FDA 510(k) Decisions During October, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K041934 10/15/2004 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3000 3M COMPANY GINGER CANTOR
K042458 10/07/2004 A.M. SURGICAL CPF DISTAL RADIAL EXTERNAL CROSS PIN FIXATION SYSTEM A.M. SURGICAL, INC. CAROLANN KOTULA
K041962 10/01/2004 XPAND BALLOON-EXPANDABLE TRANSHEPATIC BILIARY STENT SYSTEM, MODELS 20587, 20588, 20589, 20603, 20604, 20605 ABBOTT LABORATORIES JOANNA KUSKOWSKI
K042423 10/06/2004 VERIFYNOW-ASPIRIN ASSAY ACCUMETRICS, INC. BARBARA STEVENS
K041858 10/05/2004 ACUMED ANATOMIC RADIAL HEAD SYSTEM ACUMED LLC ED BOEHMER
K042376 10/26/2004 ACUMEN SHEATH, MODEL TTW7807 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K042903 10/29/2004 AUTOSPECS ADAC LABORATORIES JOY SACMAR
K041662 10/14/2004 APNEA RISK EVALUATION SYSTEM (ARES) ADVANCED BRAIN MONITORING, INC. DANIEL J LEVENDOWSKI
K040839 10/19/2004 COMPLETE BLINK-N-CLEAN LENS DROPS ADVANCED MEDICAL OPTICS, INC. PAUL J NOWACKI
K041854 10/06/2004 MPM SYSTEM AEROTEL MEDICAL SYSTEMS, LTD. GEORGE MYERS
K041628 10/14/2004 AESKULISA DS DNA G AESKU.DIAGNOSTICS STANLEY AMMONS
K042779 10/21/2004 RADIOTHERAPY SOLUTION BASED ON CR AGFA CORP. JEFFERY A JEDLICKA
K042397 10/05/2004 SCANX 14 AIR TECHNIQUES, INC. JOSEPH CAREY
K042440 10/07/2004 ALPHATEC FEMORAL TROCHANTERIC NAIL (FTN) SYSTEM ALPHATEC/NEXMED ELLEN YARNALL
K042201 10/07/2004 NOVEL VBR SPINAL SYSTEM ALPHATEC/NEXMED ELLEN YARNALL
K042673 10/27/2004 ZODIAC POLYAXIAL SPINAL FIXATION SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K041963 10/20/2004 AMERICAN BANTEX HUMIDIFIER, DRY, BUBBLE, MODELS B9000, 3 PSI AND B9100, 6 PSI AMERICAN BANTEX CORP. TRACY S BEST
K042104 10/21/2004 AMERICAN BANTEX, MODEL MS 3 AMERICAN BANTEX CORP. TRACY S BEST
K042401 10/07/2004 VARI-ABLE APB (ADAPTABLE POSITIONING BASE) AMERICAN TRACK ROADSTERS, INC. GREG PEEK
K042821 10/22/2004 DIGITAL DETECTOR, MODEL GR17 ANRAD CORP. DONALD J SHERRATT
K041506 10/15/2004 INTRAVASCULAR ACCESS INTRODUCER SHEATH APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K040760 10/15/2004 MODIFICATION TO URETERAL STENT APPLIED MEDICAL RESOURCES CORP. CHERYL BLAKE
K042300 10/25/2004 AMT INTRODUCER: MINI BUTTON DELIVERY SYSTEM APPLIED MEDICAL TECHNOLOGY, INC. CHRIS ZANTOPULOS
K040866 10/19/2004 FIRST RESPONSE ONE-STEP DIGITAL PREGNANCY TEST ARMKEL LLC STEPHEN C KOLAKOWSKY
K042367 10/14/2004 NYLON THREADED NEEDLE AROS SURGICAL INSTRUMENTS CORP. GRACE HOLLAND
K041740 10/15/2004 SILICONE COATED GUIDEWIRE ARROW INTERNATIONAL, INC. SUZANNE SCHORLE
K042460 10/29/2004 TI - SCREW ANCHOR SP ARTHROTEK, INC. GARY BAKER
K042063 10/14/2004 PRESS TACK NEEDLE ASIA-MED GMBH & CO. KG. - WERK SUHL KEVIN WALLS
