FDA 510(k) Decisions During June, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K050500 06/27/2005 FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. KIMBERLEY KLINE
K051125 06/08/2005 IVS CLIP CLOSURE SYSTEM, MODEL 1002 (IVS CLIP APPLIER), 14677 ABBOTT LABORATORIES KIM SMITH-SERVANCE
K051519 06/21/2005 FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) ABBOTT LABORATORIES (PERCLOSE, INC.) ANN E LEONARD
K050936 06/24/2005 ON CALL HOME DRUG TEST FOR MARIJUANA AND ON CALL HOME DRUG TEST FOR MARIJUANA AND COCAINE ACON LABORATORIES, INC. EDWARD TUNG
K050878 06/08/2005 ON CALL MULTI-DRUG HOME TEST CUP ACON LABORATORIES, INC. EDWARD TUNG
K042297 06/01/2005 ULTRA IVALON AND ULTRA DRIVALON PVA EMBOLIZATION PARTICLES ACTA VASCULAR SYSTEMS, INC. RICHARD M RUEDY
K051351 06/08/2005 PRECEDENCE SPECT/CT IMAGING SYSTEM ADAC LABORATORIES COLEEN A COLEMAN
K050428 06/14/2005 TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) ADVANCED SPINAL TECHNOLOGIES, INC. JEFFREY R PERELMAN
K042644 06/01/2005 AESKULISA TTG A AND AESKULISA TTG G AESKU, INC STANLEY AMMONS
K051054 06/29/2005 VISULIZE FACTOR IX ANTIGEN KIT AFFINITY BIOLOGICALS INC. DENISE FOULON
K050953 06/29/2005 AIR SAFETY MODEL 3000/06 FILTER HEPA REUSABLE AIR SAFETY LTD PAUL DRYDEN
K051554 06/29/2005 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K043358 06/06/2005 REPROCESSED ULTRASONIC SCALPELS ALLIANCE MEDICAL CORP. ELIZABETH RENKEN
K051167 06/01/2005 REVOLIX AND REVOLIX JR ALLMED SYSTEMS INC. PETER N ALLEN
K050830 06/22/2005 ZODIAC SPINAL FIXATION SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K051286 06/17/2005 ZODIAC SPINAL FIXATION SYSTEM ALPHATEC/NEXMED ELLEN A YARNALL
K050445 06/17/2005 AMS COLLAGEN DERMAL MATRIX AMERICAN MEDICAL SYSTEMS, INC. ELSA LINKE
K051059 06/28/2005 AMSURE 100% SILICONE FOLEY CATHETER AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K050919 06/14/2005 LIFEGARD II FAMILY MULTI-FUNCTION PATIENT MONITOR, MODELS AN4320, AN4320P, AN4321P, AN4322P & AN3423P ANALOGIC CORP. DONALD SHERRATT
K050236 06/27/2005 FISHVIEW APPLIED SPECTRAL IMAGING, LTD. DAN LAOR
K043176 06/17/2005 ARC SURGICAL RESORBABLE COMPRESSION SCREW SYSTEM ARC SURGICAL LLC. ED BOEHMER
K033720 06/10/2005 ARI COLD SPRAY ARI RON ARKIN
K050790 06/06/2005 SPOTCHEM II LDH TEST ARKRAY, INC. HELEN LANDICHO
K051432 06/17/2005 SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS ARKRAY, INC. HELEN LANDICHO
K051219 06/29/2005 PUSHLOCK ARTHREX, INC. SALLY FOUST
K050864 06/17/2005 PARALLAX ACRYLIC RESIN WITH TRACERS TA ARTHROCARE CORP. VALERIE DEFIESTA-NG
