FDA 510(k) Decisions During June, 2006  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K061440 06/27/2006 P.D .DECIMAL, INC. DANIEL BENNETT
K053409 06/19/2006 3M LIQUID BANDAGE 3M COMPANY BRYAN BECKER
K061456 06/21/2006 A & D MEDICAL UM-101 DIGITAL BLOOD PRESSURE MONITOR A & D ENGINEERING, INC. JERRY WANG
K060691 06/12/2006 EASY X-TRAC SYSTEM A. TITAN INSTRUMENTS, INC. MICHAEL TUBER
K060875 06/14/2006 ABBOTT AXSYM TROPONIN-I ADV ABBOTT LABORATORIES MARGARET PROCHNIAK
K061249 06/02/2006 AXSYM DIGOXIN III ABBOTT LABORATORIES KENTON SMITH
K061193 06/23/2006 CREATININE ABBOTT LABORATORIES INC LINDA MORRIS
K060670 06/02/2006 ACCIN UNI-KNEE SYSTEM ACCIN CORPORATION MICHAEL KVITNITSKY
K060888 06/23/2006 ACELL POWDER WOUND DRESSING ACELL, INC PATSY J TRISLER
K053033 06/06/2006 ACRO BIOTECH LLC RAPID METHAMPHETAMINE URINE TEST; CATALOG# MET001000 ACRO BIOTECH LLC. GREGORY LEE
K053037 06/15/2006 ACRO BIOTECH LLC RAPID OPIATES URINE TEST; CATALOG# OPI00100 ACRO BIOTECH LLC. GREGORY LEE
K053034 06/06/2006 ACRO BIOTECH LLC RAPID TETRAHYDROCANNABINOL URINE TEST; CATALOG# OPI001000 ACRO BIOTECH LLC. GREGORY LEE
K053400 06/19/2006 ACUMEN SINGLE-LUMEN DELIVERY SHEATH ACUMEN MEDICAL, INC. MARYBETH GAMBER
K061206 06/19/2006 ACUTE BONE SCREW ACUTE INNOVATIONS LLC ALYSSA THOMAS
K061395 06/23/2006 CALSET COMPOSITE HEATER ADDENT, INC. JOSHUA FRIEDMAN
K060299 06/06/2006 ART BRACHYTHERAPY APPLICATOR ADVANCED RADIATION THERAPY, LLC RAYMOND BRICAULT
K061538 06/30/2006 ALARA CRYSTALVIEW COMPUTED RADIOGRAPHY SYSTEM, MODEL R200 ALARA, INC. DIANE KING
K053422 06/15/2006 RAPIDONE-COCAINE-150 TEST AMERICAN BIO MEDICA CORP. HENRY WELLS
K061039 06/29/2006 AMSURE DISPOSABLE SYRINGE WITH/WITHOUT NEEDLE AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K061178 06/12/2006 ANGIODYNAMICS, INC. VENACURE PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K060939 06/26/2006 RANGER IRRIGATION FLUID WARMING SYSTEM ARIZANT HEALTHCARE INC. DAVID WESTLIN
K060693 06/06/2006 MICROSTRIKE AND ALLTHREAD PEEK SUTURE ANCHOR ARTHROTEK, INC. LESTER F PADILLA
K060745 06/23/2006 ASAHI TORNUS SUPPORT CATHETER WITH TORQUE DEVICE ACCESSORY ASAHI INTECC CO., LTD. YOSHI TERAI
K053476 06/26/2006 ALLWOUND AT SQUARED, LLC JULIA C TIERNEY
K053373 06/30/2006 ATLANTIS ABUTMENT FOR ZIMMER INTERFACE ATLANTIS COMPONENTS, INC. BETSY BROWN
K060347 06/05/2006 B&L L-BETA, MODEL WL-B1 B&L BIOTECH CO., LTD. DANIEL KAMM
K052764 06/09/2006 DIACAP ULTRA DIALYSIS FLUID FILTER B. BRAUN MEDIZINTECHNOLOGIE GMBH SCOTT J PEASE
