FDA 510(k) Decisions During October, 2010  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K101271 10/13/2010 HEMOSTASIS MANAGEMENT SYSTEM PLUS (HMS PLUS ), MODEL 305 XX MEDTRONIC INC. JEFFREY L KOLL
K102523 10/26/2010 MULTI-LEAD TRIALING CABLE MODEL 355531 MEDTRONIC INC. TRISHIA DWYER
K101528 10/01/2010 3M COMPLY LEAD FREE PROCESS INDICATORS FOR STEAM 3M COMPANY SUZANNE LEUNG
K101042 10/29/2010 BLADEVIEW ACCOGENT LLC TRISTAN TICE
K100123 10/06/2010 ACUMED WRIST ARTHRODESIS PLATE SYSTEM ACUMED LLC LINO TSAI
K101597 10/18/2010 WAVESENSE DIABETES MANAGER MODEL VERSION 1.3.4 AGAMATRIX CONNIE HERTEL
K103050 10/29/2010 DX-D 300 AGFA HEALTHCARE N.V. PHIL CUSCUNA
K101006 10/21/2010 WAVELIGHT FS200 LASER SYSTEM MODEL: FS200 ALCON RESEARCH, LTD. MICHAEL BUENGER
K102906 10/29/2010 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD LIU YI
K101843 10/20/2010 DURAMAX CHRONIC HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC. DAVID A GREER
K101305 10/29/2010 ARK LAMOTRIGINE ASSAY, CALIBRATOR & CONTROL ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K100926 10/29/2010 ARROWHEAD FIXATION DEVICE ARROW PRODUCTS, INC. SCOTT R ROMAN
K102728 10/07/2010 ARSTASIS ACCESS SYSTEM ARSTASIS, INC. DEBRA COGAN
K101679 10/22/2010 ARTHREX PUSHLOCK ANCHORS ARTHREX, INC. COURTNEY SMITH
K102262 10/21/2010 ARTHOCARE SPARTAN PEEK SUTURE IMPLANT SYSTEM; PUNCH TAP ; EXTRACTION TOOL ARTHROCARE CORP. VALERIE DEFIESTA-NG
K101437 10/29/2010 SPEEDFIX SUTURE SYSTEM ARTHROCARE CORP. LAURA N KASPEROWICZ
K101351 10/15/2010 NON-STERILE POWDER- FREE PEACH COLOR, NITRILE EXAMINATION GLOVES WITH LANO-E AND PEPPERMINT CITRUS SCENT ASCEND EAGLE, INC. JANNA P TUCKER
K092593 10/14/2010 PROVOX ACTIVALVE (SIZE 4.5MM, 6MM, 8MM, 10MM, 12.5MM) ATOS MEDICAL AB FERENC DAHNER
K102596 10/05/2010 ATRIUM GRADUATED WALL FLIXENE AX-BIFEM GRAFT ATRIUM MEDICAL CORP. RAYMOND J KELLY
K101355 10/26/2010 AUGEASE VASCULAR AUGMENTATION DEVICE AUGDVT LLC E. J. SMITH
K101683 10/25/2010 INFINITI CYP2C19 ASSAY AUTOGENOMICS, INCORPORATED EVELYN G LOPEZ
K100489 10/26/2010 DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771 BECKMAN COULTER CELLULAR JEANNE ROSCOE
K101849 10/01/2010 BICON DENTAL IMPLANT SYSTEM 3.0MM BICON DENTAL IMPLANT BICON, LLC VINCENT MORGAN, D.M.D.
