FDA 510(k) Applications Received During December, 2004

FDA 510(k) Number Submission Date Device Name Applicant Contact
K043581 12/28/2004 DUAL LUMEN CATHETER ACMI CORPORATION GRAHAM BAILLIE
K043507 12/20/2004 ACON OXY II ONE STEP OXYCODONE TEST STRIP; TEST DEVICE ACON LABORATORIES, INC. EDWARD TUNG
K043361 12/07/2004 ACCUHEART ELECTRODE BELT ADVANCED BIOELECTRIC CORPORATION MARC-ANDRE COTE
K043353 12/06/2004 OMEGA EXCEL/XP LASER SYSTEM ADVANCED MEDICAL TECHNOLOGIES, INC. M. JOYCE HEINRICH
K043487 12/17/2004 EVIS EXERA COLONOVIDEOSCOPE MODEL XCF-Q160W1L/1 AIZU OLYMPUS CO., LTD. LAURA STORMS-TYLER
K043392 12/10/2004 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. MOIRA BARTON
K043393 12/10/2004 REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. JENN SELVEY
K043358 12/06/2004 REPROCESSED ULTRASONIC SCALPELS ALLIANCE MEDICAL CORP. ELIZABETH RENKEN
K043543 12/20/2004 BLOOD GLUCOSE MONITORING SYSTEM AMERICAN HEALTHCARE INC. EDWARD LETKO
K043512 12/20/2004 EASYGLUCO IGM-0002 G2 AMERICAN HEALTHCARE INC. EDWARD LETKO
K043550 12/23/2004 AMPLIFE UPPER ARM BLOOD PRESSURE MONITOR, MODEL M100 AMPLIFE CORPORATION SUSAN GOLDSTEIN-FALK
K043508 12/20/2004 DERMA PRENE ULTRA POWDER-FREE POLYCHLOROPRENE SYNTHETIC SURGICAL GLOVES (CHEMOTHERAPY USE) ANSELL HEALTHCARE PRODUCTS LLC LON D MCILVAIN
K043350 12/06/2004 MISTAR, MODEL V3.2 APOLLO MEDICAL IMAGING TECHNOLOGY PTY LTD. QING YANG
K043519 12/20/2004 ARIOL HER-2/NEU FISH APPLIED IMAGING CORP. DIANE C DAY
K043337 12/03/2004 ARTHREX BIO-CORKSCREW FT SUTURE ANCHOR ARTHREX, INC. SALLY FOUST
K043422 12/13/2004 ASAHI PTCA GUIDE WIRE, J SHAPE SERIES ASAHI INTECC CO., LTD. YOSHI TERAI
K043579 12/28/2004 ATRICURE BIPOLAR SYSTEM ATRICURE, INC. ELSA C ABRUZZO, RAC
K043582 12/28/2004 OCEAN CHEST DRAIN ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K043554 12/27/2004 ULTRASOUND SCANNER MINI FOCUS, MODEL 1402 B-K MEDICAL A/S VILLY BRAENDER
K043524 12/20/2004 ULTRASOUND SCANNER PRO FOCUS, MODEL 2202 B-K MEDICAL A/S VILLY BRAENDER
K043311 12/01/2004 ASCENSIA ELITE DIABETES CARE SYSTEM BAYER HEALTHCARE, LLC GEORGE M TANCOS
K043556 12/27/2004 SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K043397 12/10/2004 MODIFICATION TO BD ECLIPSE HYPODERMIC NEEDLE BECTON DICKINSON & CO. PASQUALE AMATO
K043458 12/15/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K043389 12/09/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM -AMPICILLIN-SULBACTAM (GN) 0.5/0.25-32/16UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K043423 12/13/2004 MODEL SC-3008 SEQUENTIAL CIRCULATOR BIO COMPRESSION SYSTEMS, INC. RON MOTHERWELL
K043341 12/03/2004 BIOPLEX 2200 ANA SCREEN WITH MEDICAL DECISION SUPPORT SOFTWARE FOR USE WITH BIOPLEX 2200 MULTI-ANALYTE DETECTION SYSTEM BIO-RAD LABORATORIES, INC. CHRISTOPHER BENTSEN
K043584 12/28/2004 LIQUICHEK BNP CONTROL BIO-RAD LABORATORIES, INC. SUZANNE S PARSONS
K043514 12/20/2004 ALLOGRAN-N-BONE VOID FILLER BIOCOMPOSITES LTD. STEPHEN BRATT
K043428 12/13/2004 RELIADENT DENTAL IMPLANT SYSTEM BIOINFERA, INC. CHAN Q WANG
K043371 12/08/2004 BIOMERIX VASCULAR OCCLUSION DEVICE AND LOADER BIOMERIX CORPORATION CHRISTINA L KICHULA
K043547 12/23/2004 COMPRESS SEGMENTAL FEMORAL REPLACEMENT SYSTEM BIOMET, INC. GARY BAKER