K061038 06/23/2006 BARRIERPLUS PLATINUM POWDER-FREE SYNTHETIC POLYCHLOROPRENE SURGICAL GLOVES, MODELS 12544-125490 BARRIERMED GLOVE CO. VICTOR J RAGUCCI
K061157 06/22/2006 SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENS BAUSCH & LOMB DEBRA KETCHUM
K060375 06/06/2006 BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166 BD BIOSCIENCES CARTER NAVARRO
K061282 06/02/2006 ACCESS ULTRASENSITIVE HGH CALIBRATOR, MODEL 33585 BECKMAN COULTER, INC. JENNIFER RUETHER
K061355 06/07/2006 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM - AMPICILLIN (GN) 0.5-32 UG/ML BECTON, DICKINSON & CO. JANINE MATLAK
K060641 06/02/2006 PLATELIA ASPERGILLUS EIA, MODEL 62793 BIO-RAD CHRISTOPHER BENTSEN
K060030 06/27/2006 THE DOUBLE GLOVE BIOBARRIER, INC. DAVID W MULLIS
K060732 06/02/2006 MBCP GEL BIOMATLANTE MYRIAM VINCENT
K061347 06/20/2006 VITEK 2 GRAM POSITIVE VRSA SCREEN BIOMERIEUX, INC. NANCY WEAVER
K060716 06/12/2006 VERSA-DIAL HUMERAL HEAD PROSTHESIS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K061312 06/06/2006 36MM BIOLOX DELTA CERAMIC HEADS BIOMET, INC. PATRICIA SANDBORN BERES
K061089 06/20/2006 MODULAR THUMB IMPLANT, MODELS 17600, 17601, 17602, 17603, 17596, 17597, 17598, 17599 BIOPRO, INC. DAVID MRAK
K060047 06/19/2006 CARTO RMT EP NAVIGATION SYSTEM V8 BIOSENSE WEBSTER, INC. DIANA THORSON
K060791 06/22/2006 TRIAGE TOX DRUG SCREEN, MODEL 94400 BIOSITE INCORPORATED ROBIN WEINER
K061171 06/02/2006 SEQUITOR STEERABLE GUIDEWIRE, MODELS SQR18XX AND SQR14XX BIOSPHERE MEDICAL, INC. ROSINA ROBINSON
K051342 06/02/2006 MEDICAL INTERPOROUS BONYF AG DONNA MARIE HARTNETT
K052254 06/01/2006 MYTIS ARROW XXXX BRAINBASE CORPORATION CRAIG R BRUNS
K053159 06/06/2006 VECTORVISION SPINE BRAINLAB AG RAINER BIRKENBACH
K061351 06/05/2006 ORAL-B SONIC COMPLETE BRAUN GMBH AMANDA HEFFERNAN
K061057 06/23/2006 BREAS ISLEEP 20+ BREAS MEDICAL AB KARL-JOHAN HOLM
K060402 06/09/2006 BRIGHTWAY BRAND NITRILE EXAMINATION GLOVE (POWDER FREE, BLACK COLOUR) BRIGHTWAY HOLDINGS SDN. BHD. G. BASKARAN
K060551 06/07/2006 BRIVANT GUIDEWIRE BRIVANT LIMITED TOMAS FUREY
K061341 06/12/2006 PALMLIGHT 10, MODEL 001-00030 CAO GROUP, INC. ROBERT K LARSEN
K061308 06/05/2006 TRIMAX, MODEL 9515N, BREATHABLE SURGICAL GOWN, MODELS 3247AN AND 9015N AND OPTIMA OR SURGICAL GOWN, MODEL 9506N CARDINAL HEALTH 200, INC. LAVENIA FORD
K061114 06/06/2006 WDS, SIZE 2 AND SIZE 2 CEFLA S.C.R.L. CLAUDE BERTHOIN
K061161 06/26/2006 BLOOD PRESSURE METER, MODEL CH-311B CITIZEN WATCH CO., LTD. JOSEPH D EDMONDSON JR.