K051069 06/29/2005 NONRESORBABLE CENTRALOC TIBIAL SCREW & WASHER ARTHROTEK, INC. GARY BAKER
K051187 06/08/2005 REXEED SERIES DIALYZERS ASAHI KASEI MEDICAL CO., LTD. DAVID L WEST
K050459 06/13/2005 ATRICURE ISOLATOR TRANSPOLAR PEN ATRICURE, INC. ELSA ABRUZZO
K051250 06/09/2005 AXYA, MODEL 6500 AXYALOOP BIO-ABSORBABLE BONE ANCHOR AXYA MEDICAL, INC. HOWARD L SCHRAYER
K051392 06/29/2005 BTI-SCAN, VERSION 4.0 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEYRE ZUNIGA HERNANDO
K051168 06/29/2005 BARRX HALO 360 SYSTEM, MODEL 1100C-115A BARRX MEDICAL, INCORPORATED JONATHAN S KAHAN
K051265 06/13/2005 ADVIA IMMUNO MODULAR SYSTEM (IMS) B-TYPE NATRIURETIC PEPTIDE (BNP) ASSAY BAYER HEALTHCARE, LLC ANDRES HOLLE
K050374 06/15/2005 ADVIA IMS LITHIUM ASSAY BAYER HEALTHCARE, LLC ANDRES HOLLE
K051307 06/13/2005 SYNCHRON SYSTEMS BEBZODIAZAPINE (EBNZ) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K051138 06/03/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFTRIAXONE (STREP) 0.0625 - 4UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K051109 06/15/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - ERYTHROMYCIN (STREP) 0.0156 - 4UG/ML BECTON, DICKINSON & CO. MINICA E GIGUERE
K051183 06/21/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - GATIFLOXACIN (STREP) 0.0625 -8UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K051204 06/24/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM CEFEPIME (STREP) 0.0625-4UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K042084 06/15/2005 BIODERM SCIENCES WOUND HEALING SPRAY BIODERM SCIENCES, INC. EDWARD R GUBISH
K050734 06/03/2005 COOL.CLICK BIOJECT, INC. MELANIE TALBERT
K051411 06/29/2005 ARCOMXL POLYETHYLENE LINERS AND BIOLOX DELTA HEADS BIOMET, INC. TRACY BICKEL JOHNSON
K050441 06/29/2005 TAPER 2 POROUS FEMORAL STEM BIOMET, INC. KACY ARNOLD
K050877 06/24/2005 CORONARY SINUS DEFLECTABLE MAPPING CATHETER, 4 FR, 5 FR, 6 FR & 7 FR BIOSENSE WEBSTER, INC. MICHAEL JOHNSON
K050799 06/29/2005 TRIAGE(R) D-DIMER CALIBRATION VERIFICATION CONTROLS; TRIAGE(R) D-DIMER CONTROLS BIOSITE INCORPORATED RACHAEL S WILLIAMSON
K051470 06/08/2005 REMOTE CARE MANAGEMENT SYSTEMS (RCMS) BL HEALTHCARE, INC. MICHAEL MATHUR
K043548 06/14/2005 BLACKSTONE UNITY ANTERIOR LUMBAR PLATE FIXATION SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K051246 06/14/2005 CONSTRUX MINI PEEK VBR SYSTEM BLACKSTONE MEDICAL, INC. DEAN E CIPORKIN
K050805 06/20/2005 30 ML OR 60 ML PEDI-SYRINGE FILTER BLOOD PRODUCTS SPECIALTIES LLC ALAN A WALDMAN
K050964 06/13/2005 PV 1900 SYNCHRO 0.016 GUIDEWIRE BOSTON SCIENTIFIC - PRECISION VASCULAR RICK GAYKOWSKI