K100589 10/29/2010 MRSA SELECT - SKIN AND SOFT TISSUE WOUND SPECIMENS BIO-RAD FRAN WHITE
K092333 10/27/2010 PATHIAM SYSTEM WITH ISCAN FOR P53 AND KI-67 BIOIMAGENE, INC. INDU P LAKSHMAN
K101712 10/27/2010 ENDOVASCULAR LAER VEIN SYSTEM KIT BIOLITEC, INC. HARRY HAYES
K093076 10/21/2010 VITEK 2 GRAM POSITIVE DOXCYCLINE BIOMERIEUX, INC. JOLYN TENLLADO
K093803 10/19/2010 BIO-MODULAR REVERSE SHOLDER BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K093293 10/22/2010 VANGUARD 360 REVISION KNEE SYSTEM BIOMET, INC. GARY BAKER
K092973 10/07/2010 DISPOSABLE AND REUSABLE CONCENTRIC NEEDLES / DISPOSABLE AND REUSABLE MONOPOLAR NEEDLE BIONEN S.A.S. ALLISON SCOTT
K101831 10/01/2010 ENTERIX INSUREFIT FOB CONTROLS, MODEL 16800 BIONOSTICS, INC. MINNA RANNIKKO
K102844 10/29/2010 ALL-BOUND 3 BISCO, INC. MICHELLE SCHILTZ-TAING
K101787 10/08/2010 DUOLINK II BISCO, INC. MICHELLE SCHILTZ-TAING
K100742 10/21/2010 EXACTECH GPS BLUE ORTHO ANTHONY BOYER
K101123 10/28/2010 NEXFIN MODEL 2 BMEYE B.V. WILLIAM F GREENROSE
K101657 10/05/2010 RADIAL 4 HOT BIOPSY FORCEPS BOX 5; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 20; RADIAL JAW 4 HOT BIOPSY FORCEPS BOX 40 BOSTON SCIENTIFIC CORP. ASHLEY PYLE
K102672 10/15/2010 TARGET DETACHABLE COIL BOSTON SCIENTIFIC CORP. JAMES LEATHLEY
K100310 10/13/2010 BTL-08 ECG RECORDER MODEL BTL-08 ECG LC PLUS, BTL-08 ECG LT PLUS BTL INDUSTRIES, INC RICHARD VINCINS, CQA, RAC (US,EU)
K101331 10/08/2010 LABSYSTEM PRO EP RECORDING SYSTEM V3.1 SOFTWARE C.R. BARD INC., BARD ELECTROPHYSIOLOGY DIVISION ANASTASIA C RANDALL
K102013 10/29/2010 DIGITAL RETINAL CAMERA CANON, INC.-MEDICAL EQUIPMENT GROUP KOJI KUBO
K101811 10/15/2010 PROTEGRITY SMT LATEX SURGICALGLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K100960 10/21/2010 WDS X-POD AND ZEN-X DIGITAL X-RAY SENSORS CEFLA DENTAL GROUP CYNTHIA J.M. NOLTE, PH.D.
K101935 10/27/2010 CENTERVUE DIGITAL RETINOGRAPHY SYSTEM CENTERVUE SPA ROGER GRAY
K102071 10/08/2010 OSTENE CT, AOC CT, OSTEOTENE, CERETENE CEREMED, INC. TADEUSZ WELLISZ
K092641 10/21/2010 CHARMCARE TABLETOP PULSE OXIMETER CHARMCARE CO., LTD JOYCE BANG
K101148 10/01/2010 WARM AIR MODEL 135 HYPERTHERMIA SYSTEM AND BLANKETS CINCINNATI SUB-ZERO PRODUCTS, INC STEVEN J BERKE
K102485 10/18/2010 RE-TRACE URETERAL ACCESS SHEATH COLOPLAST A/S BRIAN SCHMIDT
K101917 10/29/2010 COMFORT RUBBER GLOVES IND.SDN.BHD. COMFORT RUBBER GLOVES INDUSTRIES SDN BHD TAN KENG BENG
