FDA 510(k) Decisions During December, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
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
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
K032830 12/14/2004 PLLA CANNULATED INTERFERENCE SCREW ADVANCED BIOMATERIALS STEVE 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
K042279 12/23/2004 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM AFFYMETRIX, INC. ROBERT LIPSHUTZ
DEN040012 12/23/2004 AFFYMETRIX GENECHIP MICROARRAY INSTRUMENTATION SYSTEM Affymetrix, Inc. ROBERT LIPSHUTZ
K043085 12/20/2004 MODIFICATION TO: PNEUTON VENTILATOR AIRON CORPORATION ERIC GJERDE
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
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
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
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
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
K043241 12/23/2004 LOFRIC HYDRO-KIT II SINGLE USE URINARY CATHETER ASTRA TECH, INC. BRUCE MANNING
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
K042221 12/30/2004 CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
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
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
K042932 12/02/2004 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-PIPERACILLIN-TAZOBACTAM 0.5/4-128/4 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
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
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
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.
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
K042552 12/14/2004 BIO-CORE INTERFERENCE SCREW BIOMET, INC. SUSAN ALEXANDER
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
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
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
K043193 12/07/2004 BARD INLAYOPTIMA URETERAL STENT WITH SUTURE C.R. BARD, INC. FRANCES E HARRISON
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
K042548 12/03/2004 CERASYS - ZR CERASYS, INC. JIN KIM
K041038 12/21/2004 CHURCHILL MEDICAL DUAL CHAMBER EMPTY CONTAINER CHURCHILL MEDICAL SYSTEMS, INC. KEITH PALUCH
K040888 12/01/2004 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE 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
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
K043332 12/13/2004 WHEELCHAIR, MODEL 8500-II CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER ZEN-JYE CHEN
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
K042687 12/10/2004 ENZYGNOST F+2 (MONOCLONAL) TEST KIT DADE BEHRING, INC. DONNA WOLF
K043276 12/23/2004 DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE DATEX-OHMEDA JOEL KENT
K042931 12/08/2004 TUF LINK SILICONE RELINER DENTATUS USA, LTD. THOMAS MURPHY
K043247 12/22/2004 DUCERA ALLCERAM DENTSPLY INTL. HELEN LEWIS
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
K042664 12/08/2004 LPS UPPER EXTREMITY DEPUY, INC. TIFFANI D ROGERS
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
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
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
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
K042675 12/06/2004 FLEXI-STAT SP02 EAR SENSOR ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K042349 12/16/2004 EMG MODEL SUA01 SUCTION UNIT EMG TECHNOLOGY CO., LTD. LEONARD FRIER
