FDA 510(k) Decisions During December, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K080428 12/09/2008 ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY MEDTRONIC INC. MARLENE PETERSON
K082670 12/04/2008 MODIFICATION TO: ATTAIN PREVAIL 6228CTH80 STEERABLE CATHETER SET MEDTRONIC INC. BETH CLAAS
K083610 12/17/2008 FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE 3M COMPANY SCOTT ERICKSON
K082985 12/17/2008 A-DEC 334/335 DELIVERY SYSTEM A-DEC, INC. THOMAS H LOUISELL
K081697 12/04/2008 THE WAND MICROACCESS SAFETY INTRODUCER, MODELS 90001, 90002, 90005, 90006 ACCESS SCIENTIFIC, INC. ALBERT MISAJON
K082993 12/19/2008 SURGISEAL TOPICAL SKIN ADHESIVE ADHEZION BIOMEDICAL RICHARD G JONES
K081751 12/19/2008 ADIN DENTAL IMPLANTS SYSTEM ADIN DENTAL IMPLANTS SYSTEM LTD BENNY ARAZY
K081309 12/19/2008 E.COLI/P. AERUGINOSA PNA FISH ADVANDX, INC. HENRIK STENDER
K081960 12/17/2008 INVISALIGN SYSTEM ALIGN TECHNOLOGY SANGEETA SACHDEVA
K071849 12/04/2008 ALLOFUSE GEL AND PUTTY ALLOSOURCE, INC. PAMELA VETTER
K083254 12/19/2008 ALOKA PROUSOUND 2 DIAGNOSTIC ULTRASOUND SYSTEM ALOKA CO., LTD. RICHARD CEHOVSKY
K082956 12/18/2008 ALPHA ORTHOPAEDICS AT2 SYSTEM ALPHA ORTHOPAEDICS GINA TO
K082898 12/19/2008 AMEDICA DRUG SCREEN TEST CUP AMEDICA BIOTECH, INC. JEFF CHEN
K083549 12/22/2008 ABT GLUCOSE CONTROL SOLUTION AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GORMLEY
K082387 12/04/2008 APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM AMERICAN MEDICAL SYSTEMS SARAH PETERSON
K082677 12/23/2008 AMS ELEVATE ANTERIOR & APICAL PROLAPSE REPAIR SYSTEM WITH INTEPRO LITE AMERICAN MEDICAL SYSTEMS, INC. MONA INMAN
K082180 12/17/2008 PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS LINDA K SCHULZ
K082729 12/19/2008 RIMCLOSE BONE ANCHOR ANULEX TECHNOLOGIES, INC RACHEL KENNEDY
K082114 12/19/2008 ELECTROCAUTERY DILATION BALLOON, MODELS: EDB-0018-00, EDB-0020-00, EDB-0022-00 APOLLO ENDOSURGERY, INC. DENNIS MCWILLIAMS
K083638 12/23/2008 FIXATION TROCARS APPLIED MEDICAL RESOURCES CORP.
