FDA 510(k) Decisions During March, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K043217 03/03/2005 A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K050501 03/14/2005 MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT VASCULAR DEVICES ANN E LEONARD
K050552 03/28/2005 PACHPEN PACHYMETER, MODEL 24-5100 ACCUTOME, INC. JEFFREY L WRIGHT
K043581 03/03/2005 DUAL LUMEN CATHETER ACMI CORPORATION GRAHAM BAILLIE
K050050 03/11/2005 ON CALL MULTI-DRUG HOME TEST ACON LABORATORIES, INC. EDWARD TUNG
K043361 03/22/2005 ACCUHEART ELECTRODE BELT ADVANCED BIOELECTRIC CORPORATION MARC-ANDRE COTE
K050241 03/14/2005 AOS HUMERAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. GARY SOHNGEN
K040883 03/15/2005 EVOTECH INTEGRATED ENDOSCOPE DISINFECTION SYSTEM ADVANCED STERILIZATION PRODUCTS NEELU MEDHEKAR
K042945 03/09/2005 AURA CPAP SYSTEM AEIOMED INC. Gary Syring
K042344 03/16/2005 EXCIA TOTAL HIP SYSTEM AESCULAP, INC. JOYCE KILROY
K050338 03/04/2005 MODIFICATION TO: INSTAREAD LITHIUM SYSTEM Akers Biosciences, Inc. ERIKA AMMIRATI
K033436 03/16/2005 REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER ALLIANCE MEDICAL CORP. MOIRA BARTON
K043392 03/25/2005 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. MOIRA BARTON
K043393 03/23/2005 REPROCESSED EP TECHNOLOGIES ELECTROPHYSIOLOGY CATHETERS ALLIANCE MEDICAL CORP. JENN SELVEY
K050390 03/14/2005 TAMARACK ANTERIOR THORACOLUNBAR ALPHATEC/NEXMED ELLEN A YARMALL
K050186 03/04/2005 AMEDITECH IMMUTEST MULTI-DRUG SCREEN PANEL III AMEDITECH, INC. JOHN WU
K042972 03/18/2005 XP TECHNOLOGY ULTRASONIC SCALER AMERICAN EAGLE INSTRUMENTS, INC. TOM THOMPSON
K050413 03/04/2005 AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 AMPLIFE CORPORATION SUSAN D GOLDSTEIN-FALK
K050551 03/22/2005 VOYAGER PERSONAL IMAGING DEVICE Ardent Sound, Inc. PETER G BARTHE
K050634 03/21/2005 MODIFICATION TO: ARTHREX V-TAK ARTHREX, INC. ANN WATERHOUSE, RAC
K050201 03/18/2005 AEU-14CF EXPENDITION ASEPTICO, INC. GRANT RAMALEY
K050052 03/07/2005 ATLANTIS ABUTMENT FOR STRAUMANN INTERFACE ATLANTIS COMPONENTS, INC. BETSY A BROWN
K043556 03/28/2005 SYNCHRON SYSTEMS BENZODIAZEPINE (BNZG) REAGENT BECKMAN COULTER, INC. ANNETTE HELLIE
K043458 03/15/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEFOTETAN (GN) 2-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K050400 03/22/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K024258 03/04/2005 NEUROTECH KNEEHAB BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K050536 03/24/2005 QUEST DIAGNOSTICS IMMUNOASSAY/TDM CONTROL BIO-RAD MARIA ZEBALLOS
K050328 03/29/2005 PREGNANCY-SKREEN BIOCHEMICAL DIAGNOSTIC, INC. ALLEN PANETZ
K050318 03/04/2005 BARI-KAD PACKING DEVICE BIOENVELOP AGRO, INC. ROBERT SCHIFF
K042981 03/10/2005 HYPERQ SYSTEM BIOLOGICAL SIGNAL PROCESSING LTD. ARAVA HACOHEN
K042711 03/14/2005 MODEL BMLS03-7 BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K050028 03/25/2005 MAESTRO CARPAL HEMIARTHROPLASTY BIOMET MANUFACTURING, INC. PATRICIA SANDBORN BERES
K042051 03/08/2005 ARCOMXL POLYETHYLENE LINERS BIOMET, INC. TRACY J BICKEL
K042091 03/25/2005 BIOLOX DELTA CERAMIC HEADS BIOMET, INC. PATRICIA SANDBORN BERES
K043521 03/24/2005 BIOSYAG 50 MED BIOS S.R.L. ALESSANDRO FRANCHI ONDE