K042057 12/17/2004 INFINITY ELECTROTHERAPY SYSTEM EMPI MARY MCNAMARA-CULLINANE
K042777 12/01/2004 HARMONIC ACE CURVED SHEARS WITH HAND CONTROL, MODEL ACE23P, ACE36P ETHICON ENDO-SURGERY, INC. KIMBERLY SHOEMAKER
K042603 12/22/2004 GYNECARE PROLENE FASTENER SYSTEM ETHICON, INC. SEAN O'BRYAN
K043243 12/09/2004 PRIMUS STENT AND DELIVERY SYSTEM EV3 INC GLEN D SMYTHE
K043403 12/28/2004 CEMEX SYSTEM GENTA FAST BONE CEMENT EXACTECH, INC. Lisa Simpson
K041757 12/23/2004 FEMSPEC DISPOSABLE VAGINAL SPECULUM FEMSPEC L.L.C. GERALD JAY SANDERS
K043244 12/20/2004 FRESENIUS OPTIFLUX F20NR, FF18NR, F16NR FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K042732 12/22/2004 ARCHITECT CA 15-3 ASSAY FUJIREBIO DIAGNOSTICS, INC. KIMBERLY PETERSON
K042148 12/03/2004 HEART RATE TURBULENCE ANALYSIS TECHNOLOGIES GE MEDICAL SYST. INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K043381 12/23/2004 INFINIA LIGHTSPEED GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K043076 12/22/2004 GE OEC FLUOROSTAR GE OEC MEDICAL SYSTEMS, INC. JEFF WAGNER
K040973 12/27/2004 BUN REAGENT GENCHEM, INC. C.C. ALLAIN
K040972 12/27/2004 CALCIUM, AZO DYE REAGENT GENCHEM, INC. C.C. ALLAIN
K040975 12/27/2004 GENCHEM CO2 ACID REAGENT GENCHEM, INC. C.C. ALLAIN
K040976 12/27/2004 GENCHEM CREATININE REAGENT GENCHEM, INC. C.C. ALLAIN
K040977 12/27/2004 GENCHEM ELECTROLYTE BUFFER GENCHEM, INC. C.C. ALLAIN
K040971 12/22/2004 GENCHEM ISE ELECTROLYTE REFERENCE GENCHEM, INC. C.C. ALLAIN
K040974 12/27/2004 GLUCOSE OXIDASE, GLUCOSE GENCHEM, INC. C.C. ALLAIN
K042427 12/03/2004 GENESTONE EXEL (XL) EXTRACORPOREAL SHOCK WAVE LITHOTRIPTER GENEMED, INC. DAVID BALZER
K043098 12/15/2004 GERBER DOUBLE ELECTRIC BREAST PUMP GERBER PRODUCTS CO. RANGA RANGANATHAN
K042322 12/07/2004 STERICHEK BLOOD LEAK REAGENT STRIPS HACH COMPANY DAVID A MORRIS, PH.D.
K042860 12/03/2004 CORRECT DENTAL IMPRESSION MATERIAL HANDAE CHEMICAL CO., LTD. JAE HO YU
K041693 12/02/2004 WRIST DIGITAL BLOOD PRESSURE MONITOR (DIGITAL SPHYGMOMANOMETER), MW-300 SERIES HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., JI BO
K043186 12/06/2004 H & L (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888EM HEALTH & LIFE CO., LTD. PAUL HUNG
K042878 12/17/2004 FLEXITIME XTREME HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K030052 12/06/2004 OSTIM HERAEUS KULZER, INC. CHERYL V ZIMMERMAN
K043239 12/22/2004 HEALTHSTAR ELITE HILL LABORATORIES CO. HOWARD A HILL
K043256 12/06/2004 HOSPIRA LIFECARE INFUSION SYSTEM, MODEL 12384-04-07; LIFECARE PCA INFUSION SYSTEM STERILE EMPY VIALS, MODEL 6021-04-03 HOSPIRA, INC. PATRICIA MELERSKI
K043069 12/03/2004 HOVEROUND E100 POWER CHAIR HOVEROUND CORP. TONY DIGIOVANNI
K042920 12/03/2004 HOVEROUND SE-3 POWERCHAIR HOVEROUND CORP. TONY DIGIOVANNI
K043404 12/27/2004 MODIFICATION TO T2 PROXIMAL HUMERAL NAIL HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K041078 12/23/2004 SURGPLAN AND PANPLAN IMAGING SCIENCES INTL., INC. EDWARD J MARANDOLA
K042519 12/01/2004 GAMMA-B 1,25-DIHYDROXY VITAMIN D IMMUNODIAGNOSTIC SYSTEMS LTD. PAUL PUNTIN
K043412 12/20/2004 MODIFICATION TO: VIEWSTATION IMPAC MEDICAL SYSTEMS, INC. THOMAS H FARIS
K040487 12/21/2004 TRABECULAR METAL KNEE SYSTEM AUGMENTS IMPLEX CORP. MARCI HALEVI
K033559 12/22/2004 12-LEAD GLOVE INEEDMD IRVING WIESEN, ESQ.