K051361 06/16/2005 EASY CORE DETACHABLE BIOPSY SYSTEM BOSTON SCIENTIFIC CORP. CHRISTINE M CAMERON
K051179 06/08/2005 EZ PLUS RETRIEVAL SHEATH, MODEL 38899-150 BOSTON SCIENTIFIC CORP. CATHERINE A PETERS
K051504 06/16/2005 SPYSCOPE ACCESS AND DELIVERY CATHETER BOSTON SCIENTIFIC CORP. JENNIFER JOHNSON
K050599 06/03/2005 TRACKER EXCEL -14 PRE-SHAPED MICROCATHETER BOSTON SCIENTIFIC CORP. VICTOR HAM
K051254 06/22/2005 PERIPHERAL CUTTING BALLOON BOSTON SCIENTIFIC IVT RENUKA KRISHNAN
K050931 06/15/2005 6 FR DL POWERPICC CATHETER C.R. BARD, INC. PEGGY KEIFFER
K051417 06/30/2005 6 FR FL POWERHOHN AND POWERLINE CATHETER C.R. BARD, INC. PEGGY KEIFFER
K050673 06/13/2005 CANDELA FAMILY OF PULSE DYE LASER SYSTEMS CANDELA CORP. LORRAINE CALZETTA PATROVIC
K051228 06/10/2005 BIOZDX HEMODYNAMIC MONITOR AND 12-LEAD ECG CARDIODYNAMICS INTERNATIONAL CORP. DENNIS HEPP
K051283 06/23/2005 MODIFICATION TO BERNOULLI VENTILATOR MANAGEMENT SYSTEM SOFTWARE CARDIOPULMONARY CORP. JORDAN SCHRECK
K050844 06/23/2005 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K051207 06/21/2005 CAVEX ORTHOTRACE CAVEX HOLLAND B.V. RICHARD WOORTMAN
K051293 06/14/2005 CRANION CRANIAL FIXATION SYSTEM; FIXLOCK; CRANIAL SOLUTIONS; CEREMED FIXATION SYSTEM CEREMED, INC. TADEUSZ WELLISZ
K043558 06/06/2005 XINFENG HEAT LAMPS, MODELS, CQ-27,CQ-36, CQ-55, CQ-55A CHONGQING XINFENG MEDICAL INSTRUMENTS CO., LTD. GEORGE SU
K033591 06/03/2005 REPROCESSED TROCARS CLEAR MEDICAL, INC. MIKE KOVACS
K051415 06/23/2005 ENDOTINE RIBBON COAPT SYSTEMS, INC. LINDA RUEDY
K051243 06/23/2005 JET BLUE BITE COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K050998 06/15/2005 CONFLUENT SURGICAL MICROMYST APPLICATOR AND AIR PUMP, MODELS 20-5000, AP-A-6063 CONFLUENT SURGICAL,INC ERIC P ANKERUD
K043296 06/06/2005 COLACTIVE AG COLLAGEN WITH SILVER ANTIMICROBIAL DRESSING COVALON TECHNOLOGIES, INC. PAUL L GUILBAUD
K050779 06/27/2005 CYNERGY MULTIPLEX LASER CYNOSURE, INC. GEORGE CHO
K050928 06/29/2005 DADE THROMBIN REAGENT DADE BEHRING, INC. KATHELEEN A DRAY-LYONS
K051202 06/23/2005 DRIED GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. CYNTHIA VAN DUKER
K051460 06/15/2005 C.CAM-AC DANISH DIAGNOSTIC DEVELOPMENT A/S NIELS SORENSEN
K042891 06/29/2005 DATEX-OHMEDA OXY-AFR SENSOR DATEX-OHMEDA JOEL C KENT
K050860 06/21/2005 GE DATEX-OHMEDA CENTIVA/5 VENTILATOR DATEX-OHMEDA, INC. DAN KOSEDNAR
K050208 06/14/2005 FRIADENT ESTHETICAP DENTSPLY INTERNATIONAL HELEN LEWIS
K051462 06/24/2005 MODIFICATION TO: CERCON BASE DENTSPLY INTL. HELEN LEWIS