K042999 03/21/2005 CARTO XP EP NAVIGATION SYSTEM, SOFTWARE VERISON 8 BIOSENSE WEBSTER, INC. MARK O'DONNELL
K050217 03/30/2005 FLOWER HIGH-DENSITY MAPPING CATHETER, 4-4-4 MM ELECTRODE SPACING), (2-6-2 MM ELECTRODE SPACING) BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K050037 03/22/2005 TRIAGE TOX DRUG SCREEN CONTROLS BIOSITE INCORPORATED JEFFREY R DAHLEN
K042373 03/02/2005 GALEO FOCUS GUIDE WIRE BIOTRONIK, INC. Jon Brumbaugh
K050630 03/22/2005 PIVOT STEERABLE MICROCATHETER BOSTON SCIENTIFIC - PRECISION VASCULAR RICK GAYKOWSKI
K050577 03/30/2005 ATLANTIS SR PRO2 CORONARY IMAGING CATHETER, MODEL 39014 BOSTON SCIENTIFIC CORP. VERONICA M KOCKEN
K050361 03/14/2005 MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K050232 03/11/2005 RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K050403 03/04/2005 SPYGLASS DIRECT VISULATION PROBE BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K042696 03/11/2005 BODYGUARD INFUSION PUMP SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. GALI TZURY
K043590 03/25/2005 SE INFUSION SYSTEM WITH MMS CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K042672 03/23/2005 14F DUAL FLOATING DIALYSIS CATHETER/TRAY CARDIOMED SUPPLIES, INC. CHRISTIAN G DUBE
K050172 03/31/2005 CARDIASSIST COUNTER PULSATION SYSTEM SERIES 4000/5000 CARDIOMEDICS, INC. JOHN HUTCHINS
K050366 03/17/2005 IMAGENPRO CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC MELANIE HASEK
K050345 03/29/2005 CIE FOLDAWAY WHEELCHAIR CARLSBAD INTERNATIONAL EXPORT, INC. LAURA MEYER
K050440 03/24/2005 AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 CEREMED, INC. TADEUSZ WELLISZ
K043133 03/02/2005 AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT, CEREPOR CEREMED, INC. TADEUSZ WELLISZ
K043580 03/24/2005 ALLIGATOR RETRIEVAL DEVICE (ARD) CHESTNUT MEDICAL TECHNOLOGIES, INC. ANNA LONGWELL
K050213 03/28/2005 FRESHLOOK ONE-DAY COLOR CONTACT LENS CIBA VISION CORPORATION ANGELA L BUNN
K042058 03/23/2005 ONEFLOW FVC, ONEFLOW FVC (KIT), ONEFLOW FVC SCREEN CLEMENT CLARKE INTL., LTD. PHILIP HALLYBONE
K050111 03/08/2005 SMARXT BMR 1900 CLOSED VENOUS RESERVOIR BAG COBE CARDIOVASCULAR, INC. EDWARD E NEWTON
K050426 03/18/2005 TEMPOSIL, MODEL 6720 COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K043570 03/14/2005 UNICONDYLAR KNEE REPAIR SYSTEM / CONFORMIS UCD CONFORMIS, INC. LYNDALL ERB
K050304 03/08/2005 FX WIRE ADVANCED MEASUREMENT GUIDEWIRE CONMED CORP. THOMAS HIRTE
K050337 03/09/2005 SIS FISTULA PLUG COOK BIOTECH, INC. MARK BLEYER
K050294 03/31/2005 COOK IRELAND SONNET POLYPECTOMY SNARE COOK IRELAND LTD EMMETT DEVEREUX
K043418 03/31/2005 COOK PEDIATRIC FLEXOR URETERAL ACCESS SHEALTH COOK UROLOGICAL, INC. CINDY RUMPLE
K050698 03/30/2005 MODIFICATION TO:ZILVER 518 BILIARY STENT COOK, INC. STEPHANIE ROBERTS
K050084 03/17/2005 COSMAN RF LESION GENERATOR, MODEL RFG-1A; COSMAN TEW TRIGEMINAL ELECTRODE KIT; COSMAN TIC TRIGEMINAL ELECTRODE KIT; COSMAN MEDICAL, INC. MICHAEL ARNOLD
K050272 03/24/2005 CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS CRYOMEDICAL INSTRUMENTS, LTD. GARETH COPPING
K050509 03/25/2005 LSO PET/CT HIREZ SERIES, MODELS 2I, 6I, 16I, 64I CTI PET SYSTEMS, INC. ALAINE MEDIO
K050047 03/31/2005 CUTERA OPTIONAL PULSED LIGHT HAND PIECE FAMILY CUTERA, INC. KATHY MAYNOR
