FDA 510(k) Decisions During September, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K080960 09/05/2008 PRECISION XCEED PRO BLOOD GLUCOSE AND B-KETONE MONITORING SYSTEM WITH MODELS BGMS:70900-03, 70090-02, G3CH STRIPS ABBOTT DIABETES CARE INC. TAMMY WHARTON
K081231 09/26/2008 ARCHITECT IPHENOBARBITAL REAGENTS AND ARCHITECT IPHENOBARBITAL CALIBRATORS, MODELS 1P33, 1P33 ABBOTT LABORATORIES CAROL JOCHUM
K080696 09/11/2008 ARCHITECT IPHENYTOIN REAGENTS AND ARCHITECH IPHENYTOIN CALIBRATORS WITH MODELS 1P34, AND 1P34-01 ABBOTT LABORATORIES CAROL JOCHUM
K081523 09/11/2008 EMBOSHIELD NAV6 EMBOLIC PROTECTION SYSTEM ABBOTT VASCULAR-VASCULAR SOLUTIONS DANIELLE TAYLOR
K082188 09/19/2008 TYMPANOSTOMY TUBE ACCLARENT, INC. KERI YEN
K082459 09/19/2008 ACRYDERM ABSORBENT OXYGEN DRESSING ACRYMED, INC. BRUCE GIBBINS
K081588 09/03/2008 RE-ZORB PLATING SYSTEM ACUTE INNOVATIONS LLC ALYSSA THOMAS
K081363 09/24/2008 NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING, SILVERCEL NON-ADHERENT ANTIMICROBIAL ALGINATE DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K080719 09/12/2008 YEAST TRAFFIC LIGHT PNA FISH ADVANDX, INC. HENRIK STENDER
K080992 09/04/2008 AESCULAP IMPLANT SYSTEMS HIGH TIBIAL OSTEOTOMY PLATING SYSTEM AESCULAP IMPLANT SYSTEMS, INC. Lisa Boyle
K082146 09/09/2008 METHA SHORT STEM HIP SYSTEM XL FEMORAL HEAD AESCULAP IMPLANT SYSTEMS, INC. KATHY A RACOSKY
K081293 09/22/2008 UNIVATION UNICONDYLAR KNEE SYSTEM AESCULAP IMPLANT SYSTEMS, INC. LISA M BOYLE
K082226 09/18/2008 S40 CREATINE KINASE (CK) ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. DENNIS TASCHEK
K081730 09/19/2008 NOVEL CERVICAL SPINAL SPACER SYSTEM ALPHATEC SPINE, INC. MARY SCANNERS
K082037 09/26/2008 SEEPLATE CERVICAL PLATE SYSTEM AMEDICA CORP. ADAM HERDER
K081613 09/17/2008 SPARC SYSTEM / MONARC, MONARC C, MONARC + SYSTEMS AMERICAN MEDICAL SYSTEMS, INC. SARAH PETERSON
K080803 09/22/2008 VISUAL PHACOEMULSIFICATION SYSTEM, MODEL 551 AMERICAN OPTISURGICAL, INC. DAVID SALZBERG
K082144 09/05/2008 AMICAS PACS, VERSION 6.0 AMICAS, INC. PATRICE JC NEDELEC
K081472 09/23/2008 SMARTPORT CT VORTEX; LP TITANIUM, SINGLE PLASTIC, SINGLE TITANIUM, TRIUMPH LOW PROFILE TITANIUM PORTS ANGIODYNAMICS, INC. BRIAN KUNST
K082073 09/11/2008 ACTIFUSE FLOW BONE GRAFT SUBSTITUTE APATECH LTD. CANDACE F CEDERMAN
K082562 09/30/2008 APPLIED BIOSYSTEMS 7500 FAST DX APPLIED BIOSYSTEMS INC JOHN D'ANGELO
K071803 09/05/2008 ARDS DENTAL IMPLANTS ARDS, LTD GEORGE J HATTUB
K073019 09/16/2008 SILVERMED ANTIMICROBIAL SILVER HYDROGEL ARGENTIS BIOMEDICAL INCORPORATED TONI MILLER
K073410 09/12/2008 SAVE RESUSCITATOR ARTIVENT CORPORATION GRACE HOLLAND
K082023 09/16/2008 REPROCESSED ELECTROPHYSIOLOGY CATHETERS ASCENT HEALTHCARE SOLUTIONS AMANDA BABCOCK