K102732 10/19/2010 VASOGRAD DVT COMPRESSION GARMENT COMPRESSION THERAPY CONCEPTS LEONARD NASS
K102216 10/01/2010 XIO RTP SYSTEM COMPUTERIZED MEDICAL SYSTEMS, INC. KATHRYN STINSON
K100933 10/06/2010 CONSENSUS CS2 PLUS ACETABULAR INSERT CONSENSUS ORTHOPEDICS, INC LUKE ROSE
K102680 10/22/2010 Z-MOTION DIGITAL DIAGNOSTIC X-RAY SYSTEM CONTROL-X MEDICAL, INC. LASZLO ADROVITZ
K102737 10/19/2010 KENDALL SCD 700 SEQUENTIAL COMPRESSION CONTROLLER COVIDIEN LLC MELODY BI
K102325 10/13/2010 IDRIVE SYSTEM (I DRIVE POWER HANDLE, IDRIVE (RALC) SINGLE USE RELOAD) COVIDIEN LLC, FORMERLY REGISTERED AS TYCO HEALTHCA NISHITH DESAI
K092398 10/06/2010 HSV STRAW CRYO BIO SYSTEM DAVE BALDING
K101911 10/18/2010 IMMUKNOW-THE CYLEX IMMUNE CELLFUNCTION ASSAY CYLEX, INC. JUDI SMITH
K102443 10/20/2010 INTRAFIX TIBIAL SHEATH DEPUY MITEK, A JOHNSON & JOHNSON COMPANY DEEP PAL
K102423 10/29/2010 DEPUY PINNACLE ALTRX ACETABULAR LINERS DEPUY ORTHOPAEDICS, INC. BRANDON HIPSHER
K101933 10/18/2010 MODIFICATION TO:EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. DAPHNEY GERMAIN
K102701 10/20/2010 VIPER SPINE SYSTEM DEPUY SPINE, INC. KEVIN G STEVENS
K102582 10/07/2010 ARTERIOFLOW MODEL 7500 SEQUENTIAL COMPRESSION DEVICE DEVON MEDICAL INC. RUTH WU
K100042 10/01/2010 DIFUSION TECHNOLOGIES XIPHOS INTERBODY FUSION SYSTEM DIFUSION TECHNOLOGIES JAMI HAFIZ
K102575 10/29/2010 ORTHO MTA (MINERAL TRIOXIDE AGGREGATE) DO CO., LTD. PRISCILLA CHUNG
K100248 10/22/2010 DRFP PROSMART ROOT CANAL OBTURATION SYSTEM, PROPOINTS 4% 6%, PT, S DRFP LTD DAGMAR MAESER
K102801 10/26/2010 PHTIP DISPOSABLE ISFET CATHETER E-CATH CO., LTD ROBERT N CLARK
K102138 10/28/2010 ULTRASONIC TABLETOP DOPPLER; ULTRASONIC TABLETOP DOPPLER EDAN INSTRUMENTS, INC. LIU YONGYING
K102420 10/26/2010 EMBOL-X ACCESS DEVICE/ AORTIC CANNULA, EMBOL-X SLIM ACCESSDEVICE/ AORTIC CANNULA, EMBOL-X GLIDE ACCESS DEVICE/ AORTIC CA EDWARDS LIFESCIENCES, LLC. DANNETTE CROOMS
K091393 10/26/2010 ELEKTA NEUROMAG WITH MAXFILTER ELEKTA NEUROMAG OY DANIEL KAMM
K100071 10/12/2010 EMCOOLSPAD EMCOOLS EMERGENCY MEDICAL COOLING SYSTEMS AG MICHAEL KUEHLING
K102003 10/22/2010 XPRESS BALLOON DEVICE ENTELLUS MEDICAL, INC. KAREN PETERSON
K101504 10/29/2010 TI-CORE FLOW ESSENTIAL DENTAL SYSTEMS, INC. JEFFREY WAN
K102632 10/07/2010 ETHICON ENDO-SURGERY 5MM LAPAROSCOPIC MULTI-FEED STAPLER ETHICON ENDO-SURGERY, INC. RENEE ROWE