K050679 03/31/2005 CUTERA SOLERA OPUS AESTHETIC PRODUCT CUTERA, INC. KATHY MAYNOR
K042626 03/28/2005 NEUROPORT NEURAL SIGNAL PROCESSOR (NSP) SYSTEM CYBERKINETICS, INC. BURKE T BARRETT
K042384 03/29/2005 NEUROPORT RECORDING MICROELECTRODE ARRAY SYSTEM CYBERKINETICS, INC. (CKI) BURKE T BARRETT
K050585 03/18/2005 MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS AMOXICILLIN/K. CLAVULANATE DADE BEHRING, INC. ROBERT EUSEBIO
K050043 03/29/2005 MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN DADE BEHRING, INC. CYNTHIA VAN DUKER
K050626 03/25/2005 GE DATEX-OHMEDA AESPIRE 7900 ANESTHESIA SYSTEM DATEX-OHMEDA, INC. DAN KOSEDNAR
K050597 03/25/2005 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR
K043120 03/01/2005 MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER DATEX-OHMEDA, INC. JOEL KENT
K043223 03/04/2005 DEPUY CAS KNEE INSTRUMENTATION DEPUY ORTHOPAEDICS, INC. RANDA FRANKLIN
K043058 03/14/2005 PINNACLE CONSTRAINED ACETABULAR LINERS DEPUY, INC. Natalie Heck
K043344 03/23/2005 DIALYSIS SERVICES WATER TREATMENT & DISTRIBUTION SYSTEM DIALYSIS SERVICES, INC. MIKE STERLING
K050447 03/08/2005 PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DIDECO S.R.L. BARRY SALL
K043491 03/16/2005 ENFANTTM DIOPSYS INC. JOSEPH FONTANETTA
K050091 03/16/2005 TRIPTER-X1 COMPACT DUET SP (SEPARATED PULSE) DIREX SYSTEMS CORP. LARISA GERSTEIN
K042887 03/18/2005 ACCU-CHEK SPIRIT DISETRONIC MEDICAL SYSTEMS AG Scott Thiel
K043235 03/08/2005 DRAGON HEART I.V. SET DRAGON HEART MEDICAL DEVICES CO., LTD. JINA YU
K050710 03/30/2005 MINIMASTER ULTRASONIC SCALER E.M.S. ELECTRO MEDICAL SYSTEMS S.A. CYNTHIA J.M. NOLTE
K050627 03/22/2005 LIFESTENT TURBO BILIARY STENT SYSTEMS EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K050563 03/29/2005 EKOS PERIPHERAL INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K050472 03/11/2005 LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K050070 03/25/2005 K-LASER, MODELS 3,4,4D,6D ELTECH, S.R.L. RICHARD ALBRIGHT
K041066 03/24/2005 ENCORE REVERSE SHOULDER PROSTHESIS ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K042556 03/11/2005 SHINEBALL PVC MANUAL RESUSCIATOR, ENT-1001, ENT-1003, ENT-1005, SHINEBALL SILICONE MANUAL RESUSCIATOR, ENT-1022, ENTER MEDICAL CORPORATION TZONG-FUH KUO
K043467 03/31/2005 FLEXIBLE SPINAL NEEDLE EPIMED INTERNATIONAL, INC. CHRISTOPHER LAKE
K050344 03/14/2005 LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER ETHICON ENDO SURGERY, INC. KIMBERLY SHOEMAKER
K050205 03/04/2005 BENEPHIT BIFURCATED INFUSION CATHETER AND 5FR. INTRODUCER SHEATH FLOWMEDICA, INC. JEFF ELKINS
K042727 03/18/2005 POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A FOREMOUNT ENT. CO., LTD. TYSON HSU
K050293 03/18/2005 FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS FOTONA D.D. STOJAN TROST
K043363 03/31/2005 FRESENIUS LIBERTY CYCLER FRESENIUS MEDICAL CARE NORTH AMERICA ARTHUR EILINSFELD
K042797 03/09/2005 WRO 300 WATER PURIFICATION SYSTEM FOR HEMODIALYSIS GAMBRO RENAL PRODUCTS ROD J RYLANDS
K042699 03/16/2005 ABILITY POWER GURNEY GATOR CUSTOM MOBILITY, INC. GREGORY S SIMS
K043493 03/04/2005 FUSION PUTTY TYPE GC AMERICA, INC. TERRY JORITZ
K050559 03/17/2005 GE DISCOVERY VCT SYSTEM GE MEDICAL SYSTEMS D DUERSTELER
