FDA 510(k) Applications Received During December, 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
K053330 12/01/2005 ARCHITECT B12 CALIBRATORS ABBOTT LABORATORIES MARGARET PROCHNIAK
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
K053473 12/14/2005 MAESTRO MDTL LASER SYSTEM ADVANCED MEDICAL TECHNOLOGIES, INC. M. JOYCE HEINRICH
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
K053479 12/14/2005 VERIFY DRY HEAT LABEL ALBERT BROWNE LTD. CYNTHIA J.M. NOLTE
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
K053371 12/05/2005 AMS MALE TRANSOBTURATOR SLING SYSTEM AMERICAN MEDICAL SYSTEMS, INC. FRANK B FREEDMAN
K053407 12/07/2005 OXYGEN ANALYZER, MODELS AII 20000A, AII 2000HC, AII 2000M ANALYTICAL INDUSTRIES, INC. PATRICK J PRINDIBLE
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
K053543 12/20/2005 ARTHREX ARTHOERESIS IMPLANT 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
K053461 12/13/2005 EZLOC FEMORAL FIXATION DEVICE ARTHROTEK, INC. SUSAN ALEXANDER
K053585 12/23/2005 VANGUARD REPROCESSED SUTURE PASSER ASCENT HEALTHCARE SOLUTIONS MOIRA BARTON
K053384 12/05/2005 FIXATURE MICROTHREAD OSSEOSPEED, A COMPONENT OF THE ASTRA TECH IMPLANT SYSTEM ASTRA TECH, INC. FLOYD G LARSON
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
K053355 12/02/2005 BTI INTERNA DENTAL IMPLANT SYSTEM B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. ALFREDO GOMEZ MENGOD
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
K053539 12/20/2005 MERIDIAN HEMODIALYSIS MACHINE, MODEL 5M5576 BAXTER HEALTHCARE CORPORATION DAVID E CURTIN
K053612 12/27/2005 DRI-STAT ACID PHOSPHATASE REAGENT BECKMAN COULTER, INC. ERI HIRUMI
K053611 12/27/2005 SMOOTHSHAPES BICELLULASE, INC. ROBERT NAGEL
K053452 12/12/2005 PURE-AID PREGNANCY TEST BIO FOCUS CO., LT. LAUREN HONG
K053492 12/15/2005 BIODUCT BIODUCT, LLC HERB SCHWARTZ
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
K053505 12/16/2005 REGENEREX ULTRA POROUS CONSTRUCT-FEMORAL AND TIBIAL KNEE AUGMENTS BIOMET MANUFACTURING, INC. TRACY B JOHNSON
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
K053329 12/01/2005 KORLEX-GR GINGIVAL RETRACTION PASTE BIOTECH ONE, INC. KAREN UYESUGI
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
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
K053324 12/01/2005 CHROMOLITE SYSTEM CHROMOGENEX PLC CHRIS WILLIAMS
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
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
K053488 12/15/2005 CONFORMIS BICOMPARTMENTAL KNEE REPAIR SYSTEM CONFORMIS, INC. PATRICK HESS
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
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
K053538 12/20/2005 MODIFICATION TO PHYTACARE ALGINATE HYDROGEL WOUND FILLER CURAPHARM, INC. THOMAS M HNAT
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
K053569 12/22/2005 AGILITY LP TOTAL ANKLE PROSTHESIS DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
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
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
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
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
K053405 12/07/2005 BACSTOP ELCAM MEDICAL A.C.A.L. TALI HAZAN
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
