FDA 510(k) Decisions During November, 2004  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K040890 11/02/2004 3M TEGADERM SILVER 3M COMPANY AMY E SHORT
K043097 11/19/2004 3VISEON 3MENSIO MEDICAL IMAGING BV CARL ALLETTO
K042390 11/19/2004 ETEST FOR GEMIFLOXACIN AB BIODISK ANNE BOLMSTROM
K042752 11/10/2004 ACCUPACH V ACCUTOME ULTRASOUND, INC. JEFFREY L WRIGHT
K042069 11/01/2004 INVISIO IRL DIGITAL RIGID LAPAROSCOPE SYSTEM ACMI CORPORATION TERRENCE E SULLIVAN
K042880 11/03/2004 JETSTREAM WORKSPACE ADAC LABORATORIES COLEEN A COLEMAN
K042496 11/02/2004 ADEPT ULTRALITE 532 LASER ADEPT MEDICAL CONCEPTS JERRY MCFARLAND
K041855 11/10/2004 PLEATS PLUS N95 PARTICULATE RESPIRATOR, MODELS 1050 AND 1050S AEARO CO. ANN PHILLIPS
K042227 11/19/2004 INSTANT-VIEW TROPONIN I TEST ALFA SCIENTIFIC DESIGNS, INC. NAISHU WANG
K041978 11/23/2004 REPROCESSED DIAMOND BURS ALLIANCE MEDICAL CORP. ERIC VARTY
K043196 11/30/2004 ALOKA SSD-ALPHA 10 ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD J CEHOVSKY
K042250 11/12/2004 SENSATOUCH ALUNA MANAGEMENT CO., LTD. CHARITY MARTIN
K042843 11/12/2004 AMBU SPUR II INFANT AND PEDIATRIC SINGLE PATIENT USE RESUSCITATORS AMBU, INC. SANJAY PARIKH
K042682 11/15/2004 AMBU SPUR II. ADULT SINGLE PATIENT RESUSCITATOR AMBU, INC. SANJAY PARIKH
K041712 11/03/2004 'RAPIDTEC 4' TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K030275 11/29/2004 MB SYSTEM, BIOENERGY LIGHT THERAPY AMEST CORP. JOHN IEST
K042889 11/16/2004 DYNAMOMETER - MODEL FCE AND MODEL MSC AMETEK PHILIP LACHANCE
K042906 11/19/2004 AMPLIFE DIGITAL INFRARED EAR THERMOMETER, MODEL E101 AMPLIFE CORPORATION SUSAN D GOLDSTEIN-FALK
K043025 11/19/2004 SYNERAD OMNI, DIGITAL X-RAY SYSTEM, MODEL AN6250 ANALOGIC CORP. DONALD J SHERRATT
K042685 11/18/2004 METRICATH SYSTEM ANGIOMETRX INC. TIM VERSPAGEN
K041766 11/26/2004 EZY-TRAVEL WRISTBAND APOTHECARY PRODUCTS, INC. DAVID KRAMER
K042443 11/24/2004 SPOTCHEM HDL, TOTAL CHOLESTEROL AND TRIGLYCERIDE REAGENT TESTS AND PANEL ARKRAY, INC. HELEN LANDICHO
K041427 11/24/2004 THE POLYMEDCO SPOTCHEM EX GLUCOSE, FRUCTOSAMINE AND AST TESTS ARKRAY, INC. HELEN LANDICHO
K041356 11/04/2004 ARTHREX TENODESIS SCREW FAMILY ARTHREX, INC. ANN WATERHOUSE
K041189 11/04/2004 ARTHREX TRIMIT FAMILY ARTHREX, INC. ANN WATERHOUSE
K042690 11/13/2004 ASCENSION PYROSPHERE (PCS) ASCENSION ORTHOPEDICS, INC. PETER STRZEPA
K042968 11/24/2004 MCL 30 DERMABLATE ER:YAG LASER SYSTEM ASCLEPION LASER TECHNOLOGIES GMBH GEORGE CHO
K043138 11/22/2004 PROVOX NID VOICE REHABILITATION SYSTEM, MODEL REF 7101 TO 7134 ATOS MEDICAL AB EDDY ABERG