K050489 03/11/2005 INNOVA 2100 GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K043144 03/14/2005 GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE GEN-PROBE, INC. ALAN MADERAZO
K050255 03/17/2005 ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 GENDEX DENTAL SYSTEMS JOHN R MILLER
K050195 03/17/2005 V-BAG WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K050144 03/03/2005 PRISMATIK CERAMIC GLIDEWELL LABORATORIES KEITH D ALLRED
K043033 03/22/2005 GLOBAL TREASURES FLUID FILLED TEETHER GLOBAL TREASURE INDUSTRIES LTD. FRAN WHITE
K043352 03/31/2005 GOCANNING GLS-700 E-PULSE ANALYSIS MONITOR GOCANNING TECHNOLOGY LTD. JENNIFER REICH
K041999 03/02/2005 GYRUS PLASMA SKIN RESURFACING SYSTEM GYRUS MEDICAL, INC. MARK JENSEN
K041781 03/14/2005 VENTILAIR II MEDICAL AIR COMPRESSOR HAMILTON MEDICAL AG J. DAVID THOMPSON
K050214 03/16/2005 NITRILE POWDER FREE EXAMINATION GLOVES (WHITE) HARTALEGA SDN BHD KUAN EU JIN
K050215 03/11/2005 NITRILE POWDERED EXAMINATION GLOVES (WHITE) HARTALEGA SDN BHD KUAN EU JIN
K043261 03/11/2005 HARVEST GRAFT DELIVERY SYRINGE HARVEST TECHNOLOGIES, CORP. JACK BONASERA
K050491 03/31/2005 H & L FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888KA, HL888LF & HL888IF HEALTH & LIFE CO., LTD. PAUL HUNG
K050249 03/30/2005 HL168JP HEALTH & LIFE CO., LTD. PAUL HUNG
K033646 03/01/2005 TRIFIT 700 HEALTHFIRST CORP. JAY SKOLNIK
K050295 03/25/2005 PRESS TACK/INTRADERMAL ACUPUNCTURE NEEDLES HELIO MEDICAL SUPPLIES, INC. ERIC CHENG
K050163 03/24/2005 HENKE SASS WOLF OF AMERICA BARIATRIC LAPAROSCOPE HENKE SASS WOLF OF AMERICA, INC. LYNETTE HOWARD
K050048 03/04/2005 HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K050539 03/29/2005 SIZE 1 TRIATHLON POSTERIOR STABILIZED (PS) TIBIAL INSERT HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K050138 03/21/2005 MODIFICATION TO: RESTORATION MODULAR SYSTEM HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K050512 03/21/2005 STRYKER LOCKED PLATING SYSTEM HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K043331 03/04/2005 DIGITAL FOREHEAD THERMOMETER, MODEL FS-100 HUBDIC CO., LTD GUENTER GINSBERG
K043433 03/07/2005 AUTOSTAT II ANTI-TISSUE TRANSGLUTAMINASE IGG ELISA HYCOR BIOMEDICAL LTD. DANIELLE M KNIGHT
K043451 03/17/2005 BIOPHEN NORMAL AND ABNORMAL CONTROL PLASMA; BIOPHEN PLASMA CALIBRATOR HYPHEN BIOMED OLA ANDERSON
K041881 03/25/2005 ADVANCE MICRO-DRAW BLOOD GLUCOSE MONITORING SYSTEM, MODEL 411100 HYPOGUARD USA, INC. BRUCE A MACFARLANE
K041374 03/02/2005 AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 IDEV TECHNOLOGIES, INC. LYNNE A DAVIES
K050145 03/15/2005 CELLTRACKA ANALYZER II IMMUNICON CORP. PETER SCOTT
K050275 03/07/2005 MODIFICATION TO: INION OTPS BIODEGRADABLE PIN INION LTD. HANNA MARTTILA
K041838 03/01/2005 MPS (OR MPS-T) INNERSPACE, INC. DONALD E BOBO
K050108 03/14/2005 SUREFLEX AND ACCUFLEX LASER LITHOTRIPSY FIBERS INNOVAQUARTZ STEVE GRIFFIN
K042208 03/18/2005 ISIS MER SYSTEM/ELEKTA MER SYSTEM INOMED MEDIZINTECHNIK GMBH ANDERS SKOGLUND
K050278 03/10/2005 HEMOSIL D-DIMER INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K050221 03/30/2005 HEMOSIL SILICA CLOTTING TIME INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K050492 03/14/2005 INTEGRA BONE FIXATION SYSTEM INTEGRA LIFESCIENCES CORP. DONNA WALLACE
K050319 03/31/2005 MAYFIELD MR/CT SKULL CLAMP, MODEL 4-0-A-1104 INTEGRA LIFESCIENCES CORP. CHARLES E DINKLER II
K042893 03/11/2005 UNDER BUTTOCKS DRAPE INTERNATIONAL MEDSURG CONNECTION, INC. TEODORO SANTIAGO
K043288 03/03/2005 MODIFICATION TO INTUITIVE SURGICAL DA VINCI SURGICAL SYSTEM AND ENDOSCOPIC INSTRUMENTS INTUITIVE SURGICAL, INC. USHA KREADEN
K050276 03/07/2005 DIVER C.E. CATHETER INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. PATRICE STROMBERG
K050301 03/24/2005 MRIDIUM 3850 MRI PUMP SYSTEM IRADIMED CORPORATION FRANCIS X CASEY
K050235 03/23/2005 IQ 200 URINE ANALYZER BODY FLUIDS MODULE IRIS INTERNATIONAL, INC. HARVEY L KASDAN
K040419 03/25/2005 DYNAGRAFT II ISOTIS ORTHOBIOLOGICS, INC ELIANE SCHUTTE
K043497 03/21/2005 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
K042102 03/08/2005 YIXIN SAFETY SYRINGE JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP LIU KUN SHENG
K042040 03/23/2005 TRIACTIV SYSTEM KENSEY NASH CORP. ROBIN M FATZINGER
K043591 03/04/2005 FEATHERLIFT EXTENDED APTOS THREAD KMI KOLSTER METHODS, INC. KEITH DAVIS
K042418 03/21/2005 KD-575 MEMORY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR KODON(TIANJIN)ELECTRONIC&ELECTRICAL APPARATUS CO., LIU YI
K041565 03/03/2005 LAZRPULSR 4X LED HEALING LIGHT LLC MICHAEL B KINDER
K043357 03/04/2005 TOSCA 500 PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM, MODEL 5202009 LINDE MEDICAL SENSORS AG JEAN-PIERRE PALMA
K050497 03/25/2005 BIOSCREW XTRALOK, 8X35MM & 8X40MM VIOLET LINVATEC CORP. ELIZABETH PAUL
K050227 03/02/2005 THREVO SUTURE ANCHOR WITH DISPOSABLE DRIVER LINVATEC CORP. ELIZABETH M PAUL
K050639 03/31/2005 LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM LUMENIS, INC. MARTHA MURARI
K050504 03/25/2005 VALIDATE URINE CHEMISTRY CALIBRATION VERIFICATION TEST SETS MAINE STANDARDS CO. CHIRSTINE BEACH
K050066 03/01/2005 C-CO2 COLORIMETRIC CO2 INDICATOR MARQUEST MEDICAL PRODUCTS, INC. THOMAS W DIELMANN
K050040 03/30/2005 MS-753 MARS INFLATE-READ BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS E.J. Smith
K050039 03/25/2005 MS-930 MARS INFLATE-READ BLOOD PRESSURE MONITOR MARS MEDICAL PRODUCTS E.J. Smith
K050372 03/25/2005 VISITRAK, VERSION 1, RELEASE 1 MATH RESOLUTIONS, LLC. WENDEL DEAN RENNER
K043292 03/16/2005 HEMOCATH MED-CONDUIT, INC. ROBERT W CUNNINGHAM
K043454 03/24/2005 CARDIOPAL AI WITH DIOGENES SV (CARDIOPAL SV), MODEL PM410 MEDICOMP, INC. SUSAN D GOLDSTEIN-FALK
K032666 03/16/2005 MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES MEDLINE INDUSTRIES, INC. LARA SIMMONS
K043585 03/08/2005 MEDLINE SURGICAL GOWNS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K043017 03/08/2005 PREVENTION BREATHABLE, IMPERVIOUS SURGICAL GOWNS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K033577 03/18/2005 UNISCAN, PULMOSCAN, PULMOSCAN RADIOGRAPHIC SYSTEMS MEDLINK IMAGING DANIEL KAMM
K050584 03/22/2005 GS-128 GRADIENT COMPRESSION SYSTEM MEDMARK TECHNOLOGIES, LLC MARK HIGGINS
K043600 03/29/2005 MEDTRONIC MICROMED 407C INFUSION PUMP, MODEL MMT-407C MEDTRONIC MINIMED GERDA P RESCH
K043488 03/21/2005 MODIFICATION TO CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K050439 03/24/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K050139 03/22/2005 MODIFICATION TO: EXPORT CATHETER MEDTRONIC VASCULAR FRED L BOUCHER
K050162 03/03/2005 CONTACT EMG ROTATABLE ENDOTRACHEAL TUBE MEDTRONIC XOMED, INC. DAVID S DODD
K050579 03/24/2005 MEGA POWER ELECTROSURGICAL GENERATOR MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K050148 03/09/2005 MENTOR ARIS TRANS-OBTURATOR TAPE AND SURGICAL KIT MENTOR CORPORATION DONNA CRAWFORD
K050457 03/14/2005 MERETE METAFIX SMALL FRAGMENT BONE PLATE SYSTEM MERETE MEDICAL GMBH JENIK RADON
K041626 03/16/2005 IMMUNOCARD STAT! FLU A & B MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K050206 03/15/2005 CEDIA TACROLIMUS ASSAY MICROGENICS CORP. LISA CHARTER
K043013 03/04/2005 MILTEX LAPAROSCOPIC INSTRUMENTS MILTEX, INC. CHARLES WEAVER
K040335 03/30/2005 MOONCUP, STYLE A & B MOONCUP LLC MORRIS WAXLER
K050125 03/18/2005 RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4 MORE DIAGNOSTICS JAMES W SNIPES
K043183 03/25/2005 EPI-K MORIA S.A. ELANIE RENAUD-SAMIRI
K050514 03/25/2005 MODELS FAC-63 AND FAC-127 FOOT AND ANKLE COILS MRI DEVICES CORPORATION THOMAS SCHUBERT
K040262 03/17/2005 DBX DEMINERALIZED BONE MATRIX PUTTY, BONE MATRIX PASTE AND BONE MATRIX MIX MUSCULOSKELETAL TRANSPLANT FOUNDATION KATHLEEN M LAFFAN
K043398 03/01/2005 MODIFICATION TO VASCUPUNCTURE PICC GUIDEWIRE NEO METRICS, INC. GENE CHAMPEAU
K043195 03/07/2005 NEO IMPLANT SYSTEM NEOSS LTD RUSSELL PAGANO
K050737 03/31/2005 NEOTHERMIA EN-BLOC BIOPSY SYSTEM NEOTHERMIA CORPORATION DAVID JACOBS
K050346 03/17/2005 STABILIZATION SCREW NEWDEAL S.A. JUDITH E O'GRADY
K050697 03/25/2005 MODEL DS-1901 DIGITAL BLOOD PRESSURE MONITOR NIHON SEIMITSU SOKKI CO., LTD. LYNETTE HOWARD
K043526 03/10/2005 SILVERSEAL TUBULAR WOUND DRESSING WITH X-STATIC NOBLE FIBER TECHNOLOGIES, INC. PATRICIA DAVIDSON
K042109 03/09/2005 DIASYS INTEGRA II NOVACOR FRANCE DOMINIQUE GRENIER
K043541 03/10/2005 ENDOLINK TRUE MOVEMENT SYSTEM NOVARE SURGICAL SYSTEMS, INC. GREGORY MATHISON
K050106 03/30/2005 NOVOFINE AUTOCOVER 30G X 8MM NOVO NORDISK INC. JOHN SIGNORIN
K041715 03/24/2005 INTRACAVITARY MOULD APPLICATOR SET, MODEL 189.001 NUCLETRON CORP. LISA DIMMICK
K043436 03/17/2005 NXSTAGE DIALYSATE PREPARATION MODULE, MODEL NX0269 NXSTAGE MEDICAL, INC. NORMA LEMAY
K050237 03/18/2005 STARSHIELD V3 RF TRNT ODIN MEDICAL TECHNOLOGIES LTD. ADI ICKOWICZ
K050416 03/29/2005 OSSAPLAST ORTHO OSSACUR AG KRISTI KISTNER
K043063 03/24/2005 OXYBAND WOUND DRESSING OXYBAND TECHNOLOGIES, INC. MAUREEN O'CONNELL
K043317 03/15/2005 OMNILUX PLUS PHOTO THERAPEUTICS LIMITED STEVEN G HUTSON
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K042901 03/16/2005 ENDOMARK STERILE INDIA INK PMT CORP. JAMES R VEALE
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K043613 03/24/2005 Q-SWITCHED ND:YAG OPHTALMIC LASER (WITH SLIT LAMP), MODEL OPTIMIS II QUANTEL MEDICAL ROGER W BARNES
K050667 03/29/2005 R2 FAMILY OF IMAGE DISPLAY UNITS WITH R2 UNIFORM DISPLAY SOFTWARE R2 TECHNOLOGY, INC. RICHARD BALL
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K050184 03/16/2005 BIOGEL SKINSENSE POLY-ISOPRENE POWDER-FREE NON-LATEX GLOVE REGENT MEDICAL AMERICAS, LLC KATHLEEN HARRIS
K042319 03/10/2005 RELIANT LASER II SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. HEATHER TANNER
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K050359 03/16/2005 ULTRA MIRAGE II MASK RESMED LTD. DAVID D'CRUZ
K042523 03/18/2005 RESECTION PUMP, RESECTOSCOPE FOR CHIP ASPIRATION, ENDOSCOPE 25/ 3.3 MM, ACCESSORIES RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K043303 03/11/2005 ONLINE DAT PROPOXYPHENE PLUS ROCHE DIAGNOSTICS CORP. KERWIN KAUFMAN
K040202 03/04/2005 SALTER LABS CPAP HIGH FLOW CANNULA SYSTEM SALTER LABS DUANE KAZAL
K043204 03/30/2005 SGARLATO LABS PAINFREE PUMP AND PAIN CONTROL INFUSION PUMP SGARLATO LABORATORIES, INC. MICHAEL MCDOUGALL
K050360 03/01/2005 TULIP CONDOM SHANGHAI LATEX FACTORY LOU JI
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K041825 03/11/2005 SMITH & NEPHEW GENESIS II DEEP FLEXION CRUCIATE RETAINING ARTICULAR INSERT SMITH & NEPHEW, INC. KIM KELLY
K042515 03/14/2005 SMITH & NEPHEW, INC. HIGH PERFORMANCE KNEE SMITH & NEPHEW, INC. JANET JOHNSON AKIL
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K043511 03/14/2005 SOLEUS POWERED WHEELCHAIR, MODEL FAD-2 SOLEUS CHAMP INTERNATIONAL CO., LTD. Ke-Min Jen
K050331 03/24/2005 ADHESIVE 1 SOUTHERN DENTAL INDUSTRIES, INC. SAMANTHA J CHEETHAM
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K043401 03/16/2005 SPECTRANETICS LLD CS, MODEL 518-039 SPECTRANETICS CORP. MICHAEL J RYAN
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K042169 03/14/2005 STANBIO LABORATORY SIRRUS CLINICAL CHEMISTRY ANALYZER STANBIO LABORATORY KIRK JOHNSON
K041541 03/16/2005 COMPEL MLR SURGICAL GOWNS STANDARD TEXTILE CO., INC. BRADLEY J BUSHMAN
K043453 03/01/2005 STERILEMED REPROCESSED IVUS IMAGING CATHETER STERILMED, INC. BRUCE LESTER
K043513 03/01/2005 STERILMED REPROCESSED DEFLECTABLE ELECTROPHYSIOLOGY DIAGNOSTIC CATHETER STERILMED, INC. BRUCE R LESTER
K043022 03/15/2005 STRYKER FLEXIBLE CYSTONEPHROSCOPE Stryker Endoscopy CHRISTOPHER L COOK
K043021 03/16/2005 STRYKER URETEROSCOPE Stryker Endoscopy CHRISTOPHER L COOK
K050535 03/17/2005 STRYKER MMF SCREW STRYKER INSTRUMENTS NATHAN M MIERSMA
K043180 03/02/2005 STRYKER SPINE TRIO PS STRYKER SPINE SIMONA VOIC
K050247 03/04/2005 CONTOUR NECKLIFT THREADS SURGICAL SPECIALTIES CORP. ELIZABETH LAZARO
K050292 03/09/2005 SHARPOINT LUKENS BONE WAX SURGICAL SPECIALTIES CORP. ELIZABETH LAZARO
K050452 03/09/2005 AURORA SR AND SRA APPLICATOR SYNERON MEDICAL LTD. AMIR WALDMAN
K050110 03/04/2005 SYNTHES (USA) LCP MODULAR FOOT PLATES SYNTHES (USA) KATHY ANDERSON
K042899 03/16/2005 SYNTHES (USA) RIA SYSTEM - EXPANDED INDICATIONS SYNTHES (USA) SHERI L MUSGNUNG
K050378 03/15/2005 SYNTHES MANDIBLE EXTERNAL FIXATOR SYNTHES (USA) SHERI L MUSGNUNG
K050204 03/04/2005 SYNTHES RAPID RESORBABLE TACK SYSTEM SYNTHES (USA) SHERI L MUSGNUNG
K050451 03/24/2005 SYNTHES VECTRA SYSTEM SYNTHES SPINE CO.LP SUSAN LEWANDOWSKI
K050341 03/29/2005 IMPLANT LOCATION SOFTWARE, MODEL 0.1.0 TACTILE TECHNOLOGIES, LTD. ZVIKA SLOVIN
K042795 03/07/2005 CLEVER CHEK TD-3213 TaiDoc Technology Corporation SHU-MEI WU
K041311 03/18/2005 TIGER ENDOTRACHEAL TUBES (VARIOUS MODELS AND SIZES) TIGER MEDICAL PRODUCTS LTD JAY MANSOUR
K050355 03/09/2005 PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 TISSUE SCIENCE LABORATORIES, PLC VICTORIA TAYLOR
K042715 03/23/2005 TITAN DENTAL IMPLANT ATTACHMENT TITAN IMPLANTS, INC. FLOYD G LARSON
K050670 03/30/2005 SENSOR MOBILE SM 100 VITAPHONE 1001R REMOS TMS TELEMEDIZINISCHE SYSTEME GMBH TILO BORCHARDT
K043486 03/03/2005 PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 TOPCON MEDICAL LASER SYSTEMS, INC JOHN JOSSY
K050316 03/16/2005 AEQUALIS REVERSED SHOULDER PROSTHESIS TORNIER Mireille Lemery
K050458 03/10/2005 TSX-201A AQUILION LB CT SCANNER TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K042482 03/21/2005 BASS ANTALGIC-TRAK TRACTION MASTERS, L.L.C. DAVID B BASS
K050412 03/14/2005 VAPORMAX TRIMEDYNE, INC. GLENN YEIK
K042107 03/09/2005 TUNG FU AIRMATE TENS, VITALITY MODE, TF-DT001 TUNG FU ELECTRIC CO., LTD. JEN KE-MIN
K050730 03/31/2005 MODIFICATION TO ORTHODONTIC COMPOSITE BRACKET SYSTEM ULTRADENT PRODUCTS, INC. TAMMY LAVERY
K050364 03/09/2005 MALIS 2000 BIPOLAR ELECTROSURGICAL SYSTEM VALLEY FORGE SCIENTIFIC CORP. JERRY L MALIS
K043594 03/31/2005 VANGUARD REPROCESSED BLADED TROCAR, NON-BLADED TROCAR, TROCAR ACCESSORIES VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K040751 03/10/2005 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K042074 03/09/2005 VANGUARD REPROCESSED DIAGNOSTIC ELECTROPHYSIOLOGY CATHETERS VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K043315 03/22/2005 VANGUARD REPROCESSED HAND-ACTIVATED ULTRASONIC SCALPEL VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K043225 03/22/2005 VANGUARD REPROCESSED ULTRASONIC SCALPEL VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
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K050442 03/23/2005 MILLENNIUM MULTI-LEAF COLLIMATOR VARIAN MEDICAL SYSTEMS VY TRAN
K042956 03/11/2005 VISION VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K050021 03/18/2005 VASCULAR SOLUTIONS VARI-LASE ENDOVENOUS LASER PROCEDURE KIT VASCULAR SOLUTIONS, INC. LINDA BUSKLEIN
K050245 03/15/2005 CELLSEARCH CIRCULATING TUMOR CELL KIT VERIDEX, LLC DEBRA J RASMUSSEN
K043515 03/31/2005 GRAFTSAVER VESCARE, INC. DAVID WALSH
K050309 03/25/2005 PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 VIASYS MEDSYSTEMS STEPHANIE WASIELEWSKI
K043004 03/16/2005 STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12020, 12021, 12022, 12030, 12031 VIASYS MEDSYSTEMS STEPHANIE WASIELEWSKI
K050362 03/15/2005 VITA PM 7 (20 GRAM BOTTLES), VITA PM 7 (50 GRAM BOTTLES) VIDENT BARBARA J LEWANDOWSKI
K050190 03/25/2005 APOLLO VILLA SISTEMI MEDICALI S.P.A. VERONICA MEREDITH
K050623 03/28/2005 VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D VOLK OPTICAL, INC. RICHARD E LIPPMAN
K050074 03/22/2005 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 WELCH ALLYN, INC. CHRISTOPHER KLACZYKN
K050042 03/14/2005 WU'S 4-WHEELED NEO SCOOTER, WT-XL4 WU'S TECH CO., LTD. JEN KE-MIN
K050137 03/18/2005 TEMPTOUCH DERMAL THERMOMETER XILAS MEDICAL, INC. RUBEN G ZAMORANO
K050455 03/29/2005 SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD KAREN ABELL
K042951 03/10/2005 PRE-POWDERED VINYL EXAM GLOVES ZIBO HENGCHANG PLASTIC & RUBBER PRODUCTS CO., LTD. MARY ANNE DOUCETTE
K042952 03/10/2005 VINYL EXAM GLOVE, POWDER-FREE, NON-STERILE ZIBO HENGCHANG PLASTIC & RUBBER PRODUCTS CO., LTD. MARY ANNE DOUCETTE
K043565 03/11/2005 MODIFICATION TO DYNESYS SPINAL SYSTEM ZIMMER SPINE, INC TIM CRABTREE
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