FDA 510(k) Decisions During April, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K050279 04/11/2005 AXS-1 LITE WHEELCHAIR ACCESS POINT MEDICAL, L.L.C. NORMAN F ESTRIN
K050280 04/11/2005 RUNABOUT WHEELCHAIR ACCESS POINT MEDICAL, L.L.C. NORMAN F ESTRIN
K050281 04/11/2005 TRANSPORT SERIES TRANSPORT CHAIR ACCESS POINT MEDICAL, L.L.C. NORMAN F ESTRIN
K050950 04/29/2005 MODELS CRYSTAL 512, RECORD 618, OPTIMA 518 PHOTO EPILATION SYSTEMS ACTIVE OPTICAL SYSTEMS, LTD./EFRAIM BIDAS EFRAIM BIDAS
K041614 04/04/2005 MICROLUX DL ADDENT, INC. JOSHUA FRIEDMAN
K050648 04/05/2005 SOVEREIGN HIGH VACUUM PACK, SOVEREIGN COMPACT HIGH VACUUM PACK ADVANCED MEDICAL OPTICS, INC. PAM SCHAUB
K050633 04/21/2005 TRIAL CABLE RETENTION CLIP ADVANCED NEUROMODULATION SYSTEMS RASHMI MOZA
K032959 04/04/2005 CIDEX OPA CONCENTRATE ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKAR
K042116 04/22/2005 STERRAD NX STERILIZER ADVANCED STERILIZATION PRODUCTS NATALIE BENNINGTON
K050752 04/27/2005 AESCULAP ORTHOPILOT 2 THA V 2.0 AESCULAP, INC. MATTHEW M HULL
K050804 04/11/2005 MODIFICATION TO: SPECTRUMTM CERVICAL SPINAL SYSTEM AESCULAP, INC. KATHY A RACOSKY
K041554 04/27/2005 AIP INTENSE PULSED LIGHT SYSTEM AESTHERA CORPORATION C. ROBERT PAYNE
K050810 04/21/2005 AGFA CR50.0 AGFA CORP. JEFFERY A JEDLICKA
K050751 04/21/2005 IMPAX ORTHOPAEDIC WORKSTATION, MODEL IMPAX ES 5.X AGFA CORP. PHIL CUSCUNA
K050553 04/18/2005 NOVEL VBR SPINAL SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K050699 04/15/2005 MODIFICATION TO: VENTED CEMENT RESTRICTOR, MODEL 60102-000-001/004 AMEDICA CORP. ROBERT M WOLFARTH
K043543 04/08/2005 BLOOD GLUCOSE MONITORING SYSTEM AMERICAN HEALTHCARE INC. EDWARD LETKO
K043512 04/08/2005 EASYGLUCO IGM-0002 G2 AMERICAN HEALTHCARE INC. EDWARD LETKO
K050256 04/26/2005 APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR APPLE MEDICAL CORP. JAMES DELANEY
K043519 04/25/2005 ARIOL HER-2/NEU FISH APPLIED IMAGING CORP. DIANE C DAY
K050652 04/06/2005 SPOTCHEM II CREATININE, AMYLASE & ALP TESTS ARKRAY, INC. HELEN LANDICHO
K050358 04/15/2005 ARTHERX CORKSCREW FT II SUTURE ANCHOR ARTHREX, INC. ANN WATERHOUSE
K042411 04/07/2005 ABBOTT IMX SIROLIMUS MICROPARTICLE ENZYME IMMUNOASSAY AXIS-SHIELD LTD. SUSAN LEONARD
K050194 04/26/2005 AXON SYSTEMS SUBDERMAL NEEDLE ELECTRODES AXON SYSTEMS, INC. HOWARD BAILIN
K050310 04/18/2005 BARDPORT TITANIUM PORTS BARD ACCESS SYSTEMS, INC. MICHAELA RIVKOWICH
K050157 04/26/2005 MAXSIGHT (POLYMACON) SPORT-TINTED CONTACT LENS BAUSCH & LOMB, INC. LISA GRANEY
K043228 04/22/2005 ACS:180 AND ADVIA CENTAUR B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAYS BAYER HEALTHCARE, LLC CAROL BIANCA
K050207 04/07/2005 BD POSIFLOW POSITIVE DISPLACEMENT VALVE BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC. LESLIE WOOD
K050555 04/14/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFAZOLIN (GP) 2-32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050747 04/29/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, LEVOFLOXACIN (STREP) 0.25-16 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050745 04/29/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM, VANCOMYCIN (STREP) 0.0625 -32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050666 04/11/2005 GENEROS, MODELS GO-01G, GO-05G, GO-10G, GO-15G, GO-20G, GO-30G, GO-40G, GO-60G, GO-XYZ SERIES, GO-DZ SERIES BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K050712 04/22/2005 4.5.* 6.0MM DENTAL IMPLANT AND 6.0*6.0 MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K050408 04/07/2005 BICON ORTHODONTIC IMPLANT SYSTEM BICON, INC. VINCENT J MORGAN
K050537 04/27/2005 LIQUICHEK CARDIAC MARKERS PLUS CONTROL, LIQUICHEK CARDIAC MARKERS PLUS CONTROL LT, LIQUICHEK CARDIAC MARKERS PLUS BIO-RAD SUZANNE S PARSONS
K050682 04/29/2005 LIQUICHEK URINE TOXICOLOGY CONTROL (LEVEL C1) BIO-RAD LABORATORIES, INC. ELIZABETH PLATT
K050487 04/26/2005 QUANTIA LA(A) BIOKIT S.A. JOAN GUIXER
K050513 04/01/2005 MDA B.30 BIOMERIEUX, INC. JOCELYN JENNINGS
K042989 04/28/2005 RX90 LOW PROFILE ACETABULAR SYSTEM BIOMET, INC. PATRICIA SANDBORN BERES
K050701 04/01/2005 THIGH AND FOOT POSITIONER, SUPRONE PLUS, MODEL RT-6010 BIONIX DEVELOPMENT CORP. JAMES HUTTNER
K050647 04/20/2005 ALL-IN-ONE BISCO, INC. BENJAMIN LICHTENWALNER
K050700 04/15/2005 MATRIX STRETCH RESISTANT (SR) COILS BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K042721 04/19/2005 KOLIBRI SPINE BRAINLAB AG RAINER BIRKENBACH
K050724 04/18/2005 SURE-POINT MIDLINE STEPPING AND STABILIZATION SYSTEM C.R. BARD, INC. LORRAINE R PATA
K050688 04/06/2005 TEGRESS IMPLANT NEEDLE C.R. BARD, INC. TERRI MORRIS
K050153 04/15/2005 SPIRIT, MODEL HAS CAIRE, INC. DAN CHLAN
K050357 04/21/2005 CAMCERAM TCP CAM IMPLANTS B.V. KIM GROENEWEGAN VAN DER WEIJDEN
K050225 04/07/2005 HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM CAMBRIDGE HEART, INC. JOHN GREENBAUM
K050987 04/27/2005 DIGITAL RADIOGRAPHY MODEL CXDI-40EG CANON, INC. SHEILA DRISCOLL
K050115 04/01/2005 BLOOD HAND PUMP ADMINISTRATION SET CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K050324 04/27/2005 INFPUMP INFILTRATION PUMP CAROLINA MEDICAL, INC. LEON WILSON
K051013 04/27/2005 SPINEMED S200B/S200C CERT HEALTH SCIENCES, LLC TIM R EMSKY
K050611 04/06/2005 ENDOTINE RIBBON COAPT SYSTEMS, INC. LINDA RUEDY
K050046 04/13/2005 REHABILICARE IF 3 WAVE INTERFERENTIAL STIMULATOR SYSTEM, MODEL 7110S COMPEX TECHNOLOGIES, INC. BRIAN J EDWARDS
K050777 04/22/2005 PROFORMA HF 4.5 CANNULA, MODEL 050906, 050907 CONMED CORP. MICHAEL A PATZ
K050578 04/22/2005 COOK IRELAND DUETTE MULTI-BAND MUCOSECTOMY DEVICE COOK IRELAND LTD EMMETT DEVEREUX
K050645 04/01/2005 CORDIS AMIIA .014" PTA BALLOON CATHETER CORDIS CORP. KAREN WILK
K043538 04/18/2005 HYPERTRANSIT INFUSION CATHETER CORDIS NEUROVASCULAR, INC. MARITZA CELAYA
K050177 04/27/2005 COLACTIVE COLLAGEN WOUND DRESSING COVALON TECHNOLOGIES, INC. PAUL L GUILBAUD
K050792 04/21/2005 LANDLEX, MODEL S300X CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN LAN
K050165 04/19/2005 MODIFICATION TO IFL PROFESSIONAL SYSTEM, MODEL C100 CYDEN LIMITED MICHAEL NOEL KIERNAN
K050695 04/19/2005 FLEX CONTROLLED PHOTOTHERAPY EQUIPMENT DAAVLIN DISTRIBUTING CO. DAVID W SWANSON
K050676 04/12/2005 GE DETAX-OHMEDA ANESTHESIA DELIVERY UNIT (ADU) DATEX-OHMEDA, INC. DAN KOSEDNAR
K043539 04/06/2005 DEMETECH STERILE SYNTHETIC ABSORBABLE SUTURES (PGA) AND NEEDLES DEMETECH CORP. ARTHUR WARD
K042965 04/15/2005 TOMAS PIN DENTAURUM, INC. THOMAS LIETZ
K050880 04/22/2005 DYRACT EXTRA RESTORATIVE DENTSPLY INTL. HELEN LEWIS
K050750 04/06/2005 LC BRACKET ADHESIVE SYSTEM DENTSPLY INTL. HELEN LEWIS
K050771 04/08/2005 LUPINE LOOP DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DENISE LUCIANO
K050675 04/11/2005 EXPEDIUM SPINE SYSTEM SPINOUS PROCESS FUSION PLATE DEPUY SPINE, INC. LISA GILMAN
K040120 04/29/2005 DIASORIN LIAISON EBNA IGG, LIAISON VCA IGG, LIAISON VCA IGM ASSAYS DIASORIN, INC. DAVID M IKEDA
K043328 04/15/2005 MICROFLO-SAFE SCALP VEIN SET DKS LOVERSAN INDUSTRIA BIOMEDICA SPA ARTHUR WARD
K050974 04/29/2005 DRAEGER MEDICAL INFORMATION BUS (MIB, MIB II, MIB DUO) PROTOCOL CONVERTERS DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K041826 04/27/2005 EKOS ULTRASOUND INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K042710 04/07/2005 SURGITRON RADIOLASE II ELLMAN INT'L INC. FRANK LIN
K042917 04/22/2005 STAT MEDICAL PEN NEEDLE EMERGO GROUP, INC. RENE VAN DE ZANDE
K050188 04/27/2005 EPIGUARD EPISAFE MEDICAL DEVICES, LTD. GEORGE J HATTUB
K043245 04/29/2005 EPS EASY PAIN SUPREME SELF MONITORING BLOOD GLUCOSE SYSTEM EPS BIO TECHNOLOGY CORP. JENNIFER REICH
K050725 04/20/2005 PROTEGE GPS SELF-EXPANDING NITINOL STENT EV3 CORPORATION GLEN D SMYTHE
K043527 04/05/2005 RELIEVA SINUS BALLOON DILATION CATHETER EXPLORAMED NC1, INC. WILLIAM M FACTEAU
K050134 04/05/2005 ICC INSULIN SAFEPRO SAFETY SYRINGE FORMOSA MEDICAL DEVICES, INC. C. Y. LIN
K050837 04/27/2005 REUSABLE TEMPERATURE PROBES (M1024254 SKIN TEMPERATURE PROBE, REUSABLE; M1024247, GP TEMPERATURE PROBE, ADULT, RESUABLE GE HEALTHCARE JOEL KENT
K050614 04/05/2005 MUSE CARDIOLOGY INFORMATION SYSTEM GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES LISA M BAUMHARDT
K050704 04/08/2005 MODIFICATION TO: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH IMAGE PASTING AND AUTOPOSITIONING GENERAL ELECTRIC CO. JOHN L SCHMIDT
K043385 04/12/2005 OSOM HCG COMBO TEST GENZYME DIAGNOSTICS E.V. GOORCHENKO
K050664 04/07/2005 SPOR-TEST PA BIOLOGICAL INDICATOR KIT GETINGE USA, INC BARD SMITH
K050576 04/21/2005 MICROALBUMIN TIA REAGENT; MALB CALIBRATOR SET 200; MALB CONTROL-L, CONTROL-H GOOD BIOTECH CORP. VICTOR CHIOU
K042927 04/15/2005 VACUETTE EDTA K3 EVACUATED BLOOD COLLECTION TUBES GREINER BIO-ONE VACUETTE NORTH AMERICA JUDI SMITH
K050755 04/06/2005 MODIFICATION TO BVBLUE GRYPHUS DIAGNOSTICS, LLC THOMAS M TSAKERIS
K043443 04/08/2005 ONE STEP HCG URINE PREGNANCY TEST GUANGZHOU WONDFO BIOTECH CO., LTD. HOWARD MANN
K042495 04/14/2005 CUMULASE HALOZYME THERAPEUTICS INC. DON KENNARD
K050768 04/28/2005 ZILOS-TK, VERSION 3, ZILOS-TK, VERSION 4 HAMILTON THORNE BIOSCIENCES DIARMAID H DOUGLAS-HAMILTON
K050932 04/26/2005 DISTAL VOLAR RADIUS ANATOMICAL PLATE SYSTEM HAND INNOVATIONS, INC. ERNIE HERNANDEZ
K050508 04/27/2005 HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES HAYWOOD VOCATIONAL OPPORTUNITIES TIM KELLEY
K050711 04/07/2005 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168JT HEALTH & LIFE CO., LTD. PAUL HUNG
K050714 04/07/2005 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL168GA, HL168GS HEALTH & LIFE CO., LTD. PAUL HUNG
K050587 04/05/2005 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KM, HL888DM HEALTH & LIFE CO., LTD. PAUL HUNG
K050169 04/05/2005 HL 200 ELECTRONIC STETHOSCOPE HEALTH & LIFE CO., LTD. JENNIFER REICH
K050567 04/05/2005 HEALTH BUDDY APPLIANCE HEALTH HERO NETWORK, INC. GEOFFREY CLAPP
K050602 04/07/2005 ALTAIRE HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K050483 04/12/2005 EVADRI BLADDER CONTROL SYSTEMS HOLLISTER, INC. JOSEPH S TOKARZ
K050719 04/26/2005 ABX PENTRA DX 120: OPTION SPS EVOLUTION HORIBA ABX TIM LAWTON
K050274 04/29/2005 DIODENT II DENTAL LASER SYSTEM HOYA PHOTONICS, INC. JIM GREEN
K050083 04/08/2005 BLOOD-PRESSURE METER, BPW120 IDT TECHNOLOGY LIMITED LEON LEONG
K050772 04/21/2005 NAVIGUS REUSABLE PASSIVE PROBE, MODEL SP-2000 IMAGE-GUIDED NEUROLOGICS, INC. DAVID M LEE
K050505 04/05/2005 DEPOTONE IMPRINT PHARMACEUTICALS LIMITED MERVYN LITTLE
K042944 04/15/2005 HOME-AWAY SYSTEM, MODEL 1041 IN-X CORPORATION DOUGLAS POWELL
K043500 04/15/2005 FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) SYSTEM, INCLUDING FAD CATHETER KIT AND FAD INTRODUCER NEEDLE INNOSPINE, INC. LARAINE PANGELINA
K050588 04/21/2005 VERTEVIEW ANTERIOR CERVICAL PLATE SYSTEM INNOVATIVE SPINAL DESIGN, LLC LEIGH COWDEN
K050544 04/26/2005 HEMOSIL D-DIMER HS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K050496 04/29/2005 REM440 INTERACOUSTICS A/S, ASSENS DANIEL EGGAN
K050404 04/21/2005 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K050369 04/29/2005 INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM, MODEL IS2000 INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K050562 04/14/2005 OCULIGHT GL/GLX IRIDEX CORP. JOHN JOSSY
K050716 04/21/2005 ISCIENCE SURGICAL VISCOINJECTOR ISCIENCE SURGICAL CORPORATION JUDY F GORDON
K043531 04/21/2005 MODIFICATION TO ARM BLOOD PRESSURE MONITOR, MODELS KP-6821, KP-6822 K-JUMP HEALTH CO., LTD. DANIEL TSENG
K043324 04/04/2005 AIDA WITH DICOM AND HL7 INTERFACE KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K050744 04/21/2005 KAVO ERGOCOM/ERGOCAM KAVO AMERICA CORPORATION KANIEL KAMM
K050601 04/15/2005 SMARTDOP 45 VASCULAR DOPPLER KOVEN TECHNOLOGY, INC. J. HARVEY KNAUSS
K050774 04/11/2005 LANX ANTERIOR CERVICAL PLATE SYSTEM LANX, LLC DAVID W SCHLERF
K050708 04/26/2005 LERADO, AVANTICARE MECHANICAL WHEELCHAIR, MR-9000 LERADO OVERSEA LTD. TWN BRANCH (BVI) JEN KE-MIN
K050707 04/18/2005 LERADO, AVANTICARE TRANSPORT WHEELCHAIR, MT-3000 LERADO OVERSEA LTD. TWN BRANCH (BVI) JEN KE-MIN
K050506 04/15/2005 PRIMASOLO ONE-PIECE IMPLANTS & HEALING CAPS LIFECORE BIOMEDICAL, INC. RACHEL KENNEDY
K050193 04/11/2005 GERSON 2130/31 TYPE N95 NIOSH CERTIFIED SURGICAL RESPIRATOR LOUIS M. GERSON CO., INC. ROBERT BRUNELL
K050131 04/05/2005 INSOSAFE BAK'SNAP RETRACTABLE INSULIN SAFETY SYRINGE M.K. MEDITECH CO. LTD. ROSINA ROBINSON
K050254 04/15/2005 SPECTRA-SP CO2 LASER SYSTEM MAX ENGINEERING LTD. MAUREEN O'CONNEL
K050770 04/14/2005 MODIFICATION TO ACCUFUSER, ACCUFUSER PLUS STANDARD PROCEDURE KIT MCKINLEY MEDICAL LLC RALPH D COOEY
K041579 04/21/2005 MEDELA SINGLE USE SILC CUP, MODEL 077.0791 MEDELA AG WERNER FREI
K043614 04/14/2005 VACULINK, MODEL VCL 3000 MEDEVCO, INC. KRISTA OAKES
K043419 04/15/2005 P&P SAFETY SYRINGE MEDEXEL MEDICAL MFG. CO., LTD. DANIEL KAMM
K042526 04/25/2005 DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX MEDICAL ACTION INDUSTRIES, INC. ROBIN BLANKENBAKER
K050376 04/07/2005 PROWIN MEDICAL TECHNOLOGIES INTERNATIONAL, INC. MARC BOZENAN
K050490 04/11/2005 OSMOSYS CALCIUM PHOSPHATE CERAMIC BONE FILLER MEDICREA J.D. WEBB
K050181 04/13/2005 MEDIGLOVES STERILE POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES MEDIGLOVES LTD. KATHE BRENNER DEANE
K050703 04/21/2005 QBRAIN MEDIS MEDICAL IMAGING SYSTEMS, B.V. J.I. HOLLANDER
K050038 04/13/2005 RELIANT STENT GRAFT BALLOON CATHETER MEDTRONIC ENDOVASCULAR INNOVATIONS WILLIE MITCHELL
K043053 04/11/2005 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K050560 04/21/2005 EUROCHAIR MEYRA, INC. KIRK L MACKENZIE
K050543 04/27/2005 NEXUS DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K050340 04/27/2005 MICROMEDICS SPHENOID SINUS STENT MICROMEDICS, INC. THOMAS A LOPAC
K050740 04/06/2005 MICROWARE 200 MICROWARE INC MICHAEL B MCGRAW
K043231 04/25/2005 PROOF POSITIVE ELECTRONIC PREGNANCY TEST MIZUHO USA, INC. BENEDICT ZIN
K043380 04/26/2005 MONEBO AUTOMATIC ARRHYTHMIA DETECTION SOFTWARE LIBRARY, VERSION 1 MONEBO TECHNOLOGIES, INC. DALE J MISCZYNSKI
K050622 04/08/2005 HRW-63-8 WRIST ARRAY COIL; HRW-127-8 WRIST ARRAY COIL MRI DEVICES CORPORATION THOMAS SCHUBERT