K042580 11/17/2004 TIDI BRAND STERILIZATION WRAP BANTA HEALTHCARE GROUP, LTD. INA GORDON
K042942 11/22/2004 MGP 15 DICOM THEATER BARCO NV BARCOVIEW FRANK FURGUSON
K042660 11/19/2004 NIO 2MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K042661 11/19/2004 NIO 3MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FURGUSON
K042662 11/22/2004 NIO 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM BARCO NV BARCOVIEW FRANK FERGUSON
K041172 11/18/2004 BASBA E-MACHINE BASBA INC. M. JOYCE HEINRICH
K040985 11/30/2004 PUMP CONNECTIVITY INTERFACE BAXTER HEALTHCARE CORP. JENNIFER M PAINE
K042936 11/26/2004 SOLUTION ADMINISTRATION WITH LUER ACCESS INJECTION SITE BAXTER HEALTHCARE CORP. NANETTE HEDDEN
K042459 11/17/2004 SYNCHRON LX SYSTEMS HEMOGLOBIN A1C2 (HBA1C2) REAGENT BECKMAN COULTER, INC. KIM WALKER
K042291 11/12/2004 UNICEL DXC 600 AND 800 SYNCHRON SYSTEMS BECKMAN COULTER, INC. MARY BETH TANG
K042812 11/22/2004 BBLCHROMAGAR MRSA BECTON DICKINSON & CO. DENNIS R MERTZ
K042491 11/22/2004 BD ONECATH PERIPHERALLY INSERTED CENTRAL CATHETER BECTON DICKINSON & CO. LESLIE WOOD
K042400 11/24/2004 MUCOTROL CONCENTRATED ORAL GEL WAFER BELCHER PHARMACEUTICALS, INC. KOTHA SEKHARAM
K042586 11/03/2004 BEST BREAST BRACHYTHERAPY APPLICATOR BEST MEDICAL INTERNATIONAL, INC. JOSEPH C WANG
K042786 11/18/2004 BEST MODEL # 81-01 SERIES IR-192 SOURCES BEST MEDICAL INTERNATIONAL, INC. JOSEPH C WANG
K031568 11/23/2004 BICONITE SURFACE TREATMENT BICON, INC. VINCENT J MORGAN
K042637 11/15/2004 THE 5.0 X 6.0MM DENTAL IMPLANT BICON, INC. VINCENT J MORGAN
K042837 11/02/2004 LIQUICHEK ELEVATED CRP CONTROL BIO-RAD ELIZABETH PLATT
K042836 11/05/2004 LIQUICHEK RETICULOCYTE CONTROL (A) BIO-RAD ELIZABETH PLATT
K042865 11/24/2004 LIQUICHEK URINE TOXICOLOGY CONTROL, (LEVELS S1S AND S2S) BIO-RAD SUZANNE S PARSONS
K042815 11/05/2004 QUEST TUMOR MARKER CONTROL, MODEL 955 BIO-RAD ELIZABETH PLATT
K042446 11/02/2004 QUANTIFY CONTROL AND QUANTIFY PLUS CONTROLS BIO-RAD LABORATORIES, INC. MARIA ZEBALLOS
K042231 11/12/2004 GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K041432 11/30/2004 ASTROGLIDE BRAND WARMING LIQUID PERSONAL LUBRICANT BIOFILM, INC. ROBERT L DE ARMOND
K042314 11/22/2004 SYRINGE GRIP FOR THE AVONEX PRE-FILLED SYRINGE BIOGEN VICTOR J GANGI
K041388 11/23/2004 COMBINATION POWERED ELECTRICAL MUSCLE STIMULATOR AND INTERFERENTIAL STIMULATOR, MODEL BMLS04-1 BIOMEDICAL LIFE SYSTEMS, INC. GARY BUSSETT
K042093 11/01/2004 VANGUARD M SERIES UNICONDYLAR TIBIAL BEARINGS BIOMET, INC. TAACY BICKEL JOHNSON
K042029 11/09/2004 X-SERIES INTEGRAL RPP FEMORAL COMPONENTS BIOMET, INC. PATRICIA SANDBORN BERES