K043505 12/20/2004 DISCOVERY-MOSAIC TOTAL HUMERUS SYSTEM BIOMET, INC. GARY BAKER
K043537 12/22/2004 TAPERLOC 12/14 TAPER FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K043598 12/29/2004 FC 1400 FETAL MONITOR BIONET CO., LTD. SUN-YOUNG JEONG
K043597 12/29/2004 FC 700 FETAL MONITOR BIONET CO., LTD. SUN-YOUNG JEONG
K043542 12/23/2004 BIOPRO TARA FEMORAL RESURFACING COMPONENT BIOPRO, INC. DAVID MRAK
K043521 12/20/2004 BIOSYAG 50 MED BIOS S.R.L. ALESSANDRO FRANCHI ONDE
K043548 12/23/2004 BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K043338 12/03/2004 BLAKSTONE LAMINOPLASTY FIXATION SYSTEM BLACKSTONE MEDICAL, INC. DEAN CIPORKIN
K043502 12/20/2004 6 FR POLY PER-Q-CATH TRIPLE LUMEN PICC C.R. BARD, INC. LYNN M KIRCHOFF
K043518 12/20/2004 RADIOPAQUE BONE CEMENT Cardinal Health SHARON NICHOLS
K043590 12/28/2004 SE INFUSION SYSTEM WITH MMS CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K043575 12/27/2004 DERMILLUME, MODEL PRO1000 CARE ELECTRONICS, INC. THOMAS MOODY
K043580 12/28/2004 ALLIGATOR RETRIEVAL DEVICE (ARD) CHESTNUT MEDICAL TECHNOLOGIES, INC. ANNA LONGWELL
K043558 12/27/2004 XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD. GEORGE SU
K043570 12/27/2004 UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD CONFORMIS, INC. LYNDALL ERB
K043418 12/13/2004 COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH COOK UROLOGICAL, INC. CINDY RUMPLE
K043509 12/20/2004 GUNTHER TULIP VENA CAVA FILTER SET COOK, INC. EARL E KNIGHT III
K043481 12/15/2004 MODIFICATION TO: ZILVER 635 BILIARY STENT COOK, INC. LELAND KEYT
K043605 12/30/2004 INSCOPE 3-STAGE BALLOON DILATOR CORDIS EUROPA, N.V. HARM HOVINGA
K043538 12/22/2004 HYPERTRANSIT INFUSION CATHETER CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K043522 12/20/2004 ISSYS PEDICLE SCREW SYSTEM CUSTOM SPINE, INC. DEBBIE IAMPIETRO
K043326 12/02/2004 BEWELL, MODEL SC 20 CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN LAN
K043332 12/02/2004 WHEELCHAIR, MODEL 8500-II CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER ZEN-JYE CHEN
K043429 12/13/2004 CYNERGY LASER CYNOSURE, INC. GEORGE CHO
K043546 12/23/2004 DIMENSION RXL MAX WITH STREAMLAB ANALYTICAL WORKCELL AND SAMPLE TRANSFER MODULE DADE BEHRING, INC. STANLEY GORAK
K043545 12/23/2004 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH DAPTOMYCIN (0.03 - 16 MCG/ML) DADE BEHRING, INC. CYNTHIA VAN DUKER
K043476 12/16/2004 STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, PBNP CALPAK CALIBRATOR, PBNP DILPAK DILUENT DADE BEHRING, INC. GEORGE M PLUMMER
K043589 12/28/2004 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM DADE MICROSCAN, INC. CYNTHIA VAN DUKER
K043572 12/27/2004 COMPATIBILITY ECG TRUNK CABLES DATEX-OHMEDA JOEL C KENT
K043551 12/23/2004 DATEX-OHMEDA S/5 PSM MODULE, (CONSISTING OF E-PSM AND E-PSMP MODULES) AND ACCESSORIES DATEX-OHMEDA JOEL KENT
K043539 12/22/2004 DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES DEMETECH CORP. ARTHUR WARD
K043330 12/02/2004 POLYPROPILENE SURGICAL SUTURES DEMETECH CORP. ARTHUR WARD
K043308 12/01/2004 MODIFICATION TO: HEALOS BONE GRAFT MATERIAL DEPUY SPINE, INC. SHARON STAROWICZ
K043406 12/10/2004 VERTEBROPLASTIC RADIOPAQUE BONE CEMENT DEPUY SPINE,INC SHARON STAROWICZ
K043530 12/21/2004 DVI CURING LIGHT DESIGNS FOR VISION, INC. MARY MCNAMARA-CULLINANE