K041698 10/05/2004 AXYA MEDICAL, INC. MODEL 5000 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC. HOWARD SCHRAYER
K041490 10/29/2004 IV ADMINISTRATION SETS WITH ULTRABLOCK UV-RESISTANT TUBING B. BRAUN MEDICAL, INC. JENNIFER A PUNG,
K041222 10/14/2004 PINNACLE TPN MANAGEMENT SYSTEM TRANSFER SET B. BRAUN MEDICAL, INC. LINDA MORGAN
K042445 10/19/2004 SITE-RITE NEEDLE GUIDE KITS AND PROBE COVER KIT BARD ACCESS SYSTEMS, INC. CHARLES MORREALE
K042410 10/08/2004 BAXJECT II BAXTER HEALTHCARE CORP. RON LAGERQUIST
K042173 10/12/2004 COULTER A T 5DIFF CAP PIERCE (CP) BECKMAN COULTER, INC. LOURDES COBA
K042651 10/05/2004 FREE T3 CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS BECKMAN COULTER, INC. VALYNDA MACHEN
K042724 10/29/2004 MODIFICATION TO COULTER LH 500 HEMATOLOGY ANALYZER BECKMAN COULTER, INC. STAN SUGRUE
K041478 10/28/2004 BD LOGIC BLOOD GLUCOSE MONITOR AND PARADIGM LINK BLOOD GLUCOSE MONITOR BECTON DICKINSON JOHN SCHALAGO
K042934 10/28/2004 1BD SOLOSHOT IX SYRINGE BECTON DICKINSON & CO. PETER ZURLO
K042759 10/20/2004 OPTIMA MX BIEN-AIR SA SWITZERLAND ALAIN LEONETTI
K041136 10/22/2004 MODIFICATION TO SILHOUETTE IC OR SILHOUETTE; LASER-LOK SURFACE TREATMENT -OPTIONAL SURFACE MODIFICATION TO IMPLANTS BIO-LOK INTL., INC. ELAINE DUNCAN
K040485 10/18/2004 MAXAIR SURGICAL HELMET SYSTEM BIO-MEDICAL DEVICES, INC. NICK HERBERT
K042324 10/07/2004 LYPHOCHEK ELEVATED IMMUNOSUPPRESSANT CONTROL, LEVEL 4, 5 BIO-RAD MARIA ZEBELLOS
K042336 10/14/2004 METER TRAX TRILEVEL, LOW LEVEL, MID LEVEL, HIGH LEVEL TRILEVEL MINIPAK BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K031296 10/15/2004 LIQUI-HEME GLYCO A1C ASSAY BIODIAGNOSTIC INTL PAUL ANAND
K042616 10/12/2004 BIOMEDIX PADNET LAB BIOMEDIX, INC. WILLIAM ROGERS
K041988 10/20/2004 ARTHROTEK MENISCAL HYBRID DEVICE BIOMET, INC. GARY BAKER
K042037 10/01/2004 M2A MAGNUM SYSTEM BIOMET, INC. KACY ARNOLD
K042032 10/07/2004 MAESTRO TOTAL WRIST BIOMET, INC. PATRICIA SANDBORN BERES
K042750 10/29/2004 QC-BEADS BIOSCREEN INC. ALICE DEUTSCH
K042708 10/20/2004 ERA 3000 PACING SYSTEM ANALYZER BIOTRONIK, INC. JON BRUMBAUGH
K042514 10/07/2004 MODIFICATION TO BLACKSTONE MODULAR PEDICLE SCREW SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K041430 10/07/2004 BLEASE SIRIUS ANESTHESIA SYSTEM, MODELS 3000 AND 2000 BLEASE MEDICAL EQUIPMENT LTD. ARTHUR J WARD
K042568 10/15/2004 EXCELSIOR 1018 AND SL-10 MICROCATHETERS BOSTON SCIENTIFIC CORP. VICTOR HAM
K042539 10/19/2004 GDC-10 360 DEGREE COIL SR; GDC-10 360 DEGREE SOFT COIL SR; GDC-18 360 DEGREE COIL BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K042469 10/06/2004 BRAEMAR ER800 SERIES ENHANCED ALGORITHM EVENT RECORDER BRAEMAR, INC. DARREN DERSHEM
