FDA 510(k) Decisions During February, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K033354 02/18/2004 FEMTEC LASER MICROKERATOME 20/10 PERFECT VISION OPTISCHE GERATE GMBH CAROL PATTERSON
K033996 02/24/2004 HERMES 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K033974 02/06/2004 HERMES BOND 3M ESPE AG DENTAL PRODUCTS ANDREAS PETERMANN
K042967 12/03/2004 A&D MEDICAL LIFESOURCE DIGITAL BLOOD PRESSURE MONITORS, MODELS UB-511 & UB-512 A & D ENGINEERING, INC. JERRY WANG
K042318 12/09/2004 AUDIT MICROCV GENERAL CHEMISTRY LINEARITY SET AALTO SCIENTIFIC LTD. ALAN J VEKICH
K033260 12/07/2004 AEQUOS AAP IMPLANTATE AG MARC SEEGERS
K042392 12/13/2004 DAPTOMYCIN AB BIODISK ANNE BOLMSTROM
K033909 02/17/2004 WAVEMAX BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT LABORATORIES JOANNA KUSKOWSKI
K032903 02/17/2004 ACON COC-150 ONE STEP COCAINE TEST STRIP & ACON COC-150 ONE STEP COCAINE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K033047 02/17/2004 ACON OXY ONE STEP OXYCODONE TEST STRIP AND ACON OXY ONE STEP OXYCODONE TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K043293 12/17/2004 MINI-GAMMA CAMERA, MODELS MGC500-101U AND MGC500-301U ACRORAD CO., LTD. T. WHIT ATHEY
K042381 12/28/2004 CORONARY SINUS VISUALIZATION SYSTEM, MODEL CSVS5508 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K040326 02/25/2004 AUTOQUANT PLUS ADAC LABORATORIES JOY M SACMAR
K040142 02/06/2004 ENSPHERE TEMPO JETSTREAM WORKSPACE CARDIOLOGY MODULE ADAC LABORATORIES COLEEN COLEMAN
K032830 12/14/2004 PLLA CANNULATED INTERFERENCE SCREW ADVANCED BIOMATERIALS STEVE JANIN
K033749 02/23/2004 TITANIUM CANNULATED INTERFERENCE SCREW ADVANCED BIOMATERIALS PATRICK JANIN
K040865 12/06/2004 AESCULAP STERRAD 100S COMPATABLE STERILCONTAINER AESCULAP MATTHEW M HULL
K043079 12/08/2004 BICONTACT HIP SYSTEM WITH U-CAP AESCULAP KATHY A RACOSKY
K043041 12/09/2004 AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX) AESCULAP, INC. MATTHEW M HULL
K041623 12/13/2004 REUSABLE STERILCONTAINER FILTER MODEL #JK090 AESCULAP, INC. MATTHEW M HULL
DEN040012 12/23/2004 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. ROBERT LIPSHUTZ
K042279 12/23/2004 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM AFFYMETRIX, INC. ROBERT LIPSHUTZ
K043085 12/20/2004 MODIFICATION TO: PNEUTON VENTILATOR AIRON CORPORATION ERIC GJERDE
K031741 02/09/2004 MEDLEY ETCO2 MODULE (INCLUDES ACCESSORIES), MODEL 8300 ALARIS MEDICAL SYSTEMS, INC. RENEE L FLUET
K043299 12/10/2004 MEDLEY PCA MODULE, MODEL 8120 ALARIS MEDICAL SYSTEMS, INC. STACY L LEWIS
K043148 12/13/2004 ALL FLOW PULMONARY FUNCTION FILTER ALLIANCE TECH MEDICAL, INC. KEITH LOWREY
K042252 12/06/2004 NEXFLEX TOTAL HIP SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K033768 02/17/2004 ALTUS MEDICAL OPTIONAL INFRARED HANDPIECE ALTUS MEDICAL, INC. KATHY MAYNOR