K051084 06/13/2005 DENVER PLEURX DRAINAGE KIT AND DENVER PLEURX VACUUM BOTTLE WITH DRAINAGE LINE DENVER BIOMEDICALS, INC. NANCY SAUER
K050523 06/15/2005 DIADEXUS PLAC TEST DIADEXUS, INC. JULIE BLACKLOCK
K040290 06/01/2005 DIASORIN LIAISON CMV IGM/IGG DIASORIN S.P.A. DAVID M IKEDA
K051258 06/01/2005 KODAK DIRECTVIEW DR 7500 SYSTEM, MODEL 8791345 EASTMAN KODAK COMPANY CHRISTINE E EHMANN
K051483 06/21/2005 KODAK DIRECTVIEW DR SYSTEM DETECTOR EASTMAN KODAK COMPANY CHRISTINE E EHMANN
K051225 06/10/2005 EKOS MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K051319 06/15/2005 MODIFICATION TO: LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K051022 06/01/2005 GAMMAPLAN ELEKTA INSTRUMENT AB PETER LOWENDAHL
K042686 06/16/2005 ENERGEX ENERGEX SYSTEMS, INC. TRISH LANDRY
K051308 06/01/2005 MYLAB 70 ULTRASOUND IMAGING SYSTEM ESAOTE, S.P.A. CARRI GRAHAM
K051036 06/02/2005 HARMONIC ACE CURVED SHEARS WITH PISTOL HANDLE AND HAND CONTROL, MODEL ACE23P, ACE36P ETHICON ENDO-SURGERY, INC. RACHEL D AUSTIN
K050845 06/29/2005 MONOCRYL PLUS ANTIBACTERIAL SUTURE ETHICON, INC. JENNIFER M PAINE
K051379 06/17/2005 PROTEGE RX GPS SELF-EXPANDING NITRINOL STENT EV3 CORPORATION GLEN D SMYTHE
K051335 06/21/2005 ACUMATCH 12/14 PRESS-FIT FEMORAL STEMS EXACTECH, INC. MARITZA ELIAS
K040871 06/01/2005 FACEMASTER FACIAL TONING SYSTEM FACEMASTER OF BEVERLY HILLS, INC. JIM ENGLAND
K050243 06/06/2005 IMMEDIA PROTHROMBIN TIME SYSTEM FARALLON MEDIAL INC JAMES MCKINLEY
K050738 06/02/2005 FT FIBER OPTIC DELIVERY SYSTEMS FIBERTECH GMBH ARMIN KAUS
K050424 06/23/2005 ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 FIM MEDICAL DANIEL KAMM
K050273 06/08/2005 FRESENIUS ART HEMOADSORPTION SYSTEM FRESENIUS MEDICAL CARE NORTH AMERICA JANET KAY
K051449 06/16/2005 GE VIVID 7 WITH OR WITHOUT SUFFIX GE MEDICAL SYSTEMS ALLEN SCHUH
K050583 06/21/2005 MODEL 250 SERIES MATERNAL/FETAL MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MELISSA ROBINSON
K051367 06/20/2005 PATIENT MONITOR, MODELS DASH 3000, 4000 AND 5000 GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES TYLER SEDONE
K050178 06/28/2005 HBA1C ENZYMATIC ASSAY GENERAL ATOMICS HUAN TRAN
K051471 06/29/2005 CARDIODAY GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG BERT SCHADOW
K051345 06/23/2005 COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET) GLOVCO (M) SDN. BHD. TAN PENG HOCK
K051166 06/07/2005 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH PLASTICIZER EBN&BET GLOVECO, INC. MICKY LIN
K050713 06/06/2005 DUET HS-CRP LIT ASSAY, CATALOG NUMBER: 4010, DUET HS-CRP CALIBRATOR SET, CATALOG NUMBER: 4511 GOOD BIOTECH CORP. VICTOR CHIOU
