FDA 510(k) Applications Received During February, 2005

FDA 510(k) Number Submission Date Device Name Applicant Contact
K053409 12/07/2005 3M LIQUID BANDAGE 3M COMPANY BRYAN BECKER
K053438 12/09/2005 GLASS CERAMICS 3M ESPE AG DENTAL PRODUCTS SABINE KRISCHER
K053552 12/20/2005 GLOBAL FERTILIZATION, EMBRYO CULTURE AND TRANSFER MEDIA INTL., INC. MICHAEL D CECCHI
K053551 12/20/2005 MICROMANIPULATION MEDIA SYSTEM, LG HYALURONIDASE AND LG PARAFFIN OIL INTL., INC. MICHAEL D CECCHI
K050500 02/28/2005 FREESTYLE 600 BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. KIMBERLEY KLINE
K053330 12/01/2005 ARCHITECT B12 CALIBRATORS ABBOTT LABORATORIES MARGARET PROCHNIAK
K050501 02/28/2005 MODIFICATION TO: XCEED NITINOL SELF-EXPANDING TRANSHEPATIC BILIARY STENT SYSTEM ABBOTT VASCULAR DEVICES ANN E LEONARD
K050279 02/07/2005 AXS-1 LITE WHEELCHAIR ACCESS POINT MEDICAL, L.L.C. NORMAN F ESTRIN
K050280 02/07/2005 RUNABOUT WHEELCHAIR ACCESS POINT MEDICAL, L.L.C. NORMAN F ESTRIN
K050281 02/07/2005 TRANSPORT SERIES TRANSPORT CHAIR ACCESS POINT MEDICAL, L.L.C. NORMAN F ESTRIN
K053509 12/16/2005 ACUBAND ACUPRESSURE WRIST BAND DEVICE ACUBAND INC. RICHARD GRIFFITH
K053400 12/06/2005 ACUMEN SINGLE-LUMEN DELIVERY SHEATH ACUMEN MEDICAL, INC. Marybeth Gamber
K053358 12/02/2005 DEPTH ELECTRODE, FORAMEN OVALE DEPTH ELECTRODES, WYLER SPHENOIDAL DEPTH ELECTRODES AD-TECH MEDICAL INSTRUMENT CORP. Gary Syring
K053363 12/02/2005 DUAL-SIDED INTERHEMISPHERIC SUBDURAL ELECTRODES, GRID SUBDURAL ELECTRODES, INTRAOPERATIVE SUBDURAL ELECTRODES AD-TECH MEDICAL INSTRUMENT CORP. Gary Syring
K053495 12/15/2005 EQUIPMENT SLUSH DRAPE ADVANCE MEDICAL DESIGNS, INC. WILLIAM SLEVIN
K053481 12/14/2005 KELO-COTE SPRAY ADVANCED BIO-TECHNOLOGIES, INC. STEVEN CHERNOFF
K050468 02/23/2005 TRIABSORB COMPOSITE SCREW ADVANCED BIOMATERIALS PATRICK JANIN
K053473 12/14/2005 MAESTRO MDTL LASER SYSTEM ADVANCED MEDICAL TECHNOLOGIES, INC. M. JOYCE HEINRICH
K050241 02/02/2005 AOS HUMERAL NAIL ADVANCED ORTHOPAEDIC SOLUTIONS, INC. GARY SOHNGEN
K050428 02/18/2005 TECHNOLOGY-ASSISTED MICRO-MOBILIZATION AND REFLEX STIMULATOR (TAMARS) ADVANCED SPINAL TECHNOLOGIES, INC. JEFFREY R PERELMAN
K053360 12/02/2005 AEROLIFE ULTRASONIC NEBULIZER, MODEL P2C AEROVECTRX CORPORATION DAVE PIPER
K053389 12/05/2005 AESCULAP STERILCONTAINER SYSTEM AESCULAP, INC. MATTHEW M HULL
K053390 12/05/2005 COLUMBUS (CR) TOTAL KNEE SYSTEM AESCULAP, INC. KATHY A RACOSKY
K053579 12/22/2005 COLUMBUS ULTRA CONGRUENT (UC) TIBIAL INSERT/GLIDING SURFACE AESCULAP, INC. MATTHEW M HULL
K053526 12/19/2005 MICROSPEED UNI MOTOR SYSTEM AESCULAP, INC. KATHY A RACOSKY