K042391 10/19/2004 KOLIBRI IMAGE GUIDED SURGERY SYSTEM BRAINLAB AG JENS WITTE
K041899 10/06/2004 VECTORVISION UNI-KNEE BRAINLAB AG RAINER BIRKENBACH
K041703 10/22/2004 IPLAN! BRAINLAB, AG RAINER BIRKENBACH
K041714 10/01/2004 E-PAIN CARE BREG, INC. KATHLEEN BARBER
K041659 10/28/2004 C-BOOT C-BOOT LTD. AVI ABRAHAM
K042156 10/06/2004 CARDEON COBRA CATHETER CARDEON CORP. JANE BEGGS
K041486 10/22/2004 VASOSTASIS VASCULAR CLOSURE SYSTEM CARDIVA MEDICAL, INC. AUGUSTINE LIEN
K033943 10/18/2004 ALPHA METASUL 28MM AND 32MM ACETABULAR INSERTS, STANDARD AND HOODED CENTERPULSE ORTHOPEDICS, INC. AUDREY SWEARINGEN
K031753 10/28/2004 KARATS MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K040750 10/28/2004 BIO-CHEM ANALYZER, MODEL 100 CLINICAL ANALYSIS CORPORATION, INC. CHARLES MCBRAIRTY
K041919 10/04/2004 PERFUDROP AIR M-P WITH NEEDLE 20 G, MODEL 48451606 CLINICO REINHARD HOPF
K042736 10/13/2004 CDX DIGITAL X-RAY IMAGING SYSTEM CNC IMAGING, INC. KORINA A AKHONDZADEH
K042647 10/07/2004 EXAM-PACS COACTIV, LLC CARL ALLETTO
K042693 10/21/2004 IV ADMINISTRATION SET B400 SP CODAN US CORP. ROHIT PATEL
K042232 10/05/2004 NP-2600 SERIES HARDCOPY PRINTERS CODONICS, INC. ALAN DESANTIS
K040849 10/01/2004 MENTAMOVE COLE & ASSOCIATES RICHARD O WOOD
K041062 10/01/2004 INTRAUTERINE VENOGRAM NEEDLE SET COOK UROLOGICAL, INC. CINDY RUMPLE
K042518 10/01/2004 ZILVER 518 BILIARY STENT COOK, INC. LELAND KEYT
K042435 10/26/2004 COOPER PROSTHETIC COOPERVISION, INC. BONNIE J TSMBAL
K042541 10/12/2004 MODIFICATION TO POLARCATH PERIPHERAL DILATATION SYSTEM CRYOVASCULAR SYSTEMS, INC. KIM TOMPKINS
K042467 10/01/2004 LSO PET/CT HIREZ 64 CTI PET SYSTEMS, INC. M. ALAINE MEDIO
K041994 10/06/2004 MULTICLEAR XL MULTIWAVELENGTH TARGETED PHOTOTHERAPY SYSTEM CURELIGHT LTD JONATHAN S KAHN
K042165 10/18/2004 CUTERA TABLETOP AESTHETIC PRODUCT CUTERA, INC. KATHY MAYNOR
K042502 10/14/2004 3 SERIES PHOTOTHERAPY CABINET DAAVLIN DISTRIBUTING CO. DAVID W SWANSON
K042209 10/21/2004 CONTROL PLASMA N AND CONTROL PLASMA P DADE BEHRING, INC. DONNA A WOLF
K042407 10/28/2004 EMIT CAFFEINE ASSAY DADE BEHRING, INC. YUK-TING LEWIS
K042771 10/15/2004 GE DATEX-OHMEDA S/5 NETWORK AND ICENTRAL '03, SALES REVISION 3.3 DATEX-OHMEDA JOEL KENT
K041775 10/26/2004 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR
K042048 10/26/2004 GELATO PROPHYLAXIS PASTE DEEPAK PRODUCTS, INC. RICARDO A CARLES
K041090 10/29/2004 HDL-EX SEIKEN ASSAY KIT DENKA SEIKEN CO., LTD. TOSHIMI MATSUNAGA
K041272 10/18/2004 DYRACT CEM PLUS CEMENT DENTSPLY INTL. P. JEFFERY LEHN
K042437 10/08/2004 DORSAL INTRAMEDULLARY PLATE DEO VOLENTE ORTHOPAEDICS, LLC DINA L WEISSMAN, J.D.