K042679 12/10/2004 IR VIEWER INFRARED IMAGING SYSTEMS, INC. DALE SIEGEL
K043190 12/14/2004 SCALLOPED ENDOPORE ENDOSSEOUS DENTAL IMPLANT SYSTEM INNOVA LIFE SCIENCES CORP. HOWARD HOLSTEIN
K042631 12/22/2004 EAR THERMOMETER, MODEL WL-320X INNOVATECH, INC TONY C CHANG
K042576 12/02/2004 COATEST SP FVIII INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K043184 12/22/2004 HEMOSIL RECOMBIPLASTIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K042982 12/22/2004 QUANTEX MYOGLOBIN INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K042825 12/21/2004 ACCUDRAIN EXTERNAL CSF DRAINAGE SYSTEM INTEGRA LIFESCIENCES CORPORATION DARLENE M WALSH
K043229 12/21/2004 MODIFICATION TO ALTIUS OCT SYSTEM INTERPORE CROSS INTL. WENDY SPIELBERGER
K041407 12/29/2004 TITANIUM MESH IMPLANT INTERPORE CROSS INTL. WENDY SPIELBERGER
K043153 12/15/2004 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS, MODELS IS1200 & IS1000 INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K042916 12/29/2004 WATCH PAT 100S ITAMAR MEDICAL JONATHAN S KAHN
K042820 12/14/2004 SYSTEMP.C&B PLUS IVOCLAR VIVADENT, INC. DONNA HARTNETT
K042847 12/17/2004 SYSTEMP.CEM IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K042846 12/20/2004 SYSTEMP.LINK IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K043221 12/20/2004 WILLI GELLER CREATION CP PORCELAIN JENSEN INDUSTRIES, INC. GARY PHELPS
K042241 12/10/2004 K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C KAMIYA BIOMEDICAL CO. BRIAN SCHLIESMAN
K042461 12/10/2004 KENDALL ARGYLE 2 FR DOUBLE LUMEN NEONATAL/PEDIATRIC PICC, MODEL 43304 KENDALL PAUL W EVANS
K043272 12/22/2004 PALLINDROME 14.5FR CHRONIC HEMODIALYSIS CATHETER WITH SLOTTED SYMMETRICAL TIP KENDALL JIM WELSH
K043114 12/10/2004 KIMBERLY-CLARK MIC-KEY LOW PROFILE GASTROSTOMY TUBE KIMBERLY-CLARK CORP. S. MCMILLAN
K042386 12/15/2004 DIRECT DIGITIZER, REGIUS MODEL 190 KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K042248 12/17/2004 KRONUS, INC.'S ACETYLCHOLINE RECEPTOR ANTIBODY (ACHRAB) ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K043177 12/17/2004 CLEAFIL DC CORE AUTOMIX KURARAY MEDICAL INC. SATOSHI YAMAGUCHI
K042929 12/06/2004 ESTENIA C&B KURARAY MEDICAL KURASHIKI PLANT KOJI NISHIDA
K043023 12/03/2004 PRUITT-INAHARA OUTLYING CAROTID SHUNT, MODELS, 2012-49, 2013-49, 2014-49,2015-49,2016-49, 2017-49 LEMAITRE VASCULAR, INC. SABA MODJARRAD
K031425 12/15/2004 GENTLEWAVES LED PHOTOMODULATION DEVICE LIGHT BIOSCIENCE, LLC ROBERT T HANDREN, JR.