K102655 10/29/2010 POWDER FREE VINYL SYNTHETIC EXAMINATION GLOVES WITH ALOE VERA (YELLOW, WHITE, BLUE) EVER LIGHT PLASTIC PRODUCTS CO., LTD. KATHY LIU
K101598 10/04/2010 EMM SURGICAL DRAPE SMS W/PE SIDES MODEL 13-005 (WITH MINOR DIMENSIONAL VARIATIONS FOR ALTERNATE CONFIGURATIONS) EXACT MEDICAL MANUFACTURING, INC ROBERT O DEAN
K100580 10/12/2010 EXSALT WOUND DRESSING EXCITON TECHNOLOGIES INC. JOHN SIMON
K101309 10/20/2010 EXELINT ALUMINUM HUB BLUNT NEEDLES EXELINT INTERNATIONAL CO. ARMAND HAMID
K101700 10/12/2010 IO FIX HAND, IO FIX FOOT, EXTREMITY MEDICAL SCREW SYSTEM EXTREMITY MEDICAL LLC JAMY GANNOE
K100011 10/08/2010 FISHER & PAYKEL HEALTHCARE BUBBLE CPAP SYSTEM FISHER & PAYKEL HEALTHCARE, LTD. ROBERT PETRY
K102314 10/29/2010 3M INTEGRATED CYCLER (110V) & (220V) FOCUS DIAGNOSTICS, INC. TARA VIVIANI
K102110 10/26/2010 24" WIDEN WHEELCHAIR (JY/CT-H28), 18" RECLINING WHEELCHAIR (JY-260), 18" LIGHT WEIGHT WHEELCHAIR (JY/CT-H06), 18" ALUMIN FOSHAN SHUNDE JAEYONG HARDWARE CO., LTD. KEVIN WALLS, RAC
K101686 10/29/2010 FDR IMAGE STITCHING OPTION FUJIFILM MEDICAL SYSTEM U.S.A., INC. DEBBIE PEACOCK
K101809 10/05/2010 FUJIREBIO DIAGNOSTICS TUMOR MARKER CONTROL MODEL 108-20 FUJIREBIO DIAGNOSTICS, INC STACEY DOLAN
K101707 10/29/2010 FULACCESS MODEL 1.0 FULCRUM MEDICAL, INC SCOTT BRAME
K102031 10/20/2010 GALAXY LITE FUTURE MOBILITY HEALTHCARE INC. ABDULSAMAD PANCHBHAYA
K101166 10/07/2010 4D-VIEW 9.1 (4D VIEW PC SOFTWARE) MODEL: H48651SZ GE HEALTHCARE BRYAN BEHN
K101874 10/05/2010 GE LOGIQ P6/P6 PRO GE HEALTHCARE BRYAN BEHN
K102239 10/18/2010 CARESCAPE MONITOR B650 GE HEALTHCARE FINLAND OY PAIVI ROIHA
K101871 10/04/2010 TRUSIGNAL SPO2 FINGERTIP SENSOR GE HEALTHCARE FINLAND OY TOMMI JOKINIEMI
K102256 10/05/2010 GE LOGIQ I/E & VIVID E COMPACT DIAGNOSTIC ULTRASOUND GE MEDICAL SYSTEMS CHINA CO., LTD. YALAN WU
K102426 10/20/2010 CARESCAPE MODEL V100 VITAL SIGNS MONITOR GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES MARY CARTER
K101324 10/05/2010 GE ECHOPAC MODEL BT10 GE VINGMED ULTRASOUND AS BRYAN BEHN
K101149 10/13/2010 GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM GE VINGMED ULTRASOUND AS BRYAN BEHN
K093244 10/19/2010 UNIQUE TEMP WARMING BLANKETS, MODEL 8001140XXX GERATHERM MEDICAL AG ANDREA PECSI
K102355 10/04/2010 ZIP'R MANTIS POWERED WHEELCHAIR GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. JUNNATA CHANG