K041595 11/12/2004 TOE MP JOINT, MODELS 10412-10414, 14958, 14960, 1060-10062,16818,-16822,16867-16870 BIOPRO, INC. DAVID MARK
K042890 11/29/2004 TRIAGE D-DIMER TEST, MODEL 98100 BIOSITE INCORPORATED JEFFERY R DAHLEN
K042083 11/16/2004 MODIFICATION TO VISITOME 20-10 MICROKERATOME BIOVISION AG DALE SADLIK
K042134 11/01/2004 VERSATILE 1 WOUND VACUUM SYSTEM BLUE SKY MEDICAL GROUP INCORPORATED RICHARD WESTON
K042882 11/09/2004 ENTERYX INJECTION CATHETER BOSTON SCIENTIFIC CORP. LISA M QUAGLIA
K041818 11/10/2004 SONICATH ULTRA IMAGING CATHETER 3.2F 20MHZ, MODELS 37410/456221/C1020 BOSTON SCIENTIFIC CORP. ROBERT Z PHILLIPS
K041464 11/05/2004 BUSSE HOSPITAL DISPOSABLES URETHRAL CATHETER BUSSE HOSPITAL DISPOSABLES MUHAMAD ANSARI
K042949 11/09/2004 PELVILACE TRANSOBTURATOR BIOURETHRAL SUPPORT SYSTEM (PELVILACE TO SYSTEM) C.R. BARD, INC. JOHN C KNORPP
K041088 11/01/2004 TRIFUSION, MODEL 0609190/0659350 C.R. BARD, INC. LYNN M KIRCHOFF
K042350 11/03/2004 TES-1 CONSTANT VOLTAGE ELECTRICAL STIMULATOR CADWELL LABORATORIES, INC. CHRIS BOLKAN
K041242 11/22/2004 CANDELA SMOOTHBEAM LASER SYSTEM CANDELA CORP. LORRAINE CALZETTA PATROVIC
K041392 11/08/2004 SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US CAO GROUP, INC. ROBERT K LARSEN
K042615 11/05/2004 CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE CARBON MEDICAL TECHNOLOGIES, INC. ROBERT W JOHNSON
K043096 11/24/2004 COMMANDER II CARDIOCOM CONSTANCE G BUNDY
K042806 11/24/2004 QUADRANT UNIT-1-BOND CAVEX HOLLAND B.V. RICHARD WOORTMAN
K042144 11/12/2004 NICOM CHEETAH MEDICAL INC. BENNY ARAZY
K042176 11/03/2004 AQUIFY LENS COMFORT DROPS CIBA VISION CORPORATION STEVEN DOWDLEY
K042039 11/17/2004 FAMILY OF CRYSTAL 20 MONITORS MODEL #CS20-600,900,1300,1400,2400 & 120 CLEVELAND MEDICAL DEVICES, INC. ROBERT N SCHMIDT
K042796 11/05/2004 ENDOTINE TRANSBLEPH 3.0/3.5 DEVICE COAPT SYSTEMS, INC. BANKIM MEHTA
K042473 11/19/2004 COBE ANGEL WHOLE BLOOD SEPARATION SYSTEM COBE CARDIOVASCULAR, INC. JACK ELLISON
K042746 11/22/2004 PET-DOSE COMECER S.R.L. E.J. Smith
K042611 11/12/2004 LUNDERQUIST EXTRA STIFF DOUBLE CURVED EXCHANGE WIRE GUIDE COOK, INC. EARL KNIGHT
K042824 11/16/2004 FREQUENCY 38 AND SILVER 07 (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS COOPERVISION, INC. BONNIE J TSYMBAL
K042969 11/08/2004 MODIFICATION TO SMART CONTROL NITINOL STENT TRANSHEPATIC BILIARY SYSTEM CORDIS CORP. DONNA MARSHALL
K042680 11/19/2004 RHIGENE HEP-ANA TEST SYSTEM CORGENIX, INC. YUSUKE KOBE
K042230 11/05/2004 POLARCATH PERIPHERAL BALLOON CATHETER SYSTEM CRYOVASCULAR SYSTEMS, INC. KIM TOMPKINS