K040270 12/16/2004 OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM LUMENIS LTD. ANDREA L RUTH
K042666 12/21/2004 LUTH-ALL SUB-Q NEEDLE SET LUTH-ALL MEDICAL PRODUCTS, LLC SHEPARD G BENTLEY
K032825 12/10/2004 VITAL VISION ARTERIAL HARDNESS AND BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS CO., LTD. E.J. Smith
K041125 12/30/2004 MASEP SRRS GAMMA RAYS STEREOTACTIC RADIATION THERAPY SYSTEM FOR HEADS (MASEP GAMMA THERAPY SYSTEM) MASEP MED SCIENCE & TECH. DEVELOPMENT (SHENZHEN) C SUSAN D GOLDSTEIN-FALK
K043132 12/21/2004 UNIVERSAL XACTTRACE MEDCARE FLAGA KOLBRUN E OTTOSDOTTIR
K033266 12/16/2004 VASCULAR TOOLS 5, CONSISTING OF BRACHIAL ANALYZER 5, CAROTID ANALYZER 5, VASCULAR IMAGER 5 AND INTEGRATED VASCULAR TOOLS MEDICAL IMAGING APPLICATIONS LLC MILAN SONKA
K043134 12/13/2004 METRX WORKSTATION MEDICAL METRX SOLUTIONS, INC. PATSY J TRISLER
K043455 12/21/2004 SA8000 SE DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. CARL ALLETTO
K042784 12/10/2004 MEDRAD SPECTRIS SOLARIS EP MR INJECTOR SYSTEM MEDRAD, INC. JOHN M KISTE
K041047 12/01/2004 ULTRADENT CARBON MASK - UPI #342 MEDSPRING GROUP, INCORPORATED BRUCE DAVIS
K033732 12/01/2004 MEDTRADE PRODUCTS ANTISEPTIC BARRIER SILVER FOAM DRESSING, MODEL 09912450 MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K042962 12/14/2004 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K043561 12/29/2004 MODIFICATION TO VERTE-STACK SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD A TREHARNE
K043343 12/28/2004 MODIFICATION TO: CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042789 12/21/2004 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042489 12/13/2004 6F Z4 GUIDE CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K043291 12/21/2004 CARDIOBLATE DISPERSIVE ELECTRODE ADAPTER (ACCESSORY), MODEL 60884 MEDTRONIC VASCULAR DAVID D COX
K043080 12/03/2004 HEPARIN DOSE RESPONSE CONTROLS, MODEL 306-20 POR MEDTRONIC VASCULAR BRUCE BACKLUND
K043287 12/10/2004 PALMSCAN AP2000; PALMSCAN A2000; PALMSCAN P2000 MICRO MEDICAL DEVICES, INC. RAFI ISRAEL
K043110 12/09/2004 MICROLIFE INSTANT DIGITAL ELECTRONIC THERMOMETER, MODEL MT18L1 MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K041364 12/13/2004 ML830 LASER SYSTEM MICROLIGHT CORPORATION OF AMERICA FRED A SIMPSON
K042000 12/21/2004 MODIFIED MSQ FAMILY OF LOVELY LIGHT/LASER SYSTEMS MSQ (M2) LTD. ANNE WORDEN
K042038 12/23/2004 MTF ALLOGRAFT ANCHOR MUSCULOSKELETAL TRANSPLANT FOUNDATION NORMAN F ESTRIN
K033973 12/13/2004 OXISENSOR II RECYCLED SENSOR AND OXIMAX RECYCLED SENSOR NELLCOR PURITAN BENNETT, INC. LUANNE NG
K030400 12/22/2004 NEOSCI MEDICAL ENDOLUMINAL BRUSH NEOSCI MEDICAL, INC. PHIL TRIOLO
K041406 12/15/2004 NEWPORT C250 AIR COMPRESSOR MODEL C250 NEWPORT MEDICAL INSTRUMENTS RICHARD WATERS
K041063 12/01/2004 SMARTWAVE MS 2000 NEWWAVE MEDICAL LLC ROBERT ARMSTRONG
K042689 12/09/2004 NICHOLS ADVANTAGE CORTISOL NICHOLS INSTITUTE DIAGNOSTICS JIMMY WONG
K042676 12/17/2004 NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY NICHOLS INSTITUTE DIAGNOSTICS XIE QIYL
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K043115 12/01/2004 LAPAROSCOPIC COMPRESSION ANASTOMOSIS CLIP (LAPCAC) NITI MEDICAL TECHNOLOGIES LTD. ORLY MAOR
K042943 12/17/2004 NOUVAG AG - VACUSON 40 AND VACUSON 60 NOUVAG AG ERICH FORSTER
K042822 12/22/2004 TCM ENDO V, MODEL 1534 NOUVAG AG ERICH FORSTER
K043319 12/17/2004 CLAREON AND SOLARUS PULSED LIGHT DEVICES AND ACCESSORIES NOVALIS MEDICAL, LLC ANTHONY DAVIS
K042132 12/21/2004 NOVASYS TRANSURETHRAL RF SYSTEM NOVASYS MEDICAL, INC. DEBRA REISENTHEL
K042079 12/20/2004 OSS/(SCARF)- AND OSW-SCREW O.M.T. OBERFLACHEN-UND MATERIALTECHNOLOGIE GMBH H. DARREL DARBY II
K043202 12/23/2004 OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 OLYMPUS AMERICA, INC. BEV HARDING
K042406 12/03/2004 OLYMPUS LACTATE, OSR6193 OLYMPUS AMERICA, INC. BEV HARDING
K043128 12/21/2004 OLYMPUS ENDOARM OLYMPUS CORPORATION TINA STEFFANIE-OAK
K043275 12/09/2004 OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CENTER OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K041679 12/16/2004 COLD LIGHT; COLD LIGHT MD; GOSSAMER DERMLIGHT ONYX MEDICAL INC. ROGER MACHSON
K042584 12/14/2004 OPUS MINIMAGNUM ANCHOR WITH INSERTER OPUS MEDICAL, INC. LAURA N KASPEROWICZ
K042838 12/09/2004 VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 23; VITROS CHEMISTRY PRODUCTS PALB PERFORMANCE VERIFIERS I & II Ortho-Clinical Diagnostics, Inc. Darlene J Phillips
K042476 12/01/2004 VITROS CHEMISTRY PRODUCTS VALP REAGENT; VITRO CHEMISTRY PRODUCTS CALIBRATOR KIT 12; VITROS CHEMISTRY PRODUCTS TDM PERFOS Ortho-Clinical Diagnostics, Inc. CAREY A MAYO
K040047 12/17/2004 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE OSTEOBIOLOGICS, INC. GABRIELE G NIEDERAUER
K043130 12/21/2004 MODIFICATION TO PAJUNK STIMULONG PLUS CATHETER SETS PAJUNK GMBH BURK A BRANDT
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K042907 12/22/2004 NEEDLE INCAPACITATOR (NEEDLE GUARD) PDMP, INC. E.J. Smith
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K042805 12/16/2004 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE COLORED NON-STERILE PERUSAHAAN GETAH ASAS SDN BHD KK LEONG
K043167 12/29/2004 PHAMATECH QUICKSCREEN BENZODIAZEPINES TEST, MODELS 9025, 9026, 9027T, 9153T AND 9195X PHAMATECH INC. CARL MONGIOVI
K043090 12/23/2004 EASYLISTENER 2 FM, RADIUM FM AND VOCALIGHT INFRARED SOUND FIELD SYSTEMS PHONIC EAR, INC. TODD BISSEY
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K042131 12/10/2004 PROMEDICAL SURGICAL DRAPES PROMEDICAL PRODUCTS CO., LTD. BOYD HARRIS
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K042239 12/16/2004 FLEXISKIN POWDER FREE NITRILE EXAMINATION GLOVES, NON STERILE PT. MANDIRI INTI BUANA P. SASITHARAN NAIR
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K042099 12/10/2004 TONOPACH ULTRASONIC TONOMETER/PACHYMETER MODEL P-201 (THE TONOPACH) RETINAPHARMA TECHNOLOGIES INC. TERRY A FULLER, PH.D.
K042399 12/17/2004 MODIFICATION TO SHORT INTRODUCER SHEATH REX MEDICAL LP SUSAN D GOLDSTEIN-FALK
K030295 12/23/2004 LTU-904 PORTABLE LASER THERAPY UNIT RIANCORP PTY LTD ROBERT T HANDREN
K043320 12/17/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II CALCHECK II ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K043318 12/23/2004 MODIFICATION TO ROCHE ELECSYS FOLATE II IMMUNOASSAY ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K043211 12/29/2004 ONLINE DAT BARBITURATES PLUS ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K042259 12/23/2004 AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC. JAMES F KELLY
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K042654 12/17/2004 PROTECTION PLUS EARLOOP PROCEDURE MASK SAFETY-MED PRODUCTS, INC. CHRIS WAGNER
K041011 12/14/2004 ULTRALIGHT II ND:YAG LASER SYSTEM SANDSTONE MEDICAL TECHNOLOGIES, LLC CONNIE WHITE HOY
K042787 12/17/2004 IS 40 MICROMOTOR SATELEC STEVE SALESKY
K043001 12/01/2004 MX POLYAXIAL PEDICLE SCREW SCIENT'X J.D. WEBB
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K043159 12/20/2004 POWDER FREE CLEAR SYNTHETIC VINYL EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE SHIJAIZHUANG BRILLIANT OCEAN PLASTIC CO., LTD. EMMY TJOENG
K042840 12/03/2004 SHIMADZU COLLIMATOR R-20J SHIMADZU CORP. RANDAL WALKERI
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K042863 12/15/2004 SCENIUM SIEMENS MOLECULAR IMAGING LTD MARIA EBIO
K043355 12/17/2004 SINTEA BIOTECH POSTERIOR LUMBAR SYSTEM WITH POLYAXIAL AND RECOVERY SCREWS, MODEL PLS.01.T5.X SINTEA BIOTECH, INC. GUIDO ZORZOLI
K043452 12/21/2004 TITAN HIGH RESOLUTION ULTRASOUND SYSTEM AND SONOSITE ULTRASOUND SYSTEM SONOSITE,INC. DAINA L GRAHAM
K042481 12/14/2004 POLARIS PRESSURE ADJUSTABLE VALVE SYSTEM, MODELS SPV-140, SPV-300, SPV-400 SOPHYSA SA JACKIE MASSE
K043307 12/17/2004 CRANEX D SOREDEX PALODEX GROUP OY KAI LANER
K043062 12/13/2004 MODEL SR-130-D PORTABLE DIGITAL X-RAY SYSTEM SOURCE-RAY, INC. RAY MANEZ
K042452 12/07/2004 RIVA SILVER SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
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K030526 12/29/2004 PEDIGUARD NERVE DETECTOR SYSTEM SPINEVISION, INC. LYNNETTE WHITAKER
K042930 12/28/2004 SPACEVISION CAGE SYSTEM SPINEVISION, INC. LYNETTE WHITAKER
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K042734 12/17/2004 SJM RIGID SADDLE RING MODEL RSAR-(SIZE) ST. JUDE MEDICAL, INC. WILLIAM MCKELVEY
K043155 12/09/2004 STARION UNIVERSAL POWER SUPPLY (UPS) STARION INSTRUMENTS BRIAN GRIGSBY
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K043482 12/21/2004 THE RELIANCE PI PROCESS INDICATOR, MODEL D5116 STERIS Corporation MARGARET MARSH
K041810 12/21/2004 SERFAS ENERGY SYSTEM Stryker Endoscopy CHRISTINE REISTETTER
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K042902 12/27/2004 HERBERT ULNAR HEAD PROSTHESIS SYSTEM STUCKENBROCK MEDIZINTECHNIK GMBH AL WEISENBORN
K042856 12/03/2004 CONTOUR FOREHEAD/BROWLIFT THREAD SURGICAL SPECIALTIES CORP. ELIZABETH LAZARO