K083370 12/12/2008 D-CLOT THROMBECTOMY CATHETER SYSTEM, MODEL: DC 4006 ARTEGRAFT, INC. LAURENCE A POTTER
K082999 12/30/2008 ARTHREX MENISCAL DART, ARTHREX MENISCAL DARTSTICK, ARTHREX CHONDRAL DART ARTHREX, INC. NANCY HOFT
K083306 12/10/2008 MODIFICATION TO ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K081551 12/24/2008 TWIN NEUROTRAC-III ASTRO-MED, INC. ALFREDO BUSTAMANTE
K082749 12/04/2008 OMNI-TIGHT BASIC DENTAL IMPLANT SYSTEMS, INC. DAN BLACKLOCK
K081920 12/19/2008 BD GENEOHM CDIFF ASSAY BD DIAGNOSTICS (GENEOHM SCIENCES, INC.) RAYMOND BOULE
K081930 12/19/2008 UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM BECKMAN COULTER, INC. LOURDES COBA
K083572 12/24/2008 BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM BECTON, DICKINSON & CO. DENNIS MERTZ
K082913 12/05/2008 BD PHOENIX AUTOMATED MICROBIOLOGY SYSTEM-DOXYCYCLINE (GP) 0.25-16 UG/ML BECTON, DICKINSON & CO. VICKI K WHITLEY
K081824 12/11/2008 BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. KATHRYN B CARR
K081825 12/11/2008 BD PROBETEC NEISSERIA GONORRHOEAE (GC) Q AMPLIFIED DNA ASSAY BECTON, DICKINSON & CO. KATHRYN B CARR
K081522 12/05/2008 BIO NUCLEAR DIAGNOSTICS (ENDO)CERVICAL SAMPLER FOR GYN CYTOLOGY BIO NUCLEAR DIAGNOSTICS, INC. SURENDER CHOUDHRY
K083164 12/16/2008 SYSTEM-ARMS, MODELS 390, X60 BIO-MEDICAL RESEARCH, LTD. ANNE-MARIE KEENAN
K081498 12/17/2008 TENSO-COMFORT BLOOD PRESSURE METER, MODELS BPM 105 AND BPM 205 BIOCOMFORT DIAGNOSTICS GMBH & CO. KG MARTIN GABLER
K083091 12/24/2008 LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES BIOCOMPATIBLES U.K. LIMITED JOHN GREENBAUM
K082953 12/22/2008 ARCHITECT IDIGOXIN AND ARCHITECT IDIGOXIN CALIBRATORS, MODELS 1P32-25 AND IP32-01 BIOKIT S.A. JOAN GUIXER
K082938 12/22/2008 EZLASE BIOLASE TECHNOLOGY, INC. IOANA RIZOIU
K082225 12/03/2008 15W CERALAS D 1470NM DIODE LASER, MODEL D1470 BIOLITEC, INC. JONATHAN S KAHAN
K080766 12/23/2008 VIDAS RUB IGG BIOMERIEUX, INC. NIKITA S MAPP
K083070 12/16/2008 TOGGLELOC SYSTEM BIOMET SPORTS MEDICINE ROBERT FRIDDLE
K082008 12/11/2008 BIONET BM3PLUS PATIENT MONITOR BIONET CO., LTD. YINGCHAO XIAO
K082705 12/15/2008 BIOPRO BIPOLAR HEAD, MODELS 18130-18152 BIOPRO, INC. DAVID MRAK
K082935 12/04/2008 VISION WIRE CORONARY GUIDEWIRE BIOTRONIK, INC. JON BRUMBAUGH
K082652 12/30/2008 BITTAR ZIRCONIA BLOCKS BITTAR ZIRCONIA BLOCK, LLC STUART R GOLDMAN
K083355 12/29/2008 WOUND WASH SALINE, 210 ML, MODEL B8552, WOUND WASH SALINE, 90 ML, MODEL B8553 BLAIREX LABORATORIES, INC. CAREY BOTTOM
K081739 12/03/2008 2-PORT THROUGH-THE-PEG (TTP) JEJUNOSTOMY TUBE KIT BOSTON SCIENTIFIC CORP. MARYBETH GAMBER
K082297 12/09/2008 BUSSE SURGICAL DRAPE BUSSE HOSPITAL DISPOSABLES, INC. MUHAMAD ANSARI
K082094 12/17/2008 BARD PTFE (TEFLON) COATED GUIDE WIRES C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION DEBORAH L HERRINGTON
K083657 12/24/2008 CONQUEST PTA BALLOON DILATATION CATHETER C.R. BARD, INC. GENEVIEVE BALUTOWSKI
K081855 12/19/2008 IMPAIR AWARE ALCOHOL LEVEL INDICATION SYSTEM (ALIS) CANADA, INC. FEDERICO FORERO
K082090 12/12/2008 9131 DEFIBRILLATION ELECTRODES CARDIAC SCIENCE CORPORATION BEVERLY MAGRANE