K042591 10/22/2004 SMARTMIX PRE-FILLED MIXING SYSTEM DEPUY ORTHOPAEDICS, INC. TIFFANI ROGERS
K042508 10/07/2004 SUMIT OCT SPINAL SYSTEM AND MOUNTAINEER OCT SPINAL SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K042243 10/04/2004 MICROALBUMIN MULTI-CALIBRATOR SET DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K042439 10/07/2004 AZURYT MODEL CLT 1401, CO2 SURGICAL LASER SYSTEM DIAMOND AGE SYSTEMS, INC. GEOFFREY D SWANK
K042193 10/29/2004 DIAZYME GLYCATED SERUM PROTEIN ENZYMATIC ASSAY KIT DIAZYME LABORATORIES CHONG YUAN
K042191 10/29/2004 DIAZYME POTASSIUM ENZYMATIC ASSAY KIT DIAZYME LABORATORIES HUAN TRAN
K042189 10/07/2004 DIAZYME SODIUM ENZYMATIC ASSAY DIAZYME LABORATORIES HUHAN TRAN
DEN040007 10/12/2004 VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER DIGITAL ANGEL CORPORATION KEVIN MCLAUGHLIN
K033440 10/12/2004 VERICHIP HEALTH INFORMATION MICROTRANSPONDER AND POCKET READER DIGITAL ANGEL CORPORATION KEVIN MCLAUGHLIN
K041018 10/18/2004 DRG SOFTRELEASE DOCTOR'S RESEARCH GROUP, INC. EDWARD H GOLDMAN
K042656 10/06/2004 INFINITY GAMMA/GAMMAXL AND VISTA WITH VF5 DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K042419 10/08/2004 FABIUS GS/FABIUS TIRO ANESTHESIA SYSTEM DRAEGER MEDICAL, INC. MICHAEL A KELHART
K042703 10/12/2004 CYBIRD LED CURING LIGHT DXM CO., LTD. CAROLANN KOTULA
K042268 10/27/2004 EBI CAS SPINE SPACER SYSTEM EBI, L.P. FREDERIC TESTA
K042408 10/08/2004 IQQA-CHEST SOFTWARE PACKAGE EDDA TECHNOLOGY, INC. DANIEL KAMM
K042002 10/20/2004 SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER ELA MEDICAL INC SUSAN OLIVE
K041598 10/06/2004 LASEREX, MODEL LP4532 ELLEX MEDICAL PTY. LTD. KEVIN HOWARD
K041808 10/01/2004 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K042493 10/15/2004 ENSITE SYSTEM, MODEL EE3000 ENDOCARDIAL SOLUTIONS, INC. KAREN J MCKELVEY
K033421 10/14/2004 ERBE BICLAMP OPEN AND LAPAROSCOPIC INSTRUMENTS ERBE USA, INC. JULIE STEPHENS
K042236 10/04/2004 G-SCAN ESAOTE, S.P.A. CARRI GRAHAM
K042183 10/27/2004 GLUCOSE TOLERANCE BEVERAGE EVER SCIENTIFIC JAY REINHARDT
K040601 10/04/2004 EXACTECH ACUMATCH A-SERIES & MCS CONSTRAINED ACETABULAR LINERS EXACTECH, INC. GARY MILLER
K042021 10/26/2004 EXACTECH EQUINOXE SHOULDER SYSTEM EXACTECH, INC. GARY MILLER
K040889 10/01/2004 EXACTECH OPTETRAK UNICONDYLAR KNEE EXACTECH, INC. GARY MILLER
K042529 10/06/2004 BALANCEBACK VNG SYSTEM FALL PREVENTION TECHNOLOGIES, LLC KEITH KRAVITZ
K042095 10/29/2004 MAMMOTEST FISCHER IMAGING CORP. ROBERT G SCHUEPPERT
K042561 10/12/2004 TWINHEADS TH-103 EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER FMD, LLC YOUSRY FARAGALLA
