FDA 510(k) Decisions During September, 2005  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K052235 09/27/2005 LCR 3M COMPANY KAREN O'MALLEY
K052063 09/30/2005 HUANQIU HEATING LAMP A & A MEDICAL SUPPLIES INC GEORGE SU
K051291 09/20/2005 NON-STERILE SURGICAL MASK A.R. MEDICOM, INC. LUC TREPANIER
K052247 09/14/2005 NEX-LINK SPINAL FIXATION SYSTEM VARIABLE CROSSLINK, MODEL 721-XX ABBOTT SPINE, INC. NOAH BARTSCH
K052454 09/14/2005 THE EMBOSHIELD EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR DEVICES DEBBIE COGAN
K052325 09/14/2005 CYBERKNIFE SYSTEM FOR STEREOTACTIC RADIOSURGERY/RADIOTHERAPY ACCURAY INCORPORATED ANNE SCHLAGENHAFT
K051593 09/02/2005 UROPASS URETERAL ACCESS SHEATH, MODEL 61224 ACMI CORPORATION GRAHAM BAILLIE
K051515 09/01/2005 MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K052418 09/26/2005 AXXESS BUTTERFLY ANCHOR ADVANCED NEUROMODULATION SYSTEMS STEVE TAMSETT
K051712 09/01/2005 MODEL 2800 PFT FILTER AIR SAFETY LTD PAUL DRYDEN
K050729 09/14/2005 ALCON MULTI-PURPOSE DISINFECTING SOLUTION ALCON RESEARCH, LTD. KIM B KRACKE
K052375 09/09/2005 ALILIFE STAND UP POWERED WHEELCHAIR, HC-300 ALILIFE TECHNOLOGICAL CO., LTD. KE-MIN JEN
K051852 09/14/2005 SINGLE AMPLIFIER FOR BOTOX ALLERGAN, INC. SUSAN O'BRIEN
K050518 09/23/2005 REPROCESSED PHACOEMUISIFICATION TIPS ALLIANCE MEDICAL, INC. ELIZABETH RENKEN
K051260 09/15/2005 SCHUCO MIST AND SCHUCO DELUXE MIST ALLIED HEALTHCARE PRODUCTS, INC. WAYNE KARCHER
K051830 09/16/2005 NEURODRIVE SYSTEM ALPHA OMEGA LTD. SHLOMO PUNDAK
K050352 09/01/2005 IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT AMERITEK RESEARCH LLC KUD CHAIANG YEE
K052447 09/21/2005 SYNERAD IMPACT 60, SYNERAD IMPACT 72 AND ANALOGIC AMS1600 ANALOGIC CORP. DONALD SHERRATT
K051779 09/30/2005 ANDROFLOW - RESPIRATORY RATE MONITOR ANDROMED, INC. GEORGE PAPAGIANNIS
K051655 09/12/2005 ANGIODYNAMICS, INC., MICRO ACCESS KITS ANGIODYNAMICS, INC. TERI JUCKETT
K050629 09/02/2005 ANGIOSCULPT SCORING BALLOON CATHETER ANGIOSCORE, INC. GARY GERSHONY
K051831 09/07/2005 GEMINI SURGICAL CONTROL & DISPLAY SYSTEM APPLIED SURGICAL, LLC DAVID A ALEXANDER
K051726 09/27/2005 ARTHREX TENODESIS FAMILY ARTHREX, INC. QNN WATERHOUSE
K052614 09/28/2005 LOW PROFILE PLATE AND SCREW SYSTEM ARTHREX, INC. SALLY FOUST
K051820 09/06/2005 PARALLAX EZFLOW CEMENT DELIVERY SYSTEM ARTHROCARE CORP. VALERIE DEFIESTA-NG
K051772 09/26/2005 ASAHI TORNUS SUPPORT CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K052362 09/09/2005 BIS EEG MONITOR, MODEL A-3000 ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K051332 09/29/2005 ADVANTA T-GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K052047 09/22/2005 ISIS IQ UNO HANDHELD ELECTRONIC BREAST PUMP, MODEL 101 AVENT AMERICA, INC. RICHARD MORRONEY
K051404 09/27/2005 B-CARE POWDER FREE LATEX EXAMINATION GLOVES B-CARE INDUSTRIES CO., LTD. RUJIRA PHANPHIPHAT
K052352 09/30/2005 COLOR CORONIS 2MP-21 AND MFCD 2321 BARCOVIEW LIEVEN DE WANDEL
K052403 09/15/2005 CORONIS 2MP-21" AND MFGD 2621 BARCOVIEW LIEVEN DE WANDEL
K052429 09/15/2005 CORONIS 3MP-21 AND MFGD 3621 BARCOVIEW LIEVEN DE WANDEL
K052529 09/30/2005 E-2320 PA S BARCOVIEW LIEVEN DE WANDEL
K052478 09/28/2005 MFCD 1219, MFCD 1219 TS BARCOVIEW LIEVEN DE WANDAL
K052276 09/21/2005 NIO 2MP-20" AND E-2620 S BARCOVIEW LIEVEN DE WANDEL
K052282 09/20/2005 VENAFLO II VASCULAR GRAFT BARD PERIPHERAL VASCULAR, INC. GLENN NORTON
K051899 09/13/2005 BD PEN NEEDLE BECTON DICKINSON & CO. JOHN SCHALAGO
K052250 09/30/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - TOBRAMYCIN (GP) 0.5-16UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K052224 09/12/2005 BD PROBE TEC URINE PRESERVATIVE TRANSPORT BECTON, DICKINSON & CO. KATHRYN BABKA POWERS
K051091 09/01/2005 SYNTHOGRAFT BICON, INC. VINCENT J MORGAN
K051397 09/16/2005 BIOBANDS BIOBANDS DISTRIBUTORS, INC. JAMES H HARTTEN
K052419 09/20/2005 MAXIMUS 3.0 AND OS IMPLANTS BIOHORIZONS IMPLANT SYSTEMS, INC. WINSTON GREER
K051885 09/16/2005 MBCP BIOMATLANTE MYRIAM VINCENT
K052311 09/29/2005 VITEK 2 GRAM NEGATIVE TIGECYCLINE BIOMERIEUX, INC. JOLYN TENLLADO
K051843 09/29/2005 COPELAND EAS HUMERAL RESURFACING HEADS BIOMET, INC. TRACY BICKEL JOHNSON
K050327 09/27/2005 E-POLY (VITAMIN E) ACETABULAR LINERS BIOMET, INC. TRACY BICKEL JOHNSON
K051975 09/06/2005 POROUS COATED DISCOVERY ELBOW BIOMET, INC. PATRICIA SANDBORN BERES
K051569 09/29/2005 RINGLOC BI-POLAR ACETABULAR COMPONENT BIOMET, INC. PATRICIA SANDBORN BERES
K051775 09/06/2005 OSTEOMIMETIC SYNTHETIC BONE MATRIX BIOMIMETIC PHARMACEUTICALS INC. SANDRA WILLIAMSON
K042681 09/29/2005 CARTO RMT EP NAVIGATION SYSTEM BIOSENSE WEBSTER, INC. DIANA THORSON
K052083 09/29/2005 NAVISTAR RMT STEERABLE TIP DIAGNOSTIC CATHETER BIOSENSE WEBSTER, INC. DIANA M THORSON
K042998 09/29/2005 REFSTAR RMT EXTERNAL REFERENCE PATCH BIOSENSE WEBSTER, INC. MARK O'DONNELL
K051787 09/22/2005 TRIAGE BNP TEST, MODEL 98000XR BIOSITE INCORPORATED JEFFREY DAHLEN
K051629 09/23/2005 BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 BLEASE USA, INC. ARTHUR J WARD
K051507 09/02/2005 MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC ALBERT ZICKMANN
K051951 09/28/2005 CERAMENT BONE VOID FILLER BONE SUPPORT AB JEFFREY R SHIDEMAN
K052302 09/12/2005 HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION BOSTON SCIENTIFIC CORP. JENNIFER BOLTON
K050863 09/02/2005 IMAGER II ANGIOGRAPHIC CATHETER BOSTON SCIENTIFIC CORP. DIANE BRINZA
K052220 09/30/2005 IPLAN RT FIBERTRACKING BRAINLAB AG RAINER BIRKENBACH
K052517 09/29/2005 SITE-RITE 5 ULTRASOUND SYSTEM C.R. BARD, INC. KIMBERLY GEISLER
K051279 09/07/2005 CALDYNE, INC. EXHALOMETER EX100, MODEL EX100 CALDYNE, INC. TOM SHANKS
K052219 09/13/2005 CRONO GO. CANE S.R.L. CARLO MUSSO
K052217 09/13/2005 CRONO SUPER PID CANE S.R.L. CARLO MUSSO
K051789 09/30/2005 VISANTE OCT CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K051887 09/27/2005 PATIENT VENTILATION OXYGEN CONCENTRATING SYSTEM, HIGH FLOW (PVOCS HF) CARLETON LIFE SUPPORT SYSTEMS INC. GARY BYRD
K051938 09/21/2005 TRITON/TRU-TRAC/TX TRACTION DEVICES CHATTANOOGA GROUP CHERYL BAGWELL
K041820 09/09/2005 SOLO-CARE AQUA ANTIMICROBIAL LENS CASE CIBA VISION CORPORATION STEVEN DOWDLEY
K051838 09/01/2005 MODIFIED CONCENTRIC RETRIEVER, MODEL 90039 CONCENTRIC MEDICAL, INC. JEAN M CAILLOUETTE
K052009 09/28/2005 CONMED SYSTEM MODEL 2450 ELECTROSURGICAL GENERATOR CONMED CORPORATION PAMELA VETTER
K051048 09/23/2005 SURGISIS STAPLE LINE REINFORCEMENT II COOK BIOTECH, INC. MARK BLEYER
K051494 09/21/2005 MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 CR TECH, LTD. LEONARD FRIER
K051130 09/09/2005 VCS S3Y CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER/CHC CHANG WAN LAN
K050382 09/14/2005 AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM CYNOSURE, INC. GEORGE CHO
K051922 09/14/2005 ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6 CYNOSURE, INC. GEORGE CHO
K051537 09/26/2005 HILT FAMILY LASER: HILT I, HILT II, HILT III CYNOSURE, INC. GEORGE CHO
K051910 09/02/2005 MAXISONIC FAMILY AND SWIFT ULTRASONIC SCALER D.B.I. AMERICA CORP. UBIRACI R FERNANDES
K052017 09/01/2005 CYCLOSPORINE EXTENDED RANGE ASSAY (CSAE) FLEX REAGENT CARTRIDGE, CATALOG # DF108 DADE BEHRING, INC. ANDREA M TASKER
K052015 09/12/2005 DIMENSION EXTENDED RANGE CYCLOSPORINE CALIBRATOR, CATALOG # DC108 DADE BEHRING, INC. ANDREA M TASKER
K051650 09/08/2005 STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. DADE BEHRING, INC. PAMELA A JURGA
K051895 09/27/2005 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR
K052593 09/28/2005 FUSION CURING LIGHT DENTLIGHT INC. RICHARD LIU
K052334 09/02/2005 CAVITRON RF ULTRASONIC SCALER SYSTEM WITH STERIMATE HANDPIECE, MODEL G-131 DENTSPLY INTL. HELEN LEWIS
K052131 09/28/2005 EXPEDIUM SPINE SYSTEM 5.5MM COMMERICALLY PURE TITANIUM SPINAL RODS DEPUY SPINE, INC. LIZ LAVELLE
K052551 09/30/2005 DEVON STANDARD SYRINGE, HYPODERMIC NEEDLE AND INSULIN SYRINGE DEVON SAFETY PRODUCTS, INC. BARRY L BERLER
K051357 09/20/2005 DS7A CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7A; DS7AH CONSTANT CURRENT HIGH VOLTAGE STIMULATOR, MODEL DS7AH DIGITIMER LTD. HARRY J BENEDICT
K052150 09/08/2005 VOLAR PLATE SYSTEM DVO EXTREMITY SOLUTIONS, LLC DINA L WEISSMAN
K051281 09/08/2005 THE NEEDLE CATCHER E.D.MEDICAL LTD. BRIAN MCNICHOLL
K052239 09/21/2005 EBI DYNAFIX VISION FOOTPLATE SYSTEM EBI, L.P. PETER ALLAN
K052149 09/02/2005 EDWARDS PERIPHERAL DILATION CATHETER EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K051825 09/12/2005 COGNITRACE EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH DANIEL KAMM
K052344 09/14/2005 COLOR LCD MONITOR, MODEL RADIOFORCE R31 & R31-C EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K052337 09/08/2005 MONOCHROME LCD MONITOR, MODEL RADIFORCE G33 EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K051749 09/13/2005 COBRA SURGICAL SYSTEM ESTECH, INC. CRAIG COOMBS
K051701 09/29/2005 VICRYL * MESH BAG ETHICON, INC. JENNIFER PAINE
K051556 09/06/2005 ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE EXACTECH, INC. DIANA TAYLOR
K042564 09/30/2005 HEMOR-RITE CRYOTHERAPHY FAMA HOLDINGS INTERNATIONAL CORP FRANK MELENDEZ
K052422 09/27/2005 THE ENVISION INTRAORAL DENTAL X-RAY MACHINES (WALL MOUNTED AND MOBILE) FLOW X-RAY CORP. SUSAN D GOLDSTEIN-FALK
K052345 09/14/2005 ADVANTAGE SIM MD GE HEALTHCARE LARRY A KROGER
K052167 09/08/2005 DATEX-OHMEDA S/5 TONOMETRY MODULE, E TONO AND ACCESSORIES GE HEALTHCARE JOEL C KENT
K051873 09/20/2005 DISPOSABLE TEMPERATURE, SKIN AND ESOPHAGEAL PROBES GE HEALTHCARE JOEL C KENT
K052412 09/16/2005 INNOVA 2100-IQ, INNOVA 3100, INNOVA 3100-IQ, INNOVA 4100, AND INNOVA 4100-IQ GE HEALTHCARE LARRY A KROGER
K052434 09/27/2005 HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA GE MEDICAL SYSTEMS ELI WERNER
K042782 09/02/2005 SEER MC GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES GRACE LEMIEUX
K052293 09/21/2005 GE 1.5T AND 3.0T SIGNA HDX MR SYSTEM GE MEDICAL SYSTEMS, LLC LARRY A KROGER, PH.D.
K052441 09/21/2005 GE LOGIQ 7 ULTRASOUND BT05 GENERAL ELECTRIC CO. ALLEN SCHUH
K051730 09/26/2005 MATRIX HOLTER SYSTEM, MODEL M12 GLOBAL INSTRUMENTATION, LLC CRAIG SELLERS
K052274 09/21/2005 GUIDANT VASOVIEW HEMOPRO ENDOSCOPIC VESSEL HARVESTING SYSTEM, MODEL VH-3000 GUIDANT CORPORATION M. LAURIE WONG
K051594 09/02/2005 MCCARTNEY ACCESS TUBE GYNETECH PTY. LTD. DENNIS HAHN
K052248 09/14/2005 DORSAL NAIL PLATE, ANATOMICAL HAND INNOVATIONS, LLC. ERNESTO HERNANDEZ
K050085 09/14/2005 OSTEOPAL V HERAEUS KULZER GMBH CHRISTIAN TUCHSCHERER
K052172 09/27/2005 HHF1 MAGNETIC RESONANCE IMAGING SYSTEM HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K050448 09/23/2005 CHROMOPEP PC, CHROMOPEP AT, MODELS 2.5 AND 5 HORIBA ABX TIM LAWTON
K052117 09/09/2005 I-FLOW ELASTOMERIC PUMP (ON-Q, PAINBUSTER, C-BLOCK, HOMEPUMP, EASYPUMP) I-FLOW CORP. SHANE NOEHRE
K052008 09/16/2005 IMC HEARTWAY - POWER WHEELCHAIR, MODEL HP 7 IMC-HEARTWAY, LLC JOHN FRYMARK
K051461 09/15/2005 3I OSSEOTITE DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUEYL A HUGHES
K051978 09/23/2005 TRABECULAR METAL VERTEBRAL BODY REPLACEMENT IMPLEX CORP. MARCI HALEVI
K051667 09/27/2005 EZ-JECT INDOLOR, LTD. GEORGE J HATTUB
K052444 09/20/2005 INION CPS BABY 1.5 BIOABSORBABLE FIXATION SYSTEM INION LTD. HANNA MARTTILA
K052329 09/21/2005 WALKAIDE SYSTEM, MODELS 20-0100, 20-0310, 20-1000 INNOVATIVE NEUROTRONICS INC. FAYYAZ MEMON
K051540 09/21/2005 INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR INOVO, INC. KEVIN CONFOY
K051160 09/02/2005 MANIPUSEAL INSITU SYSTEMS MARY MCNAMARA-CULLINANE
K051440 09/20/2005 MAYFIELD INFINITY SKULL CLAMP INTEGRA LIFESCIENCES CORP. DONNA R WALLACE
K052098 09/07/2005 CONNEXUS, .5CC, MODEL 023000-005 ISOTIS ORTHOBIOLOGICS, INC PAUL DONER
K051782 09/20/2005 BLUEPHASE 16I IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K050999 09/02/2005 YI XIN STERILE SYRINGE FOR SINGLE USE JIANGXI SANXIN (EVERSINCERE) MEDICAL DEVICES GROUP YUN YUAN GAO
K052214 09/13/2005 PRE-POWDERED STERILE EXAM GLOVES KANAM LATEX INDUSTRIES PVT. LTD. RAVI ABRAHAM
K052159 09/07/2005 AIDA COMPACT II SYSTEM KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL LEE
K050443 09/02/2005 ACCU-LEAD KENTEC MEDICAL, INC. DAVID SHERATON
K051611 09/06/2005 MBARESORB IMPLANT KINETIKOS MEDICAL, INC. JOHN G SPAMPINATO
K051552 09/19/2005 O.A.S.I. SYSTEM LANCER ORTHODONTICS, INC. GRACE HOLLAND
K052245 09/23/2005 ACCENT AND EXCEED SERIES ORTHODONTIC CERAMIC BRACKETS LAR MFG., LLC. IAN P GORDON
K051209 09/08/2005 LEVITRONIX CENTRIMAG BACK-UP CONSOLE LEVITRONIX LLC. FARZAD PARSAIE
K050435 09/06/2005 E-STIM II LHASA OMS, INC. MARK W SHEEHAN
K051614 09/09/2005 PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS LIFECORE BIOMEDICAL, INC. RACHEL KENNEDY
K051944 09/30/2005 FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES LUMENIS, INC. KAREN L BAKER
K050524 09/14/2005 EZ-IV MEDICAL PAD WARMING UNIT, MODEL 1000 MARDA MEDICAL, INC. HOWARD SCHRAYER
K051585 09/06/2005 F-400 SYSTEM MAUNA KEA TECHNOLOGIES ALEXANDRE LOISEAU
K051676 09/08/2005 SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K052330 09/09/2005 TRU-SWAB STOCOCK MEDEGEN MEDICAL MANUFACTURING SERVICES TIM TRUITT
K051697 09/21/2005 SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP C. STEPHEN LAWRENCE
K051422 09/01/2005 DUAL MODE UP-GRADE FOREHEAD/UNDERARM THERMOMETER DEVICE MEDISIM LTD. AHAVA STEIN
K052211 09/14/2005 DUREPAIR DURA REGENERATION MATRIX MEDTRONIC NEUROSURGERY JEFFREY HENDERSON
K052372 09/22/2005 MC2X MULTI-STAGE VENOUS CANNULA, MODELS 91437, 91437C MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K052376 09/23/2005 MODIFICATION TO: VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K051320 09/09/2005 SATELLITE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD W TREHARNE
K052402 09/23/2005 VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K051018 09/02/2005 INTERMEZZO IMPLANT SYSTEMS MEGAGEN CO., LTD. DAE KYU CHANG
K051698 09/29/2005 MERRIES UNI-OSTEO, MODEL CS30250-CS10102 MERRIES INTERNATIONAL INC. JESSICA LI
K051157 09/01/2005 INSTRU-SAFE INSTRUMENT PROTECTION SYSTEMS MICROMEDICS, INC. TOM A LOPAC
K051669 09/01/2005 TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM MIGADA PLANT YOSSI SHACHAR
K043373 09/02/2005 DOLOTENS DENTAL TM 1 NEUROMUSCULAR TECHNOLOGIES, INC. MARIE JENSEN
K052152 09/13/2005 B-BOP PLATE NEWDEAL S.A. JUDITH E O'GRADY
K051740 09/06/2005 TAPERED COMPRESSION PIN NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K052521 09/26/2005 NISSIN SERIES MECHANICAL WHEELCHAIR NISSIN MEDICAL INDUSTRIES CO., LTD DARREN REEVES
K051835 09/23/2005 NPAC MULTI-USE EAR THERMOMETER, MODELS TP 700,TP 702 NORM PACIFIC AUTOMATION CORP. CHI-CHU WU CHEN
K033231 09/09/2005 SPINA SYSTEM NORTH AMERICAN MEDICAL CORP (NAM) GIDGETTE RUBIN
K052024 09/07/2005 NSTRAND IMPLANTATION KIT NORTH AMERICAN SCIENTIFIC, INC. LEIGH SPOTTEN
K051718 09/15/2005 NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K051469 09/28/2005 CAREVENT ATV+ AND CAREVENT MRI O-TWO MEDICAL TECHNOLOGIES, INC. AMMAR AL-DOJALLY
K052452 09/21/2005 VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE VT OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K052154 09/08/2005 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-711AC OMRON HEALTHCARE, INC. IWAO KOJIMA
K052153 09/08/2005 OMRON AUTOMATIC BLOOD PRESSURE MONITOR, MODEL HEM-741CREL OMRON HEALTHCARE, INC. IWAO KOJIMA
K050807 09/21/2005 20G SMA LASER FIBER, MODEL LF100 OPHTHALMED LLC JAY MANSOUR
K050637 09/23/2005 ENCOMPASS CEMENTED HIP STEM & 10/12 COBALT-CHROME FEMORAL HEADS ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K051407 09/08/2005 LEGEND ALL-POLY CUP ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
K051945 09/06/2005 MIOT PLATING SYSTEM ORTHOFIX SRL CANDACE F CEDERMAN
K052237 09/06/2005 SC CERAMIC BALL HEADS ORTHOPEDIC ALLIANCE LLC HARTMUT LOCH
K052027 09/29/2005 OPTI LION ELECTROLYTE ANALYZER, MODEL GD7200 OSMETECH, INC. DANIEL MCMINN
K051576 09/01/2005 AVANA DENTAL IMPLANT SYSTEM OSSTEM CO., LTD. ALBERT REGO
K051876 09/09/2005 MULTIWAVE XR PACIFIC QUANTUM INSTRUMENTS, INC. GENNADY L NIKOLAENKO
K052389 09/09/2005 I-PORT PATTON MEDICAL DEVICES FRED SCHLADOR
K051222 09/23/2005 AV-S ANAESTHESIA VENTILATOR PENLON LIMITED BARRY PEARCE
K052134 09/22/2005 CYSTOGLIDE DILATING INTRODUCER SHEATH PERCUTANEOUS SYSTEMS, INC. THOMAS LAWSON
K052048 09/13/2005 ACCORDION PERCUTANEOUS SYSTEMS, INCORPORATED THOMAS LAWSON
K051134 09/08/2005 HEARTSTART MRX WITH Q-CPR OPTION, MODELS M3535A OR M3536A PHILIPS MEDICAL SYSTEMS DANIEL J DILLON
K052078 09/07/2005 ACHIEVA, INTERA AND PANORAMA 1.0 RELEASE 2-SERIES PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. LYNN HARMER
K051366 09/14/2005 PICONIBP OEM MODULE PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH MARKUS STACHA
K051874 09/02/2005 SEDLINE SEDATION MONITOR WITH FRONTAL PSI AND SEDTRACE EEG ELECTROSE SET PHYSIOMETRIX, INC. DAWN E FRAZER
K052579 09/27/2005 PORTAL GRAVITY SYSTEM PORTAL, INC. DAVID CARTER
K052415 09/29/2005 POWER LINEAR CUTTER REUSABLE DIGITAL LOADING UNITS WITH RELOADS POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K051192 09/06/2005 PRAXAIR MEDICAL AIR MIXER PRAXAIR, INC. TAMARA BROWN
K051866 09/06/2005 PREMIER TEMPORARY CEMENT PREMIER DENTAL PRODUCTS CO. VINCE D'ALESSANDRO
K052353 09/09/2005 Z-CHAIR PRIDE MOBILITY PRODUCTS CORP. THOMAS SCHAPPERT
K042991 09/23/2005 I-NEB AAD SYSTEM PROFILE THERAPEUTICS PLC BARBARA CAMPBELL
K051565 09/12/2005 PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA PROTON HEALTHCARE LTD. KEVIN WALLS
K052273 09/30/2005 POLYMER COATED LATEX EXAMINATION GLOVES, POWDER FREE, NON-STERILE PT. MAHAKARYA INTI BUANA SASITHARAN NAIR
K052382 09/15/2005 POWDER FREE NITRILE EXAMINATION GLOVES, BLUE PT. SHAMROCK MANUFACTURING CORP. EMMY TJOENG
K052373 09/26/2005 QUILL NONABSORBABLE POLYPROPYLENE BARBED SUTURE QUILL MEDICAL, INC. LOIS V SMART
K052005 09/06/2005 R&R EXTERNAL FIXATION SYSTEM R&R MEDICAL, INC. J.D. WEBB
K051671 09/02/2005 RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY RADIANCY (ISRAEL) LTD. JONATHAN S KAHAN
K051269 09/09/2005 RII INFRARED EAR THERMOMETER, MODELS TH00XY SERIES RADIANT INNOVATION INC. FRANK LIN
K052460 09/21/2005 POWERSERVER, POWERREADER, GATEWAY AND POWERCACHE RAMSOFT, INC. VIJAY RAMANATHAN
K052489 09/27/2005 ACTIHEART RESPIRONICS, INC. ZITA A YURKO
K051355 09/23/2005 VANISHPOINT I.V. CATHETER RETRACTABLE TECHNOLOGIES, INC. MICHELE LARIOS
K050760 09/13/2005 ACCU-CHEK POCKET COMPASS DIABETES MANAGEMENT SOFTWARE ROCHE DIAGNOSTICS CORP. SCOTT THIEL
K051297 09/08/2005 ELECSYS N-MID OSTEOCALCIN, ELECSYS OSTEOCALCIN CALSET, ELECSYS OSTEOCALCIN CALCHECK ROCHE DIAGNOSTICS CORP. KAY A TAYLOR
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