K043344 12/06/2004 DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM DIALYSIS SERVICES, INC. MIKE STERLING
K043323 12/02/2004 D 905 EOS HOLLOW FIBER OXYGENATOR WITH INTEGRATED HARDSHELL VENOUS/CARDIOTOMY RESERVOIR DIDECO S.R.L. BARRY SALL
K043491 12/17/2004 ENFANTTM DIOPSYS INC. JOSEPH FONTANETTA
K043409 12/10/2004 ACCUCHANGER DIREX SYSTEMS CORP. LARISA GERSTEIN
K043328 12/02/2004 MICROFLO-SAFE SCALP VEIN SET DKS LOVERSAN INDUSTRIA BIOMEDICA SPA ARTHUR WARD
K043461 12/15/2004 CUSTODIOL DR. FRANZ KOHLER CHEMIE GMBH T. WHIT ATHEY
K043549 12/23/2004 INFINITY GATEWAY SUITE, VF4 Draeger Medical Systems, Inc. PENELOPE H GRECO
K043439 12/14/2004 INFINITY MODULAR MONITORS WITH VF5 MODIFICATIONS (DELTA/KAPPA/DELTA XL/VISTA XL/GAMMA X XL AND SC 7000/8000/9000XL Draeger Medical Systems, Inc. PENELOPE H GRECO
K043378 12/08/2004 DREW SCIENTIFIC LTD. GLYCATED HAEMOGLOBIN TWO LEVEL CALIBRATOR KIT DREW SCIENTIFIC LTD. DIANE HILL
K043309 12/01/2004 GEODESIC PHOTOGRAMMETRY SYSTEM ELECTRICAL GEODESICS, INCORPORATED LINDA J BOVARD
K043520 12/20/2004 EMG CTA01-XXX SERIES PURO OXYGEN CONCENTRATOR EMG TECHNOLOGY CO., LTD. LEONARD FRIER
K043446 12/14/2004 EMMEBI CENTRAL VENOUS CATHETER KIT WITH LESTEP SAFETY INTRODUCER EMMEBI SRL MARJORIE BUSH
K043489 12/17/2004 ENPATH DEFLECTABLE CATHETER ENPATH MEDICAL INCORPORATED KARYL D HASKELL
K043463 12/15/2004 ENVITEC REUSABLE MULTI-SITE Y SPO2 SENSORS ENVITEC-WISMAR GMBH STEPHEN GORSKI
K043467 12/15/2004 FLEXIBLE SPINAL NEEDLE EPIMED INTERNATIONAL, INC. CHRISTOPHER LAKE
K043403 12/10/2004 CEMEX SYSTEM GENTA FAST BONE CEMENT EXACTECH, INC. Lisa Simpson
K043527 12/21/2004 RELIEVA SINUS BALLOON DILATION CATHETER EXPLORAMED NC1, INC. WILLIAM M FACTEAU
K043553 12/27/2004 SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550,04800, 05200, 02406, 04706, 04300 FOX HOLLOW TECHNOLOGIES MELISSA MURPHY
K043363 12/07/2004 FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K043407 12/10/2004 INF 4160, MODEL D-FJ27F FUJI DYNAMICS LIMITED ANTHONY AH YIN SHUM
K043525 12/21/2004 CATHETER INTRODUCER GALT MEDICAL CORP. DAVID CATLIN
K043342 12/06/2004 POLYFLUX FAMILY HEMODIALYZER/FILTER LABELED FOR SINGLE AND MULTIPLE USE, MODELS 14L, 17L, 21L, 140H, 170H, 210H,6LR, 8LR GAMBRO RENAL PRODUCTS KAE MILLER
K043471 12/16/2004 FUSION FAST GC AMERICA, INC. TERRY L JORITZ
K043493 12/17/2004 FUSION PUTTY TYPE GC AMERICA, INC. TERRY JORITZ
K043381 12/09/2004 INFINIA LIGHTSPEED GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K043415 12/13/2004 CENTRICITY PACS SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES CAROL ALLOIAN
K043346 12/06/2004 GENESIS TOTAL SHOULDER REPLACEMENT, MODEL 100-01-00 GENESIS MEDICAL L.L.C. PERRY GEREMAKIS
K043385 12/09/2004 OSOM HCG COMBO TEST GENZYME DIAGNOSTICS E.V. GOORCHENKO
K043352 12/06/2004 GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR GOCANNING TECHNOLOGY LTD. JENNIFER REICH
K043444 12/14/2004 MULTIPLE, MODEL KTJ-50 GOLDEN HORSE MEDICAL EQUIPMENT (WUXI) CO. LTD. GEORGE SU
K043443 12/14/2004 ONE STEP HCG URINE PREGNANCY TEST Guangzhou Wondfo Biotech Co., Ltd. HOWARD MANN
K043480 12/16/2004 ENHANCE CLITORAL STIMULATION AID GYNAVATIONS, INC. DAVID GLOTH
K043322 12/02/2004 MIRAMATIC SAFE SYRINGE SYSTEM HAGER WORLDWIDE, INC. JAMES DELANEY