K042332 10/07/2004 TITANIUM TELEGRAPH HUMERAL NAIL FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K040170 10/27/2004 FRIADENT PLUS DENTAL IMPLANT SYSTEMS FRIADENT GMBH CAROL PATTERSON
K042667 10/14/2004 SEEDNET GOLD WITH RENAL KIT, MODEL FPRPR 3021, (RENAL KIT), FPRCH 2024 (SEEDNETGOLD) GALIL MEDICAL LTD. JONATHAN S KAHN
K041005 10/07/2004 GAMBRO PRISMAFLEX AND GAMBRO PRISMAFLEX M60 & M100 SETS GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K042200 10/20/2004 MI PASTE GC AMERICA, INC. TERRY L JORITZ
K042525 10/01/2004 CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CAROL ALLOIAN
K042448 10/29/2004 DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT GENERAL ATOMICS HUAN TRAN
K041149 10/25/2004 GIVEN DIAGNOSTIC SYSTEM WITH M2A ESO CAPSULE GIVEN IMAGING LTD. SHOSH FRIEDMAN
K041718 10/15/2004 KELES FACEMASK GREAT LAKES ORTHODONTICS, LTD. DAVE GRAVER
K042077 10/27/2004 BITECH BIPOLAR SCISSORS GUENTER BISSINGER MEDIZINTECHNIK GMBH FRANZ MENEAN
K041633 10/22/2004 GYRUS PLASMACISION LAPAROSCOPIC SPATULA GYRUS MEDICAL, INC. DAVID E CHADWICK
K040574 10/27/2004 GALILEO GOLD HAMILTON MEDICAL, INC. J. DAVID THOMPSON
K042802 10/26/2004 H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168H, HL168J & HL168Q HEALTH & LIFE CO., LTD. PAUL HUNG
K041877 10/08/2004 ACU-STRAP MOTION SICKNESS BAND HEALTH ENT., INC. DANIEL J DILLON
K042742 10/13/2004 HEIDELBERG RETINA TOMOGRAPH II / ROSTOCK CORNEA MODULE (HRT II / RCM) HEIDELBERG ENGINEERING GERHARD ZINSER
K042503 10/01/2004 KURZ CLIP PISTON MVP, MODEL 1006 711-13/0.4 MM + 1006 761-63/0.6MM HEINZ KURZ GMBH MEDIZINTECHNIK DAGMAR MASER
K042501 10/12/2004 ETG-4000 OPTICAL TOPOGRAPHY SYSTEM HITACHI MEDICAL CORP. DOUG THISTLEWAITE
K042480 10/29/2004 INFANT WHOLE BODY SOFTWARE OPTION FOR QDR DENSITOMETERS HOLOGIC, INC. DANIEL F PHELAN
K042609 10/06/2004 HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE HOSPIRA, INC. RAY SILKAITIS
K042800 10/18/2004 LIFECARE PCA INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE HOSPIRA, INC. THOMAS KOZMA
K042545 10/21/2004 HOVEROUND MPV-5 POWERCHAIR HOVEROUND CORP. TONY DIGIOVANNI
K042396 10/08/2004 T2 PROXIMAL HUMERAL NAIL HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K042212 10/21/2004 IMPLANTMASTER I-DENT DAN LAOR
K040334 10/04/2004 NAVIGUS PASSIVE PROBE, MODEL NP-1000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K041102 10/26/2004 IMMULISA ANTINUCLEAR ANTIBODY SCREEN ELISA IMMCO DIAGNOSTICS, INC. KEVIN J LAWSON
K042357 10/22/2004 IDI-MRSA ASSAY INFECTIO DIAGNOSTIC (I.D.I.) INC. JUDITH SMITH
K042143 10/07/2004 EXCELLA-M SPINAL SYSTEM INNOVASIS, INC. BRENT A FELIX
K042558 10/06/2004 EQUI-FLOW VALVE AND SHUNT SYSTEM INTEGRA NEUROSCIENCES IMPLANTS S.A. JUDITH O'GRADY