K041080 11/30/2004 SURGICAL DRAPE KIT - D.I.R.R.A. SRL D.I.R.R.A. S.R.L. ELISABETTA BACCHI
K042347 11/19/2004 MODIFICATION TO DIMENSION NT-PROBNP FLEX REAGENT CARTRIDGE METHOD DADE BEHRING, INC. GEORGE M PLUMMER
K041680 11/10/2004 ORAJEL ADVANCED TOOTH DESENSITIZER DEL PHARMACEUTICALS, INC. MARLENE TIETJEN
K042196 11/01/2004 SAVEDENT BLUE DENFOTEX LIGHT SYSTEMS LTD JOHN COLLES
K042153 11/08/2004 SOUTH BEACH SMILE LIGHT WHITENING SYSTEM DENTOVATIONS, INC. M. JOYCE HEINRICH
K042905 11/04/2004 NEO-CLIP ORTHODONTIC BRACKET ACCESSORY DENTSPLY INTL. HELEN LEWIS
K041075 11/09/2004 FASTIN RC ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KAREN SYLVIA
K041069 11/09/2004 SPIRALOK ANCHOR DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KAREN SYLVIA
K042544 11/23/2004 UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. SHARON STAROWICZ
K041928 11/23/2004 HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K041926 11/23/2004 HDL/LDL-ADVANCE CALIBRATOR, CAT. NO. SE-278 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K041927 11/23/2004 LDL/ADVANCE ASSAY, CAT. NO. 279-20, 279-40 DIAGNOSTIC CHEMICALS LTD. NANCY OLSCAMP
K042607 11/26/2004 PRIMUS US DRAEGER MEDICAL, INC. JAMES J BRENNAN
K042197 11/15/2004 BIO-GIDE RESORBABLE BILAYER MEMBRANE FOR GUIDED TISSUE AND BONE REGENERATION ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K042704 11/26/2004 REUSABLE FINGER CLIP SPO2 SENSORS ELEKON INDUSTRIES U.S.A., INC. KRISTA OAKES
K040354 11/04/2004 METAL/METAL HIP SYSTEM ENCORE MEDICAL, L.P. DEBBIE DE LOS SANTOS
K042918 11/22/2004 MICROPROBE LASER AND ENDOSCOPY SYSTEM, MODEL E2 ENDO OPTIKS, INC. KEITH HERTZ
K041708 11/30/2004 ENPATH SAFETY INTRODUCER ENPATH MEDICAL INCORPORATED KARYL HASKELL
K042700 11/08/2004 IMAGE MEDICAL ACQUISITION STATION (IMAS) ERAD IMAGEMEDICAL CORP. GARY J ALLSEBROOK
K042897 11/19/2004 AUTOBAHN TISSUE CLOSURE DEVICE AND DISPOSABLE CARTRIDGE ETHICON ENDO-SURGERY, INC. ELIZABETH MILLER
K042753 11/08/2004 MAMMOTOME MR BIOPSY SYSTEM ETHICON ENDO-SURGERY, INC. CAROL J SPRINKLE
K042842 11/09/2004 NOVATION 12/14 PRESS-FIT FEMORAL STEM EXACTECH, INC. Lisa Simpson
K041869 11/18/2004 SELF RETAINING BICANALICULUS INTUBATION SET FCI OPHTHALMICS, INC. LOUIS ARMAND
K041470 11/22/2004 MORTON IUI CATHETERS FERTILITY TECHNOLOGY RESOURCES, INC. CONSTANCE W STURGEON
K042035 11/17/2004 ALUMINA HEAD FOURNITURES HOSPITALIERES INDUSTRIE CHRISTINE QUENDEZ
K041903 11/10/2004 FUJINON G5 COLONOSCOPES, MODELS EC-450HL5 AND EC-250HL5 FUJINON, INC. JOSEPH M AZARY
K042076 11/18/2004 FUJINON G5 DUODENSCOPES; G5 DUODENOSCOPES, ED-450XT5, ED-250XT5 FUJINON, INC. JOSEPH M AZARY