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K041834 12/03/2004 ADR PLUS SSXI IMAGING DEVICE FOR X-RAY SYSTEMS SUCH AS X-CALIBER, X-CALIBER CM, ANA-BEL AND ANA-BEL CM TAKARA BELMONT USA, INC. ROBERT SCHIFF
K040778 12/23/2004 TANITA INNERSCAN BODY COMPOSITION MONITOR, MODEL BC-53X (WHERE X=0 TO 9) TANITA CORP. OF AMERICA RHODA LYNN VALERA
K042414 12/29/2004 VISIOPLAST ACRYLIC RESIN TECRES CHRISTINE BRAUER
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K043258 12/16/2004 MODIFIED TFX MEDICAL SAFETY NEEDLE WITH INTRODUCER, PART NO. T4634-02 TELEFLEX MEDICAL SUSAN KAGAN
K043278 12/13/2004 TERATECH MODEL 8IOC4, 8IOL4 & 10LAP4 PROBES TERATECH CORP. CHARLES F HOTTINGER
K042620 12/23/2004 SONATA 3-D IMAGING ACCESSORY, MODEL 3DS TETRAD CORP. DENNIS R DIETZ
K042783 12/17/2004 ANSPACH MINIMAL ACCESS SPINAL ATTACHMENT (MASA) SYSTEM THE ANSPACH EFFORT, INC. WILLIAM G CONETY
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K043366 12/17/2004 PERMACOL SURGICAL IMPLANT TISSUE SCIENCE LABORATORIES, PLC VICTORIA TAYLOR
K042370 12/17/2004 TORAYGUIDE GUIDEWIRE TORAY INDUSTRIES (AMERICA), INC. LISA S JONES
K043077 12/17/2004 MODIFICATION TO AEQUALIS SHOULDER FRACTURE SYSTEM; AEQUALIS SHOULDER SYSTEM TORNIER LEMERY MIREILLE
K040426 12/17/2004 TRANS1 AXIAL FIXATION SYSTEM TRANS1, INC. CHERYL L JOHNS
K043119 12/17/2004 AMELOGEN PLUS ULTRADENT PRODUCTS, INC. TAMMY LAVERY
K042288 12/27/2004 UNICRYL UNITED MEDICAL INDUSTRIES CO. LTD. MOHAMMED AZEEZ
K042285 12/10/2004 UNICRYL M UNITED MEDICAL INDUSTRIES CO. LTD. MOHAMMED AZEEZ
K042286 12/01/2004 UNIESTER C UNITED MEDICAL INDUSTRIES CO. LTD. MOHAMMED AZEEZ
K042284 12/03/2004 UNIMIDE UNITED MEDICAL INDUSTRIES CO. LTD. MOHAMMED AZEEZ
K042283 12/01/2004 UNIPRO UNITED MEDICAL INDUSTRIES CO. LTD. MOHAMMED AZEEZ
K042282 12/01/2004 UNISILK UNITED MEDICAL INDUSTRIES CO. LTD. MOHAMMED AZEEZ
K043019 12/01/2004 VASCULAR SOLUTIONS SCLERO-KIT VASCULAR SOLUTIONS, INC. SARA L COON
K043181 12/17/2004 MODIFICATION TO VERTEBRON SCP CERVICAL PLATE SYSTEM VERTEBRON, INC. LUIS NESPRIDO
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K043333 12/15/2004 VITREA2, VERSION 3.7 MEDICAL IMAGE PROCESSING SYSTEM VITAL IMAGES, INC. TIMOTHY J KAPPERS
K041875 12/13/2004 VYSIS AUTOVYSION SYSTEM VYSIS LYNDA HAGUE
DEN040010 12/13/2004 VYSIS AUTOVYSION SYSTEM VYSIS LYNDA HAGUE
K043081 12/22/2004 GORE POLYPROPYLENE HERNIA MESH W. L. GORE & ASSOCIATES, INC. Michael Ivey
K043056 12/22/2004 GORE SEAMGUARD BIOABSORBABLE STAPLE LINE REINFORCEMENT MATERIAL W.L. GORE & ASSOCIATES,INC BRANDON HANSON
K042530 12/17/2004 CONSERVE PLUS HA ACETABULAR SHELLS WRIGHT MEDICAL TECHNOLOGY, INC. JEANINE H REDDEN
K042828 12/01/2004 OBTURA GUTTA PERCHA DELIVERY SYSTEM, MODEL 823-700 YOUNG O/S LLC STEPHEN W CONGER
K043131 12/15/2004 TORPICALGIN ZHERMACK S.P.A. GERALD W SHIPPS
K042871 12/21/2004 TRABECULAR METAL ACETABULAR AUGMENTS, MODELS 4894-XXX-YY, 02-212-105XX3, 02-212-205XX3, 02-212-305XX3 ZIMMER TRABECULAR MARCI HALEVI
K043227 12/10/2004 PERIARTICULAR LOCKING PLATES, 2358 SERIES ZIMMER, INC. NOAH BARTSCH


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