K060249 06/12/2006 ULTRATINE FOREHEAD COAPT SYSTEMS, INC. LINDA RUEDY
K060248 06/12/2006 ULTRATINE TRANSBLEPH COAPT SYSTEMS, INC. LINDA RUEDY
K061110 06/07/2006 GLUCOMMANDER PLUS COLLABORATIVEMED, LLC ROBERT BOOTH
K061487 06/26/2006 DURAMATRIX COLLAGEN DURA SUBSTITUTE MEMBRANE - ONLAY AND SUTURABLE COLLAGEN MATRIX, INC. PEGGY HANSEN
K061173 06/09/2006 CPIVISION DIGITAL IMAGING SYSTEM COMMUNICATIONS & POWER INDUSTRIES CANADA, INC. NORM MORIKAWA
K061183 06/01/2006 CONFLUENT SURGICAL DUAL LIQUID APPLICATOR, MODEL 70-2005-093 CONFLUENT SURGICAL,INC ERIC P ANKERUD
K053464 06/06/2006 SERVICE MANAGER SM40SE CONMED INTEGRATED SYSTEMS, CANADA, ULC MICHAEL T TAGGART
K060526 06/09/2006 TIPI CONTIPI LTD. PAUL DRYDEN
K060908 06/29/2006 SONOHYSTEROGRAPHY BIOPSY DEVICE COOK UROLOGICAL, INC. CINDY RUMPLE
K061301 06/23/2006 COPAN LIQUID AMIES ELUTION SWAB (ESWAB) COLLECTION AND TRANSPORT SYSTEM COPAN DIAGNOSTICS, INC. CYNTHIA SINCLAIR
K042955 06/19/2006 CUTICOVER SKIN BARRIER DEVICE D & D HOLDINGS, LLC MARK CITRON
K061503 06/22/2006 DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A) DADE BEHRING, INC. ANDREA M TASKER
K061218 06/30/2006 DIMENSION VISTA SYSTEM CHEMISTRY CALIBRATOR 4, MODEL KC140 DADE BEHRING, INC. VICTOR M CARRIO
K052759 06/14/2006 DAN MONOPOLAR LAP ACCESSORIES DANNORITZER MEDIZINTECHNIK GMBH & CO. KG ANGELIKA SCHERP
K061609 06/27/2006 GE DATEX-OHMEDA AISYS DATEX-OHMEDA, INC. DAN KOSEDNAR
K060862 06/05/2006 GE DATEX-OHMEDA ENGSTROM CARESTATION DATEX-OHMEDA, INC. DAN KOSEDNAR
K061314 06/02/2006 BARD EXTRA LARGE COMPOSIX KUGEL HERNIA PATCH DAVOL INC., SUB. C.R. BARD, INC. ROBIN N DRAGO
K052513 06/28/2006 BABY SNOOPY WATER FILLED TEETHER, MODEL 95367 DELTA ENTERPRISE CORPORATION MARIA E CELIS
K060501 06/16/2006 IMPLANTIUM II DENTIUM CO., LTD. CATHRYN N CAMBRIA
K060500 06/16/2006 SPEEDY ORTHODONTIC SCREW DENTIUM CO., LTD. CATHRYN N CAMBRIA
K061427 06/26/2006 PRE-IMPRESSION CONDITIONING SOLUTION DENTSPLY INTL. HELEN LEWIS
K060664 06/06/2006 FASTIN RC ANCHOR DEPUY MITEK RUTH FORSTADT
K060830 06/15/2006 MILAGRO INTERFERENCE SCREW DEPUY MITEK, A JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K061144 06/08/2006 DEPUY CMW 2 AND CMW 3 GENTAMICIN BONE CEMENT DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K060874 06/28/2006 DEPUY GLOBAL AP SHOULDER SYSTEM DEPUY ORTHOPAEDICS, INC. NATALIE S HECK
K061520 06/23/2006 VIPER SPINE SYSTEM DEPUY SPINE, INC. MARY GRAY
K060488 06/08/2006 DERMATECH IV HOLDER DERMATECH MEDICAL INC GLENN THIBAULT
K060668 06/12/2006 SAFE TIP SYRINGE DEVON SAFETY PRODUCTS, INC. ELAINE DUNCAN
K061296 06/13/2006 DIAZYME HOMOCYSTEINE ENZYMATIC ASSAY KIT FOR COBAS INTEGRA AND HOMOCYSTEINE CALIBRATOR DIAZYME LABORATORIES ROLAND STRICKLAND