K051402 06/13/2005 ONEPASS NUCLEAR MEDICINE IMAGING SYSTEM GVI TECHNOLOGY PARTNERS KEVIN M MURROCK
K043480 06/08/2005 ENHANCE CLITORAL STIMULATION AID GYNAVATIONS, INC. DAVID GLOTH
K051103 06/07/2005 HAAG-STREIT CONTACT GLASSES STERY CUP, ACCESSORY HAAG-STREIT USA, INC. EDUARDO MARCH
K050277 06/07/2005 CHLORINATED POWDER FREE LATEX EXAMINATION GLOVES (YELLOW) HARTALEGA SDN BHD NURUL AISYAH KONG
K051546 06/24/2005 BPCALIBRATOR MC3000/MC3100 HEALTHSTATS INTERNATIONAL PTE. LTD. STEPHEN GORSKI
K051325 06/15/2005 WEBPAX, MODEL 200 HEART IMAGING TECHNOLOGIES, LLC ROBERT M JUDD
K050858 06/29/2005 ASCENTIA HEARTSTATION ECG MANAGEMENT SYSTEM HEARTLAB, INC. RICHARD PETROCELLI
K051154 06/20/2005 POWDERED VINYL PATIENT EXAMINATION GLOVES, WHITE (NON-COLORED) HEBEI MANFUL IMPORT & EXPORT CO., LTD. YANCHAI ZHANG
K043050 06/03/2005 HEMCON BANDAGE AND HEMCON BANDAGE OTC HEMCON, INC. JOHN W MORGAN
K051006 06/07/2005 IBOND NEXT GENERATION HERAEUS KULZER GMBH CHERYL V ZIMMERMAN
K050721 06/01/2005 ABX ERYTROL HORIBA ABX TIM LAWTON
K051363 06/23/2005 RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051306 06/17/2005 HOFFMANN II MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K050696 06/17/2005 MEDLITE C1 Q-SWITCHED ND:YAG LASER HOYA PHOTONICS, INC. JIM GREEN
K050852 06/22/2005 CLAVICULAPLATE WITH ANGULAR STABLITY BONE PLATE SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH ALBERT LIPPINCOTT
K051189 06/08/2005 PREVAIL DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JIM BANIC
K051196 06/17/2005 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT, MODEL 06-165-011X1 AND 06-166-051X1 IMPLEX CORP. MARCI HALEVI
K050662 06/13/2005 QUANTA LITE SP100 ELISA INOVA DIAGNOSTICS, INC. GARY L NORMAN
K051630 06/29/2005 SUPER VIEW DISPOSABLE BIOM LENS SET INSIGHT INSTRUMENTS, INC. MICHAEL ANNEN
K051408 06/29/2005 INTELIFUSE, INC. WARM SYSTEM WITH STIMULINKS INTELIFUSE, INC. SHARON ROCKWELL
K050538 06/07/2005 IMC DRAPES INTL. MEDSURG CONNECTION, INC. MANNY GUPTA
K050915 06/07/2005 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K050916 06/08/2005 SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] INTRALUMINAL THERAPEUTICS, INC. PAMELA MISAJON
K051037 06/28/2005 IMAGEQUBE PACS INTUITIVE IMAGING INFORMATICS, LLC DONALD MUNDT
K050802 06/29/2005 MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K051512 06/28/2005 CAC-127-8 CARDOAC ARRAY COIL INVIVO CORP. THOMAS SCHUBERT
K050156 06/17/2005 WHS-1000 WOUND HEALING SYSTEM IYIA TECHNOLOGIES, INC. ALAN DONALD
K051481 06/29/2005 JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP JAN MAO INDUSTRIES CO., LTD. KE-MIN JEN
K051482 06/29/2005 JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP JAN MAO INDUSTRIES CO., LTD. KE-MIN JEN
K051127 06/03/2005 KIKA IMAGING LAB VIEWER, MODEL 2.0.1.0 KIKA MEDICAL INC. HOWARD HOSTEIN
K051347 06/07/2005 KIMBERLY-CLARK* STERLING* NITRILE POWDER-FREE EXAMINATION GLOVE KIMBERLY-CLARK CORP. RICHARD V WOLFE
K051521 06/28/2005 REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K050918 06/06/2005 KOO AMERICAS VALVE PEEP, MODEL KM-809 KOO AMERICAS, INC. WILLIAM SLEVIN
K043314 06/20/2005 MANZI CLEANER SYSTEM LANGFORD IC SYSTEMS, INC. TERRY LANGFORD
K051608 06/29/2005 STAR 50 MONITORING SYSTEM LARSEN & TOUBRO LIMITED E.J. SMITH
K043479 06/30/2005 MC+ PARTIAL VBR LDR SPINE USA BRIAN BURKINSHAW
K043349 06/29/2005 OPEN RADIOTRANSPARENT INTERSOMATIC IMPLANT (ROI) LDR SPINE USA BRAIN BURKINSHAW
K051387 06/10/2005 LEVO COMFORT II LEVO AG MARKUS BURGER
K051088 06/24/2005 MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. CHENG-I LIN
K050733 06/13/2005 OXYCODONE ENZYME IMMUNOASSAY AND OXYCODONE CALIBRATORS AND CONTROLS LIN-ZHI INTERNATIONAL, INC. CHENG-I LIN
K051416 06/16/2005 SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA MALLINCKRODT MEDICAL PATRICK GARVEY
K041177 06/23/2005 SYNTHACER; SYNTRICER MEDARTIS MEDIZINPRODUKTE UND FORSCHUNG AG HANS-PETER WETTL
K051499 06/22/2005 INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET MEDEGEN MEDICAL MANUFACTURING SERVICES SALVADORE F PALOMARES
K051247 06/16/2005 SONOTIP II ULTRASOUND NEEDLE SYSTEM MEDI-GLOBE CORP. SCOTT KARLER
K050478 06/15/2005 MEDICON IMF-ORION SCREWS MEDICON, E.G. JOACHIM SCHMID
K042164 06/09/2005 SILVER ANTIMICROBIAL WOUND GAUZE (SPONGE) MEDLINE INDUSTRIES, INC. BRUCE GIBBINS
K051448 06/29/2005 MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) MEDOC LTD. ADVANCED MEDICAL SYSTEMS GEORGE J HATTUB
K051349 06/23/2005 3.0T PROSTATE IMAGING SYSTEM MEDRAD, INC. LISA A EWING
K050456 06/17/2005 MEDRAD AVANTA FLUID MANAGEMENT INJECTION SYSTEM MEDRAD, INC. GEOFF M FATZINGER
K050371 06/07/2005 MEDRAD VANGUARD DX ANGIOGRAPHIC CATHETER MEDRAD, INC. GEOFF M FATZINGER
K051303 06/10/2005 BIO-CONSOLE, MODEL 560 MEDTRONIC PERFUSION SYSTEMS DAWN M STENSTROM
K051105 06/09/2005 BASIS VERTEBRAL BODY SPACER MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K050809 06/14/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K050082 06/06/2005 CENTERPIECE PLATE FIXATION SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD W TREHARNE, PHD.
K051029 06/08/2005 STELTHSTATION WIRELESS SURGEON MOUSE MEDTRONIC SURGICAL NAVIGATION TINA DREILING
K050438 06/02/2005 STEALTHSTATION SYSTEM UPDATE MEDTRONIC SURGICAL NAVIGATION TECHNOLOGIES TINA DREILING
K050008 06/03/2005 MENTOR SELF-CATH HYDROGEL INTERMITTENT CATHETER MENTOR CORP. DONNA A CRAWFORD
K051321 06/13/2005 INVIEW METRIKA, INC. ERIKA B AMMIRATI
K051425 06/22/2005 NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K051560 06/28/2005 NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K051074 06/06/2005 MAS IMMUNOSUPPRESSANT CONTROLS MICROGENICS CORP. LISA CHARTER
K050954 06/28/2005 MICROPLEX COIL SYSTEM (MCS) AND HYDROCOIL EMBOLIC SYSTEM (HES) MICROVENTION, INC. VINCENT CUTARELLI
K050776 06/06/2005 AUSS-6 ULTRASONIC SURGICAL ASPIRATOR SYSTEM MISONIX, INC. RONALD R MANNA
K051007 06/16/2005 ACCU02 SYSTEM MITI CORP. JONATHAN S KAHAN
K050072 06/13/2005 GOODKNIGHT 425ST NELLCOR PURITAN BENNETT, INC. JAMES BONDS
K050603 06/09/2005 OLPUR DIALYZER, MODEL HD 190 NEPHROS, INC. NADIA C GREENIDGE
K050784 06/01/2005 NICHOLS ADVANTAGE ALDOSTERONE ASSAY NICHOLS INSTITUTE DIAGNOSTICS XIE QIYI
K050406 06/08/2005 NOBELSPEEDY IMPLANTS NOBEL BIOCARE AB ELIZABETH J MASON
K050649 06/13/2005 SILVERSEAL CONTACTING WOUND DRESSING WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. WILLIAM F MCNALLY
K050056 06/21/2005 MODEL 2500A PALMSAT PULSE OXIMETER NONIN MEDICAL, INC. LORI ROTH
K051107 06/01/2005 ONYX II FINGER PULSE OXIMETER, MODEL 9550 NONIN MEDICAL, INC. LORI M ROTH
K050727 06/13/2005 MODIFICATION TO NXSTAGE CARTRIDGE EXPRESS NXSTAGE MEDICAL, INC. NORMA LEMAY
K050525 06/24/2005 NXSTAGE SYSTEM ONE NXSTAGE MEDICAL, INC. NORMA LEMAY
K050885 06/03/2005 OLYMPUS ULTRASONIC SURGICAL SYSTEM SONOSURG OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K051551 06/28/2005 SMALL INTESTINAL VIDEOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K051233 06/21/2005 OMRON MODEL 514N TYMPANIC THERMOMETER OMRON HEALTHCARE, INC. IWAO KOJIMA
K050568 06/01/2005 ORLUS MINI SCREW ORTHOLUTION CO., LTD. CATHRYN N CAMBRIA
K050795 06/03/2005 IMBIBE BONE MARROW ASPIRATION NEEDLE ORTHOVITA, INC. JANICE M HOGAN
K041382 06/17/2005 POLYGRAFT BGS; BONE GRAFT SUBSTITUTE OSTEOBIOLOGICS, INC. GABRIELE G NIEDERAUER, PH.D.
K050370 06/15/2005 PALOMAR LUXIR HANDPIECE PALOMAR MEDICAL TECHNOLOGIES, INC. MARCY MOORE
K041496 06/30/2005 PENTATRASFU BLOOD TRANSFUSION SETS PENTAFERTE S.P.A VICTOR PEREIRA
K051218 06/09/2005 MODIFICATION TO: UNICAP SPECIFIC IGE PHARMACIA DIAGNOSTICS AB MARTIN R MANN
K043408 06/08/2005 PIEZOSURGERY DEVICE PIEZOSURGERY SRL MARIA E DONAWA
K051464 06/24/2005 PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) PLANMECA OY BOB PIENKOWSKI
K051317 06/20/2005 POLYMER COATED POWDER FREE NITRILE EXAMINATION GLOVES, BLUE, GREEN AND WHITE COLOR PLATINUM GLOVE INDUSTRIES SDN.BHD. SO SOON CHEAW
K051318 06/17/2005 POWDER FREE NITRILE EXAMINATION GLOVES (WHITE, BLUE, AND PURPLE COLOR) PLATINUM GLOVE INDUSTRIES SDN.BHD. SO SOON CHEAW
K031196 06/07/2005 SURGETICS ORTHO KNEELOGICS NAVIGATION SYSTEM PRAXIM SHEILA HEMEON-HEYER
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