K042043 11/24/2004 FUJINON INC. G5 GASTROSCOPES, MODELS EC-450WR5, EC-250WR5 FUJINON, INC. JOSEPH M AZARY
K042731 11/19/2004 ARCHITECT CA 125 II ASSAY FUJIREBIO DIAGNOSTICS, INC. KIMBERLY PETERSON
K040301 11/01/2004 GAMCATH HIGH FLOW CATHETER, REF: GDHK 13XX A GAMBRO RENAL PRODUCTS THOMAS B DOWELL
K042348 11/18/2004 GRADIA DIRECT LOFLO GC AMERICA, INC. TERRY JORITZ
K042866 11/02/2004 AMX5 AND AMX5D MOBILE X-RAY SYSTEMS GE HEALTHCARE TECHNOLOGIES D. DUERSTELER
K042694 11/18/2004 ADVANCED LUNG ANALYSIS II GE MEDICAL SYSTEMS LARRY A KROGER
K042642 11/03/2004 AWARE TRANSPORT MONITOR SYSTEM (INCLUDES AWARE POD AND AWARE TRANSPORT MONITOR) GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES ANDREW KLUESSENDORF
K042844 11/03/2004 GE SIGNA EXCITE 1.5T 6 CHANNEL PHASED ARRAY FLEX COIL, GE SIGNA EXCITE 3.0T 6 CHANNEL PHASED ARRAY FLEX COIL GE MEDICAL SYSTEMS, INC. LARRY KROGER
K042559 11/17/2004 GEM-TWIN TENS/ MODELS GM3XY/Z GEMORE TECHNOLOGY CO., LTD. BODEN S.P. LAI
K042748 11/12/2004 GENEMAX POWER WHEELCHAIR, PW3 GENEMAX MEDICAL PRODUCTS INDUSTRY CORP. Ke-Min Jen
K042749 11/12/2004 GENEMAX POWER WHEELCHAIR, PW4 GENEMAX MEDICAL PRODUCTS INDUSTRY CORP. Ke-Min Jen
K043112 11/24/2004 GE 0.2T SIGNA PROFILE EXCITE MR SYSTEM GENERAL ELECTRIC CO. LARRY A KROGER
K041239 11/08/2004 GENESIS MEDICAL TECHNOLOGIES, INC. PHARMAJET NEEDLE-FREE INJECTOR, MODEL M2000 GENESIS MEDICAL TECHNOLOGY, INC. THOMAS KROENKE
K041968 11/03/2004 GENICON BIPOLAR FORCEPS MODEL # 600-005-005 GENICON GARY HABERLAND
K041967 11/12/2004 GENICON SUCTION IRRIGATION SYSTEM GENICON GARY HABERLAND
K042960 11/24/2004 GIVEN DIAGNOSTIC SYSTEM WITH PILLCAM ESO GIVEN IMAGING LTD. SHOSH FRIEDMAN
K042953 11/22/2004 MODIFICATION TO PROTEX STABILIZATION SYSTEM GLOBUS MEDICAL, INC. KELLY J BAKER
K042830 11/17/2004 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES GRAND WORK PLASTIC PRODUCTS CO., LTD. JAMES CHU
K041501 11/30/2004 GUANGZHOU FORTUNIQUE DRAPES, BAGS AND COVERS GUANGZHOU FORTUNIQUE LTD. JANE B CAMPBELL
K042908 11/12/2004 RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM GUIDANT CORP. VIRGINIA SINGER
K040660 11/15/2004 STERICHEK GLUTARALDEHYDE REAGENT STRIPS HACH COMPANY DAVID A MORRIS
K040045 11/04/2004 HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) HAMILTON THORNE BIOSCIENCES DIARMAID DOUGLAS-HAMILTON
DEN040009 11/04/2004 HAMILTON THORNE ZONA INFRARED LASER OPTICAL SYSTEM (ZILOS TK) HAMILTON THORNE BIOSCIENCES DIARMAID DOUGLAS-HAMILTON
K042853 11/10/2004 FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODELS HL888EA, HL888CF, HL888GF AND HL888QA HEALTH & LIFE CO., LTD. PAUL HUNG