K082539 12/02/2008 MASTERSCOPE, MASTERSCOPE ECG, MASTERSCOPE CT CARDINAL HEALTH GERMANY 234 GMBH THOMAS RUST
K072964 12/30/2008 NICOLET CORTICAL STIMULATOR CARDINAL HEALTH, INC. GARY SYRING
K083673 12/30/2008 CARESTREAM PACS, MODEL CARESTREAM PACS VII CARESTREAM HEALTH, INC. LINDA STEWART
K082829 12/22/2008 AIRCRAFT MEDICAL OXYGEN GENERATION SYSTEM (AMOGS) CARLETON LIFE SUPPORT SYSTEMS INC. GARY BYRD
K080558 12/05/2008 STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K080595 12/05/2008 CELLAVISION DM96 WITH THE BODY FLUID APPLICATION CELLAVISION AB CONSTANCE G BUNDY
K073417 12/15/2008 EMBOZENE MICROSPHERES CELONOVA BIOSCIENCES, INC. THOMAS A GORDY
K083093 12/15/2008 CHEETAH RELIANT CHEETAH MEDICAL INC. RHONA SHANKER
K081768 12/23/2008 COOK INCORPORATED POLYVINYL ALCOHOL FOAM EMBOLIZATION PARTICLES COOK INCORPORATED SUSANNE GALIN
K081060 12/24/2008 FERROFIBRE STAINLESS STEEL SUTURES, MODEL 610 SERIES SIZES (USP) 5-0 TO #5 CORE ESSENCE ORTHOPAEDICS, LLC SHAWN T HUXEL
K083210 12/29/2008 CORFLO ANTI IV ENTERAL FEEDING TUBE CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083379 12/12/2008 CYNOSURE SMARTLIPO MPX LASER WITH SMARTSENSE C MODULE CYNOSURE, INC. GEORGE CHO
K082731 12/17/2008 ML24000 UVA-1 PHOTOTHERAPY CABINET DAAVLIN DISTRIBUTING CO. TARA MANSUR
K073681 12/09/2008 NANOBEAM 940, MODEL 940-900-02 DAVARAY, INC. DAVID J ARNDT
K083400 12/11/2008 CUSTOM COMFORT NIGHTGUARD DENTEK ORAL CARE, INC. HOWARD M HOLSTEIN
K082408 12/03/2008 LEDEX, MODEL: WL-070 DENTMATE TECHNOLOGY CO., LTD. CHENG-FENG CHOU
K082643 12/19/2008 3.5 MM SIDE EFFECT ELECTRODE WITH INTEGRATED HANDPIECE, MODEL 227301, 3.5 MM ANGLED SIDE EFFECT ELECTRODE WITH INTEGRATE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY ZHENG LIU
K083364 12/11/2008 2.5 MM MULTIDIRECTIONAL THREADED PEGS, MODELS 131211110-131211130, 1.5 MM LOCKING SCREWS, MODELS 131220408-131220424 DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K082585 12/04/2008 DEPUY ASPHERE M-SPEC HEAD DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K082715 12/18/2008 DEPUY GLOBAL AP CTA HUMERAL HEAD DEPUY ORTHOPAEDICS, INC. RHONDA MYER
K081746 12/23/2008 D3 DUET DFA INFLUENZA A/RESPIRATORY VIRUS SCREENING KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K081928 12/23/2008 D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT DIAGNOSTIC HYBRIDS, INC. GAIL R GOODRUM
K082248 12/12/2008 STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K082049 12/05/2008 LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV DIASORIN, INC. CAROL A DEPOUW
K080485 12/04/2008 ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS DIASYS DIAGNOSTICS SYSTEMS GMBH STEPHANIE KLEIN
K082001 12/05/2008 DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B DIAZYME LABORATORIES ABHIJIT DATTA
K082904 12/17/2008 STASYS MOTION CORRECTION SOFTWARE DIGIRAD CORP. JOEL TUCKEY
K083050 12/29/2008 EVITE XL DRAEGER MEDICAL AG & CO. KG JOYCE KILROY
K082308 12/09/2008 MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR EDWARDS LIFESCIENCES, LLC. JASON SMITH
K082421 12/17/2008 HEARTSUITE HEMODYNAMICS 7.10 EMAGEON INC.
K083555 12/16/2008 PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION EMSOMA CO., LTD. WEONBUM LEE
K082233 12/18/2008 VIKY ENDOCONTROL CARINE HUGUEL
K082380 12/03/2008 VICARDIO 12B ENERGY-LAB TECHNOLOGIES GMBH GEORGE MYERS
K083452 12/31/2008 ERBE MODEL VIO 300 D WITH ACCESSORIES ERBE USA, INC. JULIE STEPHENS
K082893 12/05/2008 PRAGER SHELL ESI, INC. GEORGE MYERS
K082278 12/16/2008 MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS ETHICON ENDO-SUGERY, LLC CAROL HUBBARD
K082854 12/04/2008 NANOCORSS .014 OTW PTA DILATATION CATHETER EV3 INC. DAVID WORRELL
K083392 12/17/2008 NOVATION 12/14 CEMENTED FEMORAL STEMS EXACTECH, INC. GRAHAM L CUTHBERT
K082837 12/18/2008 STERILE FIELD SALINE PRE-FILLED SYRINGE(S) EXCELSIOR MEDICAL CORP. JOHN LINFANTE
K081990 12/05/2008 LUBRICANO STERILE GEL FARCO PHARMA GMBH SETH A MAILHOT
K071573 12/09/2008 RUGALIFT, MODEL# V.2.1 FATROTEK S.R.L. FRANSICO PELUSO
K083347 12/24/2008 IMPULSE 7010 DEFIBRILLATOR SELECTABLE LOADS FLUKE BIOMEDICAL COLLEEN BOSWELL
K083542 12/29/2008 FRESENIUS STERILE STAY SAFE CAP FRESENIUS MEDICAL CARE NORTH AMERICA JANET KAY
K083504 12/12/2008 GE DISCOVERY NM/CT 570C GE MEDICAL SYSTEMS F.I. HAIFA LAURENCE BIGIO
K082676 12/18/2008 GENADYNE A4 WOUND VACUUM SYSTEM GENADYNE BIOTECHNOLOGIES, INC. CHIEN-MING GOH
K082210 12/16/2008 TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 GENZYME DIAGNOSTICS P.E.I. INC. PENNY J WHITE
K083272 12/16/2008 SKINCLEAR Q-SWITCHED ND:YAG LASER GLOBAL USA DISTRIBUTION, LLC. MATT MAKOUSKY
K083232 12/24/2008 MODIFICATION TO:MICROFUSE BONE VOID FILLER GLOBUS MEDICAL INC. KELLY J BAKER
K081929 12/16/2008 VACUETTE BLOOD COLLECTION TUBE WITH CLOT ACTIVATOR AND GEL SEPARATOR GREINER BIO-ONE NORTH AMERICA, INC. JUDI SMITH
K083013 12/09/2008 PK DIEGO POWERED DISSECTOR CONSOLE, MODEL 7033-9050, DIEGO TRIGGER-ENABLED POWERED DISSECTOR HANDPIECE, MODEL 7033-9001 GYRUS ACMI, INC. GRAHAM A.L. BAILLIE
K082591 12/05/2008 FLEXITIME BITE HERAEUS KULZER, INC., DENTAL PRODUCTS DIVISION CHERYL V ZIMMERMAN
K083086 12/05/2008 ECHELON HIGH RESOLUTION FOOT COIL (MR-HRF-150), ECHELON LONG BONE COIL (MR-LBC-150) HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K083049 12/23/2008 TORNADO ROTATABEL SNARE AND POLYP CATCHER HORIZONS INTL. CORP. RAFIC SALEH
K081412 12/17/2008 PLUM A+ HYPERBARIC INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE HOSPIRA, INC. DANIELA WEKSLER