K080156 09/17/2008 OSSEOSPEED TM PROFILE SYSTEM ASTRA TECH AB LINDA K SCHULZ
K073425 09/16/2008 MODIFICATION TO AURORA MRI SYSTEM AURORA IMAGING TECHNOLOGY, INC. MICHAEL A DOUGLAS
K081742 09/17/2008 BAXANO NEURAL LOCALIZATION PROBE 1.75 AND 1.25 BAXANO, INC. TRENA DEPEL
K080933 09/26/2008 HANDHELD ECG MONITOR, MODEL MD100 BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. Diana Hong
K082087 09/11/2008 EYEFEEL OPHTHALMIC WARMER BIO-LIPID, INC. PAMELA FURMAN
K081547 09/08/2008 BIO-MED SOFT INSULIN SYRINGE: MODELS 1CC, 0.5CC, 0.3CC BIO-MED U.S.A., INC. YOUNG CHI
K082036 09/08/2008 LYPHOCHEK TUMOR MARKET PLUS CONTROL LEVEL 1, 2 AND 3 AND MINIPAK Bio-Rad Laboratories ELIZABETH PLATT
K082383 09/05/2008 FORTOSS VITAL BIOCOMPOSITES LTD. MARIE WHALLEY
K082141 09/03/2008 ARCHITECT C-PEPTIDE CALIBRATORS, AND ARCHITECT C-PEPTIDE CONTROLS, MODELS 3L53-01, 3L53-10 BIOKIT S.A. JOAN GUIXER
K080017 09/26/2008 VIDAS AFP ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K081451 09/18/2008 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM100 BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K081450 09/11/2008 RIGHTEST BLOOD GLUCOSE MONITORING SYSTEM, MODEL GM110 BIONIME CORPORATION SUSAN D GOLDSTEIN-FALK
K082395 09/18/2008 GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 BIONOSTICS, INC. KATHLEEN STORRO
K081656 09/10/2008 VISUALASE THERMAL THERAPY SYSTEM BIOTEX, INC. ROGER MCNICHOLS
K082293 09/09/2008 SURGVIEW INTEGRATED VISUALIZATION SYSTEM BIOVISION TECHNOLOGIES, LLC
K082449 09/25/2008 BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 BISCO, INC. Michelle Schiltz-Taing
K081684 09/15/2008 BLACKSTONE PEDICLE SCREW SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K082235 09/04/2008 BLACKSTONE PILLAR XL PEEK SPACERS BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K080332 09/05/2008 POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 Boston Scientific Corporation ASHLEY PYLE
K073615 09/05/2008 BRAINLAB KNEE ESSENTIAL, BRAINLAB KNEE UNLIMITED CI KNEE, CI KNEE UNLIMITED BRAINLAB AG PER PERSSON
K081961 09/05/2008 3M UNITEK LAVA CHAIRSIDE ORAL SCANNER BRONTES TECHNOLOGIES JOHN GREENBAUM
K081042 09/03/2008 MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES BSD MEDICAL SYSTEMS CORP. PHIL TRIOLO
K082571 09/30/2008 AVAULTA SUPPORT SYSTEM C.R. BARD, INC. JOHN C KNORPP
K081777 09/29/2008 VENTRIO HERNIA PATCH C.R. BARD, INC. STEPHANIE BAKER
K082425 09/18/2008 TANDEMHEART TRANSSEPTAL CANNULA- EF 72 CARDIAC ASSIST, INC. ROBERT BOLLINGER
K081225 09/05/2008 CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM CARDICA, INC. ISKRA MRAKOVIC
K082542 09/17/2008 ANEROID SPHYGMOMANOMETER WITH STETHOSCOPE MODEL HBPK-A CARDICARE COMPANY, LTD.
K080570 09/30/2008 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION STEPHEN LINDSTROM
K082140 09/29/2008 XPERT MRSA/SA BLOOD CULTURE ASSAY CEPHEID RUSSEL K ENNS
K080837 09/24/2008 XPERT MRSA/SA SSTI ASSAY CEPHEID RUSSEL K ENNIS
K082245 09/18/2008 AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV CEREMED, INC. TADEUSZ WELLISZ
K082491 09/24/2008 OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE CEREMED, INC. TADEUSZ WELLISZ
K082159 09/30/2008 CIVASTRING PD-103 CIVATECH ONCOLOGY, INC. LOIS V SMART
K080196 09/05/2008 Z3D CONTRAST ACUITY CLARIO MEDICAL IMAGING, INC. CHRIS WOOD
K081602 09/19/2008 DIZZYFIX CLEARWATER CLINICAL LIMITED MATTHEW BROMWICH
K082107 09/17/2008 CLINIQA LIQUID QC URINE CHEMISTRY CONTROLS, LEVELS 1 AND 2 CLINIQA CORPORATION CAROL RUGGIERO
K080638 09/17/2008 CLARO CLRS TECHNOLOGY CORPORATION MAUREEN O'CONNELL
K081151 09/08/2008 COMPUMEDICS NEUVO COMPUMEDICS USA, LTD. DAVID CARDONA
K081644 09/10/2008 BEAMER ARGON PROBE CONMED CORPORATION KAREN PROVENCHER
K080531 09/05/2008 CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY CONMED LINVATEC JON WARD
K071783 09/09/2008 VERSAPOD (TM) INSTRUMENT TRAYS CONTAINMED, INC. TODD E BETTENHAUSEN
K081987 09/26/2008 UNISYN IMAGE FUSION, VERSION 1.0 CONVERGENT IMAGING SOLUTIONS MATHEW A THOMAS
K082319 09/25/2008 INJEKT FILIFORM INJECTION NEEDLE COOK UROLOGICAL, INC. CINDY FOOTE
K081425 09/30/2008 COOK VASCULAR INC. VITAL-PORT VASCULAR ACCESS SYSTEM POWER INJECTABLE PORT COOK VASCULAR, INC. JIM FERGUSON
K081865 09/29/2008 PROCLEAR MULTIFOCAL TORIC AND XR AND TORIC XR COOPERVISION, INC. BONNIE TSYMBAL
K082324 09/12/2008 TRUFILL DCS SYRINGE CORDIS NEUROVASCULAR, INC. Amarilys Machado
K082077 09/02/2008 BT3/6, BT12 CORSCIENCE GMBH & CO. KG PATRIK KAREM
K082659 09/19/2008 MODIFIED ENDO STICH COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES ROBERT ZOTT
K081898 09/10/2008 EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K081758 09/03/2008 HEALOS FX INJECTABLE BONE GRAFT REPLACEMENT, MODELS 276175002, 276175005, 276175010, 276175015 DEPUY SPINE, INC. HANDE TUFAN
K082195 09/03/2008 MODIFICATIONS TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K082273 09/10/2008 UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K082167 09/26/2008 PORTABLE X-RAY SYSTEM, MODELS DIOX-602, PROX DIGIMED CORPORATION SHIN KUK YOO
K082368 09/12/2008 CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM DIGIRAD CORP. Joel Tuckey
K082246 09/09/2008 DIGNITY 100 DIGNITY MEDICAL DEVICES, INC CHARMAINE SUTTON
K080382 09/24/2008 SELLAS DINONA CO., LTD. Kevin Walls
K081493 09/18/2008 INFILTRATION KIT DMG USA, INC. PAMELA PAPINEAU
K081743 09/22/2008 CLASSICSTAR NV SE AND NOVASTAR NV SE AND AAV FULL FACE MASKS DRAEGER MEDICAL AG & CO. KG KARIN LUEBBERS
K081694 09/12/2008 DENJECTOR DXM CO., LTD. MARIA GRIFFIN
K081569 09/12/2008 DYNAREX/TILLOTSON NON-STERILE POWDER FREE BLUE NITRILE PATIENT EXAM GLOVE FOR USE WITH CHEMOTHERAPY DRUGS DYNAREX CORPORATION VIJAY SACHDEV
K081357 09/05/2008 5MP GRAYSCALE FLAT PANEL DISPLAY, MODEL, 6GF6201-5C$2# (WHERE $ = A-Z AND # = 0-9) EIZO GMBH JAMES BERGE
K081448 09/30/2008 ENCORE SHOULDER REVISION GLENOID ENCORE MEDICAL, L.P. TEFFANY HUTTO
K081394 09/15/2008 PTFE INTERLOCK PEELABLE INTRODUCERS ENPATH MEDICAL, INC. SHANNON SPRINGER
K082569 09/18/2008 ENTELLUS MEDICAL FLEXIBLE ENDOSCOPE AND EYEPIECE Entellus Medical, Inc. Sew-Wah Tay
K082121 09/17/2008 EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 EPS BIO TECHNOLOGY CORP. Y.C. LEI
K081386 09/25/2008 MODEL 6150 (MYLAB70) AND MODEL 6100 (MYLAB90) ESAOTE S.P.A. Allison Scott
K082216 09/05/2008 TBD ETHICON MESH ETHICON INC. BRYAN A LISA
K082307 09/11/2008 EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT EVENFLO COMPANY, INC. AMY NEFF
K082029 09/26/2008 SYNTHETIC POWDER FREE (PINK) VINYL PATIENT EXAMINATION GLOVE EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K082022 09/02/2008 OPTETRAK 9MM CRUCIATE RETAINING TIBIAL INSERT, SLOPE ++ EXACTECH, INC. GRAHAM CUTHBERT
K073317 09/03/2008 STARLIGHT, MODEL PD9012 F.P. RUBINSTEIN Y CIA S.R.L. HAYDEE N DEMARCO
K080209 09/12/2008 FISHER AND PAYKEL HEALTHCARE ZEST NASAL MASK FISHER & PAYKEL HEALTHCARE, LTD. TINA MASON
K081029 09/12/2008 SLEEPSTYLE 200 AUTO SERIES HC254 FISHER & PAYKEL HEALTHCARE, LTD. JAMES THOMPSON
K080751 09/11/2008 ARCHITECT CYCLOSPORINE FUJIREBIO DIAGNOSTICS, INC. STACEY MOLL
K081919 09/09/2008 UF-870 AG DIAGNOSTIC ULTRASOUND SYSTEM FUKUDA DENSHI CO., LTD. LORAN VAN NOY
K082656 09/30/2008 MODEL FF SONIC US-750 XT DIAGNOSTIC ULTRASOUND SYSTEM 3D IMAGING UNIT FUKUDA DENSHI USA, INC. LORAN VAN NOY
K082374 09/02/2008 VIVID I AND VIVID Q GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. ISRAEL CITRON
K082104 09/02/2008 GE LIGHTSPEED RT16 / LIGHTSPEED XTRA V2 CT SYSTEM (AKA GE LIGHTSPEED RT16 / LIGHTSPEED XTRA CT SYSTEM GE MEDICAL SYSTEMS, INC. STEVEN KACHELMEYER
K081985 09/25/2008 AW SERVER GE MEDICAL SYSTEMS, LLC STEPHEN SLAVENS
K082317 09/26/2008 GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION GENERAL ELECTRIC CO. JAMES P RASKOB
K082484 09/12/2008 ACCELAWAVE SYSTEM GENESIS BIOSYSTEMS, INC. BRIAN BUSS
K081821 09/02/2008 D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) GLOBAL PATHOGEN SOLUTIONS INC. CARSON LINKER
K081712 09/12/2008 FINGERTIP PULSE OXIMETER, MODEL M70, AND HANDHELD PULSE OXIMETER, MODEL M700 GUANGDONG BIOLIGHT MEDITECH CO., LTD. Diana Hong
K081521 09/25/2008 MODIFICATION TO HAMILTON-G5 HAMILTON MEDICAL AG JOERG SCHNEIDER
K080682 09/11/2008 HHC, SCORE, HENRY SCHEIN CANISTER HANDPIECE HANDPIECE HEADQUARTERS INC. - HPR INC. TINA STEFFANIE-OAK
K082616 09/26/2008 HASELMEIER PEN 8 HASELMEIER GMBH STEPHEN J GOLDNER
K081738 09/17/2008 ULTRASONIC NEBULIZER SYSTEM, MODEL HL100 HEALTH & LIFE CO., LTD. SAMUEL PIPER
K081442 09/24/2008 HEART SYNC PEDIATRIC, MODEL PED-100 HEART SYNC LLC STEPHEN SHULMAN
K082312 09/12/2008 PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) HEARTSCAPE TECHNOLOGIES LTD PAUL PHILLIPS
K080221 09/09/2008 EA STIMULATOR HELIO MEDICAL SUPPLIES, INC. YUKUO HSO
K082206 09/04/2008 BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES HELIX MEDICAL, LLC CYNTHIA ANDERSON
K082366 09/26/2008 LIFEBED PATIENT VIGILANCE SYSTEM HOANA MEDICAL, INC. NANCY GERTLAR
K080711 09/02/2008 1.10-YEAR FRACTURE RISK QUESTIONNAIRE OPTION FOR QDR X-RAY BONE DENSITOMETER, MODEL QDR OPTION HOLOGIC, INC. BRYAN COWELL
K082483 09/12/2008 QUANTRA HOLOGIC, INC. CATHERINE A WILLIAMS
K081276 09/12/2008 ABX PENTRA GLUCOSE HK CP, ABX PENTRA URIC ACID CP, ABX PENTRA URINE CONTROL L/H HORIBA ABX OLIVIER DUCAMP
K080579 09/11/2008 EFFECTIVE (TM) CAP HOSPIRA, INC. REBECCA ANDERSEN
K082496 09/09/2008 PACSMATE MMD-3213M MONITOR IEI TECHNOLOGY CORP. SHALLY CHEN
K081653 09/19/2008 MDI MII ONE-PIECE IMPLANT, 2.9MM IMTEC CORP. GLENN GEE
K081782 09/30/2008 COLLIEVA INNOCOLL PHARMACEUTICALS AARON WYSE
K080602 09/25/2008 AUDICOR SENSOR, MODELS: 2.0, 3.0 INOVISE MEDICAL, INC. KENDRA RATHKEY
K073545 09/09/2008 AUDICOR, HEMO AMBULATORY MONITOR INOVISE MEDICAL, INC. KENDRA RATHKEY
K081925 09/02/2008 SNAPSHOT INSTRUMENTARIUM DENTAL, PALODEX GROUP OY JOUNI ONNELA
K081693 09/11/2008 NS SERIES NIF (NEGATIVE INSPIRATORY FORCE) METERS INSTRUMENTATION INDUSTRIES, INC. DORIS F WALTER
K081778 09/12/2008 NS SERIES VACUUM/PRESSURE GAUGES, CUFF PRESSURE MONITORS INSTRUMENTATION INDUSTRIES, INC. DORIS F WALTER
K082256 09/26/2008 LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE INTEGRATED MEDICAL SYSTEMS, INC. RENATE A MACLAREN
K081614 09/05/2008 ZEUS SMALL CERVICAL CAGE AND LARGE, EXTRA LARGE, CURVED AND STRAIGHT LUMBAR CAGES INTERBODY INNOVATIONS, LLP J.D. WEBB
K082047 09/30/2008 SECURACATH CATHETER, MODEL SPK01 INTERRAD MEDICAL, INC. Sew-Wah Tay
K081579 09/17/2008 INVENTUS IMPLANT SYSTEM INVENTUS CO., LTD ROSHANA AHMED
K070250 09/04/2008 NUTRITONE FACIAL BEAUTY SYSTEM ISOMERS LABORATORIES INC. ROBERT MAZZAFERRO
K081817 09/24/2008 ACCELL TBM-R ISOTIS ORTHOBIOLOGICS, INC JUDITH E O'GRADY
K081557 09/10/2008 PORTABLE SUPINE PATIENT SUPPORT AND CASSETTE HOLDER JDDB MANUFACTURING, INC JACQUIN C YOUNGBLOOD-JOHNSON
K081658 09/30/2008 POWDER-FREE VINYL EXAMINATION GLOVES JIANGSU ALFA GLOVE CO., LTD CHU XIAOAN
K081267 09/23/2008 HYGEIA-5 OXYGEN CONCENTRATOR KEDL INTERNATION LIMITED Lee Leichter
K082560 09/08/2008 PANASIL IMPRESSION MATERIALS, INCLUDING PUTTY, BINETICS, TRAY, MONOPHASE AND CONTACT KETTENBACH GMBH & CO KG MICHAELA ZINKE
K080795 09/03/2008 ULTRA SURGICAL GOWN & FLUID BARRIER SURGICAL GOWN KIMBERLY-CLARK CORP. DAVID M LEE
K082752 09/29/2008 QUICKPIN LABORATORIOS GRIFOLS, S.A. SEBASTIAN GASCON
K081705 09/17/2008 LANG DENTAL RESINCAP PATTERN AND COPING ACRYLIC RESIN LANG DENTAL MFG. CO., INC. CHAH M SHEN
K081514 09/22/2008 TEMPO CUSHION TREATMENT DENTURE RELINE ACRYLIC RESIN LIQUID, PROFESSIONAL SIZE PACKAGE AND POWDER LANG DENTAL MFG. CO., INC. CHAH M SHEN
K082685 09/26/2008 GALAXY 55 LARSEN & TOUBRO LIMITED S.B. BHOSALE
K081371 09/24/2008 SKINTACT PEDIATRIC MULTIFUNCTION ELECTRODES WITH DH03 GEL LEONHARD LANG GMBH ELAINE DUNCAN
K081864 09/25/2008 PROLONG LIFE-TECH, INC. JEFF KASOFF
K080788 09/17/2008 VIVASCOPE SYSTEM, MODEL 1500, 3000 LUCID, INC. JAMES JOY
K081704 09/11/2008 SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS LUMENIS, INC. TINA MAYER
K072094 09/25/2008 CHOOSTENT M.I. TECH CO., LTD. DANIEL KAMM
K080592 09/11/2008 HLM TUBING SET WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENGLENKS
K080470 09/12/2008 ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 MAQUET CARDIOPULMONARY AG KATRIN SCHWEKGLENKS
K081659 09/09/2008 RAINBOW ADHESIVE CO-OXIMETRY SENSOR, MODELS RI-25-L, RI-25, RI-20 AND RI-20-L MASIMO CORPORATION MARGUERITE THOMLINSON
K081236 09/25/2008 K-Y BRAND INTRIGUE 2-IN-1 MASSAGE CREME MCNEIL-PPC, INC. NADER FOTOUHI
K081904 09/23/2008 PRO-PICC (BASIC TRAY, LONG WIRE TRAY, BASIC NURSING TRAY, FULL NURSING TRAY) MEDCOMP JEAN CALLOW
K080473 09/03/2008 EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED MEDICULT A/S RONALD G LEONARDI
K081639 09/19/2008 ICSI CUMULASE MEDICULT A/S RONALD G LEONARDI
K081784 09/17/2008 MASTERGRAFT PUTTY MEDTRONIC SOFAMOR DANEK MICHELLE OBENAUER
K082342 09/12/2008 MODIFICATION TO CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK CHRIS MCKEE
K081277 09/05/2008 XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONS0LE (IPC) MEDTRONIC XOMED, INC. ANTOINE KOUCHAKJY
K081443 09/23/2008 MENICON Z RIGID GAS PERMEABLE CONTACT LENS MENICON CO. LTD. BEVERLEY D VENUTI
K081913 09/05/2008 METACEM, META P&BOND, METACEM SILANE CERAMIC PRIMER META BIOMED CO., LTD. TAE-HOON KIM
K070488 09/04/2008 MICARDIA ANNULOPLASTY BAND DR MICARDIA CORPORATION JEFFREY P DUMONTELLE
K081800 09/24/2008 T12S TELEMETRY TRANSMITTER MORTARA INSTRUMENT, INC. LAURA SPIEGELHOFF
K080722 09/17/2008 PRIMADO SURGICAL DRILL NAKANISHI, INC. KEITH A BARRITT
K081553 09/29/2008 AED BIPOLAR FORCEPS, MODEL 13-1646 NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GAYLE M BUTLER
K081503 09/25/2008 AED MONOPOLAR LAP ACCESSORIES NATIONAL ADVANCED ENDOSCOPY DEVICES, INC. GAYLE M BUTLER
K081480 09/12/2008 KEGEL8 PELVIC EXERCISER, MODEL OPH 400 NE SERVICES LTD. BRENT REIDER
K081871 09/29/2008 UNIVERSAL ELECTRODES NEUROMETRIX, INC. RAINER MAAS
K082485 09/09/2008 MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YANFANG
K081792 09/17/2008 SPY ANALYSIS TOOLKIT, MODEL SA9000 NOVADAQ TECHNOLOGIES, INC. ALLISON MANNERS
K082524 09/26/2008 MINI GHOST, MODEL: 507 NUMED, INC. NICHELLE LAFLESH
K082070 09/24/2008 NUVASIVE LATERAL PLATE SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K073508 09/11/2008 PARKONE OCULUS OPTIKGERATE GMBH JOERG IWANCZUK
K080435 09/05/2008 OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) STEPHANIE G DONNELLY
K080094 09/03/2008 OLYMPUS TOTAL BHCG TEST SYSTEN OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) STEPHANIE DONNELLY
K080948 09/26/2008 HD ENDOEYE LAPARO-THORACO VIDEOSCOPE OLYMPUS LTF TYPE VH OLYMPUS MEDICAL SYSTEMS CORPORATION LAURA STORMS-TYLER
K081744 09/09/2008 PASCAL SYNTHESIS DELIVERY SYSTEM OPTIMEDICA CORPORATION JUDY F GORDON
K081415 09/24/2008 DAMON 4CLEAR ORMCO CORP. Wendy Garman
K081994 09/12/2008 STARLIGHT ORTHOMERICA PRODUCTS, INC. ALAN T SANDIFER
K082523 09/26/2008 OSSTELL ISQ IMPLANT STABILITY METER OSSTELL AB CHERITA JAMES
K081575 09/02/2008 HU/HS/HG PROSTHETIC SYSTEM OSSTEM IMPLANT CO.,LTD MINJOO KIM
K080594 09/03/2008 MS SYSTEM (NARROW RIDGE) OSSTEM IMPLANT CO.,LTD MINJOO KIM
K082004 09/26/2008 SMOOTHKIT+ OSYRIS JAOUAD ZEMMOURI
K073328 09/09/2008 CARDIOP-B SYSTEM, VERSION 2.1 WITH LVA PAIEON, INC. RAVIT BARKAMA
K082228 09/22/2008 PLANISIGHT LINASYS PATHFINDER THERAPEUTICS, INC. JAMES D STEFANSIC
K081518 09/05/2008 ULTRASOUND VIDEO BRONCHOSCOPE, MODEL EB-1970UK PENTAX MEDICAL COMPANY PAUL SILVA
K081749 09/30/2008 AVANTE Z ZIRCONIA (AS)3 BLOCKS PENTRON CERAMICS, INC. CINDY SALTER
K081489 09/25/2008 L-ANEURYSM-CLIP SYSTEM & L-ANEURYSM CLIP APPLIERS, YASARGIL ANEURYSM CLIPS & YASARGIL ANEURYSM CLIP APPLIERS PETER LAZIC GMBH FRANZ MENEAN
K081601 09/04/2008 VEO MULTIGAS MONITOR FOR POCKET PC PHASEIN AB DAVID WEISSBURG
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