K060300 06/21/2006 CONFIDENCE HIGH VISCOSITY BONE CEMENT DISC-O-TECH MEDICAL TECHNOLOGIES, LTD. HILA WACHSLER-AVRAHAMI
K060876 06/15/2006 ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWARE (STANDARD), MODEL 04625137001; ACCU-CHEK INSULIN PUMP CONFIGURATION SOFTWA DISETRONIC MEDICAL SYSTEMS AG SCOTT THIEL
K060524 06/15/2006 DOLPHIN 2000 DATEX COMPATIBLE OXIMETRY DISPOSABLE AND REUSABLE SENSORS AND EXTENSION CABLES DOLPHIN MEDICAL INC. BILL CURNAN
K051573 06/26/2006 TGP (GUTTA PERCHA CONTAINING TETRACYCLINE OR DOXYCYCLINE) DR. HOWARD MARTIN, P.A. KYLE H SIBINOVIC
K060705 06/14/2006 CARINA HOME DRAEGER MEDICAL B.V. MONICA FERRANTE
K060510 06/19/2006 DREW SCIENTIFIC GLYCATED HEMOGLOBIN FIVE LEVEL LINEARITY KIT DREW SCIENTIFIC LTD. DIANE HILL
K060642 06/07/2006 DUTECK BODY COMPOSITION ANALYZER DUTECK INDUSTRIAL CO., LTD. JOSEPH CHEN
K060814 06/14/2006 DYNATRON ION IONTOPHORESIS ELECTRODE DYNATRONICS CORP. KELVYN CULLIMORE, JR
K061328 06/13/2006 THINK POSITIVE DIABETES MANAGEMENT SYSTEM (T+DIABETES SYSTEM) E-SAN LIMITED KRISTIN M ZIELINSKI
K061563 06/23/2006 EBI ARRAY SPINAL SYSTEM EBI, L.P. JENNIFER P HARAKAL
K061016 06/08/2006 EBI ESL PEEK-OPTIMA SPINE SYSTEM EBI, L.P. JENNIFER HARAKAL
K061244 06/06/2006 MUCOGRAFT ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE PETER S REICHERTZ
K052661 06/07/2006 QUIX DIGITAL RADIOGRAPHIC UPGRADE EDGE MEDICAL DEVICES LTD. VERED SCHARF
K061235 06/05/2006 LIFESTENT TURBO BILIARY STENT SYSTEM EDWARDS LIFESCIENCES, LLC. KEVIN DRISKO
K060759 06/29/2006 Y-CLICK CONNECTOR ELCAM MEDICAL ACAL TALI HAZAN
K061174 06/28/2006 SURGI-MAX ELLMAN INT'L INC. JON GARITO
K052711 06/23/2006 EMJOI TENS DEVICE EMJOI, INC. MIKE JUDGE
K061345 06/06/2006 MODIFICATION TO ENDIUS ATAVI SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K060537 06/08/2006 EFLOW IV FLUID WARMER, MODEL 100, EFLOW DISPOSABLE CARTRIDGE, MODEL 200 AND EFLOW AC POWER SUPPLY, MODEL 120 ENGINIVITY LLC PENELOPE GRECO
K053195 06/23/2006 SPIDERX EMBOLIC PROTECTION DEVICE EV3 INC. BRENDA JOHNSON
K060997 06/15/2006 SNAP II EEG MONITOR EVEREST BIOMEDICAL INSTRUMENTS CO. RANDALL J KROHN
K061454 06/12/2006 EXACTECH EQUINOXE SHOULDER STEMS EXACTECH, INC. MARITZA ELIAS
K060316 06/23/2006 COMPAT GO ENTERAL FEEDING PUMP AND ADMINISTRATION SETS FRESENIUS KABI DEUTSCHLAND GMBH BARBARA BREUER-THAL
K061672 06/29/2006 SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS FUJIFILM MEDICAL SYSTEMS USA, INC. DEBBIE PEACOCK
K061625 06/26/2006 AUTOBONE2 GE HEALTHCARE LARRY A KROGER
K061587 06/23/2006 FULLCARD ANALYSIS GE HEALTHCARE LARRY A KROGER
K061163 06/07/2006 INNOVA 2121IQ, INNOVA 3131IQ, INNOVA 4100, INNOVA 4100IQ, INNOVA 3100, INNOVA 3100IQ, INNOVA 2100IQ WITH INNOVA IVUS OPT GE MEDICAL SYSTEMS, LLC LARRY A KROGER
K061028 06/07/2006 PRECISION THUNIS 800+ GE MEDICAL SYSTEMS, LLC LARRY KROGER