K043437 12/13/2004 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168ET HEALTH & LIFE CO., LTD. PAUL HUNG
K043414 12/13/2004 HL 188 & HL 189 BODY FAT METER HEALTH & LIFE CO., LTD. JENNIFER REICH
K043504 12/20/2004 PALAIMPACT HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K043376 12/08/2004 HOME HEALTH POWER WHEELCHAIR, MODEL HC-200TR HOME HEALTH TECHNOLOGY CO., LTD. Ke-Min Jen
K043374 12/08/2004 DURACON CONVERSION AND X-SMALL SYMMETRIC PATELLA WITH PERI-APATITE COATING HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K043431 12/13/2004 GAMMA3 NAIL SYSTEM HOWMEDICA OSTEONICS CORP. JENNIFER KOSOY
K043404 12/10/2004 MODIFICATION TO T2 PROXIMAL HUMERAL NAIL HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K043331 12/02/2004 DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 HUBDIC CO., LTD GUENTER GINSBERG
K043433 12/13/2004 AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA HYCOR BIOMEDICAL LTD. DANIELLE M KNIGHT
K043451 12/14/2004 BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR HYPHEN BIOMED OLA ANDERSON
K043456 12/15/2004 MODIFICATION TO SOAKER CATHETER I-FLOW CORP. SHANE NOEHRE
K043410 12/10/2004 EPIPHYSIS SCREW I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K043336 12/03/2004 OPTISTRAND, MODEL 1032S IBT SA RUTH FEICHT
K043412 12/10/2004 MODIFICATION TO: VIEWSTATION IMPAC MEDICAL SYSTEMS, INC. THOMAS H FARIS
K043500 12/20/2004 FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE INNOSPINE, INC. LARAINE PANGELINA
K043612 12/30/2004 ORTHOPANTOMOGRAPH OP200, OP200D, AND ORTHOCEPH OC200, OC200D INSTRUMENTARIUM CORP. IMAGING DIVISION MARK MASON
K043459 12/15/2004 HEMOSIL FACTOR XII DEFICIENT PLASMA INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K043427 12/13/2004 DURAGEN II DURAL REGENERATION MATRIX INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K043354 12/06/2004 MODULAR TELEMETRY SYSTEM FOR THE VISION TELEPAK, MODEL 20701 INVIVO RESEARCH, INC. NEIL BATTISTE
K043573 12/27/2004 DYNAGRAFT II DENTAL ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K043497 12/17/2004 AIR SOLFY, MODELS AS-4H, AS-4H-O, AS-4H-V, AS-4H-OV, AS-1,AS-1-0,AS-1-V, AS-1-OV J. MORITA USA, INC. KEITH A BARRITT
K043496 12/17/2004 SPACELINE EMCIA, MODEL CU580 J. MORITA USA, INC. KEITH A BARRITT
K043498 12/17/2004 TWIN POWER TURBINE HIGH SPEED AIR TURBINE DENTAL HANDPIECE J. MORITA USA, INC. KEITH A BARRITT
K043468 12/16/2004 WILLI GELLER CREATION II PORCELAIN JENSEN INT'L, INC. GARY PHELPS
K043531 12/21/2004 MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 K-JUMP HEALTH CO., LTD. DANIEL TSENG
K043375 12/08/2004 FISCH TITANIUM MIDDLE EAR PROSTHESES KARL STORZ ENDOSCOPY YVONNE FERNANDEZ
K043324 12/02/2004 AIDA WITH DICOM AND HL7 INTERFACE KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K043591 12/28/2004 FEATHERLIFT EXTENDED APTOS THREAD KMI KOLSTER METHODS, INC. KEITH DAVIS
K043367 12/08/2004 GLAID OCULAR ELECTROPHYSIOLOGY DEVICE LACE ELECTRONICA S.R.L. IAN P GORDON
K043314 12/01/2004 MANZI CLEANER SYSTEM LANGFORD IC SYSTEMS, INC. TERRY LANGFORD
K043484 12/17/2004 LANX SPINAL FIXATION SYSTEM LANX, LLC DAVID W SCHLERF
K043370 12/08/2004 PLANET 50 MONITORING SYSTEM LARSEN & TOUBRO LIMITED E.J. Smith
K043347 12/06/2004 BF+ LDR SPINE USA BRIAN BURKINSHAW