K102358 10/04/2010 ZIP'R3/ ZIP'R3 XTRA SCOOTER GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. JUNNATA CHANG
K102361 10/04/2010 ZIP'R4/ ZIP'R4 XTRA SCOOTER GLOBAL FABTECH WHEELCHAIR (SHANGHAI) CO., LTD. JUNNATA CHANG
K102089 10/06/2010 GRAND WORK PLASTIC PRODUCTS CO., LTD. POWDER FREE VINYL PATIENT EXAMINATION GLOVES GRAND WORK PLASTIC PRODUCTS CO., LTD. KATHY LIU
K102094 10/05/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES GRAND WORK PLASTIC PRODUCTS CO., LTD. KATHY LIU
K102774 10/15/2010 VACUETTE QUICKSHIELD WITH SNAPPY TUDE HOLDER GREINER BIO-ONE NORTH AMERICA, INC. JUDI SMITH
K101998 10/04/2010 KAIYANG ALUMINUM WHEELCHAIR GUANGDONG KAIYANG MEDICAL TECHNOLOGY CO., LTD. KE-MIN JEN
K101999 10/04/2010 KAIYANG STEEL WHEELCHAIR GUANGDONG KAIYANG MEDICAL TECHNOLOGY CO., LTD. JEN KE-MIN
K101828 10/04/2010 POWDER FREE LATEX EXAMINATION GLOVES (18 ML), BLUE TESTED FOR USE WITH CHEMOTHERAPY DRUGS GX CORPORATION SDN BHD CHO SOW FONG
K092571 10/20/2010 GYRUS ACMI BIOCOAG PROBE GYRUS ACMI, INC. LORRAINE CALZETTA
K102168 10/22/2010 SENSEI X ROBOTIC CATHETER SYSTEM HANSEN MEDICAL, INC. KATE WHITIN
K101223 10/01/2010 SPECTRALIS HRA+OCT, SPECTRALIS FA_OCT, SPECTRALIS ICGA+ OCT, SPECTRALIS HRA, SPECTRALIS FA HEIDELBERG ENGINEERING DIANE MANDELL-HORWITZ
K101096 10/08/2010 HT III SA FIXTURE SYSTEM HIOSSEN INC. PATRICK LIM
K102901 10/27/2010 HI VISION AVIUS DIAGNOSTIC ULTRASOUND SCANNER HITACHI MEDICAL SYSTEMS AMERICA, INC. DOUG THISTLETHWAITE
K102099 10/06/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES HONG DI PLASTIC PRODUCTS CO, LTD. KATHY LIU
K103010 10/26/2010 STRYKER PATIENT SPECIFIC POLYMER IMPLANT HOWMEDICA OSTEONICS CORP DBA STRYKER ORTHOPAEDICS STEPHANIE FITTS
K093893 10/05/2010 SUPERA VERITAS INTERWOVEN SELF-EXPANDING NITINOL STENT TRANSHEPATIC BILIARY SYSTEM IDEV TECHNOLOGIES, INC. DARLENE GARNER
K092601 10/07/2010 IMMULISA ANCA SCREEN ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K092599 10/07/2010 IMMULISA MPO ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K092600 10/07/2010 IMMULISA PR3 ANTIBODY ELISA IMMCO DIAGNOSTICS, INC. KEVIN LAWSON
K101813 10/05/2010 IMRX SYSTEM V1 AND IMRISNV/IMRISCARDIO IMRIS, INC. THOMAS M TSAKERIS
K093545 10/15/2010 PINPOINTE FOOTLASER MODEL 6W, 30W, 100W INCISIVE, INC. (FORMERLY NAMED INCISIVE, LLC) ANNE WORDEN
K102684 10/01/2010 XELIS DENTAL INFINITT CO., LTD. TRISTAN CHOI