K061129 06/01/2006 GE LOGIQ 9, MODELS 2188900, 2375600, 2404587 AND 5150000 GENERAL ELECTRIC CO. PATRICIA TAIGE
K061459 06/30/2006 TRANQUIL TRI-BTE GENERAL HEARING INSTRUMENTS, INC. ROGER P JUNEAU
K061508 06/12/2006 OSOM INFLUENZA A&B TEST GENZYME CORP. FRED D LASKY
K061380 06/08/2006 RETAIN RADIOLUCENT SPACER GLOBUS MEDICAL, INC. KELLY J BAKER
K061007 06/14/2006 GOOD MEDY, DISPOSABLE THERMOMETER SHEATHS GOOD MEDY ENTERPRISE LTD. JEN KE-MIN
K060518 06/28/2006 PARTIAL OSSICULAR REPLACEMENT PROSTHESES GRACE MEDICAL, INC. JEFF COBB
K061453 06/22/2006 HI-TORQUE WHISPER VIEW GUIDE WIRE GUIDANT CORP. KATHLEEN VITTUM
K060817 06/15/2006 OMNILINK. 018 BILIARY STENT SYSTEM GUIDANT ENDOVASCULAR SOLUTIONS, INC. MARA CALER
K061115 06/30/2006 SPEEDFLOW 0.2UM FILTER, MODEL 11214; SPEEDFLOW 1.2UM FILTER, MODEL 11215; EASYDROP CONTROLLER, MODEL 11216 GVS SPA DAWN I MOORE
K052583 06/14/2006 BLUE POWDER FREE NITRILE EXAMINATION GLOVES HARTALEGA SDN BHD KUAN KAM HON
K052469 06/05/2006 GLUCOPACK HEALTHPIA AMERICA CORP. STEVEN KIM
K061047 06/08/2006 HEMOCUE HB 301 ANALYZER, MODEL 121804 AND MICROCUVETTES, MODEL 111801 HEMOCUE AB ALLAN WHITE
K060858 06/08/2006 LATEX POWDERED EXAMINATION GLOVE HIGH MOMENTUM SDN BHD HUE K FAH
K061087 06/09/2006 GENESIS OTC MONITOR HONEYWELL HOMMED, LLC TOMMIE J MORGAN
K061088 06/09/2006 SENTRY OTC MONITOR HONEYWELL HOMMED, LLC TOMMIE J MORGAN
K061159 06/26/2006 OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN HOSPIRA, INC. THOMAS KOZMA
K061006 06/05/2006 IKOENGELO IKOETECH, LLC. HUIMIN CHAO
K060463 06/06/2006 HEMA SCREEN SPECIFIC IFOBT IMMUNOSTICS, INC. JEFFREY FLEISHMAN
K061032 06/21/2006 DEPOTONE IMPRINT PHARMACEUTICALS LIMITED MERVYN LITTLE
K052908 06/23/2006 INTRAREDX NIR IMAGING SYSTEM, MODEL MC-5 INFRAREDX, INC. NANDINI MURTHY
K061147 06/30/2006 OPTERYX ANTERIOR CERVICAL PLATE SYSTEM INNOVASIS, INC. DAVID N MCKEAN
K061281 06/19/2006 INSIGHT HEAD COIL INSIGHT NEUROIMAGING SYSTEMS LLC PATRICIA A MILBANK
K061443 06/23/2006 SMART USBLITE, MODEL M011120 INTELLIGENT HEARING SYSTEMS EDWARD MISKIEL
K060883 06/23/2006 PILOT TEST OR DETECTIVE AUDIOMETERS INTERACOUSTICS A/S DANIEL EGGAN
K053571 06/30/2006 MICROGEL ALKALINE HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM, MICROGEL ACID HEMOGLOBIN ELECTROPHORESIS TEST SYSTEM INTERLAB S.R.L. GARY LEHNUS
K060280 06/13/2006 ICHEM 100 URINE CHEMISTRY ANALYZER IRIS INTERNATIONAL, INC. GERALD J HADDOCK
K052798 06/06/2006 CAPSULS, MODELS 2003-PUR8C, 2004-PVC8C ISOVAC PRODUCTS LLC LISA S JONES
K061322 06/02/2006 PORCELAIN PRIMER J. MORITA USA, INC. HOWARD ROWE
K060844 06/06/2006 SILKLINE SOFT RELINING KIT, MODEL 28-100100 J. MORITA USA, INC. HOWARD ROWE
K060910 06/07/2006 POWDERED FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIANGSU EVERYGUARD PLASTIC PRODUCTS CO., LTD CHU XIA OAN
K060914 06/09/2006 TRIDENT ANCHOR JOHNSON & JOHNSON COMPANY RUTH FORSTADT
K060580 06/06/2006 K-SHIELD PORT ACCESS INFUSION SET KAWASUMI LABORATORIES, INC. JACK PAVLO
K061197 06/30/2006 KAWASUMI LABORATORIES EMPTY SOLUTION CONTAINER KAWASUMI LABORATORIES, INC. SUZAN ONEL
K061271 06/30/2006 ERCH ARCH BAR, MODEL 38-690-00 KLS-MARTIN L.P. JENNIFER DAMATO
K061437 06/14/2006 SIGMA 5000 SERIES, IMAGIC KONTRON MEDICAL SYSTEMS SAS LARRY WALKER
K053444 06/09/2006 KOWA KT-800 KOWA CO. LTD. SHINICHI YAMANAKA
K061210 06/27/2006 FUNCTIONAL ANAESTHETIC DISCOGRAPHY (FAD) CATHETER SYSTEM, MODEL D01A ; INTRODUCER NEEDLE, MODEL D01B KYPHON, INC. CINDY DOMECUS
K061255 06/13/2006 BRAINACQUIRERX / BRAINPROCESSRX DATA SUITE VERSION 1.0 KYRON CLINICAL IMAGING, INC. JAMES L REUSS
K061360 06/27/2006 NEOMARKERS RABBIT MONOCLONAL ANTI-HUMAN ESTROGEN RECE[PTOR ANTIBODY (CLONE SP1) LAB VISION CORP. GRACE HSIAO-FEN CHANG
K061646 06/27/2006 LASERSCOPE GUIDED DELIVERY DEVICE (GDD) CYSTOURETHROSCOPE & ACCESSORIES LASERSCOPE PAUL HARDIMAN
K052767 06/23/2006 AFIBALERT ATRIAL FIBRILLATION DETECTOR LECHNOLOGIES RESEARCH INC. TIM LOHMAN
K061080 06/14/2006 IR PRO 250 LHASA OMS, INC. MARK W SHEEHAN
K060517 06/19/2006 POINTER EXCEL LHASA OMS, INC. MARK W SHEEHAN
K060508 06/19/2006 POINTER PLUS LHASA OMS, INC. MARK W SHEEHAN
K060848 06/27/2006 BOD POD LIFE MEASUREMENT, INC. MICHAEL SULLIVAN
K061240 06/02/2006 SHERLOCK TIP LOCATION SYSTEM (TLS) DETECTOR AND ACCESSORIES LUCENT MEDICAL SYSTEMS CYNTHIA PESTKA
K053372 06/30/2006 LBI CATHETER SYSTEM LUMEN BIOMEDICAL, INC. AMY PETERSON
K060885 06/05/2006 MODEL MI 44 TYMPANOMETER MAICO-DIAGNOSTICS DANIEL EGGAN
K061546 06/20/2006 QUART ARTERIAL FILTER WITH SAFELINE COATING, MODEL BSQ-HBF 140 MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K060143 06/16/2006 LNCS AND SPO2.COM SENSORS MASIMO CORPORATION JAMES J CRONIN
K060431 06/19/2006 ANTI RNA POLYMERASE III ELISA KIT, MODEL 7805 MBL INTERNATIONAL CORPORATION DANIEL KAMM
K053137 06/14/2006 ENDOTOOL DRUG DOSE CALCULATOR MD SCIENTIFIC LLC SHADE M MECUM
K060404 06/22/2006 AG-PLUS, MODEL 91210 MEDEL S.P.A. TERRENCE O'BRIEN
K061205 06/21/2006 MEDELA VARIO 8/18/CI SECRETION & SURGICAL ASPIRATOR MEDELA AG WERNER FREI
K061435 06/08/2006 MEDELA VARIO SUCTION PUMPS MEDELA AG WERNER FREI
K061684 06/27/2006 MEDI-GLOBE ROTA-CUT SPHINCTEROTOME MEDI-GLOBE CORPORATION SCOTT KARLER
K060439 06/22/2006 LUNG FLUTE MEDICAL ACOUSTICS LLC NICOLAAS J SMIT
K061606 06/21/2006 DEFIBRILLATOR CABLE TESTER, MODEL DT2200 MEDICAL DEVICES/PADPRO, INC. DANIEL KAMM
K060819 06/16/2006 COOL.CLICK 2 MEDICAL HOUSE PRODUCTS LIMITED ROSE Y GUANG
K060456 06/19/2006 MEDLINE COLLAGEN WOUND DRESSING MEDLINE INDUSTRIES, INC. LARA N SIMMONS