K050621 04/07/2005 NVA-127-8-A NEUROVASCULAR ARRAY COIL MRI DEVICES CORPORATION THOMAS SCHUBERT
K040501 04/29/2005 DBX DEMINERALIZED BONE MATRIX PUTTY, PASTE AND MIX MUSCULOSKELETAL TRANSPLANT FOUNDATION KAREN HARDWICK
K050765 04/08/2005 LANO-E POWDER-FREE NITRILE EXAMINATION GLOVE N.S. UNI-GLOVES SDN. BHD. KENNETH J STANTON
K043156 04/28/2005 D-CARIE, MODEL N121-M1 NEKS TECHNOLOGIES, INC. CHARLES H KYPER
K050377 04/07/2005 NBD HEAD SCREW NEW BUSINESS DEVELOPMENT, LLC TIM B LUSBY
K050833 04/29/2005 ELECTRODE JUNCTION BOX, MODEL JE-921A NIHON KOHDEN AMERICA, INC. SERRAH NAMINI
K050258 04/19/2005 GROOVY IMPLANTS NOBEL BIOCARE AB HERBERT CRANE
K050641 04/07/2005 ZYGOMA TIUNITE NOBEL BIOCARE USA LLC ELIZABETH MASON
K050350 04/29/2005 THE NOTAL VISION PREVIEW PREFERENTIAL HYPERACUITY PERIMETER (PREVIEW PHP) NOTAL VISION, INC. RICHARD E LIPPMAN
K050244 04/08/2005 MALE NATURAL RUBBER LATEX CONDOM NRS GLOBAL PARTNERS ELI J CARTER
K042506 04/05/2005 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-780M OMRON HEALTHCARE, INC. IWAO KOJIMA
K042505 04/05/2005 OMRON DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL HEM-609N OMRON HEALTHCARE, INC. IWAO KOJIMA
K042565 04/11/2005 ENCOMPASS HIP STEM, TRI-PLUS ACETABULAR SHELL, TRI-PLUS DCM LINER ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K050866 04/27/2005 CENTRION 500 C-ARM SYSTEM OSTEOSYS CO., LTD. T. WHIT ATHEY
K041495 04/15/2005 PENTADEFLUE IV SOLUTION ADMINISTRATION SETS PENTAFERTE S.P.A VITTORIO SERVIDORI
K050742 04/05/2005 M3290A INTELLIVUE INFORMATION CENTER SOFTWARE RELEASE G.00 PHILIPS MEDICAL SYSTEMS DAVID OSBORN
K050692 04/08/2005 FLXIS PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. LYNN HARMER
K050762 04/22/2005 PHILIPS INTELLIVUE PATIENT MONITOR, MODELS MP20, MP30, MP40, MP50, MP60, MP70 AND MP90 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH EGON PFEIL
K050794 04/28/2005 ANGIOJET DVX RHEOLYTIC THROMBECTOMY CATHETER POSSIS MEDICAL, INC. MARK STENOIEN
DEN050003 04/18/2005 PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH JING ZHANG
K042613 04/18/2005 PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH JING ZHANG
K050488 04/01/2005 TURBT-RF ELECTRODES AND ELECTROSURGICAL DEVICES PROSURG, INC. ASHVIN DESAI
K050691 04/21/2005 R. POON MEDICAL PRODUCTS WHEELCHAIRS R. POON MEDICAL PRODUCTS CO., LTD. RICHARD GRAVER
K043143 04/22/2005 SAFEPICO RADIOMETER MEDICAL APS LENE MEINECHE MARNAES
K050533 04/26/2005 ECLIPSE LATEX POWDER FREE STERILE SURGEON'S GLOVE REGENT MEDICAL AMERICAS, LLC KATHLEEN HARRIS
K050414 04/11/2005 PLIX RESPIRONICS, INC. ZITA YURKO
K050423 04/22/2005 OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE) ROCHE DIAGNOSTICS DIMITRIS DEMIRTZOGLOU
K043529 04/08/2005 ACCU-CHEK ADVISOR INSULIN GUIDANCE SOFTWARE ROCHE DIAGNOSTICS CORP. SCOTT THIEL
K043474 04/27/2005 ACCU-CHEK AVIVA SYSTEM ROCHE DIAGNOSTICS CORP. SCOTT THIEL
K050387 04/25/2005 ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
K050895 04/20/2005 SURPASSON P5 NEWTRON SATELEC PASCAL DUPEYRON
K050778 04/13/2005 TELEREHAD 2004 SCOTTCARE WAYNE STRIPE
K042449 04/18/2005 DOLPHIN INFLATION DEVICE SEDAT S.A. LAETITIA BERNARD
K050419 04/01/2005 QMS VANCOMYCIN SERADYN INC. JACK ROGERS
K050510 04/01/2005 ECHOVIEW/SHIMASONIC DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SDU-1100 SHIMADZU MEDICAL SYSTEMS RANDAL WALKER
K050401 04/28/2005 CERAMAGE SHOFU DENTAL CORP. DAVID MORAIS
K040757 04/13/2005 SIC PRO SIC INVENT AG GEORG SCHILLI
K050867 04/14/2005 SYNGO BODY PERFUSION-CT SIEMENS AG RUEDIGER KOERNER
K042018 04/15/2005 ACUTE PORTABLE EXCHANGE DEIONIZATION (PEDI) SYSTEM, CENTRAL PEDI SYSTEM, BACK-UP PEDI SYSTEM SIMPLY CLEAN AIR & WATER, INC. RAYMOND KOWALEC
DEN050001 04/18/2005 DECAPINOL ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED MICHAEL KILLEEN
K041482 04/18/2005 DECAPINOL ORAL RINSE SINCLAIR PHARMACEUTICALS LIMITED MICHAEL KILLEEN
K050462 04/26/2005 SBI HAND FIXATION SYSTEM (TM) SMALL BONE INNOVATIONS LLC DONALD GUTHNER
K050122 04/18/2005 POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) (THIS PRODUCT DOES NOT CONTAIN THIURAM, AND/OR CARBAMATE AND/OR THIAZOLE) SMART GLOVE CORP. SDN BHD FOO KHON PU
K050598 04/07/2005 POWDER FREE NITRILE EXAMINATION GLOVE WITH TESTED FOR USE WITH CHEMOTHERAPY DRUGS LABELING CLAIM (BLUE) SMART GLOVE CORP. SDN BHD FOO KHON PU
K050580 04/20/2005 SMITH & NEPHEW INTELIJET FLUID MANAGEMENT SYSTEMS SMITH & NEPHEW ENDOSCOPY, INC. KATHLEEN BURNS
K050030 04/21/2005 ACTICOAT MOISTURE CONTROL DRESSING SMITH & NEPHEW, INC. TERRY C MCMAHON
K043495 04/22/2005 BABYPAC SMITHS MEDICAL INTERNATIONAL LTD., LUTON DONALD ALEXANDER
K050532 04/14/2005 CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES WITH PROTEIN LABELING CLAIM (CONTAINS 50 MICROGRAMS OR LESS OF TOTAL WA SPI GLOVES SDN. BHD. CHOOI FONG CHUN
K050706 04/15/2005 HARMONY PORT SYSTEM, MODEL 1907 SERIES SPINAL CONCEPTS, INC. NOAH BARTSCH
K042958 04/08/2005 DUREX PLAY TINGLING LUBRICANT SSL AMERICAS, INC. CHRIS ROBINSON
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K043083 04/18/2005 ADVANCE HA COATED SPIKED TIBIAL BASE AND ADVANCE HA COATED MODULAR KEEL WRIGHT MEDICAL TECHNOLOGY, INC. EHAB M ESMAIL
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K050450 04/04/2005 SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD KAREN ABELL
K043356 04/18/2005 WAGNER SL REVISION STEM LATERAL ZIMMER AUSTIN, INC. AUDREY SWEARINGTON
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K050101 04/15/2005 THE TRABECULAR METAL BONE STABILIZATION IMPLANT, MODEL 99-11197-XX-10 ZIMMER TRABECULAR ROBERT A POGGIE
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