K100660 10/22/2010 INFRARED EAR THERMOMETER MODEL DR. SCHVEN ICT-1000 INNOCHIPS TECHNOLOGY CO., LTD. BRANDON CHOI
K100574 10/28/2010 COLLEXA INNOCOLL PHARMACEUTICALS AARON WYSE
K102248 10/07/2010 EXCELLA II SPINAL SYSTEM MODEL EC2-00 INNOVASIS, INC. MARSHALL C MCCARTY
K094060 10/13/2010 QUANTA FLASH H-TTG IGA INOVA DIAGNOSTICS, INC. TANA KEIVENS
K093683 10/06/2010 ORTHOPANTOMOGRAPH OP300 INSTRUMENTARIUM DENTAL, PALODEX GROUP OY MATTI TULIKOURA
K102686 10/15/2010 MYOSURE ROD LENS SCOPE SEALS INTERLACE MEDICAL, INC. JOHN J VOZELLA
K100991 10/05/2010 IMC SURGICAL DRAPE INTERNATIONAL MEDSURG CONNECTION PETER KIM
K092451 10/29/2010 INTERSURGICAL INTER-THERM BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER, INTERSURGICAL INTER-GUARD BREATHING FILTER INTERSURGICAL, INC. MICHAEL ZALEWSKI
K102362 10/04/2010 POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) JIANGSU HUAYUAN GLOVES CO., LTD. YU BANG TING
K102538 10/27/2010 ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI JYOTI CERAMIC INDUSTRIES PRIVATE LIMITED RAJU MERANI
K101084 10/04/2010 CASPIAN SPINAL SYSTEM K2M, INC. NANCY GIEZEN
K101839 10/22/2010 KANEKA PHARMA AMERICA XPRESS-WAY RX KANEKA PHARMA AMERICA LLC RAYMOND KELLY
K093471 10/18/2010 KARL STORZ ARTHROPUMP POWER IRRIGATION/SUCTION PUMP KARL STORZ ENDOSCOPY-AMERICA, INC. CRYSTAL DIZOL
K102890 10/21/2010 K-SHIELD SMALL VEIN INFUSION / WINGED COLLECTION SET W/ ANTI NEEDLE STICK PROTECTOR (AND MULTISAMPLE LUER ADAPTER) KAWASUMI LABORATORIES AMERICA, INC. JACK PAVLO
K102000 10/12/2010 IMAGYS KEOSYS S.A.S. ANTHONY MOTTIER
K102133 10/07/2010 GIRAFFE2 KERR CORPORATION WENDY GARMAN
K102163 10/16/2010 REALSEAL XT SEALER KERR CORPORATION WENDY GARMEN
K101756 10/26/2010 TSC KERR CORPORATION WENDY GARMAN
K101545 10/28/2010 GENESIS IMPLANT SYSTEM KEYSTONE DENTAL JOHN CAPONE
K101961 10/29/2010 TIGERPAW SYSTEM LAAX, INC. MICHAEL A DANIEL
K100653 10/08/2010 JET XR RADIOPAQUE ACRYLIC RESIN POWDER 45 GRAMS, JET XR RADIOPAQUE ACRYLIC RESIN POWDER 100 GRAMS, JET LIQUID 118 ML MOD LANG DENTAL MFG. CO., INC. DAVID LANG
K102331 10/15/2010 LDR SPINE USA SPINETUNE TL SPINAL SYSTEM LDR SPINE USA BECKINAM NOWATZKE
K101626 10/18/2010 LENSX LASER SYSTEM LENSX LASERS, INC. JUDY GORDON
K093093 10/13/2010 SMALL PLATEAU SPACER SYSTEM LIFE SPINE CHARLES P GILL
K100593 10/13/2010 SUTURE PLACEMENT DEVICE AND ACCESSORIES, FLEXIBLE SUTURE PLACEMENT DEVICE AND ACCESSORIES, LSI "R" SERIES SUTURE PLACEME LSI SOLUTIONS, INC. PETER SPATH