K043479 12/16/2004 MC+ PARTIAL VBR LDR SPINE USA BRIAN BURKINSHAW
K043349 12/06/2004 OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) LDR SPINE USA BRAIN BURKINSHAW
K043357 12/06/2004 TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 LINDE MEDICAL SENSORS AG JEAN-PIERRE PALMA
K043534 12/22/2004 MODIFICATION TO OUTBACK CATHETER LUMEND, INC. MICHAEL A DANIEL
K043506 12/20/2004 ACUPUNCTURE NEEDLES MARKNEW PRODUCTS GREG HOLLAND
K043494 12/17/2004 MASTEL LASER CLEAN ROOM, MODEL EBS-100 MASTEL PRECISION SURGICAL INSTRUMENTS, INC. MERLE GOERINGER
K043544 12/23/2004 MEDELA DOMINANT 35 C/I SECRETION AND SURGICAL ASPIRATOR MEDELA AG WERNER FREI
K043614 12/30/2004 VACULINK, MODEL VCL 3000 MEDEVCO, INC. KRISTA OAKES
K043419 12/13/2004 P&P SAFETY SYRINGE MEDEXEL MEDICAL MFG. CO., LTD. DANIEL KAMM
K043523 12/20/2004 INTERV BRAND SNARELOK BONE MARROW BIOPSY NEEDLE MEDICAL DEVICE TECHNOLOGIES, INC. NICOHL WILDING
K043454 12/15/2004 CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 MEDICOMP, INC. SUSAN D GOLDSTEIN-FALK
K043472 12/16/2004 MEDIN TECH ZIRCONIA-CP10, SS1000 MEDIN TECH ABDESLAM KASSEH
K043455 12/15/2004 SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. CARL ALLETTO
K043585 12/28/2004 MEDLINE SURGICAL GOWNS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K043600 12/29/2004 MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C MEDTRONIC MINIMED GERDA P RESCH
K043568 12/27/2004 EQUESTRA FLUID DELIVERY SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K043488 12/17/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K043561 12/27/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD A TREHARNE
K043566 12/27/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K043321 12/02/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K043343 12/06/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K043602 12/29/2004 QUADRANT RETRACTOR SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K043564 12/27/2004 HORIZON ANGIO CATHLAB MENNEN MEDICAL LTD. MICHA OESTEREICH
K043586 12/28/2004 LASER SYS*STIM 540, MODEL ME 540 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K043528 12/21/2004 SPIROTEL MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K043380 12/08/2004 MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 MONEBO TECHNOLOGIES, INC. DALE J MISCZYNSKI
K043398 12/10/2004 MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE NEO METRICS, INC. GENE CHAMPEAU
K043373 12/08/2004 DOLOTENS DENTAL TM 1 NEUROMUSCULAR TECHNOLOGIES, INC. MARIE JENSEN
K043517 12/20/2004 TRANSMITTER, ZS-940PA SERIES NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K043312 12/01/2004 NOBELRONDO DENTAL CERAMIC - ZIRCONIA NOBEL BIOCARE USA, LLC ELIZABETH J MASON
K043526 12/21/2004 SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. PATRICIA DAVIDSON
K043359 12/06/2004 4100 PATIENT OXIMETER MODULE NONIN MEDICAL, INC. JOHN R DALPEE
K043462 12/15/2004 CZR PRESS LF NORITAKE CO., INC. IVAN J WASSERMAN
K043319 12/02/2004 CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES NOVALIS MEDICAL, LLC ANTHONY DAVIS
K043541 12/22/2004 ENDOLINK TRUE MOVEMENT SYSTEM NOVARE SURGICAL SYSTEMS, INC. GREGORY MATHISON