K042980 11/17/2004 HOSPIRA GEMSTAR INFUSION PUMP SYSTEM, HOSPIRA GEMSTAR CONNECT SOFTWARE HOSPIRA, INC. PATRICIA MELERSKI
K042883 11/23/2004 SIZE 1 TRIATHLON CRUCIATE RETAINING (CR) TIBIAL INSERT HOWMEDICA OSTEONICS CORP DENISE DUCHENE
K041170 11/09/2004 SECUR-FIT HA AND SECUR-FIT PLUS HIP STEMS HOWMEDICA OSTEONICS CORP. KAREN ARIEMMA
K032315 11/18/2004 IOP8 INTRA OPERATIVE PROBE HUNTLEIGH HEALTHCARE, INC. B.J. COLLEYPRIEST
K041007 11/15/2004 MILLENIUM, MODELS 2000, 2001 AND 2002 HYPERBARIC FOR LIFE LLC RICK RYDER
K042697 11/19/2004 SECOND LOOK VIEWER ICAD INC. JOHN ROSENSTENGEL
K042894 11/19/2004 IMALUX NIRIS IMAGING SYSTEM IMALUX CORPORATION STEPHANIE HARRINGTON
K041817 11/19/2004 WEST NILE DETECT IGM ELISA INBIOS INTL., INC. ESTELA I RAYCHAUDHURI
K042557 11/08/2004 INNOJECT AUTO-INJECTOR INNOJECT, INC JONATHAN S KAHAN
K042798 11/04/2004 C-TEK C-TRUN ANTERIOR CERVICAL PLATE SYSTEM INTERPORE CROSS INTL. WENDY SPIELBERGER
K042855 11/12/2004 INTUITIVE SURGICAL HARMONIC CURVED SHEARS INSTRUMENT INTUITIVE SURGICAL, INC. MICHAEL H YRAMATEGUI
K042538 11/08/2004 SAILOR PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SAEXXXXXXXXX INVATEC INNOVATIVE TECHNOLOGIES MIKE WINEGAR
K042537 11/08/2004 SUBMARINE PLUS PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CATHETER, MODEL SUVXXXXXXXXX INVATEC INNOVATIVE TECHNOLOGIES MIKE WINEGAR
K042775 11/04/2004 INQUIRY AFOCUS, INQUIRY AFOCUS II AND INQUIRY OPTIMA STEERABLE ELECTROPHYSIOLOGY CATHETER IRVINE BIOMEDICAL, INC. BONNIE BISHOP
K042848 11/22/2004 FRC POSTEC PLUS IVOCLAR VIVADENT, INC. DONNA M HARTNETT
K042819 11/09/2004 TETRIC EVOCERAM IVOCLAR VIVADENT, INC. DONNA HARTNETT
K042900 11/05/2004 K.E.P. CONNECTOR AND CLIP K.E.P., LLC ROSINA ROBINSON
K042340 11/24/2004 KASIOS TCP KASIOS BIOMATERIALS LAETITA BERNARD
K042872 11/23/2004 RONDOFLEX PLUS 360 KAVO AMERICA CORPORATION DANIEL KAMM
K042572 11/05/2004 KENDALL CO2NFIRM NOW CO2 DETECTOR KENDALL BRIDGET GARDNER
K042888 11/10/2004 DEMETRON IDS CURING LIGHT KERR CORP. COLLEEN BOSWELL
K042133 11/24/2004 DRY LASER IMAGER, MODEL DRYPRO MODEL 793 KONICA MINOLTA MEDICAL & GRAPHIC, INC. SHINICHI YAMANAKA
K042913 11/26/2004 CLEARFIL TRI-S BOND KURARAY MEDICAL INC. SATOSHI YAMAGUCHI
K042618 11/26/2004 LAGLOVE BRAND DOUBLE POLYMER COATED NITRILE EXAMINATION GLOVES (POWDER FREE - BLUE COLOR) LAGLOVE (M) SDN. BHD. G. BASKARAN
K041747 11/24/2004 IMPACT TEST SYSTEM SALIVA TEST MODULE-OPIATE (WORKPLACE) LIFEPOINT,INC DAVID B GOLDBERG
K041746 11/23/2004 IMPACT TEST SYSTEM; SALIVA TEST MODULE-OPIATE (PRESCRIPTION USE) LIFEPOINT,INC DAVID B GOLDBERG, PH.D.