K100213 10/04/2010 LUMANOSITY CELEBRITY, MODEL 204 LUMANOSITY, INC JEFF PROVISSIERO
K101014 10/21/2010 BOND BONE M.I.S. IMPLANTS TECHNOLOGIES LTD. IMAN KHORSHID
K101896 10/21/2010 MASIMO LNCS/M-LNCS OXIMETRY SENSORS MASIMO CORPORATION MARGUERITE THOMLINSON
K102556 10/07/2010 VOLPARA, VERSION 1.3 MATAKINA TECHNOLOGY LIMITED SHEILA W PICKERING
K101606 10/01/2010 MICROMED PD-8K INSULATION DEFECT DETECTOR MCGAN TECHNOLOGY, LLC JACK GANIS
K101177 10/08/2010 APEXNRG RIDER MEDICNRG LTD. GEORGE HATTUB
K093816 10/05/2010 DIGITAL RADIOGRAPHY SYSTEM, MODELS GALAXY 900 AND 1600 MEDIEN INTERNATIONAL CO., LTD CHARLES MACK
K102905 10/29/2010 GUIDED MEDICAL POSITIONING SYSTEM II (GMPS II) MEDIGUIDE, LTD. JONATHAN S KAHAN
K101417 10/19/2010 BABYLANCE HEEL INCISION DEVICE , MODELS BLP50, BLP200, BLN50, BLN200 MEDIPURPOSE PTE. LTD. JULIE STEPHENS
K101145 10/21/2010 SURGILANCE SAFETY LANCETS, MODELS SLN100, SLN200, SLN240, SLN300, SLB200, SLB250 MEDIPURPOSE PTE. LTD. JULIE STEPHENS
K100951 10/18/2010 MEDTOX BUPRENORPHINE TEST MEDTOX DIAGNOSTICS, INC. PHILLIP HARTZOG
K101864 10/14/2010 KYPHON XPANDER II INFLATABLE BONE TAMP MEDTRONIC HEINZ STENEBERG
K103095 10/22/2010 SPRINTER LEGEND 1.25MM RX AND SPRINTER LEGEND 1.25MM OTW BALLOON MEDTRONIC IRELAND GERARDINE FINN
K100976 10/21/2010 T2 XVBR 1.5 SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. THERESA LEISTER
K101765 10/22/2010 KYPHON ANCHOR FACET SCREW SYSTEM MEDTRONIC SPINE LLC. ERICA HOFFMAN
K101939 10/07/2010 OSTEOBRIDGE IKA INTRAMEDULLARY KNEE ARTHRODESIS ROD FIXATION SYSTEM MERETE MEDICAL GMBH DONNA COLEMAN
K100244 10/28/2010 METRO SOFT METRO OPTICS OF AUSTIN, INC. MARTIN DAISING
K101280 10/07/2010 MIDWESTERN REPROCESSING CENTER REPROCESSED PULSE OXIMETER PROBE MIDWEST REPROCESSING CENTER LLC JEROME JAMES
K101768 10/05/2010 MIE SCINTRON GAMMA CAMERA SYSTEMS MIE GMBH THOMAS KUHL
K102687 10/04/2010 MIRADA RT MIRADA MEDICAL LTD. GWILYM OWEN
K101518 10/13/2010 COMPASS VASCULAR ACCESS; COMPASS LUMBAR PUNCTURE MIRADOR BIOMEDICAL, INC. JUSTIN HULVERSHORN MD, PHD
K102441 10/20/2010 NANO-CHECK AMI 2 IN 1 CARDIAC MARKER, CTNL AND MYOGLOBIN NANO-DITECH CORPORATION YOUNG WOO KIM
K102131 10/20/2010 NANO-CHECK AMI CTNI CARDIAC MARKER TEST NANO-DITECH CORPORATION YOUNG HOON KIM
