE BXE EELE LABORATORIES, LLC ROBERT GRASMAN
K030347 02/03/2003 20.1" MONOCHROME LCD MONITOR, RADIFORCE G20 EIZO NANAO CORPORATION AKIRA WAKAYAMA
K030637 02/28/2003 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K030621 02/27/2003 ATAC CALIBRATOR ELAN DIAGNOSTICS WYNN STOCKING
K034043 12/29/2003 H-FLOW VALVE ELCAM MEDICAL A.C.A.L. TALI HAZAN
K030466 02/12/2003 HANDYDOP ELCAT, GMBH JAY MANSOUR
K030483 02/14/2003 SYNTHETICARE POWDER-FREE VINYL EXAMINATION GLOVES EMERALD MEDICAL, INC. SUSAN D GOLDSTEIN-FALK
K030484 02/14/2003 SYNTHETICARE POWDERED VINYL EXAMINATION GLOVES EMERALD MEDICAL, INC. SUSAN D GOLDSTEIN-FALK
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