K082892 12/29/2008 REJUVENATE MONOLITHIC HIP SYSTEM HOWMEDICA OSTEONICS CORP DENISE DAUGERT
K083437 12/18/2008 MODIFICATION TO T2 RECON NAIL SYSTEM HOWMEDICA OSTEONICS CORP. AVITAL MERL-MARGULIES
K083591 12/29/2008 IKOENGELO, VERSION 2 IKOETECH, LLC. HUIMIN CHAO
K071526 12/10/2008 UNI-VENT 731 SERIES VENTILATORS, MODEL 731, 731EMV IMPACT INSTRUMENTATION, INC. LESLIE H SHERMAN
K083137 12/16/2008 NEURO III-SV IMRIS, INC. THOMAS M TSAKERIS
K082020 12/24/2008 ENVISION BLOOD GLUCOSE TEST SYSTEM INFOPIA CO., LTD MARIA F GRIFFIN
K081788 12/17/2008 INFRARED EAR THERMOMETER, MODELS INNOTHERM ICT-100 AND ICT-200 INNOCHIPS TECHNOLOGY CO., LTD. BRANDON CHOI
K082384 12/08/2008 HAV-LOK BUNION CORRECTION SYSTEM INSTRATEK, INC. JEFF SEAVEY
K082859 12/19/2008 HEMOSIL ROUTINE CONTROL LEVEL 1, LEVEL 2, LEVEL 3 UNASSAYED INSTRUMENTATION LABORATORY CO. CAROL MARBLE
K081635 12/04/2008 INTEGRA MESHED BILAYER WOUND MATRIX INTEGRA LIFESCIENCES CORP. DIANA M BORDON
K082795 12/12/2008 SINGLE USE PERPOS PLS SYSTEM, 4.5 BONE-LOK PLS IMPLANT INTERVENTIONAL SPINE, INC. CAROL EMERSON
K081207 12/19/2008 INTUITIVE SURGICAL DA VINCI S SURGICAL SYSTEM, MODEL IS2000, WITH DA VINCI CONNECT AND ONSITE INTUITIVE SURGICAL, INC. JERRY TSUTSUMI
K080740 12/31/2008 CLEARVIEW ENDOSCOPE COVER INVOTEC INTERNATIONAL, INC. JEFFREY L AULL
K082416 12/12/2008 IBA PROTON THERAPY SYSTEM- PROTEUS 235 ION BEAM APPLICATIONS S.A. JOHN REISS
K070541 12/11/2008 IVIVI SOFPULSE, MODELS 912-M10, ROMA3 AND TORINO II IVIVI TECHNOLOGIES, INC. ANDRE DIMINO
K082911 12/19/2008 SMOOTHCOOL HR SYSTEM JEISYS MEDICAL, INC. KEVIN WALLS
K080542 12/15/2008 DISTRAX JOHN W. KING EMILY B ROSSITER
K082769 12/11/2008 MESA AND RANGE SPINAL SYSTEMS K2M, INC. RICHARD W WOODS
K082925 12/18/2008 XENON-100 SCB LIGHT SOURCE, MODEL 20132620 KARL STORZ ENDOSCOPY-AMERICA, INC. MONIKA CAMPBELL
K082509 12/15/2008 EOS SPINAL SYSTEM KOREA BONE BANK CO., LTD JUNG BAE BANG
K082922 12/09/2008 FREEWAY AND RAILRUNNER GUIDEWIRES LAKE REGION MFG., INC. DEEP PAL
K082590 12/17/2008 SYMPHONY METER REMOTE LIFESCAN, INC. MARTHA MURARI
K083560 12/11/2008 EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X LIGHTHOUSE TECHNICAL INNOVATIONS, INC. JEAN ASQUITH
K081008 12/22/2008 BUPRENORPHINE ENZYME IMMUNOASSAY, CALIBRATORS AND CONTROLS FOR BECKMAN COULTER SYNCHRON SYSTEMS LIN-ZHI INTERNATIONAL, INC. MARIE LIN