K061079 06/02/2006 MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES MEDTRADE PRODUCTS LTD. JONATHAN D RANFIELD
K061254 06/23/2006 EOPA 3D ARTERIAL CANNULA, MODELS 78220,78222,78320,783222 MEDTRONIC PERFUSION SYSTEMS RONALD W BENNETT
K051965 06/16/2006 OSTEOBRIDGE IDSF INTRAMEDULLARY DIAPHYSEAL SEGMENTAL DEFECT FIXATION ROD SYSTEM MERETE MEDICAL GMBH CARL KNOBLOCH
K060686 06/09/2006 MICROLIFE AUTOMATIC BLOOD PRESSURE MONITOR, MODEL BP3AC1-1PC MICROLIFE INTELLECTUAL PROPERTY GMBH ARIEL WANG
K061403 06/14/2006 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3AX1-4U MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K061558 06/29/2006 MICROLIFE WRIST WATCH BLOOD PRESSURE MONITOR, MODEL BP3BU1-4U MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K061302 06/23/2006 DIGITAL PRINTER P6000D SERIES, MODEL P6000DU MITSUBISHI ELECTRIC CORPORATION KYOTO WORKS SHINICHI YAMANAKA
K060825 06/19/2006 MULTI-USE ELECTRONIC PREGNANCY TEST MIZUHO USA, INC. BENEDICT ZIN
K061117 06/20/2006 NANOLITE SKIN CARE SYSTEM NANOLITE TECHNOLOGY, INC. EDWIN BURGOS
K061280 06/27/2006 V-2200 INFANT INCUBATOR NEOFORCE GROUP, INC. MARY STANIEWICZ
K061003 06/30/2006 SFB & CFB IMPLANTS NOBEL BIOCARE AB HERBERT CRANE
K061169 06/20/2006 ENDOSSEOUS DENTAL IMPLANT NORTHERN IMPLANTS, LLC GRETA M HOLS
K060744 06/02/2006 O'BRIEN MPA (MANDIBULAR POSITIONING APPLICANCE) O'BRIEN DENTAL LAB, INC. SUZIE DOWNING
K060201 06/06/2006 OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WITH MODEL(S): ODC0028, AND OSR61105. OLYMPUS AMERICA, INC. BEV HARDING
K060243 06/23/2006 OLYMPUS GUIDE SHEATH, MODEL XBO1-836-13 OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K060192 06/15/2006 APEX KNEE SYSTEM OMNI LIFE SCIENCE, INC. EDWARD J CHEAL
K060766 06/09/2006 PORTABLE, ELECTROCARDIOGRAPH (ECG) MONITOR, MODEL HCG-801 OMRON HEALTHCARE, INC. DONNA DJINOVICH
K061464 06/15/2006 VITROS CHEMISTRY PRODUCTS TIBC KIT, MODEL 886 7541; CALIBRATOR KIT 4, MODEL 120 4668 ORTHO-CLINICAL DIAGNOSTICS, INC. DARLENE J PHILLIPS
K060632 06/06/2006 VITROS IMMUNODIAGNOSTIC PRODUCTS NT PRO-BNP REAGENT PACK,CALIBRATORS,RANGE VERIFIERS,680 2156,680 2157,680 2158 ORTHO-CLINICAL DIAGNOSTICS, INC. LEAH DE WATER
K061400 06/29/2006 CALCANEAL TRAUMA SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. LEE A STRNAD
K060536 06/02/2006 OSTEOMED 1ST MPJ HEMI IMPLANT SYSTEM OSTEOMED L.P. DAWN T HOLDEMAN
K053172 06/09/2006 UNIVERSAL-X (USA) OR /KRYSTAL-X (EUROPE) OWANDY SAS OLIVIER MAURIER
K060563 06/02/2006 EPISPIN, EPISPIN II SAFETY, EPISPIN II, EPISPIN I, EPISPIN IV PAJUNK GMBH CHRISTAIN QUASS
K060311 06/13/2006 EPILONG KIT FOR ANESTHESIOLOGY PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
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