K041918 10/15/2004 INTEGRATED PATIENT MONITORING SYSTEM INVIVO RESEARCH, INC. NEIL BATTISTE
K041163 10/07/2004 ISOPURE COMPLETE WATER SYSTEM FOR HEMODIALYSIS, MD 400 AND MD 600 SERIES ISOPURE CORP. KEVIN GILLESPIE
K042706 10/20/2004 OSSATURA DENTAL ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K041755 10/22/2004 CROMAX HIGH SPEED TURBINE HANDPIECE J.R. MEDICAL TECHNOLOGIES, INC. J. HARVEY KNAUSS
K033523 10/21/2004 COLLAGEN-ORC ANTIMICROBIAL MATRIX JOHNSON & JOHNSON MEDICAL, LTD. JOHN D PAULSON
K041353 10/08/2004 FURLONG H-AC TOTAL HIP REPLACEMENT SYSTEM JRI MANUFACTURING LTD E.J. SMITH
K041912 10/25/2004 SCB/VALLEYLAB FORCE FX INTERFACE UNIT KARL STORZ ENDOSCOPY-AMERICA, INC. SUSIE S CHEN
K031728 10/12/2004 KLIMAMED THERMAL BLANKETS, INCLUDING ARM SHOULDER WEST THERMAL BLANKET AND LEG WARMER THERMAL BLANKET KLIMAMED TECHNOLOGIE MEDIZINGERATE GMBH
K042573 10/18/2004 KLS MARTIN DRILL-FREE MMF SCREW KLS-MARTIN L.P. JENNIFER DAMATO
K042560 10/06/2004 STELLAR 404 MONITORING SYSTEM LARSEN & TOUBRO LIMITED HARRY GUGNANI
K042517 10/08/2004 BIOSORB FX AND BIOSORB PDX 1.5 AND 2.0 SCREWS LINVATEC BIOMATERIALS, LTD. TUIJA ANNALA
K041975 10/15/2004 VALIDATE LIPOPROTEIN CALIBRATION VERIFICATION TEST SET, MODEL 501 MAINE STANDARDS CO. CHRISTINE BEACH
K042590 10/14/2004 TRANSDERM IONTO SYSTEM, MK 2 MATTIOLI ENGINEERING CORP. MELISSA MAHALL
K042674 10/19/2004 COLON CAR 1.2 MEDICSIGHT CAROL MACDONALD
K042383 10/20/2004 RSA-CMS MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K041019 10/08/2004 THE FUGO BLADE FOR GLAUCOMA MEDISURG LTD. RICHARD J FUGO
K042764 10/08/2004 MEDLINE STRIDER MIDI 4 MEDLINE INDUSTRIES, INC. MARGARET STEPHENS
K042763 10/07/2004 MODIFICATION TO MEDLINE STRIDER MIDI 3 MEDLINE INDUSTRIES, INC. ANDREA HAFERKAMP
K042465 10/19/2004 PS MEDICAL STRATA II VALVE MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K042524 10/08/2004 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042499 10/07/2004 ORION ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042498 10/07/2004 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042453 10/07/2004 MODIFICATION TO EQUATION FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K042402 10/01/2004 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K042070 10/01/2004 HEPARIN DOSE RESPONSE CARTRIDGE, MODEL 304-20 MEDTRONIC VASCULAR DAWN STENSTROM
K042175 10/18/2004 HEPARINASE HR ACT CONTROL, MODEL 550-12 MEDTRONIC VASCULAR DAWN STENSTROM
K042206 10/18/2004 PURPLE/BLACK HEPARIN ASSAY CONTROL MEDTRONIC VASCULAR DAWN STENSTROM
K031832 10/20/2004 MEGA PURE CART MEGA SERVICES ROBERT OLIVER
K040959 10/29/2004 MENTOR GENESIS PENILE PROSTHESIS MENTOR CORP. DONNA A CRAWFORD