K043405 12/10/2004 NUVASIVE COROENT SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K043436 12/13/2004 NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 NXSTAGE MEDICAL, INC. NORMA LEMAY
K043460 12/15/2004 OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071 OLYMPUS AMERICA, INC. BEV HARDING
K043384 12/09/2004 VITROS CHEMISTRY PRODUCTS TOBRA REAGENT, CALIBRATOR KIT 14 AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. CAREY A MAYO
K043386 12/09/2004 VITROS CHEMISTRY PRODUCTS VANC REAGENT, CALIBRATOR KIT 11 AND TDM PERFORMANCE VERIFIERS I, II AND III Ortho-Clinical Diagnostics, Inc. CAREY A MAYO
K043536 12/22/2004 NAVITRACK SYSTEM - S&N IMAGE FREE KNEE ORTHOSOFT, INC. CHRISTOPHER MCLEAN
K043434 12/13/2004 OSTEOMED PEDIATRIC INTRAORAL MANDIBULAR DISTRACTION SYSTEM OSTEOMED L.P. DAWN T HOLDEMAN
K043615 12/30/2004 OXYTEC, MODEL 900 OXYTEC MEDICAL CORPORATION PAUL E DRYDEN
K043557 12/27/2004 MODEL PC-1000 PANORAMIC/CEPHALOMETRIC X-RAY SYSTEMS PANORAMIC CORP. DANIEL KAMM
K043587 12/28/2004 SUCRALFATE AND CARAFATE PASTE KITS PATRICK D. MCGRATH PH.D PATRICK D MCGRATH
K043388 12/09/2004 PEGASUS BIOLOGICS ORTHADAPT SURGICAL MESH PEGASUS BIOLOGICS, INC. MUIR S MEINHOLD
K043599 12/29/2004 MOMENTS MENOPAUSE CHECK, MODEL 9113 PHAMATECH INC. CARL A MONGIOVI
K043535 12/22/2004 HD11 DIAGNOSTIC ULTRASOUND SYSTEM PHILIPS ULTRASOUND, INC. STEVE SINGLAR
K043317 12/02/2004 OMNILUX PLUS PHOTO THERAPEUTICS LIMITED STEVEN G HUTSON
K043329 12/02/2004 OMNILUX REVIVE AND BLUE PHOTO THERAPEUTICS LIMITED STEVE G HUTSON
K043383 12/09/2004 N-DO ENDOINJECTOR NEEDLE, MODEL PH00961109 AND PH00961110 PHYSION, INC. ERIC J NEMETH, ESQ.
K043360 12/07/2004 IMT.LAB PIE MEDICAL CARRI GRAHAM
K043588 12/28/2004 MYLAB 15 / MYLAB 20, MODEL 2700 PIE MEDICAL CARRI GRAHAM
K043408 12/10/2004 PIEZOSURGERY DEVICE PIEZOSURGERY SRL Maria E Donawa
K043571 12/27/2004 CRYOCHECK CLOT S PRECISION BIOLOGIC INC. STEPHEN L DUFF
K043613 12/30/2004 Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II QUANTEL MEDICAL ROGER W BARNES
K043421 12/13/2004 OPTEFORM, OSTEOFIL, RTI ALLOGRAFT PASTE IC, RTI ALLOGRAFT STRIP IC REGENERATION TECHNOLOGIES, INC. CARRIE HARTILL
K043420 12/13/2004 OSTEOFIL, OPTEFIL, REGENAFIL, RTI ALLOGRAFT PASTE REGENERATION TECHNOLOGIES, INC. CARRIE HARTILL
K043574 12/27/2004 ALLIENT SORBENT HEMODIALYSIS SYSTEM, MODEL 1000 RENAL SOLUTIONS, INC. RICHARD CONFER
K043411 12/10/2004 RESOFIX BIOABSORBABLE EXPANSION BOLT RESOFIX, INC. CARL KNOBLOCH
K043607 12/30/2004 BIPAP PRO 2 BI-LEVEL SYSTEM WITH BI-FLEX RESPIRONICS, INC. ZITA A YURKO
K043529 12/21/2004 ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE ROCHE DIAGNOSTICS CORP. Scott Thiel
K043474 12/16/2004 ACCU-CHEK AVIVA SYSTEM ROCHE DIAGNOSTICS CORP. Scott Thiel
K043320 12/02/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K043318 12/02/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K043327 12/02/2004 ONLINE DAT BENZODIAZEPINES PLUS ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
DEN040011 12/20/2004 AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC. JAMES F KELLY
K043576 12/27/2004 ROCHE AMPLICHIP CYP450 TEST ROCHE MOLECULAR SYSTEMS, INC. JAMES F KELLY
K043325 12/02/2004 ZOOMCAM LD-10 INTRAORAL CAMERA AND ACCESSORIES ROLENCE ENTEPRISE, INC. STERLING CHENG
K043369 12/08/2004 CERVEX-BRUSH COMBI ROVERS MEDICAL DEVICES B.V. IR. M.D. ZWART