K042966 11/19/2004 DUET SUTURE ANCHOR, MODELS BXS4216, BXS4216H; IMPACT SUTURE ANCHOR, MODELS BXS4218, BXS4218H LINVATEC BIOMATERIALS, LTD. TUIJA ANNALA
K042778 11/04/2004 BIOANCHOR WITH DISPOSABLE DRIVER, PRELOADED WITH ONE #2 HERCULINE SUTURE LINVATEC CORP. ELIZABETH PAUL
K042744 11/30/2004 OPTIV ANTAGE DH POWER INJECTION SYSTEM MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS ELLIS ROGERS
K042228 11/08/2004 BEELINE MOTIV, PROPOLIS, PCA MCKINLEY, INC. MICHELLE PRATTE
K042382 11/30/2004 DUAL LED LITE ENGINE WITH ILLUMINATION LED CABLE COUPLED TO A LED LITE HEAD MED-GENERAL TECHNOLOGIES LLC PAUL MCCREIGHT
K040328 11/24/2004 15.5F JET MEDICAL FREE FLOW LONG-TERM COAXIAL CATHETER MEDCOMP ROSANNA SEVERINI
K042527 11/08/2004 SPATULA, CERVICAL, CYTOLOGICAL, MODEL 22-9107 MEDICAL ACTION INDUSTRIES, INC. ROBIN BLANKENBAKER
K042717 11/05/2004 MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL MEDICAL ANALYSIS SYSTEMS, INC. MARY THORSNESS
K042359 11/17/2004 SUBDURAL EVACUATING PORT SYSTEM CRANIAL ACCESS KIT (SEPS-CA), (SEPS-CAL), (SEPS-CAND),MODELS 11-0401 CA, 11-0401-CAL MEDICAL DESIGNS, LLC PAUL JOHN AXT
K040744 11/30/2004 ATRILAZE SOFT TISSUE ABLATION SYSTEM MEDICALCV, INC. DENNY STEGER
K041284 11/22/2004 MEDICULT IVM SYSTEM MEDICULT A/S RONALD G LEONARDI
K030901 11/26/2004 MEDTRADE PRODICT'S SOOTHING GEL PATCH MEDTRADE PRODUCTS LTD. JONATHAN RANFIELD
K042790 11/04/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042886 11/18/2004 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042210 11/04/2004 MSD SILO SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK RICHARD TREHARNE
K042922 11/19/2004 VENTURE ANTERIOR CERVICAL PLATING SYSTEM MEDTRONIC SOFAMOR DANEK, INC. RICHARD TREHARNE
K042859 11/24/2004 KOBRA GPS FIXATION SYSTEM MEDTRONIC VERTELINK, INC. ALBERT REGO
K042851 11/09/2004 MENTOR OBTAPE TRANS-OBTURATOR SURGICAL KIT MENTOR CORP. DONNA CRAWFORD
K042769 11/24/2004 ADSEAL ROOT CANAL SEALER META BIOMED CO., LTD. JENNY SHON
K042171 11/10/2004 AX'S ENDO 04, 06, 08, 2.5, 40 , MODELS 50100206, 50100217, 50100218, 50100230, 50100232 MICRO-MEGA SOCIETE ANONYME PHILIPPE GARCIA
K041852 11/15/2004 MR TESTED FIBER OPTIC SHORT LARYNGOSCOPE HANDLE, MODEL 310002 MINRAD, INC. JOHN MCNEIRNEY
K033095 11/17/2004 SMOKE EVACUATION ATTACHEMENT MODERN MEDICAL EQUIPMENT MFG., LTD. DAVID LOU
K041632 11/17/2004 MINIMESH POLYPROPYLENE MESH MPATHY MEDICAL DEVICES, LTD. LOUIS J MAZZARESE
K042353 11/24/2004 AXIS I (1MP), II (2MP), III (3MP), AND V (5MP) MONOCHROME DISPLAYS NATIONAL DISPLAY SYSTEMS RON HANSEN
K042339 11/02/2004 NEOPLANT IMPLANT SYSTEM NEOBIOTECH CO., LTD. DAE KYU CHANG
K041323 11/17/2004 PULSED LIGHT THERAPY SYSTEM, MODEL PRIMA NEW STAR LASERS, INC. DONALD V JOHNSON
K041861 11/26/2004 NEXUS INTRAVENOUS TUBING SETS (NIVTS) NEXUS MEDICAL, LLC AL BOEDEKER
K043042 11/18/2004 PROCERA IMPLANT BRIDGE, MODELS 15-1001, 15-1002, 15-1051, 15-1052 NOBEL BIOCARE AB ELIZABETH J MASON
K042434 11/03/2004 MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55 NOUVAG AG ERICH FORSTER
K042089 11/24/2004 NX STAGE WATER PURIFICATION SYSTEM NX STAGE MEDICAL INC NORMA LEMAY
K043018 11/10/2004 OMRON DIGITAL BLOOD PRESSURE MONITOR, MODEL HEM-906 OMRON HEALTHCARE, INC. LARRY LEPLEY
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K042216 11/12/2004 COOL-TIP RF ABLATION SYSTEM VALLEYLAB CHARLES COPPERBERG
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