K033053 02/25/2004 ALVEOLUS, TB-STS TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC. HOWARD SCHRAYER
K032421 02/27/2004 AMBU PEDIATRIC MULTI-FUNCTION DEFIBRILLATION ELECTRODE AMBU, INC. SANJAY PARIKH
K042975 12/29/2004 AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL II AMEDITECH, INC. JOHN WU
K033044 12/21/2004 DREAM CLEANSE "S" SCALER, DREAM COMPACT "S" SCALER AMERICAN GREEN DENT. MFG, INC. ANDREW ROWE
K042592 12/14/2004 INTEMESH SILICONE-COATED SLING AND SURGICAL MESH WITH INHIBIZONE, MODEL 72403304 AMERICAN MEDICAL SYSTEMS, INC. KRISTYN BENSON
K030293 02/04/2004 AMSURE RED RUBBER URETHRAL CATHETER AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K042873 12/10/2004 ANIMAS MODEL IR1250 INSULIN INFUSION PUMP ANIMAS CORP. THOMAS L PARKER
K042817 12/06/2004 MICRO-TOUCH SMOOTH NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) ANSELL HEALTHCARE PRODUCTS, INC. LON D MCLLVAIN
K040671 12/14/2004 EROJECT, MINIJECT, SELF ASPIRATING SYRINGES, ASPIRATING SYRINGES, NON ASPIRATING SYRINGES ANTHOGYR ERIC GENEVE
K022650 02/04/2004 APEX MEDICAL CPAP RT 21XX APEX MEDICAL CORP. ALAN CHANG
K041950 12/21/2004 APEX K2 HIP SYSTEM APEX SURGICAL, LLC. EDWARD J CHEAL, PH.D
K043350 12/15/2004 MISTAR, MODEL V3.2 APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD. QING YANG
K042413 12/09/2004 ACS MODEL NCP-2 APPLIED CARDIAC SYSTEMS R. BEN GHADIMI
K043027 12/02/2004 MONARCH, TRANSSHAPING GASTROSTOMY TUBE, MODEL 9-XX20 APPLIED MEDICAL TECHNOLOGY, INC. DEREK WILLIAMS
K041477 12/09/2004 PATHFINDER ARMSTRONG HEALTHCARE LIMITED PATRICK A FINLAY
K040078 02/13/2004 CANNON II PLUS ARROW INTERNATIONAL, INC. BRANDON EPTING
K043337 12/14/2004 ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR ARTHREX, INC. SALLY FOUST
K041553 12/10/2004 ARTHREX SUTURE GRAFTING KIT ARTHREX, INC. ANN WATERHOUSE
K042947 12/27/2004 PARALLAX ACRYLIC RESIN WITH TRACERS, MODEL KP-PAR-003 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K031859 02/18/2004 CAP GREAT TOE RESURFACING HEMI-ARTHROPLASTY IMPLANT ARTHROSURFACE, INC. ROBERT J MICHALIK
K033718 02/12/2004 MAXBRAID POLYESTER PLUS AND POLYETHYLENE PLUS SUTURE ARTHROTEK, INC. PATRICIA SANDBORN BERES
K040183 02/25/2004 BISX ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K043241 12/23/2004 LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER ASTRA TECH, INC. BRUCE MANNING
K033978 02/18/2004 ADAM ASTRO-MED, INC. MICHAEL J SULLIVAN
K043140 12/08/2004 EXPRESS AND OASIS CHEST DRAIN ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K042638 12/17/2004 RADIANCE PORCELAIN AURIDENT, INC. BRUCE D SPIVACK
K032436 02/04/2004 DURAMAX .018 BILIARY STENT SYSTEM AVANTEC VASCULAR CORP. JAMES M SHY
K033527 02/05/2004 INTRADYN PEDIATRIC HEMOSTASIS INTRODUCER B. BRAUN MEDICAL, INC. AMY SMITH
K033575 02/09/2004 ONE.CLICK NEEDLE B. BRAUN MEDICAL, INC. JENNIFER A KOSOY
K033952 02/04/2004 PERIFIX CATHETER CONNECTOR B. BRAUN MEDICAL, INC. AMY SMITH