K081848 12/04/2008 LIPOSE FAT TRANSFER SYSTEM LIPOSE CORP. ALAN CURTIS
K082460 12/15/2008 CENEFOM PVA SURGICAL SPEAR LONGTEK SCIENTIFIC CO., LTD. JOSEPH J CHANG
K082809 12/18/2008 ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM LUMENIS, INC. FRANCES E HARRISON
K083171 12/16/2008 INTROL CF PANEL I CONTROL, MODEL: G106 MAINE MOLECULAR QUALITY CONTROLS, INC. JOAN GORDON
K082700 12/09/2008 TEMPORARY COLD.V AND SELF-CURE DENTINE MAJOR PRODOTTI DENTARI S.P.A. MONICA FUNAI
K082725 12/17/2008 GRAFTGUARD PRESSURE CONTROLLING SYRINGE MAQUET CARDIOVASCULAR, LLC CHRISTINA L ROWE
K082818 12/23/2008 SUBCUTANEOUS NEEDLE INFUSION SET MARCAL MEDICAL, INC. ARTHUR WARD
K082792 12/29/2008 MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA H AND R FEMORAL STEMS MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K083472 12/09/2008 MEDEGEN PRESSURE RATED EXTENSION SETS MEDEGEN INC. TIM L TRUITT
K083765 12/30/2008 MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL MEDEGEN MEDICAL MANUFACTURING SERVICES MATTHEW FRIED
K080810 12/10/2008 EASYRA BILIRUBIN DIRECT AND TOTAL REAGENT, PHOSPHORUS INORGANIC REAGENT AND IRON AND MAGNESIUM REAGENT MEDICA CORP. PHOTIOS MAKRIS
K082472 12/30/2008 VIROCULT, MODEL MW950 MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD DAVID ELLIS
K083308 12/10/2008 PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES J.D. WEBB
K080172 12/18/2008 BLASTASSIST WITHOUT PHENOL RED, MODEL REF 1215, BLASTASSIST WITH PHENOL RED, MODEL REF 1216 MEDICULT A/S RONALD G LEONARDI
K081355 12/18/2008 BIOFLEX LD-R100 TREATMENT HEAD MEDITECH INTERNATIONAL, INC. FRED KAHN
K083026 12/29/2008 CLYDESDALE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK LEE GRANT
K080741 12/16/2008 MEGA SOFT REUSABLE PATIENT RETURN ELECTRODE MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K083063 12/16/2008 BIS INTERFACE FOR VITALOGIK PATIENT MONITORS MENNEN MEDICAL LTD. IFAT OREN
K081962 12/29/2008 LAPEX BCS MERIDIAN CO., LTD. DANIEL KAMM
K082613 12/30/2008 MERIT MICROCATHETER MERIT MEDICAL SYSTEMS, INC. MICHAELA RIVKOWICH
K083576 12/23/2008 MISER CONTRAST MANAGEMENT SYSTEM MERIT MEDICAL SYSTEMS, INC. STEPHANIE ERSKINE
K082385 12/11/2008 CHAPERON GUIDING CATHETER MICROVENTION, INC. FLORIN TRUUVERT
K083343 12/04/2008 HEADWAY 17 MICROCATHETER MICROVENTION, INC.
K072562 12/04/2008 MICROWARE BONE PLATES AND BONE SCREWS MICROWARE PRECISION CO., LTD. HARRISON DU
K082766 12/17/2008 MODIFICATION TO MINISPIR, SPIROLAB III MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K080458 12/17/2008 MIS CREST WIDENER MIS - IMPLANT TECHNOLOGIES LTD. IMAN KHORSHID
K082946 12/29/2008 MORTARA ELI 350 ELECTROCARDIOGRAPH MORTARA INSTRUMENT, INC. CHARLES MORREALE
K082203 12/30/2008 NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 NCONTACT SURGICAL, INC. JANE RICUPERO
K083538 12/16/2008 NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 NEURONETICS JUDY P WAYS
K072831 12/12/2008 FROG NEWBY-COOMBS, LLC KARLA COOMBS
K082724 12/16/2008 NEWPORT HTS50 VENTILATOR WITH DUAL PAC BATTERY SYSTEM NEWPORT MEDICAL INSTRUMENTS, INC. DIANA RODRIGUEZ
K082566 12/03/2008 MARK 5 NUVO LITE OCSI AND STD NIDEK MEDICAL PRODUCTS, INC. JENNIFER MCWILLIAMS
K083271 12/24/2008 BSM-2300 &BSM6000 WITH CGS-9001 SERIES COMMUNICATION GATEWAY, MODEL CGS-9001 SERIES OPTIONAL ACCESSORY NIHON KOHDEN AMERICA, INC. JACK COGGAN
K081972 12/11/2008 BIOCLEAN CHEMO EMERALD POWDER FREE NITRILE EXAMINATION GLOVES NITRITEX (M) SDN. BHD. DEREK WATTS
K081971 12/23/2008 BIOCLEAN CHEMO ULTIMATE POWDER FREE POLYCHLOROPRENE EXAMINATION GLOVES NITRITEX (M) SDN. BHD. DEREK WATTS
K083476 12/22/2008 NOVEON MODEL LS1100-03 NOMIR MEDICAL TECHNOLOGIES, INC. RICHARD F BURTT
K081861 12/04/2008 HOLTER LX ANALYSIS NORTH EAST MONITORING INC. JOSEPH AZARY
K082672 12/09/2008 NOVABONE PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT NOVABONE PRODUCTS, LLC DAVID M GALSSER
K082878 12/30/2008 NEVONI CLASSIC, MODEL 6600-PO NSR COMERCIO E REPRESENTACOES LTDA POLLY SCHERMAN
K083042 12/18/2008 WOUND FLUSH, STERILE WATER & NORMAL SALINE NURSE ASSIST, INC. DENICE GALLAGHER
K081173 12/23/2008 ENDOSCOPIC CO2 REGULATION UNIT UCR OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K083335 12/15/2008 MODIFIED OMNIWAVE ENDOVASCULAR SYSTEM OMNISONICS MEDICAL TECHNOLOGIES ANNE M KULIS
K083173 12/22/2008 VITROS IMMUNODIAGNOSTIC PRODUCTS TSH REAGENT PACK AND CALIBRATORS, VITROS 3600 IMMUNODIAGNOSTIC SYSTEM ORTHO-CLINICAL DIAGNOSTICS LEAH VAN DE WATER
K082574 12/08/2008 MAXTORQUE MINI CANNULATED SCREW SYSTEM ORTHOHELIX SURGICAL DESIGNS, INC. DEREK LEWIS
K082950 12/05/2008 STARBAND ORTHOMERICA PRODUCTS, INC. ALAN T SANDIFER
K081786 12/02/2008 ZIOCERA & CONVERTIBLE SYSTEM OSSTEM IMPLANT CO LTD MINJOO KIM
K080149 12/18/2008 HEATER BASE, MODEL PMH7000 PACIFIC MEDICO CO., LTD. YOSHIMO TOYAMA
K081073 12/05/2008 HDR VISION, VISION HDR, HD R/F, UROMAT HD R/F PAUSCH LLC JUSTIN TICE
K082786 12/03/2008 PULSAR GENERATOR, PEAK PLASMABLADE; 4.0, NEEDLE, AND EXT TISSUE DISSECTION DEVICES PEAK SURGICAL, INC. GRACE CARLSON
K083413 12/18/2008 COMPURECORD PERI-OPERATIVE ANESTHESIOLOGY INFORMATION SYSTEM PHILIPS MEDICAL SYSTEMS TERESA SCHMIDT
K083498 12/17/2008 PHILIPS MODEL MX 16 SLICE CT SYSTEM PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. MICHAEL CHILBERT
K080794 12/17/2008 POLYVUE 55 SINGLE VISION, TORIC AND MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR POLYVUE DISTRIBUTION, INC. GAROLD L EDWARDS
K082382 12/12/2008 ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 POSSIS MEDICAL, INC. MARK STENOIEN
K083527 12/18/2008 INTELLIGENT ARTICULATING ENDOSCOPIC LINEAR CUTTER REVERSE WITH RELOADS POWER MEDICAL INTERVENTIONS, INC. BARBARA J WHITMAN
K082302 12/09/2008 POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM PT. MEDISAFE TECHNOLOGIES ANIL TANEJA
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