K053455 12/09/2005 ENCOMPASS.NET EMPIRIC SYSTEMS, LLC CARL ALLETTO
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
K053557 12/21/2005 ESKA-LIBUR HIP STEM ESKA IMPLANTS GMBH & CO. J. D WEBB
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
K053386 12/05/2005 XLTEK EMU40 EEG HEADBOX, MODEL PK1072 EXCEL TECH. LTD. NICOLE LANDREVILLE
K053494 12/15/2005 OIL FOR TISSUE CULTURE, GRADIENT SYSTEM AND SPERMFREEZE FERTI PRO N.V. GRACE HOLLAND
K053460 12/13/2005 MODIFICATION TO SILVERHAWK PERIPHERAL PLAQUE EXCISION SYSTEM, MODELS 02550, 04800, 05200, 06002, 02406, 04706, 04300, FOX HOLLOW TECHNOLOGIES MELISSA MURPHY
K053356 12/02/2005 MODIFICATION TO: CIC PRO CLINICAL INFORMATION CENTER CENTRAL STATION GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES RONALD N BLASKI
K053446 12/12/2005 GEN-PROBE APTIMA ASSAY FOR CHLAMYDIA TRACHOMATIS, MODEL 1088 GEN-PROBE, INC. BRIAN J SHEA
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
K053573 12/22/2005 GSS PEDICLE SCREW SYSTEM GS MEDICAL CO., LTD. SUN-EUN JUNG
K053497 12/15/2005 GUAVA EZCD4 SYSTEM GUAVA TECHNOLOGIES, INC. LAWRENCE F BRUDER
K053459 12/13/2005 OMNILINK .035 BILIARY STENT SYSTEM GUIDANT CORPORATION SYLVIA HERNANDEZ
K053454 12/09/2005 RX HERCULINK ELITE BILIARY STENT SYSTEM GUIDANT CORPORATION KEITH KROHN
K053555 12/20/2005 ULTRASONIC SCALER, MODELS UDS-N1, UDS-N2. UDS-J, UDS-K, UDS-L GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD CHARLIE MACK
K053486 12/15/2005 TREND 200 CPAP DEVICE, MODEL 5CP201; TRENDSET PC SOFTWARE, MODEL TRENDSET HOFFRICHTER GMBH STEPHEN H GORSKI
K053453 12/12/2005 HOMMED CENTRAL STATION, VERSION 3.5 HONEYWELL HOMMED LLC TOMMIE J MORGAN
K053472 12/14/2005 HOFFMANN II MRI EXTERNAL FIXATION SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K053349 12/02/2005 HOFFMANN II ROD TO WIRE COUPLING HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K053348 12/02/2005 STRYKER ORTHOPAEDICS RFID INSTRUMENTATION HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K053466 12/13/2005 HSINER RESUSCITATOR HSINER CO., LTD. TOM SHANKS
K053369 12/05/2005 MEDILOG DARWIN HOLTER ANALYSIS HUNTLEIGH HEALTHCARE JAMES PARDEY
K053618 12/28/2005 INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325 HUTCHINSON TECHNOLOGY, INC. JOSEPH P ORTNER
K053575 12/22/2005 HYGIA HEALTH SERVICES REPROCESSED KENDALL SCD EXPRESS SLEEVES/FOOT CUFFS HYGIA HEALTH SERVICES, INC. KYLE FERGUSON
K053597 12/23/2005 I-STAT B-TYPE NATRIURETIC PEPTIDE (BNP) I-STAT CORPORATION SUE KENT
K053367 12/05/2005 MALE NATURAL RUBBER LATEX CONDOM INNOLATEX SDN. BHD GOH MIAH KIAT
K053499 12/16/2005 HEMOSIL PROS INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K053655 12/30/2005 TENDON WRAP TENDON PROTECTOR INTEGRA LIFESCIENCES CORPORATION DIANA M BORDON
K053571 12/22/2005 MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM INTERLAB S.R.L. Gary Lehnus
K053540 12/20/2005 INTERMEDIC DIODE LASER FAMILY 810NM AND 980NM (AND THE DELIVERY ACCESSORIES THAT ARE USED WITH THEM TO DELIVER LASER ENE INTERMEDIC ARFRAN, S.A. KLAUS SIVEC
K053462 12/13/2005 3160 MRI PATIENT MONITORING SYSTEM INVIVO CORPORATION NEIL BATTISTE
K053641 12/30/2005 IBA PROTON THERAPY SYSTEM-PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN B REISS
K053622 12/28/2005 SURGISIS OCULAR GRAFT IOP, INC. JASON MALECKA
K053582 12/23/2005 INQUIRY AFOCUS II DIAGNOSTIC CATHETER IRVINE BIOMEDICAL, INC. ELVIA ZAVALA
K053556 12/20/2005 BODY COMPOSITION ANALYZER, MODELS ZEUS 9.9 AND VENUS 5.5 JAWON MEDICAL CO., LTD. HEUNG BONG LIM
K053403 12/06/2005 LUCAS JOLIFE AB HOWARD HOLSTEIN
K053627 12/29/2005 MODIFICATION TO: V.A.C. GRANUFOAM SILVER PROTECTION DRESSING KCI USA, INC. CHRISTY H OVIATT
K053410 12/07/2005 GIENTRIPORT WITH UNIVERSAL SINGLE LUMEN ADAPTOR KENDALL JIM WELSH
K053629 12/29/2005 ANCHOR PLUS/NEO ANCHOR PLUS KJ MEDITECH CHARLIE MACK
K053419 12/08/2005 KONICA MINOLTA PULSOX-300, 300I KONICA MINOLTA SENSING, INC. NANCI DEXTER
K053444 12/09/2005 KOWA KT-800 KOWA CO. LTD. SHINICHI YAMANAKA
K053630 12/29/2005 LEVITRONIX CENTRIMAG PRIMARY CONSOLE LEVITRONIX LLC. FARZAD PARSALE
K053643 12/30/2005 STAGE- 1 TEMPORARY/HEALING CAP, MODEL 42021-42026 LIFECORE BIOMEDICAL, INC. BRIAN SMEKAL
K053529 12/19/2005 ONETOUCH ULTRA 2 BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. LISA MCGRATH
K053510 12/16/2005 IR WIRELESS FOOT SWITCH LINEMASTER SWITCH CORP. MIKE SZOSTEK
K053372 12/05/2005 LBI CATHETER SYSTEM LUMEN BIOMEDICAL, INC. AMY PETERSON
K053628 12/29/2005 LIGHTSHEER DUET LASER SYSTEM LUMENIS, INC. Connie Hoy
K053568 12/22/2005 BILISOFT PHOTOTHERAPY SYSTEM LUMITEX, INC. JEFF WILLIAMS
K053637 12/29/2005 MANI NEEDLE & SUTURE PACK (NYLON) MANI, INC. DAVID J BLOCH
K053636 12/29/2005 MANI NEEDLE & SUTURE PACK (PGA ABSORBABLE) MANI, INC. DAVID J BLOCH
K053638 12/29/2005 MANI NEEDLE & SUTURE PACK (SILK) MANI, INC. DAVID J BLOCH
K053477 12/14/2005 MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS MASIMO CORPORATION JAMES J CRONIN
K053592 12/23/2005 SIMPLANT DR. JAMES MATERIALISE N.V. CARL VAN LIERDE
K053397 12/06/2005 K-Y BRAND SENSUAL MIST MCNEIL-PPC, INC. NADER FOTOUHI
K053485 12/15/2005 THERATRON EQUINOX, MODELS 80 CM AND 100 CM MDS NORDION INC. ROSS KACHANIWSKY
K053345 12/02/2005 PRO-LINE CT POWER INJECTABLE CVC, MODELS CTLINES5S, CTLINE6D MEDCOMP JEAN CALLOW
K053518 12/19/2005 INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR MEDICAL DEVICE TECHNOLOGIES, INC. KRISTINE LIBERACKI
K053624 12/28/2005 MEDICON STERN-A-FIX STERNAL CLOSURE SYSTEM MEDICON, E.G. ANGELIKA SCHERP
K053530 12/19/2005 SONOACE X4 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K053325 12/01/2005 MEDIWATCH MULTISCAN ULTRASOUND SYSTEM/SCANNER, MODEL M0002 (SCANNER ONLY); MULTISCAN ULTRASOUND SYSTEM, MODEL M0001 MEDIWATCH LTD ANDREW HOPKINS
K053574 12/22/2005 MEDLINE PEDIATRIC WHEELCHAIRS MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K053431 12/09/2005 ATTAIN SELECT II 6248DEL DELIVERY CATHETER SYSTEM MEDTRONIC IRELAND MICHELLE NIVALA
K053474 12/13/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K053483 12/15/2005 MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K053430 12/09/2005 TONO-PEN AVIA TONOMETER AND OCU-SHILED TIP COVER MEDTRONIC XOMED, INC. PENNY LAYMAN
K053354 12/02/2005 INTERMEZZO PLUS FIXTURE MEGAGEN CO., LTD. DAE CHANG
K053353 12/02/2005 RESCUE IMPLANT SYSTEM MEGAGEN CO., LTD. DAE CHANG
K053414 12/07/2005 MENTOR NOVASILK MESH MENTOR CORP. DONNA A CRAWFORD
K053335 12/01/2005 PREMIER PLATINUM HPSA PLUS, MODELS 601396, 601480 MERIDIAN BIOSCIENCE, INC. SUSAN ROLIH
K053490 12/15/2005 MERITS HEALTH PRODUCTS PORTABLE NEBULIZER MERITS HEALTH PRODUCTS CO., LTD. STEVE CHAO
K053546 12/20/2005 SONICATOR 740, MODEL ME 740 METTLER ELECTRONICS CORP. ROBERT E FLEMING
K053411 12/07/2005 DRI HEMOGLOBIN A1C ASSAY AND CALIBRATORS MICROGENICS CORP. TONY C LAM
K053554 12/20/2005 COMPUFLO MILESTONE SCIENTIFIC, INC. HOWARD HOLSTEIN
K053451 12/12/2005 LIPOSAT (INFILTRATION PUMP), MODEL 00 002 274; VACUSAT (SUCTION UNIT), MODEL 00 002 252 (220 V), 00 002 318 (110 V); MOELLER MEDICAL GMBH & CO. KG BILL KELLEY
K053361 12/02/2005 MODIFICATION TO: MINIMESH POLYPROPYLENE MESH MPATHY MEDICAL DEVICES, LTD. LOUIS J MAZZARESE
K053339 12/01/2005 ALLOFIX ANCHOR MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY L BENNEWITZ
K053623 12/28/2005 NFIX FUSION SYSTEM N-SPINE, INC. ELAINE DUNCAN
K053468 12/13/2005 NESS L300 NESS-NEUROMUSCULAR ELECTRICAL STIMULATION SYSTEMS JONATHAN S KAHN
K053626 12/28/2005 INTERX500 FLEXIBLE ARRAY ELECTRODE NEURO RESOURCE GROUP, INC. KRISTA OAKES
K053502 12/16/2005 NEWPORT E360 VENTILATOR NEWPORT MEDICAL INSTRUMENTS, INC. RICHARD WATERS
K053408 12/07/2005 NEXA BONE PLATE AND SCREW SYSTEM NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K053394 12/06/2005 NEXA BONE SCREW SYSTEM NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K053602 12/23/2005 PROCERA SOFTWARE, MODEL 33145 NOBEL BIOCARE AB HERBERT CRANE
K053478 12/14/2005 ENDOSSEOUS DENTAL IMPLANT SYSTEM NORTHERN IMPLANTS, LLC GRETA M HOLS
K053387 12/05/2005 PERIOGLAS BONE GRAFT PARTICULATE NovaBone Products, LLC DAVID M GAISSER
K053470 12/14/2005 NOVOFINE 32G TIP NOVO NORDISK INC. JOHN SIGNORIN
K053581 12/23/2005 NUVASIVE SMARTPLATE GRADIENT PLUS SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K053382 12/05/2005 LAPARO-THORACO VIDEOSCOPE XLTF-VAW OLYMPUS MEDICAL SYSTEMS CORPORATION TRACY GULSEN
K053583 12/23/2005 OPTIVIA HYSTEROSCOPIC INTRODUCER, OPTIVIA STEERABLE WORKING CHANNEL OPTIVIA MEDICAL LLC ROBERT M KELLEY
K053587 12/23/2005 ORTHO DEVELOPMENT CERAMIC FEMORAL HEADS WITH PRES-FIT STEMS ORTHO DEVELOPMENT CORP. WILLIAM J GRIFFIN
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K053378 12/05/2005 LOOP RECORDER VITAPHONE, 3100 SERIES TMS TELEMEDIZINISCHE SYSTEME GMBH TILO BORCHARDT
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K053644 12/30/2005 THROMBIGEL THROMBIN/GELATIN FOAM HEMOSTAT VASCULAR SOLUTIONS, INC. LINDA BUSKLEIN
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K053648 12/30/2005 PIONEER TC8080, COMPANION III VIASYS NEURO CARE Gary Syring
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K053364 12/02/2005 HALUX IRIS EXAMINATION AND SURGICAL LAMP WALDMANN LIGHTING DANIEL KAMM
K053604 12/27/2005 WAVELIGHT IDAS WAVELIGHT LASER TECHNOLOGIE AG THORSTEN CRETER
K053381 12/05/2005 WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE WELCH ALLYN, INC. CHRIS KLACZYK
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K053588 12/23/2005 PROFEMUR LX HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. THERESA LEISTER
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K053433 12/09/2005 CAUTERY TIP CLEANER, MODEL 30500 XODUS MEDICAL, INC. BRENDA NIEL
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