K053440 12/09/2005 AMPLATZER SIZING BALLOON II AGA MEDICAL CORP. AMANDA JOHNSON
K053458 12/13/2005 WEB1000 AGFA CORP. PHIL CUSCUNA
K053634 12/29/2005 COMPUTED RADIOGRAPHY SYSTEM WITH NX 1.0 WORKSTATION AGFA CORPORATION JEFFERY A JEDLICKA
K050338 02/11/2005 MODIFICATION TO: INSTAREAD LITHIUM SYSTEM Akers Biosciences, Inc. ERIKA AMMIRATI
K053479 12/14/2005 VERIFY DRY HEAT LABEL ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
K050390 02/16/2005 TAMARACK ANTERIOR THORACOLUNBAR ALPHATEC/NEXMED ELLEN A YARMALL
K053550 12/20/2005 AMBU BLUE SENSOR NEO AND NEO X AMBU A/S SANJAY PARIKH
K053422 12/08/2005 RAPIDONE-COCAINE-150 TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K053359 12/02/2005 RAPIDTOX AMERICAN BIO MEDICA CORP. FRAN WHITE
K050445 02/22/2005 AMS COLLAGEN DERMAL MATRIX AMERICAN MEDICAL SYSTEMS, INC. ELSA LINKE
K053371 12/05/2005 AMS MALE TRANSOBTURATOR SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. FRANK B FREEDMAN
K050352 02/11/2005 IN-VITRO DIAGNOSTIC VAGINITIS TEST KIT AMERITEK RESEARCH LLC KUD CHAIANG YEE
K050413 02/18/2005 AMPLIEF WRIST BLOOD PRESSURE MONITOR, MODEL M600 AMPLIFE CORPORATION SUSAN D GOLDSTEIN-FALK
K053407 12/07/2005 OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M ANALYTICAL INDUSTRIES, INC. PATRICK J PRINDIBLE
K050256 02/03/2005 APPLE MEDICAL/OB MOBIUS ELASTIC RETRACTOR APPLE MEDICAL CORP. JAMES DELANEY
K053590 12/23/2005 SILVERLON CA (CALCIUM ALGINATE) ARGENTUM MEDICAL, LLC. WILLIAM A CLEMNTI
K053645 12/30/2005 MODIFICATION TO:BAIR HUGGER TEMPERATURE MANAGEMENT SYSTEMS ARIZANT HEALTHCARE INC. DAVID WESTLIN
K053401 12/06/2005 SPOTCHEM II CHEMISTRY BASIC 1 AND CHEMISTRY BASIC 2 TESTS ARKRAY, INC. HELEN LANDICHO
K050358 02/14/2005 ARTHERX CORKSCREW FT II SUTURE ANCHOR ARTHREX, INC. ANN WATERHOUSE
K053543 12/20/2005 ARTHREX ARTHOERESIS IMPLANT ARTHREX, INC. ANN WATERHOUSE
K050259 02/03/2005 ARTHREX BIO-PIN ARTHREX, INC. ANN WATERHOUSE
K053338 12/01/2005 ARTHREX TITANIUM AND BIO-DEGRADABLE (POLYMER) IMPLANTS ARTHREX, INC. ANN WATERHOUSE
K053447 12/09/2005 ARTHROCARE PERC-D SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K053567 12/22/2005 ATHROCARE TOPAZ ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K050373 02/14/2005 UNICAP UNICOMPARTMENTAL KNEE RESURFACING PROSTHESIS ARTHROSURFACE, INC. STEVEN EK
K053461 12/13/2005 EZLOC FEMORAL FIXATION DEVICE ARTHROTEK, INC. SUSAN ALEXANDER
K050320 02/09/2005 FREESCAN LATEX-FREE ULTRASOUND TRANSDUCER COVER KIT ASCENDIA MEDTECH AB JANE B CAMPBELL
K053585 12/23/2005 VANGUARD REPROCESSED SUTURE PASSER ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON
K050313 02/09/2005 BIS SRS (SEMI-RESUABLE SENSOR) ASPECT MEDICAL SYSTEMS, INC. CHRISTINE VOZELLA
K053384 12/05/2005 FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM ASTRA TECH, INC. FLOYD G LARSON
K050425 02/18/2005 AURA-PSG ASTRO-MED, INC. MICHAEL J SULLIVAN
K053476 12/14/2005 ALLWOUND AT SQUARED, LLC JULIA C TIERNEY
K053654 12/30/2005 ATLANTIS ABUTMENT FOR NOBEL REPLACE INTERFACE ATLANTIS COMPONENTS, INC. BETSY A BROWN
K053373 12/05/2005 ATLANTIS ABUTMENT FOR ZIMMER INTERFACE ATLANTIS COMPONENTS, INC. BETSY BROWN
K053450 12/12/2005 ATLANTIS ABUTMENT FOR ZIMMER INTERFACE ATLANTIS COMPONENTS, INC. BETSY A BROWN
K050459 02/23/2005 ATRICURE ISOLATOR TRANSPOLAR PEN ATRICURE, INC. ELSA ABRUZZO
K050311 02/08/2005 ATRIUM MEDICAL CORPORATION C-QUR MESH ATRIUM MEDICAL CORP. JOSEPH P DE PAOLO
K053355 12/02/2005 BTI INTERNA DENTAL IMPLANT SYSTEM B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ALFREDO GOMEZ MENGOD
K050310 02/08/2005 BARDPORT TITANIUM PORTS BARD ACCESS SYSTEMS, INC. MICHAELA RIVKOWICH
K053589 12/23/2005 LONG-TERM HEMODIALYSIS CATHETERS WITH BIOBLOC COATING BARD ACCESS SYSTEMS, INC. MICHAELA RIVKOWICH
K053501 12/16/2005 POWERPICC BARD ACCESS SYSTEMS, INC. LYNN M KIRCHOFF
K053406 12/07/2005 BARRIERPLUS GOLD POWDER-FREE SYNTHETIC POLYISOPRENE SURGICAL GLOVES BARRIERMED GLOVE CO. VICTOR J RAGUCCI
K053512 12/16/2005 HOMECHOICE/HOMECHOICE PRO PERSONAL CYCLER PERITONEAL DIALYSIS SYSTEM, MODELS 5C4471 AND 5C8310 BAXTER HEALTHCARE CORP. DAVID E CURTIN
K050495 02/28/2005 EASYSPRAY AND SPRAY SET FOR TISSEEL (FIBER SEALANT) BAXTER HEALTHCARE CORP., BIOSCIENCE RON LAGERQUIST
K053539 12/20/2005 MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 BAXTER HEALTHCARE CORPORATION DAVID E CURTIN
K050374 02/14/2005 ADVIA IMS LITHIUM ASSAY BAYER HEALTHCARE, LLC ANDRES HOLLE
K053612 12/27/2005 DRI-STAT ACID PHOSPHATASE REAGENT BECKMAN COULTER, INC. ERI HIRUMI
K050400 02/16/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - CEPHALOTHIN (GP) 0.5-64 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K053611 12/27/2005 SMOOTHSHAPES BICELLULASE, INC. ROBERT NAGEL
K050408 02/17/2005 BICON ORTHODONTIC IMPLANT SYSTEM BICON, INC. VINCENT J MORGAN
K053452 12/12/2005 PURE-AID PREGNANCY TEST BIO FOCUS CO., LT. LAUREN HONG
K050328 02/09/2005 PREGNANCY-SKREEN BIOCHEMICAL DIAGNOSTIC, INC. ALLEN PANETZ
K053492 12/15/2005 BIODUCT BIODUCT, LLC HERB SCHWARTZ
K050318 02/09/2005 BARI-KAD PACKING DEVICE BIOENVELOP AGRO, INC. ROBERT SCHIFF
K050493 02/28/2005 QUANTIA IGE BIOKIT S.A. JOAN GUIXER
K050487 02/25/2005 QUANTIA LA(A) BIOKIT S.A. JOAN GUIXER
K053595 12/23/2005 CURAY CUSTOM SEED ARRAY BIOLUCENT, INC. SHERYL HIGGINS
K053383 12/05/2005 FIDIS CELIAC BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K053653 12/30/2005 FIDIS CONNECTIVE 10, MODEL MX006 BIOMEDICAL DIAGNOSTICS (BMD) SA CHRISTELLE COURIVAUD
K050286 02/07/2005 FIDIS CONNECTIVE 8 BIOMEDICAL DIAGNOSTICS (BMD) SA COURIVAUD CHRISTELLE
K053505 12/16/2005 REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS BIOMET MANUFACTURING, INC. TRACY B JOHNSON
K050251 02/03/2005 BALANCE HIP SYSTEM BIOMET, INC. GARY BAKER
K050327 02/09/2005 E-POLY (VITAMIN E) ACETABULAR LINERS BIOMET, INC. TRACY BICKEL JOHNSON
K050441 02/22/2005 TAPER 2 POROUS FEMORAL STEM BIOMET, INC. KACY ARNOLD
K053635 12/29/2005 MODIFICATION TO RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K053327 12/01/2005 OXICOM CONTROL BIONOSTICS, INC. KATHLEEN STORRO
K050305 02/08/2005 ONE STEP HCG PREGNANCY URINE TEST FORMATS: STRIP, CASSETTE AND MIDSTREAM, MODELS BM-1-1, BM-1-2, BM-1-3, BM-2-1, BM-2-2 BIOSCREEN MEDICAL INC. JIMMY LIANG
K053329 12/01/2005 KORLEX-GR GINGIVAL RETRACTION PASTE BIOTECH ONE, INC. KAREN UYESUGI
K050361 02/14/2005 MODIFICATION TO CONCERTO BIPOLAR NEEDLE ELECTRODE BOSTON SCIENTIFIC CORP. NICHOLAS CONDAKES
K050232 02/01/2005 RIGIFLEX SINGLE-USE ACHALASIA BALLOON DILATOR BOSTON SCIENTIFIC CORP. PAIGE SWEENEY
K050403 02/17/2005 SPYGLASS DIRECT VISULATION PROBE BOSTON SCIENTIFIC CORP. KATHLEEN MORAHAN
K050389 02/15/2005 ULTRA-SOFT SV BALLOON DILATATION CATHETER BOSTON SCIENTIFIC CORP. ANGIE BYLAND
K053500 12/16/2005 FRAMELESS RADIOSURGERY COMPONENTS BRAINLAB AG RAINER BIRKENBACH
K053584 12/23/2005 IPLAN RT DOSE BRAINLAB AG RAINER BIRKENBACH
K053607 12/27/2005 BREAS VIVO 40 SYSTEM BREAS MEDICAL AB KARL-JOHAN HOLM
K053424 12/08/2005 POPMESH CALDERA MEDICAL, INC. MARLA KENGEN
K050357 02/14/2005 CAMCERAM TCP CAM IMPLANTS B.V. KIM GROENEWEGAN VAN DER WEIJDEN
K050225 02/01/2005 HEARTWAVE II CARDIAC DIAGNOSTIC SYSTEM CAMBRIDGE HEART, INC. JOHN GREENBAUM
K053395 12/06/2005 BP PRO BLOOD PRESSURE MONITOR CARD GUARD SCIENTIFIC SURVIVAL, LTD. ALEX GONOROVSKY
K053524 12/19/2005 C-PORT DISTAL ANASTOMOSIS SYSTEM CARDICA, INC. DAVID CASAL
K050230 02/01/2005 TURBO TEMP TRIO CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K050366 02/14/2005 IMAGENPRO CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC MELANIE HASEK
K050345 02/11/2005 CIE FOLDAWAY WHEELCHAIR CARLSBAD INTERNATIONAL EXPORT, INC. LAURA MEYER
K050324 02/09/2005 INFPUMP INFILTRATION PUMP CAROLINA MEDICAL, INC. LEON WILSON
K050440 02/22/2005 AOC BONE WAX, OSTENE, OSTEOTENE, ORTHOSEAL, OSTEOSEAL, CERETENE, MODEL BW-12 CEREMED, INC. TADEUSZ WELLISZ
K053324 12/01/2005 CHROMOLITE SYSTEM CHROMOGENEX PLC CHRIS WILLIAMS
K050265 02/04/2005 CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 CHRONO-LOG CORP. NICHOLAS J VERIABO
K053376 12/05/2005 CHUNG CHENG FAR INFRARED RAY HEALTHFUL LAMP (OR MEDICAL FIR RADIATOR), MODEL CH-8810 CHUNG CHENG ELECTRIC HEATING CO., LTD. JENNIFER REICH
K050250 02/03/2005 AQUIFY MULTIPURPOSE SOLUTION CIBA VISION CORPORATION STEVEN DOWDLEY
K053379 12/05/2005 RELI-ON ONE STEP, ORTHODONTIC ADHESIVE CLASSONE ORTHODONTICS, INC. JUDY RIBORDY
K053350 12/02/2005 MODIFICATION TO CODMAN HAKIM SHUNT SYSTEMS Codman & Shurtleff, Inc. BRIAN KANERVIKO
K050426 02/18/2005 TEMPOSIL, MODEL 6720 COLTENE/WHALEDENT AG HENRY J VOGELSTEIN
K050470 02/23/2005 CONCENTRIC EMBOLIC PEARLS CONCENTRIC MEDICAL, INC. JEAN M CAILLOUETTE
K053488 12/15/2005 CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. PATRICK HESS
K050304 02/08/2005 FX WIRE ADVANCED MEASUREMENT GUIDEWIRE CONMED CORP. THOMAS HIRTE
K053464 12/13/2005 SERVICE MANAGER SM40SE CONMED INTEGRATED SYSTEMS, CANADA, ULC MICHAEL T TAGGART
K053561 12/21/2005 BIO-MINI REVO SUTURE ANCHOR CONMED LINVATEC ELIZABETH PAUL
K050246 02/02/2005 SIS DERMAL AUGMENTATION STRAND COOK BIOTECH, INC. MARK BLEYER
K050337 02/10/2005 SIS FISTULA PLUG COOK BIOTECH, INC. MARK BLEYER
K050294 02/07/2005 COOK IRELAND SONNET POLYPECTOMY SNARE COOK IRELAND LTD EMMETT DEVEREUX
K053415 12/07/2005 LESIONPOINT RF CANNULA COSMAN MEDICAL, INC. MICHAEL ARNOLD
K053436 12/09/2005 SURGIFROST 6CM, 7CM AND 10 CM CRYOSURGICAL DEVICES PLUS FROSTBYTE CLAMP AND CRYOSURGICAL CONSOLE CRYOCATH TECHNOLOGIES, INC. FRED MILDER
K050272 02/04/2005 CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS CRYOMEDICAL INSTRUMENTS, LTD. GARETH COPPING
K050379 02/15/2005 CS MEDICAL ADULT TTCF CATHETER CS MEDICAL INC. LEWIS WARD
K050381 02/15/2005 CS MEDICAL TTCF GAS DELIVERY SYSTEM CS MEDICAL INC. LEWIS WARD
K053538 12/20/2005 MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER CURAPHARM, INC. THOMAS M HNAT
K050507 02/28/2005 SMARTECH, MODEL HOLI I CYCLING AND HEALTH TECH. INDUSTRY R&D CENTER CHANG WAN-LAN
K050382 02/15/2005 AFFINITY QS Q-SWITCHED ND:YAG LASER SYSTEM CYNOSURE, INC. GEORGE CHO
K053608 12/27/2005 CYNOSURE PHOTOGENICA V-STAR LASER CYNOSURE, INC. GEORGE CHO
K053421 12/08/2005 YAG MIR FAMILY LASER CYNOSURE, INC. GEORGE CHO
K053337 12/01/2005 DIMENSION URINE ECSTASY SCREEN FLEX REAGENT CARTRIDGE, MODEL DF 109 DADE BEHRING, INC. YUK-TING LEWIS
K053577 12/22/2005 DIMENSION VISTA CTNI FLEX FLEX REAGENT CARTRIDGE, CALIBRATOR AND SDIL SAMPLE DILUENT DADE BEHRING, INC. GEORGE M PLUMMER
K053531 12/19/2005 DIMENSION VISTA FREE THYROXINE FLEX REAGENT CARTRIDGE AND LOCI 1 CALIBRATOR DADE BEHRING, INC. LORRAINE H PIESTRAK
K053576 12/22/2005 DIMENSION VISTA MYO REAGENT CARTRIDGE AND CALIBRATOR DADE BEHRING, INC. GEORGE M PLUMMER
K053504 12/16/2005 MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH ERYTHROMYCIN (0.12-16 UG/ML) DADE BEHRING, INC. ROBERT EUSEBIO
K053580 12/22/2005 DOCTOR'S NIGHTGUARD DENTAL CONCEPTS LLC. HOWARD M HOLSTEIN
K053368 12/05/2005 INTERPROXIMAL REDUCTION SYSTEM DENTSPLY INTERNATIONAL HELEN LEWIS
K050386 02/15/2005 PRIME & BOND NT DUAL CURE NANO-TECHNOLOGY UNIVERSAL DENTAL ADHESIVE SYSTEM DENTSPLY INTERNATIONAL HELEN LEWIS
K053569 12/22/2005 AGILITY LP TOTAL ANKLE PROSTHESIS DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K050315 02/09/2005 DELTA HUMERAL CUPS DEPUY ORTHOPAEDICS, INC. TIFFANI D ROGERS
K053445 12/12/2005 SMARTMIX CEMVAC PRE-FILLED WITH SMARTSET HV BONE CEMENT DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K053593 12/23/2005 PRODIGY DIAGNOSTIC DEVICES INC. DANIEL KAMM
K053533 12/19/2005 IMMULITE/IMMULITE 1000 TURBO INTACT PTH DIAGNOSTIC PRODUCTS CORPORATION DEBORAH L MORRIS
K053566 12/22/2005 MODIFICATION TO: DIAZYME POTASSIUM ENZYMATIC ASSAY, MODEL DZ113A DIAZYME LABORATORIES HUAN TRAN
K050447 02/22/2005 PERFORMA ADULT HOLLOW FIBER MEMBRANE OXYGENATOR DIDECO S.R.L. BARRY SALL
K053640 12/30/2005 INTEGRA DIREX SYSTEMS CORP. LARISA GERSHTEIN
K053399 12/06/2005 VERSALET 7700 CARE CENTER DRAEGER MEDICAL INFANT CARE, INC. MONICA FERRANTE
K053484 12/15/2005 INFINITY GAMMA / GAMMAXL, INFINITY VISTA Draeger Medical Systems, Inc. KAREN A LORIO
K050234 02/01/2005 REMOTE CARE E.CARE SOLUTIONS, INC. CONSTANCE G BUNDY
K053333 12/01/2005 EAGLEVISION GELLANSERTS, MODEL REF 0040 EAGLE VISION, INC. JEFF COBB
K053347 12/02/2005 KODAK CARESTREAM PACS EASTMAN KODAK COMPANY CAROLYN L WAGNER
K053606 12/27/2005 BE PLUS / AURA-LTM64 AMPLIFIER EB NEURO, S.P.A. CARRI GRAHAM
K050446 02/22/2005 BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K053404 12/07/2005 LIFESTENT FLEXSTART BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K053609 12/27/2005 PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC. DIANE PETERSON
K053432 12/09/2005 EKOS MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K053437 12/09/2005 EKOS MICRO-INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K050472 02/24/2005 LYSUS INFUSION SYSTEM EKOS CORP. JOCELYN KERSTEN
K053405 12/07/2005 BACSTOP ELCAM MEDICAL A.C.A.L. TALI HAZAN
K050248 02/03/2005 ELECTRODE ELECTRAMOLD E.W. JOHNSON
K053563 12/21/2005 HUMAPEN MEMOIR ELI LILLY AND COMPANY LEEANN CHAMBERS
K053507 12/16/2005 ELITE ELECTROMED L.I.T.E. 4/1 ELITE ELECTROMEDICAL GARY HUDDLESTON
K050239 02/02/2005 EMD THERMOGRAPHY SYSTEM EM DIAGNOSTICS, INC. RICHARD KEEN
K053455 12/09/2005 ENCOMPASS.NET EMPIRIC SYSTEMS, LLC CARL ALLETTO
K050347 02/11/2005 MODIFICATION TO CRYOCARE CS SURGICAL SYSTEM ENDOCARE, INC. EBEN GORDON
K053326 12/01/2005 ESTECH COBRA ELECTROSURGICAL UNIT & CABLE ENDOSCOPIC TECHNOLOGIES, INC. CRAIG COOMBS
K053429 12/09/2005 ADVANCED UROLOGICAL CATHETER ENTRACARE, LLC AL BOEDEKER
K050326 02/09/2005 7350 ULTRASOUND IMAGING SYSTEM, MODEL 7350 ESAOTE, S.P.A. CARRI GRAHAM
K053557 12/21/2005 ESKA-LIBUR HIP STEM ESKA IMPLANTS GMBH & CO. J. D WEBB
K050344 02/11/2005 LIGACLIP 5 M/L MM ENDOSCOPIC MULTIPLE CLIP APPLIER ETHICON ENDO SURGERY, INC. KIMBERLY SHOEMAKER
K053631 12/29/2005 CONTOUR TRANSTAR CURVED CUTTER STAPLER SET ETHICON ENDO-SURGERY, INC. WENDY TURNER
K053493 12/15/2005 BERRY FRUITY TEETHER EVENFLO COMPANY, INC. RUBEN D COLMENARES
K053427 12/08/2005 FRESH, DENTAL IMPRESSION MATERIAL EXACTA DENTAL PRODUCTS, INC. RICHARD KEEN
K050398 02/16/2005 EXACTECH ZIRAMIC ZIRCONIA 12/14 FEMORAL HEADS EXACTECH, INC. Lisa Simpson
K053386 12/05/2005 XLTEK EMU40 EEG HEADBOX, MODEL PK1072 EXCEL TECH. LTD. NICOLE LANDREVILLE
K050243 02/02/2005 IMMEDIA PROTHROMBIN TIME SYSTEM FARALLON MEDIAL INC JAMES MCKINLEY
K053494 12/15/2005 OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE FERTI PRO N.V. GRACE HOLLAND
K050424 02/18/2005 ERGOFILTER SPI ACCESSORY TO SPIROLYSER SPL-50 FIM MEDICAL DANIEL KAMM
K050293 02/07/2005 FOTONA XP PLUS ND: YAG FAMILY OF LASER SYSTEMS, FONTONA DUALIS XP PLUS ND: YAG FAMILY OF LASER SYSTEMS FOTONA D.D. STOJAN TROST
K053460 12/13/2005 MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, FOX HOLLOW TECHNOLOGIES MELISSA MURPHY
K050273 02/07/2005 FRESENIUS ART HEMOADSORPTION SYSTEM FRESENIUS MEDICAL CARE NORTH AMERICA JANET KAY
K050363 02/14/2005 FUKUDA DENSHI MODEL UF-850XTD FUKUDA DENSHI USA, INC. LARRY D WALKER
K053356 12/02/2005 MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES RONALD N BLASKI
K050489 02/25/2005 INNOVA 2100 GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K053446 12/12/2005 GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 GEN-PROBE, INC. BRIAN J SHEA
K050255 02/03/2005 ARTHORALIX 8500, MODELS 110-0199G1, 110-0199G2, 110-0199G3, 110-0199G4 GENDEX DENTAL SYSTEMS JOHN R MILLER
K053435 12/09/2005 GE VOLUSON I GENERAL ELECTRIC CO. ALLEN SMITH
K053559 12/21/2005 PF4 ENHANCED SOLID PHASE ELISA GENETIC TESTING INSTITUTE LEIGH ANN TIDEY
K053463 12/13/2005 AIM ACCURACY IN MARKING SYSTEM GEORGENE AUSTRIA GEORGENE AUSTRIA
K053639 12/30/2005 GIVEN DIAGNOSTIC SYSTEM GIVEN IMAGING LTD. SHOSHANA FRIEDMAN
K050473 02/24/2005 RBK PATELLA FEMORAL KNEE GLOBAL ORTHOPAEDIC TECHNOLOGY, USA, INC. CARL KNOBLOCH
K050391 02/16/2005 PROTEX CT CERVICOTHORACIC SPINAL SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
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K053578 12/22/2005 SCORPION ULTRASONIC SCALING INSERTS SCORPION DANIEL KAMM
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K053523 12/19/2005 POWDER FREE STERILE VINYL GLOVE (CLEAR AND YELLOW) SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD MICKY LIN
K053521 12/19/2005 PRE-POWDERED STERILE VINYL GLOVE, CLEAR SHIJIAZHUANG HONGXIANG PLASTICS PRODUCTS CO., LTD WILLIAM WANG
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K050355 02/14/2005 PERMACOL SURGICAL IMPLANT T-PIECE, PERMACOL SURGICAL IMPLANT RECTOCELE-PIECE, MODELS 5928-150, 5645-150 TISSUE SCIENCE LABORATORIES, PLC VICTORIA TAYLOR
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K050245 02/02/2005 CELLSEARCH CIRCULATING TUMOR CELL KIT VERIDEX, LLC DEBRA J RASMUSSEN
K050309 02/08/2005 PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 VIASYS MEDSYSTEMS STEPHANIE WASIELEWSKI
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K053560 12/21/2005 MODIFIED ENDOSHEATH SYSTEM FOR VSI FLEXIBLE CYSTOSCOPE VISION-SCIENCES, INC. PAMELA PAPINEAU
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K053364 12/02/2005 HALUX IRIS EXAMINATION AND SURGICAL LAMP WALDMANN LIGHTING DANIEL KAMM
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K053498 12/16/2005 HYPEROX 101 WJO, INC CHRIS BELLETIERI
K053642 12/30/2005 OSTEOSET DBM PELLETS WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K053588 12/23/2005 PROFEMUR LX HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
K053519 12/19/2005 SAFETY SYRINGE WUXI YUSHOU MEDICAL APPLICANCES CO., LTD GARY POND
K053433 12/09/2005 CAUTERY TIP CLEANER, MODEL 30500 XODUS MEDICAL, INC. BRENDA NIEL
K050388 02/15/2005 REFIX INTERNAL FRACTURE FIXATION SCREWS XTREMI-T, LLC SHAWAN T HUXEL
K053619 12/27/2005 COLORBITE ZHERMACK S.P.A. GERALD W SHIPPS
K050417 02/18/2005 ELITE IMPLANT ZHERMACK S.P.A. GERALD W SHIPPS
K050455 02/22/2005 SYNTHETIC POWEDERED VINYL EXAMINATION GLOVES ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD KAREN ABELL
K050450 02/22/2005 SYNTHETIC, POWDER-FREE VINYL EXAMINATION GLOVES ZIBO BLUE INTCO PLASTIC & RUBBER PRODUCTS CO., LTD KAREN ABELL
K053536 12/19/2005 DUROM ACETABULAR COMPONENT AND METASUL LDH LARGE DIAMETER HEADS ZIMMER GMBH LAURA D WILLIAMS
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