K043441 12/14/2004 MIRAGE, RELEASE 5.5 SEGAMI CORPORATION PHILIPPE BRIANDET
K043425 12/13/2004 SHEATHES NEEDLE GUIDE, MODEL NG-SR-A-484-KIT (THERE WILL BE VARIOUS MODEL NUMBERS BASED ON TRANSDUCER AND COVER) SHEATHING TECHNOLOGIES, INC. LARRY POLAYES
K043563 12/27/2004 DP-9900 DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K043348 12/06/2004 MODIFICATION TO PM-8000 PATIENT MONITOR SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K043499 12/17/2004 POWDER FREE SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. EMMY TJOENG
K043478 12/16/2004 POWDERED YELLOW SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. EMMY TJOENG
K043475 12/16/2004 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) SHIJIAZHUANG WINFUL PLASTIC CO., LTD. CHEN YUHONG
K043477 12/16/2004 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) SHIJIAZHUANG WINFUL PLASTIC CO., LTD. CHEN YUHONG
K043379 12/08/2004 SHIMADZU SURGICAL MOBILE C-ARM IMAGING X-RAY SYSTEM, MODEL WHA-200 SHIMADZU CORP. RANDAL WALKER
K043469 12/16/2004 SYNGO INSPACE 4D SIEMENS AG, MEDICAL SOLUTIONS RUEDIGER KOERNER
K043316 12/02/2004 RABEA SPINAL IMPLANT SIGNUS MEDIZINTECHNIK GMBH TRACY L GRAY
K043355 12/06/2004 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X SINTEA BIOTECH, INC. GUIDO ZORZOLI
K043306 12/01/2004 SKYLARK INFRARED PHOTON STIMULATOR, MODELS, SD-956IR AND SD-100IR SKYLARK DEVICE & SYSTEMS CO., LTD BETTY CHIEN
K043395 12/10/2004 SMITH & NEPHEW VIDEOARTHROSCOPE SMITH & NEPHEW, INC. KATHLEEN BURNS
K043440 12/14/2004 SMITH & NEPHEW, INC. REVISION KNEE SYSTEM SMITH & NEPHEW, INC. GINO ROUSS
K043495 12/17/2004 BABYPAC SMITHS MEDICAL INTERNATIONAL LTD., LUTON DONALD ALEXANDER
K043483 12/17/2004 RADIN, MODEL V 3.0 SOHARD AG RALPH LOOS
K043578 12/28/2004 THE 4CIS SPINAL SYSTEM AND 4CIS LOW BACK SYSTEM SOLCO BIOMEDICAL CO., LTD. SAEYOUNG AHN
K043511 12/20/2004 SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 SOLEUS CHAMP INTERNATIONAL CO., LTD. Ke-Min Jen
K043559 12/27/2004 SONOSITE HIGH-RESOLUTION DIAGNOSTIC ULTRASOUND SYSTEM (C3 SERIES) SONOSITE,INC. DAINA L GRAHAM
K043452 12/15/2004 TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM SONOSITE,INC. DAINA L GRAHAM
K043307 12/01/2004 CRANEX D SOREDEX PALODEX GROUP OY KAI LANER
K043465 12/15/2004 2.5 MM TURBO CLIRPATH EXCIMER LASER CATHETER, MODEL 225-011 SPECTRANETICS CORP. ADRIAN E ELFE
K043401 12/10/2004 SPECTRANETICS LLD CS, MODEL 518-039 SPECTRANETICS CORP. MICHAEL J RYAN
K043457 12/15/2004 MODIFICATION TO ENDOVASCULAR GUIDE WIRE STEREOTAXIS, INC. GARY RAUVOLA
K043592 12/29/2004 REPROCESSED ENDOSCOPIC TROCAR STERILMED, INC. BRUCE R LESTER
K043453 12/15/2004 STERILEMED REPROCESSED IVUS IMAGING CATHETER STERILMED, INC. BRUCE LESTER
K043513 12/20/2004 STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER STERILMED, INC. BRUCE R LESTER
K043482 12/17/2004 THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 STERIS Corporation MARGARET MARSH
K043334 12/03/2004 BONE SOURCE HAC RAPID SETTING CEMENT STRYKER INSTRUMENTS WADE T RUTKOSKIE
K043466 12/15/2004 PAINPUMP2 STRYKER INSTRUMENTS JENNIFER MARS
K043442 12/14/2004 STRYKER RF COAXIAL BIPOLAR ELECTRODES & CANNULAE STRYKER INSTRUMENTS JEAN SHEPPARD
K043473 12/16/2004 MODIFICATION TO XIA SPINAL SYSTEM STRYKER SPINE SIMONA VOIC