K092896 10/29/2010 REMPRESS AND ANGIOGRAPHY CONTRAST DELIVERY SYSTEM REMPRESS NEMOTO KYORINDO CO., LTD. JIM KNIPFER
K101235 10/25/2010 CRANIAL LOOP CRANIAL BONE FIXATION SYSTEM NEOS SURGERY S.L. MARCOS VELEZ-DURAN
K092477 10/29/2010 NEUROSENSE MONITORING SYSTEM, MODEL NS-701 NEUROWAVE SYSTEMS, INC. TRACIE CAPOZZIO
K102435 10/15/2010 BEYONDIMAGE WORKSTATION NEUSOFT MEDICAL SYSTEMS CO., LTD. TIAN YUEHUI
K100744 10/22/2010 CERTUS 140 MICROWAVE ABLATION SYSTEM AND ACCESSORIES, MODEL CERTUS 140 NEUWAVE MEDICAL, INC DANIEL KOSEDNAR
K100944 10/22/2010 CLAVICLE LOCKING PLATE SYSTEM NEWCLIP TECHNICS J.D. WEBB
K101540 10/29/2010 GRANITEC DUAL-CURE CORE BUILD-UP, N'DURANCE DIMER CORE NOVOCOL INC. DBA SEPTODONT AND CONFI-DENTAL PRODUC STEVE RUDOLPH
K102135 10/22/2010 VECTOR EVENT GRID ARCHITECTURE (VEGA) SYSTEM NUVON, INC. JONATHAN S KAHAN
K093069 10/23/2010 NXSTAGE SYSTEM ONE WITH THERAPEUTIC PLASMA EXCHANGE CARTRIDGE NXSTAGE MEDICAL, INC. MICHAEL DOYLE
K102059 10/08/2010 AUTOCLAVABLE CAMER HEAD MODEL OTV-Y0017 OLYMPUS MEDICAL SYSTEMS CORPORATION STACY ABBATIELLO KLUESNER
K100499 10/27/2010 ORGENTEC RHEUMATOID FACTOR EIA ORGENTEC DIAGNOSTIKA GMBH GARY LEHNUS
K101921 10/22/2010 VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT ORTHO-CLINICAL DIAGNOSTICS DECLAN HYNES
K101936 10/20/2010 CONTOURS VSP III VOLAR PLATING SYSTEM ORTHOFIX, INC. MARY BIGGERS, RAC
K102545 10/27/2010 FM-02 BONE GRAFT SUBSTITUTE ORTHOVITA, INC. DEBORAH L JACKSON
K101497 10/20/2010 DELIVERY SHEATH, MODEL ADELANTE BREEZEWAY OSCOR INC. MILA DOSKOCIL
K093105 10/18/2010 VISTEO OWANDY JAY MANSOUR
K093438 10/06/2010 PARADIGM INTERSPINOUS FUSION PLATE PARADIGM SPINE, LLC JUSTIN EGGLETON
K102526 10/22/2010 BLO2X OXYGEN BLOCKER PASCAL CO., INC. VINCENT M TENTARELLI
K102562 10/21/2010 INTELLIVUE PATIENT MONITOR, MODELS MP2, X2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP80, MP90, & MX800 PHILIPS MEDIZINSYSTEME BOBLINGEN GMBH ANDREAS SUCHI
K093547 10/15/2010 PINPOINTE FOOTLASER PINPOINTE USA, INC. ANNE WORDEN
K101525 10/22/2010 PIONEER SPINOUS PROCESS FUSION PLATE PIONEER SURGICAL TECHNOLOGY BARRY E SANDS
K102903 10/20/2010 PIONEER CANNULATED SCREW SYSTEM PIONEER SURGICAL TECHNOLOGY, INC. EMILY M DOWNS
K101193 10/18/2010 PMC LAPAROSCOPIC INSTRUMENTS PMC MEDICAL GMBH ANDREA PECSI
K100356 10/05/2010 TDS PRECISION DENTAL BAR POU YU BIOTECHNOLOGY CO., LTD. DANIEL TASO
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