K033997 02/04/2004 SOLERA PLUS THROMBECTOMY CATHETER, 55 CM AND 110 CM, MODELS BAC SMG 007 055, BAC SMG 007 110 BACCHUS VASCULAR, INC. LISA CAPARRA
K033723 02/24/2004 DISPOSABLE POWDERED VINYL PATIENT EXAMINATION GLOVES BAODING GUANZHONG GLOVE CO., LTD. HUAN-CHUNG LI
K042221 12/30/2004 CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K033941 02/10/2004 MILLENNIUM MICROSURGICAL SYSTEM AND PERISTALTIC PHACO PACK BAUSCH & LOMB, INC. DENNIS POZZO
K031434 02/06/2004 BAWMED E-Z BAG RESUSCITATOR BAWMED UK BARBARA WOODS
K043158 12/22/2004 ASCENSIA BRIO BLOOD GLUCOSE MONITORING SYSTEM BAYER HEALTHCARE, LLC GEORGE M TANCOS
K043311 12/22/2004 ASCENSIA ELITE DIABETES CARE SYSTEM BAYER HEALTHCARE, LLC GEORGE M TANCOS
K033791 02/13/2004 BAYER SPECIFIC PROTEIN REFERENCE SERUM BAYER HEALTHCARE, LLC ANDRES HOLLE
K033036 02/03/2004 BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647 BECKMAN COULTER, INC. BRENT TABER
K033784 02/03/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN 0.0625-8 UG/ML BECTON DICKINSON & CO. KATHRYN BABKA POWERS
K040006 02/27/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-LINEZOLID-GRAM POSITIVE BECTON DICKINSON & CO. MICHELLE B BANDY
K043397 12/29/2004 MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE BECTON DICKINSON & CO. PASQUALE AMATO
K042862 12/03/2004 BD ONECATH BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K032843 02/27/2004 NEXIVA CLOSED IV CATHETER SYSTEM BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K033889 02/03/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM FOR USE WITH THE ANTIMICROBIAL AGENT CHLORAMPHENICOL 1-32 UG/ML GRAM POSITIVE BECTON, DICKINSON & CO. DAVID STREETT
K042932 12/02/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K032462 02/10/2004 CURAD SILVER ACTIVE GEL BANDAGE BEIERSDORF AG DANIEL J DILLON
K032463 02/10/2004 CURAD SILVER BANDAGE BEIERSDORF AG DANIEL J DILLON
K042636 12/14/2004 BIOPLUS BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K043117 12/09/2004 BEST RADIOPAQUE STRAND; BEST RADIOPAQUE MARKER BEST MEDICAL INTERNATIONAL, INC. JOSEPH C WANG
K033771 02/27/2004 BIO-DETEK MODIFIED ADULT MULTI-FUNCTION ELECTRODE WITH CONNECTOR BIO-DETEK, INC. ROBERT MORSE
K040275 02/27/2004 LYPHOCHEK HEMOSTASIS CONTROL BIO-RAD ELIZABETH PLATT
K041658 12/20/2004 BIOPLEX 200 ANA SCREEN ON THE BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM, MODEL BIOPLEX 2200 BIO-RAD LABORATORIES, INC. CHRISTOPHER BENSTEN
K043108 12/07/2004 LIQUICHEK SPECIALTY IMMUNOASSAY CONTROL BIO-RAD LABORATORIES, INC. SUZANNE S PARSONS
K033924 02/03/2004 LIQUICHEK URINE TOXICOLOGY CONTROL (SCREEN SERIES) BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K042532 12/13/2004 BIOCARE SYSTEMS PREMIR 818 BIOCARE SYSTEMS, INC. CLAY ANSELMO
K041619 12/17/2004 BIO CHECK WHOLE BLOOD/PLASMA/SERMON MODEL #801116 BIOCHECK, INC. ROBIN J HELLEN, M.S.
K033761 02/04/2004 GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K041238 12/13/2004 HELICOBACTER PYLORI IGG ELISA BIOHIT PLC ROBERT P GEARTY
K043230 12/30/2004 VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR ERTAPENEM BIOMERIEUX, INC. JOLYN TENLLADO
K043237 12/23/2004 VITEK GRAM NEGATIVE SUSCEPTIBILITY (GNS) CARD FOR MOXIFLOXACIN BIOMERIEUX, INC. JOLYN TENLLADO
K042963 12/13/2004 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR ERTAPENEM BIOMERIEUX, INC. JOLYN TENLLADO
K042946 12/07/2004 VITEK GRAM POSITIVE SUSCEPTIBILITY (GPS) CARD FOR RIFAMPIN BIOMERIEUX, INC. JOLYN TENLLADO
K041850 12/21/2004 MEDALLION MODULAR HIP SYSTEM BIOMET MANUFACTURING, INC. LONNIE WITHAM
K033838 02/13/2004 TITANIUM TOGGLE BUTTON(S) BIOMET MANUFACTURING, INC. TRACY J BICKEL
K042552 12/14/2004 BIO-CORE INTERFERENCE SCREW BIOMET, INC. SUSAN ALEXANDER
K033506 02/02/2004 COMPREHENSIVE HUMERAL FRACTURE POSITIONING SLEEVE BIOMET, INC. TRACY J BICKEL
K042841 12/21/2004 M2A/C2A ACETABULAR SYSTEM BIOMET, INC. PATRICIA S ANDBORN BERES
K043280 12/21/2004 MIMIX MP BONE VOID FILLER BIOMET, INC. KACY ARNOLD
K042409 12/02/2004 MODULAR ARTHRODESIS NAIL BIOMET, INC. GARY BAKER
K032216 02/04/2004 BIOPTRON PRO LIGHT THERAPY SYSTEM AND BIOPTRON COMPACT III LIGHT THERAPY SYSTEM BIOPTRON AG KEVIN WALLS
K042379 12/15/2004 ANEMIAPRO SELF-SCREENER BIOSAFE LABORATORIES, INC. JACK A MAGGIORE
K042723 12/07/2004 TRIGAGE PROFILER S.O.B. PANEL, MODEL 97300 BIOSITE INCORPORATED JERRREY R DAHLEN
K033210 12/30/2004 BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET BIOTEQUE CORP. JENNIFER REICH
K043038 12/22/2004 BIOTOP HOOKSAFE LUER-LOCK SAFETY SYRINGE, MODELS 3CC/ML, 5CC/ML AND 10CC/ML BIOTOP TECHNOLOGY CO., LTD. MARK LIEN
K040034 02/11/2004 BLACKSTONE ASCENT POCT SYSTEM LATERAL OFFSET ADAPTER BLACKSTONE MEDICAL, INC. DEAN CIPORKIN
K033717 02/25/2004 TRANSET FRACTURE FIXATION SYSTEM BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K040104 02/18/2004 COBRA ADHERE SURGICAL SYSTEM, MODEL M00415977C0 BOSTON SCIENTIFIC CORP. APRIL I MALMBORG
K040219 02/24/2004 COBRA SURGICAL PROBE BOSTON SCIENTIFIC CORP. APRIL I MALMBORG
K040140 02/12/2004 IQ GUIDE WIRE BOSTON SCIENTIFIC CORP. ANNE V ROSSI
K023651 02/17/2004 VECTORVISION CRANIAL/ENT BRAINLAB AG RAINER BIRKENBACH
K042395 12/01/2004 OUTPATIENT III MINOR SURGERY LIGHT BURTON MEDICAL PRODUCTS CORP. ASLE ASMUL
K041652 12/29/2004 ACUPUNCTURE NEEDLES C.A.I. INDUSTRIES CORP. LU RAO
K040243 02/13/2004 BARD ATLAS PTA BALLOON DILATATION CATHETER C.R. BARD, INC. AYMEE R BERRY
K043193 12/07/2004 BARD INLAYOPTIMA URETERAL STENT WITH SUTURE C.R. BARD, INC. FRANCES E HARRISON
K033497 02/04/2004 BARD LUMINEXX 3 BILIARY STENT AND DELIVERY SYSTEM C.R. BARD, INC. AYMEE R BERRY
K033719 02/04/2004 BARD TIGERTAIL URETERAL CATHETER C.R. BARD, INC. FRANCES HARRISON
K040020 02/18/2004 C.T.M. POWER CHAIR, MODEL HS-1000 C.T.M. HOMECARE PRODUCT, INC. ROBERT S MCQUATE
K043070 12/09/2004 LIQUID STABLE HBA1C CONTROL CANTERBURY SCIENTIFIC LTD. MAURICE OWEN
K043162 12/29/2004 PMP4 OXY PRO CARD GUARD SCIENTIFIC SURVIVAL, LTD. BORIS ARADOVSKY
K042574 12/08/2004 ESTEEM BLUE POLYISOPRENE SURGICAL GLOVES WITH COATING (CONTAINING CHITOSAN, PROVITAMIN B, GLUCONOLACTONE AND GLYCEROL) CARDINAL HEALTH ERICA SETHI
K041294 12/08/2004 BIOZDX HEMODYNAMIC MONITOR CARDIODYNAMICS INTERNATIONAL CORP. DENNIS HEPP
K031363 02/05/2004 QCA (VERSION 3.1) CELL ANALYSIS, INC. JOEL HERM
K033840 02/10/2004 CELLAVISION DM96 AUTOMATIC HEMATOLOGY ANALYZER CELLAVISION AB CONSTANCE G BUNDY
K042548 12/03/2004 CERASYS - ZR CERASYS, INC. JIN KIM
K032531 02/02/2004 CHASE CARDIAC ANALYSIS SYSTEM CHASE MEDICAL, INC. DAVID M HERNON
K041038 12/21/2004 CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER CHURCHILL MEDICAL SYSTEMS, INC. KEITH PALUCH
K033608 02/02/2004 AQUIFY MULTI-PURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K040091 02/23/2004 LINICAL ESOTERICS CALIBRATION VERIFIERS LEVELS A-E FOR OLYMPUS AU SYSTEMS CLINIQA CORPORATION CAROL RUGGIERO
K040184 02/26/2004 DIDECO MICRO 40 PH.I.S.I.O. ADULT ARTERIAL FILTER COBE CARDIOVASCULAR, INC. LYNNE LEONARD
K033213 02/06/2004 CODENT DENTAL AIR-POWERED HANDPIECE, MODEL HPS CODENT TECHNICAL INDUSTRY CO., LTD. JEN KE-MIN
K033395 02/25/2004 CODMAN DURAL GRAFT IMPLANT, MODELS 80-1471, 80-1472, 80-1473, 80-1474, 80-1475, 80-1476, 80-1477, 80-1478, 80-1480, 80-1 CODMAN & SHURTLEFF, INC. LIZ DOLAN
K032857 02/04/2004 PRESS-MATE BX-10 VITAL SIGN MONITOR COLIN MEDICAL INSTRUMENTS CORP. MARK RISON
K040888 12/01/2004 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE COLLAGEN MATRIX, INC. PEGGY HANSEN
K040211 02/27/2004 MODIFICATION TO: COLLAGEN TOPICAL WOUND DRESSING COLLAGEN MATRIX, INC. PEGGY HANSEN
K042588 12/09/2004 CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005093 CONFLUENT SURGICAL,INC ERIC ANKERUD
K041833 12/10/2004 CONSOLIDATED SR AND SSE MC-SERIES STEAM STERILIZER CONSOLIDATED MACHINE CORP. ARTHUR TRAPOTSIS
K034039 02/18/2004 SIS PLASTIC SURGERY MATRIX COOK BIOTECH, INC. MARK BLEYER
K032274 02/26/2004 COOK FIVE LUMEN CENTRAL VENOUS CATHETER COOK, INC. JENNIFER J BOSLEY
K043481 12/29/2004 MODIFICATION TO: ZILVER 635 BILIARY STENT COOK, INC. LELAND KEYT
K042970 12/07/2004 COPAN UNIVERSAL TRANSPORT MEDIUM (UTM-RT) SYSTEM COPAN DIAGNOSTICS, INC. CYNTHIA SINCLAIR
K040592 12/17/2004 CORDIS STEER-IT DEFLECTING TIP GUIDEWIRE CORDIS CORP. DAVID KORNHAUSER
K042823 12/01/2004 COSMEDENT PIT & FISSURE SEALANT COSMEDENT, INC. JAMES L SANDRIK
K032434 12/27/2004 CLINICAL ELECTRONIC THERMOMETER COTRONIC MANUFACTURING SHINE WAN
K042385 12/17/2004 DOC BAND-POSTOP CRANIAL TECHNOLOGIES, INC. TIMOTHY R LITTLEFIELD
K033622 02/10/2004 POLARCATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. KIM TOMPKINS
K043332 12/13/2004 WHEELCHAIR, MODEL 8500-II CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER ZEN-JYE CHEN
K034030 02/09/2004 APOGEE ELITE CYNOSURE, INC. GEORGE CHO
K042333 12/01/2004 CONTROL PLASMA N, PROC CONTROL PLASMA DADE BEHRING, INC. RADAMES RIESGO
K042941 12/02/2004 DADE BEHRING HEPARIN CALIBRATOR AND CONTROLS DADE BEHRING, INC. RADAMES RIESGO
K033809 02/20/2004 DIMENSION LIDOCAINE (LIDO) FLEX REAGENT CARTRIDGE METHOD, DIMENSION DRUG CALIBRATOR II, MODELS DF113. DC49D DADE BEHRING, INC. RICHARD M VAUGHT
K042687 12/10/2004 ENZYGNOST F+2 (MONOCLONAL) TEST KIT DADE BEHRING, INC. DONNA WOLF
K032706 02/10/2004 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS WITH ERTAPENEM (0.002-32 MCG/ML DADE BEHRING, INC. CYNTHIA VAN DUKER
K033940 02/25/2004 MICROSCAN DRIED GRAM-NEGATIVE MIC/COMBO PANELS-AMOXICILLIN/CLAVULANATE POTASSIUM (AUGMENTIN) DADE BEHRING, INC. CYNTHIA VAN DUKER
K033713 02/09/2004 URINE COCAINE METABOLITE SCREEN FLEX REAGENT CARTRIDGE, CATALOG# DF92A DADE BEHRING, INC. ANDREA M TASKER
K032338 02/11/2004 TRIO MONITOR MODEL 0998-00-0600 DATASCOPE CORP. SUSAN E MANDY
K043276 12/23/2004 DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE DATEX-OHMEDA JOEL KENT
K033697 02/27/2004 POWER LED DENTAL PRODUCTS OF USA, INC. GEORGE ECHEVERRI
K042931 12/08/2004 TUF LINK SILICONE RELINER DENTATUS USA, LTD. THOMAS MURPHY
K043247 12/22/2004 DUCERA ALLCERAM DENTSPLY INTL. HELEN LEWIS
K033703 02/06/2004 IDEAL 1 ORTHODONTIC BRACKET ADHESIVE DENTSPLY INTL. P. JEFFERY LEHN
K033878 02/20/2004 ACE ANTEGRADE RETROGRADE HUMERAL NAIL SYSTEM DEPUY ACE RHONDA MYER
K033806 02/20/2004 ACE PROXIMAL HUMERAL NAIL SYSTEM DEPUY ACE RHONDA MYER
K043298 12/10/2004 BLUE ORTHOCORD SUTURE DEPUY MITEK RUTH C FORSTADT
K042959 12/22/2004 DEPUY C-STEM AMT HIP PROSTHESIS DEPUY ORTHOPAEDICS, INC. DINA L WEISSMAN
K033272 02/05/2004 DEPUY SIGMA TIBIAL INSERTS DEPUY ORTHOPAEDICS, INC. CHERYL K HASTINGS
K040166 02/23/2004 DEPUY SIGMA XLK TIBIAL INSERTS DEPUY ORTHOPAEDICS, INC. CHERYL K HASTINGS
K033563 02/05/2004 SMARTSET GHV GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K033382 02/05/2004 SMARTSET GMV ENDURANCE GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K042664 12/08/2004 LPS UPPER EXTREMITY DEPUY, INC. TIFFANI D ROGERS
K040101 02/05/2004 MODIFICATION TO DIADEXUS PLAC TEST DIADEXUS, INC. ROBERT L WOLFERT
K042362 12/27/2004 MODIFICATION TO CARBON DIOXIDE-L3K ASSAY, CAT. NOS. 299-30, 299-17, 299-50, 299-80 AND 299-12 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K042329 12/27/2004 SALICYLATE-SL ASSAY DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K032844 02/12/2004 LIAISON 25 OH VITAMIN D DIASORIN, INC. DAVID IKEDA
K033426 02/12/2004 LIAISON N-TACT PTH DIASORIN, INC. DAVID M IKEDA
K041957 12/01/2004 EVLT KIT AND THE D15PLUS AND D30PLUS DIODE LASERS DIOMED, INC. MAUREEN O'CONNELL
K043000 12/01/2004 MODIFICATION TO D-TRONPLUS DISETRONIC MEDICAL SYSTEMS AG SCOTT THIEL
K042547 12/01/2004 DRAGON HEART PISTON SYRINGE DRAGON HEART MEDICAL DEVICES CO., LTD. JINA YU
K043378 12/29/2004 DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT DREW SCIENTIFIC LTD. DIANE HILL
K042478 12/28/2004 CAPSULE TENSION RING INSERTER, MODEL 7-810 DUCKWORTH & KENT, LTD. MARTIN LOCK
K043164 12/10/2004 PANALIGHT-BLU, MODEL 4175 DUSA PHARMACEUTICALS, INC. SCOTT LUNDAHL
K033950 02/20/2004 DORC VITRECTOMY LENSES, MODEL 1284 SERIES DUTCH OPHTHALMIC RESEARCH CENTER (D.O.R.C.) FRAN CARLETON
K033821 02/20/2004 KODAK DRYVIEW 8900 LASER IMAGER MAMMOGRAPHY ACCESSORY EASTMAN KODAK COMPANY STEPHEN SLAVENS
K040113 02/18/2004 SANDMAN SD20 AMPLIFIER EB NEURO, S.P.A. COLLEEN DENSMORE
K042772 12/13/2004 EBI ARRAY SPINAL FIXATION SYSTEM AND SPINELINK II SPINAL FIXATION DEVICE EBI, L.P. FREDERIC TESTA
K042985 12/23/2004 LIFESTENT NT35 BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K043103 12/09/2004 VIGILANCE II CONTINUOUS CARDIAC OUTPUT/OXIMETRY/VOLUMETRIC MONITOR, MODEL VIG2 EDWARDS LIFESCIENCES, LLC. PAULA A TORRIANNI
K033466 02/20/2004 COLOR LCD DISPLAY, MODEL RADIFORCE R22 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K043269 12/22/2004 MODIFICATION TO LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K043068 12/29/2004 DIFOTI USB 2.0 SYSTEM ELECTRO-OPTICAL SCIENCES, INC. MICHAEL GREENEBAUM
K042705 12/29/2004 DISPOSABLE NON-ADHESIVE SPO2 SENSORS ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
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