K042627 10/18/2004 EAR THERMOMETER MODELS ST61, ST62, ST63, ST64, AND ST65 MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K042554 10/08/2004 AUTO THERM 390, MODEL ME 390 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K033589 10/04/2004 BAXTER DUPLOTIP SURGICAL SEALANT APPLICATOR MICROMEDICS, INC. CHARLES K GROTE
K041110 10/13/2004 MB 105 MILLENNIUM BLADES MILLENNIUM BIOMEDICAL, INC. JERRY KAENI
K042060 10/06/2004 EASYPASS US Y-CONNECTOR HEMOSTATIC VALVE MILLIMED A/S JUDITH DANIELSON
K042484 10/20/2004 NAI TECH PRODUCTS MEDICAL DIGITAL RECORDER NAI TECHNOLOGY PRODUCTS ROBERT E JOHNSON
K042380 10/25/2004 SILICONE BLOCK NATIONAL MEDICAL DEVICES, INC. JAMES ELIST
K040875 10/15/2004 CAP-ONE, MODEL TG-920P NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K042492 10/19/2004 HAND STC, MODEL 60MM NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K042658 10/20/2004 PROCERA ABUTMENT BRANEMARK, MODELS 10-4001, 10-4004, 10-5001, 10-5004, 10-6001, 10-6004 NOBEL BIOCARE UAS INC ELIZABETH J MASON
K042810 10/28/2004 CENTURION SES EPIKERATOME NORWOOD ABBEY , LTD. PAUL CLARK
K042728 10/22/2004 CAMINO SLIM-LINE INTRACRANIAL MONITORING SYSTEM NOVUS MONITORING LTD JUDITH E GRADY
K042034 10/26/2004 NUVASIVE MAXCESS LIGHT GUIDE NUVASIVE, INC. LAETITIA COUSIN
K042001 10/07/2004 PANORAMIC 200A OPTOS PLC HOWARD M HOLSTEIN
K042031 10/19/2004 OPUS SPEEDSTITCH SUTURE DEVICE OPUS MEDICAL, INC. LAURA N KASPEROWICZ
K042494 10/19/2004 VITROS CHEMISTRY PRODUCTS C3 AND CR REAGENT, CALIBRATOR KIT 20, PROTEIN PERFORMANCE VERIFIERS I, II, AND III ORTHO-CLINICAL DIAGNOSTICS DARLENE J PHILLIPS
K042006 10/28/2004 VITROS CHEMISTRY PRODUCTS DHDL SLIDES, VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 25, VITROS CHEMISTRY PRODUCTS PERFORMACE ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K042305 10/21/2004 OSSAPLAST ORTHO, O.5ML, MODEL# 221 900, OSSAPLAST ORTHO, 1.0ML, MODEL# 221 901, OSSAPLAST ORTHO, 3.0ML, MODEL# 221 903 OSSACUR AG KRISTI KISTNER
K041208 10/01/2004 POWERED WHEELCHAIR, MODEL B-500 OTTO BOCK HEALTH CARE, LP BOB CLARKE
K041210 10/01/2004 POWERED WHEELCHAIR, MODEL B-600 OTTO BOCK HEALTH CARE, LP BOB CLARKE
K041211 10/01/2004 POWERED WHEELCHAIR, MODEL C-1000 OTTO BOCK HEALTH CARE, LP BOB CLARKE
K041068 10/20/2004 WEST NILE VIRUS IGG INDIRECT ELISA PANBIO LIMITED CRAIG BREADMORE
K042331 10/07/2004 PASCO MIC AND MIC/ID PANELS PASCO LABORATORIES, INC. LINDA K DILLON
K042741 10/19/2004 EC-3870CILK, CONFOCAL VIDEO COLONOSCOPE PENTAX MEDICAL COMPANY PAUL SILVA
K042740 10/19/2004 ISC-1000 PENTAX CONFOCAL LASER SYSTEM PENTAX MEDICAL COMPANY PAUL SILVA
K042368 10/04/2004 PRACTIX CONVENIO PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
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