K043435 12/13/2004 QUICKIE INTERCHANGE FWD W/LIFT POWER WHEELCHAIR SUNRISE MEDICAL JOSEPH E OLSAVSKY
K043533 12/22/2004 SURGICAL DESIGN CIRCUMCISION CLAMP SURGICAL DESIGN, INC. MOHAMMAD BASHIR
K043310 12/01/2004 SYNTHES (USA) ELECTRIC PEN DRIVE SYSTEM SYNTHES (USA) LISA M BOYLE
K043555 12/27/2004 SYNTHES 9USA) ALVEOLAR RIDGE DISTRACTOR SYNTHES (USA) KATHY ANDERSON
K043593 12/29/2004 SPINE-FIX BIOMIMETIC BONE CEMENT TEKNIMED SA J. D. WEBB
K043596 12/29/2004 THERALOAD CUSTOM LOADED NEEDLES, MODELS 200 AND 125.S06 THERAGENICS CORP. BETSY CORTELLONI
K043402 12/10/2004 THERMAGE THERMACOOL SYSTEM THERMAGE, INC. PAMELA M BUCKMAN
K043438 12/14/2004 LARGE BORE SPLITTABLE INTRODUCER KIT THOMAS MEDICAL PRODUCTS, INC. TIM STOUDT
K043382 12/09/2004 TMS FULL ADVANTAGE FULL FACE MASK, MODELS TMS-2820, TMS-2830, TMS-2840 TIARA MEDICAL SYSTEMS, INC. GEOFFREY SLEEPER
K043366 12/08/2004 PERMACOL SURGICAL IMPLANT TISSUE SCIENCE LABORATORIES, PLC VICTORIA TAYLOR
K043486 12/17/2004 PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 TOPCON MEDICAL LASER SYSTEMS, INC JOHN JOSSY
K043430 12/13/2004 20.8-INCH (53 CM) COLOR LCD MONITOR, MODELS CDL2114A AND DV3MC-HB TOTOKU ELECTRIC CO., LTD MIKIO HASEGAWA
K043351 12/06/2004 4.5MM BONE-LOK FACET SCREW, MODELS TFCD-45-3040S OR N; SFCD-45-3040S OR N TRIAGE MEDICAL INC GAYLE HIROTA
K043377 12/08/2004 ZENO TYRELL, INC. DARLA J ELKIN
K043594 12/29/2004 VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K043315 12/01/2004 VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K043387 12/09/2004 VASCON POLARIS GUIDING CATHETER VASCON LLC STEPHEN F VADAS
K043552 12/27/2004 VASCUTEK PTFE SUPPORTED EPTFE VASCULAR PROSTHESES VASCUTEK LTD. STEVEN ARICK
K043562 12/27/2004 BC PLUS VERICOM CO., LTD. MYUNG-HWAN OH
K043515 12/20/2004 GRAFTSAVER VESCARE, INC. DAVID WALSH
K043490 12/17/2004 PD-IO DISPOSABLE INTRAOSSEOUS INFUSION NEEDLE VIDACARE CORPORATION GREG HOLLAND
K043340 12/03/2004 EZ SMART VIP DIAGNOSTICS LLC DAVID L ROSEN
K043368 12/08/2004 VITELCARE TURTLE, MODEL 400 VISUAL TELECOMMUNICATIONS NETWORK, INC. ALLEN IZADPANAH
K043503 12/20/2004 VISX CUSTOMVUE SLIT ILLUMINATOR WITH DESKTOP CHARGER, MODEL CV SI-1 VISX, INCORPORATED ALAN F RUSSELL
K043333 12/03/2004 VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM VITAL IMAGES, INC. TIMOTHY J KAPPERS
K043604 12/29/2004 LIFESHIRT REAL-TIME WITH VIVOMONITOR SOFTWARE VIVOMETRICS, INC. HOWARD M HOLSTEIN
K043396 12/10/2004 INTEGRITY, MODEL V500 VIVOSONIC, INC. EDWARD GOSS
K043540 12/22/2004 HORIZON 59 OASIS (HIOXIFILCON A) DAILY WEAR CONTACT LENSES WESTCON CONTACT LENS CO., INC. CAROL NOBLE
K043583 12/28/2004 CHARLOTTE SNAP-OFF SCREW, MODELS 45110001, 45110002, 45110003 WRIGHT MEDICAL TECHNOLOGY, INC. WESLEY L REED
K043339 12/03/2004 REFIX PIN (PLLA), MODELS 2070L, 2770L, 3570L, 4570L; (PLGA), MODELS 2070LG, 2770LG, 3570LG, 4570LG XTREMI-T, LLC SHAWN T HUXEL
K043356 12/06/2004 WAGNER SL REVISION STEM LATERAL ZIMMER AUSTIN, INC. AUDREY SWEARINGTON
K043565 12/27/2004 MODIFICATION TO DYNESYS SPINAL SYSTEM ZIMMER SPINE, INC TIM CRABTREE
K043560 12/27/2004 PERIARTICULAR LOCKING PLATES AND SCREWS, SERIES 2358 AND 2359 ZIMMER, INC. LAURA D WILLIAMS


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact