FDA 510(k) Applications Received During June, 2005

FDA 510(k) Number Submission Date Device Name Applicant Contact
K051657 06/21/2005 A-DEC SELF-CONTAINED WATER SYSTEM A-DEC, INC. TOM LOUISELL
K051719 06/27/2005 A.B. DENTAL DEVICES A.B. DENTAL DEVICES, LTD. BENNY ARAZY
K051519 06/08/2005 FOX SV PTA CATHETER (82XXX SERIES). FOX PLUS PTA CATHETER (12XXX SERIES) ABBOTT LABORATORIES (PERCLOSE, INC.) ANN E LEONARD
K051593 06/16/2005 UROPASS URETERAL ACCESS SHEATH, MODEL 61224 ACMI CORPORATION GRAHAM BAILLIE
K051501 06/06/2005 ZIRACE ACUCERA, INC. KYUNG-BIN LEE
K051410 06/01/2005 ACUMED RIB CONGRIENT BONE PLATE SYSTEM ACUMED LLC ED BOEHMER
K051515 06/13/2005 MODIFIED ACUMEN SHEATH, MODEL TTW 10-65 ACUMEN MEDICAL, INC. MARYBETH GAMBER
K051544 06/14/2005 VITALCAREGIVING SYSTEM ADVANCED MONITORING CAREGIVING INC. GEORGE MYERS
K051643 06/20/2005 STERRAD STERILIZER CYCLESURE TEST PACK ADVANCED STERILIZATION PRODUCTS JOSEPH M ASCENZI
K051492 06/06/2005 AESKULISA ASCA A AESKU.INC STANLEY AMMONS
K051589 06/16/2005 SLIMMANAGER, MODEL SM-X, SM-E AIIA COMMUNICATION INC. JOHN MYUNG
K051712 06/27/2005 MODEL 2800 PFT FILTER AIR SAFETY LTD PAUL DRYDEN
K051554 06/13/2005 ALLIANCE MEDICAL CORPORATION REPROCESSED EXTERNAL FIXATION DEVICES ALLIANCE MEDICAL CORP. MOIRA BARTON
K051438 06/01/2005 VANGUARD REPROCESSED COMPRESSION GARMENTS (HILL-ROM) ALLIANCE MEDICAL, INC. MOIRA BARTON
K051636 06/21/2005 CAMLOG DENTAL IMPLANT ABUTMENTS, HEALING CAPS, AND ACCESSORIES ALTATEC GMBH TINA STEFFANIE-OAK
K051621 06/21/2005 ENDOVENTIONS ALIMAXX-E ESOPHAGEAL STENT SYSTEM ALVEOLUS, INC. DONALD V CANAL
K051529 06/09/2005 AMBU NEUROLINE GROUND AMBU, INC. SANJAY PARIKH
K051525 06/08/2005 ARX SPINAL SYSTEM AMEDICA CORP. ROBERT M WOLFARTH
K051485 06/06/2005 AMS PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS, INC. ELSA LINKE
K051530 06/09/2005 MONARC + SUBFASCIAL HAMMOCK, MODEL 72404193; MONARC C SUBFASCIAL HAMMOCK, MODEL 72404195. AMERICAN MEDICAL SYSTEMS, INC. DENISE THOMPSON
K051655 06/28/2005 ANGIODYNAMICS, INC., MICRO ACCESS KITS ANGIODYNAMICS, INC. TERI JUCKETT
K051648 06/24/2005 SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS ARKRAY, INC. HELEN LANDICHO
K051432 06/03/2005 SPOTCHEM II TOTAL BILIRUBIN, TOTAL PROTEIN AND ALBUMIN TESTS ARKRAY, INC. HELEN LANDICHO
K051726 06/28/2005 ARTHREX TENODESIS FAMILY ARTHREX, INC. QNN WATERHOUSE
K051639 06/20/2005 AS-OBGYN INFORMATION SYSTEM; AS-EMR SYSTEM AS SOFTWARE, INC. KIM A NATHANSON
K051561 06/15/2005 ASAHI ANGIOGRAPHIC CATHETER ASAHI INTECC CO., LTD. YOSHI TERAI
K051652 06/22/2005 ATLANTIS ABUTMENT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI+ ABUTMENT ATLANTIS COMPONENTS, INC. BETSY BROWN
K051332 06/01/2005 ADVANTA T-GRAFT ATRIUM MEDICAL CORP. KAREN HALL
K051404 06/02/2005 B-CARE POWDER FREE LATEX EXAMINATION GLOVES B-CARE INDUSTRIES CO., LTD. RUJIRA PHANPHIPHAT
K051392 06/01/2005 BTI-SCAN, VERSION 4.0 B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. LEYRE ZUNIGA HERNANDO
K051672 06/23/2005 POWERPICC BARD ACCESS SYSTEMS, INC. LYNN M KIRCHOFF
K051722 06/28/2005 TRICOS T BAXTER HEALTHCARE CORP. BRIAN L BISHOP
K051619 06/17/2005 LIPOPROTEIN FOR MULTIPLE ANALYTES BAYER HEALTHCARE, LLC ANDERS HOLLE
K051693 06/23/2005 MODIFICATION TO BAYER ADVIA 2120 HEMATOLOGY ANALYZER WITH AUTOSLIDE SYSTEM BAYER HEALTHCARE, LLC ANDREA HOLLE
K051670 06/22/2005 RF TUNNELER WIRE BAYLIS MEDICAL CO., INC. MEGHAL KHAKHAR
K051692 06/23/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMOXICILLIN (STREP) 0.0313 - 32 UG/ML BECTON, DICKINSON & CO. MONICA E GIGUERE
K051689 06/23/2005 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - DAPTOMYCIN 0.125 - 32 UG/ML BECTON, DICKINSON & CO. MONICA GIGUERE
K051695 06/23/2005 MARROW PLUS (M+) BERKELEY ADVANCED BIOMATERIALS, INC. FRANCOIS GENIN
K051620 06/20/2005 MATRIX DIGITAL REVERSE OSMOSIS WATER TREATMENT SYSTEM, MODEL EQRMD SERIES BETTER WATER, INC. MICHAEL CLINE
K051397 06/03/2005 BIOBANDS BIOBANDS DISTRIBUTORS, INC. JAMES H HARTTEN
K051675 06/23/2005 BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZER BIODYNAMICS CORP. EDWARD M RIFKIN
K051479 06/03/2005 RS (REDUCED SIZE) OSS (ORTHOPEDIC SALVAGE SYSTEM) ADDITIONAL COMPONENTS BIOMET MANUFACTURING, INC. GARY BAKER
K051570 06/14/2005 AVL HINGE KNEE SYSTEM BIOMET, INC. PATRICIA SANDBORN BERES
K051496 06/06/2005 COBALT BONE CEMENT BIOMET, INC. LONNIE WITHAM
K051532 06/09/2005 COBALT G HV BONE CEMENT BIOMET, INC. LONNIE WITHAM
K051569 06/14/2005 RINGLOC BI-POLAR ACETABULAR COMPONENT BIOMET, INC. PATRICIA SANDBORN BERES
K051480 06/03/2005 ENTERAL FEEDING TUBE BIOSEARCH MEDICAL PRODUCTS, INC. GENE BOYD
K051513 06/21/2005 BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER BIPORE, INC. KEITH PALUCH
K051470 06/03/2005 REMOTE CARE MANAGEMENT SYSTEMS (RCMS) BL HEALTHCARE, INC. MICHAEL MATHUR
K051629 06/20/2005 BLEAS ESIRIUC ANAESTHSIA SYSTEM, MODELS 3000, 2000 BLEASE USA, INC. ARTHUR J WARD
K051507 06/07/2005 MODIFICATION TO BLUE SKY BIO DENTAL IMPLANT SYSTEM BLUE SKY BIO, LLC ALBERT ZICKMANN
K051679 06/23/2005 ILAB ULTRASOUND IMAGING SYSTEM BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K051504 06/07/2005 SPYSCOPE ACCESS AND DELIVERY CATHETER BOSTON SCIENTIFIC CORP. JENNIFER JOHNSON
K051417 06/01/2005 6 FR FL POWERHOHN AND POWERLINE CATHETER C.R. BARD, INC. PEGGY KEIFFER
K051748 06/29/2005 HEMOGLIDE SERIES AND HEMOGLIDE STAR SERIES XK LONG-TERM HEMODIALYSIS CATHETERS C.R. BARD, INC. MICHAELA RIVKOWICH
K051649 06/21/2005 VERICIS CARDIOVASCULAR IMAGE AND INFORMATION SYSTEM, MODEL 4.0 CAMTRONICS MEDICAL SYSTEMS STEVE KRUEGER
K051641 06/20/2005 ALARIS SYSTEM PC UNIT, MODEL 8001 CARDINAL HEALTH, ALARIS PRODUCTS STACY L LEWIS
K051681 06/23/2005 DERMILLUME RED, MODEL HR1000 CARE ELECTRONICS, INC. THOMAS O MOODY
K051533 06/09/2005 I-STOP CL MEDICAL VINCENT GORIA
K051435 06/01/2005 ESENSOR CYSTIC FIBROSIS CARRIER DETECTION TEST , ESENSOR 4800 DNA DETECTION SYSTEM, MODEL 4800 CLINICAL MICRO SENSORS WILLIAM A COTY
K051415 06/01/2005 ENDOTINE RIBBON COAPT SYSTEMS, INC. LINDA RUEDY
K051660 06/23/2005 DENTRONIX DDS 7000 RAPID DRY HEAT STERILIZER STERILIZATION SYSTEM COLTENE/WHALEDENT INC. LORETTA MOONEY
K051494 06/22/2005 MEDICAL IMAGE DIGITIZER, MODELS CDCR 5020S, UCCR7001 AND TCCR 7001 CR TECH, LTD. LEONARD FRIER
K051443 06/02/2005 CERASORB DENTAL, CERASORB M DENTAL AND CERASORB PERIO CURASAN AG, FRANKFURT FACILITY ERIC WIECHERT
K051537 06/10/2005 HILT FAMILY LASER: HILT I, HILT II, HILT III CYNOSURE, INC. GEORGE CHO
K051442 06/03/2005 PHOTOSILK PLUS PULSED LIGHT SYSTEM AND LASER ATTACHMENT CYNOSURE, INC. GEORGE CHO
K051478 06/29/2005 MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - RIFAMPIN DADE BEHRING, INC. ROBERT EUSEBIO
K051650 06/21/2005 STRATUS CS ACUTE CARE MB ISOENZYME OF CREATINE KINASE (CKMB) TEST PAK; STRATUS CS ACUTE CARE CKMB TESTPAK. DADE BEHRING, INC. PAMELA A JURGA
K051597 06/16/2005 STRATUS CS D-DIMER DADE BEHRING, INC. KATHLEEN A DRAY-LYONS
K051350 06/01/2005 SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS DADE BEHRING, INC. ROBERTO EUSEBIO
K051460 06/03/2005 C.CAM-AC DANISH DIAGNOSTIC DEVELOPMENT A/S NIELS SORENSEN
K051707 06/27/2005 ECLIPSE BONDING AGENT DENTSPLY INTL. HELEN LEWIS
K051462 06/03/2005 MODIFICATION TO: CERCON BASE DENTSPLY INTL. HELEN LEWIS
K051463 06/03/2005 XENO ADHESIVE WITH ACTIVATOR DENTSPLY INTL. HELEN LEWIS
K051711 06/28/2005 PLEURX PERITONEAL CATHETER KIT AND PLEURX DRAINAGE KITS DENVER BIOMEDICAL, INC. NANCY SAUER
K051714 06/27/2005 TOTAL BILE ACIDS ASSAY, MODEL DZ042A DIAZYME LABORATORIES HUAN TRAN
K051549 06/13/2005 CARDIUS-1, CARDIUS-2, CARDIUS-3, 2020TC SPECT IMAGING SYSTEM DIGIRAD CORP. JOEL TUCKEY
K051571 06/14/2005 SKYLIGHT LED CURING LIGHT DMETEC CO., LTD. CAROLANN KOTULA
K051487 06/08/2005 DRG LARYNGEAL AUGMENTATION IMPLANT DEVICE DOCTOR'S RESEARCH GROUP, INC. MAHMUD AHMED
K051658 06/21/2005 INFINITY ALPHA DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K051628 06/20/2005 INFINITY MONITORS WITH SCIO MODIFICATIONS DRAEGER MEDICAL SYSTEMS, INC. PENELOPE H GRECO
K051733 06/29/2005 ENZYME IMMUNOASSAY FOR THE DETECTION OF SALIVARY CORTISOL DRG INTL., INC. GARY LEHNUS
K051680 06/23/2005 DYNATRON DX2 TRACTION UNIT DYNATRONICS CORP. RON HATCH
K051483 06/06/2005 KODAK DIRECTVIEW DR SYSTEM DETECTOR EASTMAN KODAK COMPANY CHRISTINE E EHMANN
K051724 06/27/2005 ACUMEN IMAGE GUIDED SURGICAL SYSTEM EBI, L.P. WHITNEY TORNING
K051746 06/29/2005 ELEKTA ESARTE FRAME SYSTEM ELEKTA INSTRUMENT AB PETER LOWENDAHL
K051420 06/01/2005 HABIB 4X EMCISION, LTD. NAGY HABIB
K051509 06/09/2005 ERBE ERBOKRYO CA CRYOSURGICAL UNIT & ACCESSORIES ERBE USA, INC. JULIE STEPHENS
K051764 06/30/2005 T-PLATE ANTERIOR FIXATION SYSTEM ESM TECHNOLOGIES CLIFF TRIBUS
K051534 06/10/2005 CARDIOLINE AR 600, AR 1200, AR 2100 ET MEDICAL DEVICES SPA ATTILIO CASTELLI
K051732 06/28/2005 ENDOSCOPIC APPLICATOR ETHICON INC. PETER CECCHINI
K051701 06/29/2005 VICRYL * MESH BAG ETHICON, INC. JENNIFER PAINE
K051455 06/02/2005 WIESLAB CAP MPO-ANCA EURODIAGNOSTICA WILLIAM L BOTELER JR.
K051458 06/02/2005 WIESLAB CAP PR-3 ANCA EURODIAGNOSTICA WILLIAM L BOTELER JR.
K051489 06/14/2005 EUROIMMUN ANCA IFA GRANULOCYTE BIOCHIP MOSCAIC IGG ANTIBODY IN HUMAN SERUM EUROIMMUN US LLC KATHRYN KOHL
K051550 06/14/2005 INSPIRATION VENTILATOR SYSTEM EVENT MEDICAL LTD. ROBBIE WALSH
K051498 06/07/2005 DISPOSABLE POWDERED VINYL EXAM GLOVE YELLOW COLOR EVER GLOBAL ENTERPRISE CORPORATION NICK BIEN
K051556 06/13/2005 ACUMATCH A-SERIES CONNEXION GXL ENHANCED CROSSLINKED POLYTHYLENE EXACTECH, INC. DIANA TAYLOR
K051682 06/23/2005 EXACTECH 12/14 ALUMINA FEMORAL HEADS 36 MM EXACTECH, INC. MARITZA ELIAS
K051684 06/23/2005 EYEPORT VISION TRAINING SYSTEM EXERCISE YOUR EYES, INC. JACOB LIBERMAN
K051446 06/29/2005 FEMTEX AND PRIVATE LABEL OPAL FRESH SCENTED PLASTIC APPLICATOR TAMPONS FIRST QUALITY HYGIENIC INC. ROBERT J STAAB
K051580 06/15/2005 VP SHEATH FLOWCARDIA, INC. RICHARD SPANO
DEN050007 06/20/2005 HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL FMG INNOVATIONS, INC. LINDA D BENTLEY
K051653 06/20/2005 HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL FMG INNOVATIONS, INC. LINDA D BENTLEY
K051522 06/08/2005 SILBRONCHO DOUBLE LUMEN TUBE FUJI SYSTEMS CORP. PAUL E DRYDEN
K051553 06/13/2005 FUJI SYNAPSE WORKSTATION SOFTWARE FUJIFILM MEDICAL SYSTEMS USA, INC. ROBERT BERRY
K051520 06/08/2005 GAMBRO POLYFLUX HEMODIALYZER, MODEL 6H GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K051427 06/06/2005 GC FUJI FIL LC GC AMERICA, INC. TERRY L JORITZ
K051358 06/01/2005 NATURE-CRYL HI PLUS GC AMERICA, INC. TERRY L JORITZ
K051634 06/20/2005 DATEX-OHMEDA S/5 DEVICE INTERFACING SOLUTION GE HEALTHCARE JOEL C KENT
K051635 06/20/2005 DATEX-OHMEDA S/5 NEUROMUSCULAR TRANSMISSION MODULE, E-NMT AND ACCESSORIES GE HEALTHCARE JOEL C KENT
K051734 06/28/2005 GE HEALTHCARE INSTA TRAK 3500PLUS/ FLUORO TRAK 9800 PLUS SYSTEM WITH AXCESS BONE PIN, MODEL PART # 1006955 GE HEALTHCARE TECHNOLOGIES RAJ KASBEKAR
K051449 06/02/2005 GE VIVID 7 WITH OR WITHOUT SUFFIX GE MEDICAL SYSTEMS ALLEN SCHUH
K051673 06/23/2005 XELERIS 2 PROCESSING AND REVIEW WORKSTATION GE MEDICAL SYSTEMS LARRY A KROGER
K051518 06/10/2005 UNITY NETWORK ID GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES RONALD N BLASKI
K051490 06/06/2005 GE OEC EVERVIEW 7500 GE OEC MEDICAL SYSTEMS, INC. SUSAN SCHMIDT
K051666 06/22/2005 GAV - GENERAL ANAESTHETIC VAPORIZER GENERAL ANAESTHETIC SERVICES LIMITED ANDREW JW WALL
K051508 06/08/2005 MED FLASH II INTENSE PULSED LIGHT SYSTEM. GENERAL PROJECT S.R.L. MAUREEN O'CONNELL
K051727 06/28/2005 AIMSTICK URINE REAGENT STRIPS GERMAINE LABORATORIES, INC. MARTIN O'CONNOR
K051471 06/03/2005 CARDIODAY GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG BERT SCHADOW
K051686 06/27/2005 CARDIOMEM CM 3000-12 GETEMED MEDIZIN- UND INFORMATIONSTECHNIK AG CAROLANN KOTULA
K051606 06/22/2005 GISH ATR2900 AND CAP35 SERIES RESERVOIRS WITH GBS COATING GISH BIOMEDICAL, INC. J. HARVEY KNAUSS
K051730 06/28/2005 MATRIX HOLTER SYSTEM, MODEL M12 GLOBAL INSTRUMENTATION, LLC CRAIG SELLERS
K051345 06/01/2005 COLORED POWDER FREE AND POLYMER COATED PATIENT EXAMINATION GLOVE (PINK, BLUE, GREEN AND VIOLET) GLOVCO (M) SDN. BHD. TAN PENG HOCK
K051668 06/22/2005 THE ART OF INTIMACY RESPONSE PERSONAL LUBRICANT GOODMARK USA, INC. ROBERT J MICHALIK
K051662 06/24/2005 VINYL NITRILE CO-POLYMER POWDER FREE EXAM GLOVES (BLUE COLOR) GRAND WORK PLASTIC PRODUCTS CO., LTD. MICKY LIN
K051429 06/10/2005 CLARIS NON-STICK BIPOLAR FORCEPS GUENTER BISSINGER MEDIZINTECHNIK GMBH CHRISTA HEITMANN-FRANKE
K051594 06/16/2005 MCCARTNEY ACCESS TUBE GYNETECH PTY. LTD. DENNIS HAHN
K051728 06/30/2005 MODIFICATION TO SHOULDER FIXATION SYSTEM HAND INNOVATIONS, LLC. ERNESTO HERNANDEZ
K051610 06/17/2005 HANS HERMANN LAPAROSCOPES AND ACCESSORIES HANS HERMANN GMBH HARALD JUNG
K051546 06/13/2005 BPCALIBRATOR MC3000/MC3100 HEALTHSTATS INTERNATIONAL PTE. LTD. STEPHEN GORSKI
K051677 06/29/2005 OPTIGEN ALLERGEN SPECIFIC IGE ASSAY HITACHI CHEMICAL DIAGNOSTICS, INC. EMI ZYCHLINSKY
K051588 06/15/2005 BIOLOX DELTA CERAMIC FEMORAL HEADS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051737 06/28/2005 MODIFICATION TO V-40/C-TAPER ADAPTER SLEEVE HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051738 06/28/2005 SECUR-FIT MAX AND PLUS MAX HIP STEMS HOWMEDICA OSTEONICS CORP KAREN ARIEMMA
K051624 06/20/2005 T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP VIVIAN KELLY
K051590 06/15/2005 T2 ANKLE ARTHRODESIS NAIL HOWMEDICA OSTEONICS CORP. VIVIAN KELLY
K051430 06/01/2005 EXTREME H2O 54% (HIOXIFILCON D) SOFT CONTACT LENS (SPHERICAL AND TORIC) HYDROGEL VISION CORPORATION DONNA HOVANEC
K051472 06/07/2005 BIOPHEN LMWH CONTROL, LMWH CONTROL LOW, UFH CONTROL, HEPARIN CALIBRATOR & UFH CALIBRATOR HYPHEN BIOMED OLA ANDERSON
K051514 06/08/2005 ASSURE PRO BLOOD GLUCOSE MONITORING SYSTEM, MODEL 460002 HYPOGUARD USA, INC. BRUCE A MACFARLANE
K051401 06/01/2005 ON-Q CATHETER, ON-ANTIMICROBIAL CATHETER, SOAKER CATHETER, I-FLOW CATHETER I-FLOW CORP. SHANE NOEHRE
K051433 06/01/2005 I-STAT CREATINE KINASE MB (CK-MB) I-STAT CORPORATION SUE KENT
K051642 06/20/2005 FR.O.H. CALCANEUS REPAIR SYSTEM I.T.S. IMPLANTAT-TECHNOLOGIE-SYSTEME GMBH AL LIPPINCOTT
K051437 06/01/2005 CML 1000 ICU MEDICAL, INC. JIM COOMBES
K051713 06/27/2005 JBAIDS ANTHRAC DETECTION SYSTEM IDAHO TECHNOLOGY, INC. BETH LINGENFELTER
K051579 06/15/2005 IMMUNALYSIS AMPHETAMINE ELISA FOR ORAL FLUIDS IMMUNALYSIS CORPORATION MICHAEL VINCENT
K051578 06/15/2005 IMMUNALYSIS COCAINE/COCAINE METABOLITE ELISA FOR ORAL FLUIDS IMMUNALYSIS CORPORATION MICHAEL VINCENT
K051577 06/15/2005 IMMUNALYSIS METHAMPHETAMINE ELISA FOR ORAL FLUIDS IMMUNALYSIS CORPORATION MICHAEL VINCENT
K051626 06/21/2005 IMMUNALYSIS OPIATES ELISA FOR ORAL FLUIDS IMMUNALYSIS CORPORATION MICHAEL VINCENT
K051476 06/03/2005 UNI-VENT MODEL 73X IMPACT INSTRUMENTATION, INC. LESLIE H SHERMAN
K051461 06/03/2005 3I OSSEOTITE DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUEYL A HUGHES
K051419 06/01/2005 INDITHERM PATIENT WARMING SYSTEM, MODELS MECU1; OTM1; OTM2; GTM1; PTM1; OTB; RB1 INDITHERM MEDICAL M.W. (ANDY) ANDERSON
K051715 06/27/2005 STARPACS DENTAL INFINITT CO., LTD. CARL ALLETTO
K051436 06/01/2005 PRE' VAGINAL LUBRICANT INGFERTLITY, LLC DENNIS CLIFTON
K051742 06/28/2005 OOCYTE RETRIEVAL NEEDLE SET, MODELS 917-IH AND 917-SH INNTEC, INC. GARY SYRING
K051450 06/02/2005 EXTENDED MEASUREMENTS SYSTEM INOVISE MEDICAL, INC. STEVE C HESLER
K051540 06/10/2005 INOVO, INC. INDEPENDENCE OXYGEN CONSERVING REGULATOR INOVO, INC. KEVIN CONFOY
K051630 06/17/2005 SUPER VIEW DISPOSABLE BIOM LENS SET INSIGHT INSTRUMENTS, INC. MICHAEL ANNEN
K051717 06/27/2005 RN SYNOCTA TEMPORARY MESO ABUTMENT INSTITUT STRAUMANN SA LINDA JALBERT
K051440 06/02/2005 MAYFIELD INFINITY SKULL CLAMP INTEGRA LIFESCIENCES CORP. DONNA R WALLACE
K051512 06/07/2005 CAC-127-8 CARDOAC ARRAY COIL INVIVO CORP. THOMAS SCHUBERT
K051548 06/13/2005 IRRADIA MID - LASER (S3) IRRADIA AB THEO RUSSO-LARSSON
K051481 06/03/2005 JAN MAO WHEELCHAIR, MODEL JMC611-F18EPP JAN MAO INDUSTRIES CO., LTD. KE-MIN JEN
K051482 06/03/2005 JAN MAO WHEELCHAIR, MODEL JMC612-F18EPP JAN MAO INDUSTRIES CO., LTD. KE-MIN JEN
K051454 06/09/2005 ALEUTIAN SPACER SYSTEM K2M, LLC RICH WOODS
K051531 06/09/2005 TECTONIC CERVICAL PLATE SYSTEM K2M, LLC RICH WOODS
K051505 06/13/2005 SCB/STERIS OR-LIGHT INTERFACE BOX KARL STORZ ENDOSCOPY-AMERICA, INC. PAUL S LEE
K051584 06/16/2005 14.5 FR CHRONIC HEMODIALYSIS CATHETER WITH INSERTION STYLETS ACCESSORY KENDALL JAMES WELSH
K051586 06/16/2005 VIEWSEND MEDICAL SYSTEM KENEI CO., LTD. JENNIFER LI
K051545 06/10/2005 L.E. DEMETRON II KERR CORPORATION (DANBURY) COLLEEN BOSWELL
K051611 06/17/2005 MBARESORB IMPLANT KINETIKOS MEDICAL, INC. JOHN G SPAMPINATO
K051418 06/01/2005 DIRECT DIGITIZER REGIUS MODEL 370 KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI MAMANAKA
K051523 06/14/2005 REGIUS CONSOLE CS-2000 AND REGIUS CONSOLE CS-3000, MEDICAL IMAGE PROCESSING WORKSTATION KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K051521 06/14/2005 REGIUS RS-1000, MEDICAL IMAGE PROCESSING WORKSTATION KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K051552 06/13/2005 O.A.S.I. SYSTEM LANCER ORTHODONTICS, INC. GRACE HOLLAND
K051608 06/17/2005 STAR 50 MONITORING SYSTEM LARSEN & TOUBRO LIMITED E.J. SMITH
K051538 06/10/2005 AVANTICARE, MODEL SA4022 LERADO CHINA LIMITED JEFF CHANG
K051473 06/03/2005 LEARDO, AVANTICARE ELECTRICAL SCOOTERSM3021 LERADO CHINA LIMITED JEN KE-MIN
K051614 06/17/2005 PRIMACONNEX INTERNAL CONNECTION IMPLANT SYSTEM, PRIMACONNEX INTERNAL CONNECTION PROSTHETICS LIFECORE BIOMEDICAL, INC. RACHEL KENNEDY
K051416 06/01/2005 SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND INNER CANNULA MALLINCKRODT MEDICAL PATRICK GARVEY
K051439 06/02/2005 LNOP BLUE OXIMETRY SENSOR MASIMO CORPORATION JAMES J CRONIN
K051585 06/15/2005 F-400 SYSTEM MAUNA KEA TECHNOLOGIES ALEXANDRE LOISEAU
K051676 06/23/2005 SPINEASSIST DEVICE WITH ADDITIONAL ACCESSORIES MAZOR SURGICAL TECHNOLOGIES LTD. AHAVA STEIN
K051567 06/14/2005 APTUS TITANIUM OSTEOSYNTHESIS SYSTEM MEDARTIS, INC. FLOYD G LARSON
K051700 06/24/2005 OPTICLEAN LENS IRRIGATOR & OPTIDOCK TISSUE LIGATOR MEDCHANNEL, LLC FREDERICK TOBIA
K051499 06/07/2005 INTRAVASCULAR ADMINISTRATION SET AND EXTENSION SET MEDEGEN MEDICAL MANUFACTURING SERVICES SALVADORE F PALOMARES
K051697 06/23/2005 SELECTIVE-AXIS POSTERIOR NONCERVICAL PLATING SYSTEM MEDICAL DEVICE ADVISORY DEVELOPMENT GROUP C. STEPHEN LAWRENCE
K051694 06/23/2005 CLICKZIP NEEDLE RETRACTABLE SAFETY SYRINGE MEDICAL DEVICE MANUFACTURER (THAILAND) LTD. OYTIP KUNWUNLOP
K051421 06/01/2005 INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR MEDICAL DEVICE TECHNOLOGIES, INC. KRISTINE LIBERACKI
K051488 06/13/2005 MEDICINELODGE ZIPKNOT MEDICINELODGE, INC. M. MRY SINNOTT
K051448 06/03/2005 MODIFIED CONTACT-HEAT EVOKED POTENTIAL STIMULATOR (CHEPS) MEDOC LTD. ADVANCED MEDICAL SYSTEMS GEORGE J HATTUB
K051745 06/29/2005 ECHOSYSTEM MEDSTRAT, INC. ROBERT J BISHOP
K051082 06/03/2005 MEDTRADE PRODUCTS SKIN PROTECTIVE BARRIER WIPE (STERILE AND PRESERVED) MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K051674 06/23/2005 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. RICHARD TREHARNE
K051698 06/24/2005 MERRIES UNI-OSTEO, MODEL CS30250-CS10102 MERRIES INTERNATIONAL INC. JESSICA LI
K051528 06/15/2005 MEVIS LIVERANALYSER/LIVERVIEWER SOFTWARE MEVIS TECHNOLOGY GMBH & CO. KG CARL ALLETTO
K051477 06/06/2005 MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) MI GWANG CONTACT LENS CO., LTD. MARTIN DALSING
K051423 06/06/2005 MICK HDR INTERSTITIAL IMPLANT ACCESSORIES MICK RADIO-NUCLEAR INSTRUMENTS, INC. FELIX MIOK
K051425 06/01/2005 NEXUS DETACHABLE COIL SYSTEM, HELIX SUPER SOFT CSR MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K051560 06/14/2005 NEXUS DETACHABLE COIL, MULTI-DIAMETER CSR AND HELIX SUPER SOFT CSR MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K051618 06/29/2005 SPECIAL PROCEDURES II HEAD COIL, MODEL 1400GE-64 MIDWEST R.F. LLC. DAVID M PETERSON
K051669 06/22/2005 TEVADAPTOR CLOSED DRUG RECONSTITUTION AND TRANSFER SYSTEM MIGADA PLANT YOSSI SHACHAR
K051445 06/03/2005 MILLIKEN SILVER WOUND DRESSINGS MILLIKEN CHEMICAL MARY MCNAMARA-CULLINANE
K051625 06/21/2005 BARRIER SURGICAL DRAPES MOLNLYCKE HEALTH CARE, INC. JOHN CLAY
K051739 06/28/2005 POCKET TRANSCRANIAL AND VASCULAR DOPPLER SPECTRUM ANALYZER, MODEL 500P; PW DOPPLER ULTRAOUND PROBE, MODEL 2MPB. MULTIGON INDUSTRIES, INC. WILLIAM STERN
K051596 06/23/2005 STATUSFIRST CHF (CONGESTIVE HEART FAILURE) NT-PROBNP, MODEL 20204 NANOGEN, INC. VAN N SCHRAMM
K051765 06/30/2005 CERETOM, MODEL NL3000 NEUROLOGICA CORPORATION BRAHIM HADRI
K051599 06/16/2005 NEURORECOVERY, INC. (NRI) COMPREHENSIVE INTRACRANIAL PRESSURE EVALUATION AND RELIEF (CIPER) KIT NEURORECOVERY, INC. ROSINA ROBINSON
K051434 06/01/2005 COOLTOUCH ND:YAG LASER SYSTEMS, MODELS CT3S AND CTEV NEW STAR LASERS, INC. DONALD V JOHNSON
K051740 06/28/2005 TAPERED COMPRESSION PIN NEXA ORTHOPEDICS, INC. LOUISE M FOCHT
K051574 06/14/2005 NIPRO DISPOSABLE SYRINGE WITH OR WITHOUT NEEDLE NIPRO MEDICAL CORP. KAELYN HADLEY
K051486 06/06/2005 NORWOOD ABBEY CENTURION SES EPIKERATOME NORWOOD ABBEY , LTD. PAUL CLARK
K051617 06/23/2005 NOVABONE PUTTY - RESORBABLE BONE VOID FILLER NOVABONE PRODUCTS, LLC DAVID M GAISSER
K051607 06/21/2005 NOVASPINE CEMENT RESTRICTOR "NSCR" NOVASPINE LLC HAMID KHOSROWSHAHI
K051718 06/27/2005 NUVASIVE NEUROVISION JJB SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K051469 06/03/2005 CAREVENT ATV+ AND CAREVENT MRI O-TWO MEDICAL TECHNOLOGIES, INC. AMMAR AL-DOJALLY
K051541 06/10/2005 GF-UE160-AL5 ULTRASOUND ENDOSCOPE OLYMPUS AMERICA, INC. LAURA STORMS-TYLER
K051564 06/14/2005 OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBRATOR NORMAL SET, ODC0026; OLYMPUS CRP LATEX CALIBRATOR HIGH OLYMPUS AMERICA, INC. BEV HARDING
K051645 06/20/2005 EVIS EXERA 160A SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K051613 06/17/2005 MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 3 OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K051551 06/13/2005 SMALL INTESTINAL VIDEOSCOPE SYSTEM OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K051753 06/30/2005 ACCU-SOURCE ONCOLOGY SYSTEMS, INC. JENNIFER WILLIAMS
K051647 06/21/2005 FORTADERM ANTIMICROBIAL WOUND DRESSING ORGANOGENESIS, INC. PATRICK BILBO
K051751 06/29/2005 EQUA-PULL SAFETY RELEASE MODULE ORTHO TECHNOLOGY STEVE KLAMIC
K051754 06/29/2005 ORTHOSCAN, ORTHOSCAN HD ORTHOSCAN, INC. ARLEN ISSETTE
K051576 06/14/2005 AVANA DENTAL IMPLANT SYSTEM OSSTEM CO., LTD. ALBERT REGO
K051656 06/27/2005 OCT (OSTEOCHONDRAL TRANSPLANT) COMPREHENSIVE SYSTEM OSTEOBIOLOGICS, INC. GABRIELE G NIEDERAUER
K051664 06/24/2005 SCAN300FP / RETROPAN (VDC) OY AJAT, LTD. CLAUDE D BERTHOIN
K051465 06/03/2005 POWDERED LATEX PATIENT EXAMINATION GLOVES P.T. ANLIS ABADI INTERNASIONAL HUAN-CHUNG LI
K051758 06/30/2005 PENUMBRA ASPIRATION PUMP, MODEL 115V PENUMBRA, INC. THERESA B BRANDNER-ALLEN
K051632 06/20/2005 PHILIPS HEARTSTART FR2+ AUTOMATED EXTERNAL DEFIBRILLATOR, MODELS M3860A, M3861A, M3840A, M3841A PHILIPS MEDICAL SYSTEMS TAMARA YOUNT
K051428 06/01/2005 VTRAC EXCIMER LAMP SYSTEM PHOTO MEDEX, INC. BOB ROSE
K051464 06/03/2005 PLANMECA PROMAX WITH DEC (DYNAMIC EXPOSURE CONTROL) PLANMECA OY BOB PIENKOWSKI
K051646 06/21/2005 ISE DILUENT, 1N KCL, INTERNAL REFERENCE AND ISE STANDARDS LOW AND HIGH POINTE SCIENTIFIC, INC. WILLIAM F WALTERS
K051691 06/23/2005 MINIMATE COMPRESSOR PRECISION MEDICAL, INC. JAMES PARKER
K051565 06/17/2005 PROTON DIGITAL BLOOD PRESSURE MONITOR, MODELS PH168A, PH168E, PH168W, PHC888JA, PH888HA PROTON HEALTHCARE LTD. KEVIN WALLS
K051566 06/17/2005 PROTON PHC 8731 10 SECOND DIGITAL THERMOMETER; PROTON PHC 109 EAR THERMOMETER; PROTON 889 EAR THERMOMETER PROTON HEALTHCARE LTD. KEVIN WALLS
K051572 06/15/2005 KOKO LEGEND PULMONARY DATA SERVICES, INC. DONALD HENTON
K051767 06/30/2005 LTV 1000 VENTILATOR PULMONETIC SYSTEMS, INC. ROBERT C SAMEC
K051609 06/23/2005 QUILL SYNTHETIC ABSORBABLE BARBED SUTURE QUILL MEDICAL, INC. LOIS V SMART
K051339 06/01/2005 R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL R & D SYSTEMS, INC. RALPH E HOGANCAMP
K051743 06/29/2005 R2 BREAST IMAGING WORKSTATION R2 TECHNOLOGY, INC. DENISE F GOTTFRIED
K051671 06/22/2005 RADIANCY SKINSTATION WITH MODIFIED LIGHT UNIT ADDEMBLY RADIANCY (ISRAEL) LTD. JONATHAN S KAHAN
K051615 06/17/2005 STERLING CANCELLOUS CHIPS; STERLING CANCELLOUS CUBES REGENERATION TECHNOLOGIES, INC. CARRIE HARTILL
K051468 06/03/2005 INNER-LOCK INTRODUCER SHEATH REX MEDICAL SUSAN D GOLDSTEIN-FALK
K051276 06/01/2005 HYSAFE MICRO MODULAR FORCEPS AND SCISSORS SYSTEM RICHARD WOLF MEDICAL INSTRUMENTS CORP. ROBERT L CASARSA
K051752 06/29/2005 ROCHE ELECSYS TROPONIN T STAT (SHORT TURNAROUND TIME) ROCHE DIAGNOSTICS THERESA M AMBROSE
K051517 06/08/2005 ELECSYS PRECICONTROL ANEMIA ROCHE DIAGNOSTICS CORP. CORNIA HARPER
K051543 06/10/2005 ELECSYS PRECICONTROL BONE ROCHE DIAGNOSTICS CORP. CORINA HAPER
K051687 06/24/2005 ELECSYS PRECICONTROL UNIVERSAL ROCHE DIAGNOSTICS CORP. CORINA HARPER
K051592 06/15/2005 MODIFICATION TO ACCU-CHEK GO SYSTEM ROCHE DIAGNOSTICS CORP. DIMITRIS DEMIRTZOGLOU
K051762 06/30/2005 SAF-T-SYRINGE/SAF-T-NEEDLE SAFETY MEDICAL INTERNATIONAL, INCORPORATED DAVID ZARRILLI
K051581 06/15/2005 SANARUS CASSI II ROTATIONAL CORE BIOPSY SYSTEM, MODEL CS2000 SANARUS MEDICAL, INC. TRENA DEPEL
K051409 06/01/2005 SLIVASURE SCANDINAVIAN FORMULAS, INC. CATHERINE P PEKLAK
K051368 06/03/2005 BR 102 PLUS BLOOD PRESSURE HOLTER SYSTEM SCHILLER AG MARKUS BUETLER
K051663 06/24/2005 MALIBU SPINAL SYSTEM SEASPINE, INC. DIANA SMITH
K051456 06/02/2005 SENTINEL CERULOPLASMIN SENTINEL CH. SRL DAVIDE SPADA
K051444 06/02/2005 SENTINEL CHOLINESTERASE LIQUID SENTINEL CH. SRL DAVIDE SPADA
K051452 06/02/2005 SENTINEL CLIN CHEM CAL SENTINEL CH. SRL DAVIDE SPADA
K051447 06/02/2005 SENTINEL PANCREATIC AMYLASE SENTINEL CH. SRL DAVIDE SPADA
K051457 06/02/2005 SENTINEL PLASMAPROTEINS CAL 3X SENTINEL CH. SRL DAVIDE SPADA
K051683 06/23/2005 POWDER-FREE SYNTHETIC VINYL EXAM GLOVES WITH VITAMIN E COATING SHEN WEI (USA), INC. STANLEY DUAN
K051704 06/24/2005 MYKRES SPINAL SYSTEM SHOWA IKA KOHGYO CO.,LTD. FLOYD G LARSON
K051333 06/28/2005 NITRILE EXAMINATION GLOVES, POWDER FREE SHUN THAI RUBBER GLOVES INDUSTRY CO., LTD. ANAN JETSADAWISUT
K051736 06/29/2005 FOX PULSE OXIMETER SHUNSUKE NAKANISHI YINGCHAO XIAO
K051602 06/16/2005 AXIOM SIRESKOP SD SIEMENS MEDICAL SYSTEMS, INC. GARY JOHNSON
K051510 06/07/2005 SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEM SIGNAL MEDICAL CORP. LOUIS A SERAFIN
K051659 06/24/2005 SEMIAL SPINAL IMPLANT SIGNUS MEDIZINTECHNIK GMBH TRACY L GRAY
K051661 06/22/2005 IMPLANT HANDPIECES SIRONA DENTAL SYSTEMS GMBH MARY MCNAMARA-CULLINANE
K051605 06/20/2005 SBI K-WIRES SMALL BONE INNOVATIONS, LLC DONALD GUTHNER
K051747 06/29/2005 SBI WRISTFIT SMALL BONE INNOVATIONS, LLC DONALD GUTHNER
K051557 06/13/2005 TRIGEN RETROGRADE FEMORAL, SUPRACONDYLAR AND TIBIAL NAILS SMITH & NEPHEW, INC. DAVID HENLEY
K051524 06/08/2005 LOCK-IT PLUS REGIONAL ANESTHESIA CATHETER SECUREMENT DEVICE, MODEL 100/399/216 SMITHS MEDICAL ASD, INC. CYNTHIA ENGELHARDT
K051568 06/14/2005 CADD-MS 3 AMBULATORY INFUSION PUMP SMITHS MEDICAL MD, INC. MELANIE HESS
K051426 06/01/2005 CARLO SURGICAL GOWN SOFILM TECHNOLOGY CO., LTD. JEFFRY O STULL
K051503 06/08/2005 UGYTEX SUAL KNIT MESH SOFRADIM PRODUCTION PAMELA PAPINEAU
K051631 06/20/2005 EXCALIBUR IV LIGHT THERAPY SYSTEM, MODEL SGEX4-001 STARGATE INTERNATIONAL, INC. ROBERT H WALKER
K051760 06/29/2005 NAVIGANT WORKSTATION WITH NIOBE MAGNETIC NAVIGATION SYSTEM, MODEL NWS05 STEREOTAXIS, INC. PETER A TAKES
K051506 06/07/2005 MIELO-CAN, BEST-LISAS, BEN - BONE BIOPSY. FAST-CUT, COLT, SPRING-CUT, BIO-CUT - SOFT TISSUE BIOPSY STERYLAB S.R.L. PAUL E DRYDEN
K051633 06/20/2005 CD-CHEX PLUS BC STRECK CAROL THOMPSON
K051706 06/27/2005 IQ BODY FLUIDS CONTROL STRECK MARK LEWALLEN
K051603 06/17/2005 STRYKER INJECTABLE CEMENT STRYKER LEIBINGER MICRO IMPLANTS WADE T RUTKOSKIE
K051741 06/28/2005 ACCOLADE HFX FEMORAL STEM STRYKER ORTHOPAEDICS TIFFANI ROGERS
K051474 06/07/2005 SYMBIOS DISPOSABLE INFUSION PUMP KIT SYMBIOS MEDICAL PRODUCTS, LLC JEFFERY J ALHOLM
K051720 06/29/2005 SYNTHES (USA) BONE MARROW ASPIRATION SYRINGE SYNTHES (USA) KATHY ANDERSON
K051600 06/16/2005 SYNTHES (USA) DISTRACTION OSTEOGENESIS SYSTEM SYNTHES (USA) KATHY ANDERSON
K051678 06/23/2005 SYNTHES HINDFOOT ARTHRODESIS NAIL SYSTEM SYNTHES (USA) SHERI L MUSGNUNG
K051665 06/22/2005 SYNTHES VECTRA-T SYSTEM SYNTHES SPINE SUSAN LEWANDOWSKI
K051459 06/07/2005 SYSMEX MODEL XE-2100DC AUTOMATED HEMATOLOGY ANALYZER SYSMEX AMERICA, INC. NINA GAMPERLING
K051703 06/24/2005 CLEVER TD-3018A BLOOD PRESSURE MONITOR TAIDOC TECHNOLOGY CORPORATION SHU-MEI WU
K051526 06/08/2005 URITEK-720+ URINE ANALYZER TECO DIAGNOSTICS STEPHANIE LOW
K051562 06/13/2005 NUZONE SYNGARD POWDER FREE POLYMER COATED POLYISOPRENE STERILE SURGICAL GLOVE - ALOE VERA COATED GREEN COLOUR TERANG NUSA SDN BHD CHIN-GUAN LOW
K051563 06/13/2005 NUZONE X2A NEOPRENE - POLYISOPRENE POWDER FREE SURGICAL GLOVES POLYMER AND ALOE COATED TERANG NUSA SDN BHD CHIN-GUAN LOW
K051601 06/16/2005 PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH TERUMO MEDICAL CORP. MARK UNTERREINER
K051710 06/27/2005 THERMAGE THERMACOOL COUPLING FLUID THERMAGE, INC. PAMELA M BUCKMAN
K051502 06/07/2005 SPI DENTAL IMPLANT THOMMEN MEDICAL, AG FLOYD LARSON
K051527 06/08/2005 SPI EASY TEMPORARY CAP THOMMEN MEDICAL, AG FLOYD G LARSON
K051583 06/16/2005 TIARA SNAPP X SOFT NASAL ACCESSORY FOR POSITIVE PRESSURE, MODELS TMS-3020, TMS-3030, TMS- 3040, TMS-3050 TIARA MEDICAL SYSTEMS, INC. GEOFFREY SLEEPER
K051414 06/01/2005 EYE CUP, STERILE 1 AND NON STERILE TOLLOT PTY.LTD.(AAXIS PACIFIC) KEVIN WALLS
K051500 06/07/2005 FAMIO DIAGNOSTIC ULTRASOUND SYSTEMS, MODEL SSA-530A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. PAUL BIGGINS
K051763 06/30/2005 QD KNEE/FOOT COIL, MODEL MJQJ-147A TOSHIBA AMERICA MEDICAL SYSTEMS, INC. MICHAELA MAHL
K051547 06/14/2005 POWERMAX 25, MODEL PM25; POWERMAX 30, MODEL PM30 TPC ADVANCED TECHNOLOGY, INC. SCOTT BECKLEY
K051587 06/15/2005 TRACOE-VARIO TRACHEOSTOMY TUBES (VARIOUS) REFERENCE MODELS: 450, 455, 460, 465, 470 TRACOE MEDICAL GMBH MICHAEL A WARREN
K051688 06/23/2005 FOR PLAY, SLIP, PREPAIR - PERSONAL LUBRICANTS TRIMENSA PHARMACEUTICALS ROBIN J OGILVIE
K051542 06/10/2005 TRIOSYN T40 ANTIMICROBIAL WOUND DRESSING TRIOSYN CORP. KYLE ANDERSON
K051595 06/16/2005 TSO3 OZONE STERILIZER, MODEL 125L TSO3 INC. CHARLES O HANCOCK
K051750 06/29/2005 FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 ULTRADENT PRODUCTS, INC. TAMMY LAVERY
K051638 06/20/2005 INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBC UNIPATH LTD. LOUISE ROBERTS
K051640 06/20/2005 U2 TOTAL KNEE SYSTEM UNITED ORTHOPEDIC CORP. GENE HUANG
K051637 06/20/2005 DSNARE, MODEL 00711087 UNITED STATES ENDOSCOPY GROUP, INC. GRETCHEN Y COHEN
K051644 06/20/2005 VALLEYLAB FORCETRIAD ELECTROSURGICAL GENERATOR VALLEYLAB HERBERT VINSON
K051627 06/20/2005 VALLEYLAB G3000 ELECTROSURGICAL INSTRUMENT VALLEYLAB HERBERT VINSON
K051616 06/17/2005 VANGUARD REPROCESSED EXTERNAL FIXATION DEVICES VANGUARD MEDICAL CONCEPTS, INC. HEATHER CRAWFORD
K051497 06/06/2005 VITESSE 2.0 VARIAN MEDICAL SYSTEMS, INC. VY TRAN
K051716 06/27/2005 VERTEBRON PSS PEDICLE SCREW SYSTEM VERTEBRON, INC. LUIS NESPRIDO
K051709 06/28/2005 HIPPOCAMPE WHEELCHAIR VIPAMAT TECHNOLOGIE MARY MCNAMARA-CULLINANE
K051559 06/15/2005 IMASK, MODELS 100, 200 AND 300 VITAL SIGNS COLORADO, INC. TOM DIELMANN
K051535 06/15/2005 MODIFICATION TO:REGISTRADO X-TRA VOCO GMBH GERALD W SHIPPS
K051295 06/03/2005 I-D GLIDE WESTRIDGE LABORATORIES INC. YOLANDA SMITH
K051539 06/10/2005 TRICOT BLOOD PRESSURE CUFF YA HORNG ELECTRONIC CO., LTD. JEN KE-MIN
K051484 06/09/2005 ZEUS SCIENTIFIC, INC., ATHENA MULTI-LYTE MMRV IGG TEST SYSTEM. ZEUS SCIENTIFIC, INC. MARK K KOPNITSKY
K051424 06/10/2005 HYDROGUM 5 ZHERMACK S.P.A. GERALD W SHIPPS
K051723 06/27/2005 POWDER-FREE VINYL PATIENT EXAMINATION GLOVES (WHITE, YELLOW) ZIBO SINOCARE PLASTIC PRODUCTS CO., LTD. CHU XIAOAN
K051623 06/20/2005 ANATOMICAL SHOULDER KEELED GLENOID ZIMMER GMBH BRANDON HIPSHER
K051756 06/29/2005 MODIFICATION TO:TRABECULAR METAL FEMORAL CONE AUGMENTS, MODELS 03-125-ZZZZ ZIMMER TRABECULAR MARCI HALEVI
K051491 06/06/2005 TRABECULAR METAL PRIMARY HIP PROSTHESIS ZIMMER, INC. DALENE T BINKLEY
K051516 06/08/2005 TRABECULAR METAL REVISION SHELL LINERS ZIMMER, INC. TONY KINGSLEY
K051475 06/06/2005 ZOLL M SERIES 12SL ANALYSIS OPTION ZOLL MEDICAL CORPORATION SEAN REYNOLDS


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact