FDA 510(k) Applications Received During July, 2011

FDA 510(k) Number Submission Date Device Name Applicant Contact
K111972 07/11/2011 AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF MEDTRONIC INC. JESSICA SIXBERRY
K112083 07/21/2011 LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES INTL., INC. MICHAEL D CECCHI
K111883 07/05/2011 SMARTLOC SPINAL FIXATION SYSTEM A-SPINE ASIA, CO., LTD FRANK HSU
K111964 07/13/2011 AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY AALTO SCIENTIFIC LTD. DESSI LYAKOV
K111874 07/05/2011 FREESTYLE INSULINX BLOOD GLUCOSE MONITORING SYSTEMS ABBOTT LABORATORIES ARUL STERLIN
K111882 07/01/2011 LAMINAR FLOW PHACO TIPS ABBOTT MEDICAL OPTICS INC ROSANNE M YETEMIAN
K111899 07/05/2011 ARMADA 35/35LL PTA CATHETER ABBOTT VASCULAR LAARNI RICAFORT
K111875 07/01/2011 RELIEVA SPIN SINUS DILATION SYSTEM ACCLARENT, INC. KERI YEN
K111930 07/07/2011 ACKERMANN EUROPCLIP ACKERMANN INSTRUMENTE GMBH KAREN E WARDEN, PHD
K112111 07/25/2011 ACU-SINCH REPAIR SYSTEM AND ACUMED SUTURE ANCHOR ACUMED LLC LINO TSAI
K112094 07/22/2011 BRAIN BIOPSY NEEDLE AD-TECH MEDICAL INSTRUMENT CORP. GARY J SYRING
K112159 07/28/2011 CMS-1000FM CENTRAL MONITORING SYSTEM ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112022 07/18/2011 DUS-3000/DUS-3000PLUS DIGITAL ULTRASONIC DIAGNOSTIC IMAGING SYSTEM ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112135 07/26/2011 ECG-6 SERIES ELECTROCARDIOGRAPH ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K111934 07/11/2011 PD-100 SERIES ULTRASONIC POCKET DOPPLER ADVANCED INSTRUMENTATIONS, INC. JORGE MILLAN
K112087 07/21/2011 TYVEK SELF-SEAL POUCHES ,TYVEK HEAT-SEAL ROLLS ADVANCED STERILIZATION PRODUCTS NANCY CHU
K111959 07/11/2011 AESCULAP HISTOACRYL AND HISTOACRYL BLUE TOPICAL SKIN ADHESIVE AESCULAP, INC. KATHY A RACOSKY
K111945 07/08/2011 IMPAX NEXT GENERATION AGFA HEALTHCARE N.V. JODI COLEMAN
K112031 07/15/2011 ALMA LASERS MODIFIED DIODE LASER MODULE WITH SHR TREATMENT MODE FOR USE WITH THE FAMILY OF SOPRANO XL MULTI-APPLICATION ALMA LASERS, INC. ANNE WORDEN
K112047 07/18/2011 AMCOM COMMTECH MESSENGER AMCOM SOFTWARE,INC. THOMAS KROENKE
K112116 07/25/2011 DIGITAL CLINICAL THERMOMETER MODEL V901US AMPEROR-ELECTRONIC(SZ) CO., LTD RAJ KASBEKAR
K112044 07/18/2011 ANAXBLEND MODEL 20XXX (SEVERAL), ANAXGUM MODEL 25XXX (U), MOCK-UP DIRECT MODEL 240XXX (U), MOCK-UP DIRECT FLOW MODEL 24A ANAXDENT GMBH JOHN BALISTRERI
K112046 07/18/2011 MTA ANGELUS ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS LINDA K SCHULZ
K112182 07/28/2011 ANGIOSCULPT PTA SCORING BALLOON CATHETER ANGIOSCORE, INC. JONATHAN S KAHAN
K112079 07/21/2011 APEX MEDICAL XT AUTO CPAP WITH COMPLIANCE IMPROVEMENT ALGORITHM 9S-005720 APEX MEDICAL CORP. ALAN CHANG
K111904 07/05/2011 ARK METHOTREXATE ASSAY, ARK METHOTREXATE CALIBRATOR, ARK METHOTREXATE CONTROL, ARK METHOTREXATE CONTROL (CALIBRATION RAN ARK DIAGNOSTICS,INC KENNETH C KASPER
K112040 07/18/2011 ARTHREX BIOCOMPOSITE TRANSFIX ARTHREX, INC. SALLY FOUST
K111981 07/12/2011 TREGOR DUAL MOBILITY ACETABULAR SYSTEM ASTON MEDICAL CATHERINE GLOSTER
K112138 07/26/2011 ATLANTIS ABUTMENT IN ZIRCONIA FOR ASTRA TECH OSSEOSPEED PLUS IMPLANT ASTRA TECH, INC. BETSY A BROWN
K112072 07/20/2011 ATRICURE CRYO MODULE SYSTEM ATRICURE, INC. JAMES L LUCKY
K112090 07/21/2011 BAHADIR STERILIZATION TRAYS BAHADIR USA CORP. ISMAIL KILIC
K111990 07/13/2011 CORONIS 5MP BARCO NV LIEVEN DE WANDEL
K111989 07/13/2011 CORONIS FUSION 4MP DL BARCO NV LIEVEN DE WANDEL
K111991 07/13/2011 NIO COLOR 2MP BARCO NV LIEVEN DE WANDEL
K111877 07/01/2011 EZS05 CLEANING AND DISINFECTING SOLUTION, BAUSCH + LOMB EZS05 CLEANING AND DISINFECTING SOLUTION BAUSCH & LOMB, INC. HEATHER MICHAELS
K112192 07/29/2011 NATURELLE DAILY DISPOSABLE (HILAFILCON B) COSMETICALLY TINTED CONTACT LENS BAUSCH & LOMB, INC. TRICIA GARRETT
K111952 07/11/2011 ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033 BECKMAN COULTER, INC. KERRIE S OETTER
K111860 07/05/2011 BD MAX GBS ASSAY, BD MAX INSTRUMENT BECTON DICKINSON & CO. MARY ANNE WILLIAMS
K111979 07/12/2011 RADIOACTIVE SEED LOCALIZATION NEEDLE BIOCOMPATIBLES INC. WAYNE RICHARDSON
K111951 07/08/2011 ISOAMP HSV ASSAY BIOHELIX CORPORATION FRAN WHITE
K112013 07/14/2011 EVOLVE(R) HPD 980/1470NM MULTIWAVELENGTH DIODE LASER BIOLITEC, INC. HARRY HAYES
K112186 07/29/2011 FIBER DISK AND BLOCK BIOLOREN SRL ANDREA RATTI
K111976 07/12/2011 VITEK 2 STREPTOCOCCUS ERYTHROMYCIN BIOMERIEUX, INC. JENNIFER CHIA-HSUAN LIN
K111909 07/05/2011 VITEK 2 STREPTOCOCCUS INDUCIBLE CLINDAMYCIN RESISTANCE BIOMERIEUX, INC. NATHAN HARDESTY
K112000 07/13/2011 VITEK 2 STREPTOCOCCUS PENICILLIN BIOMERIEUX, INC. JOLYN TENLLADO
K112075 07/20/2011 VITEK 2 STRPTOCOCCUS AMPICILLIN BIOMERIEUX, INC. JOLYN TENLLADO
K112129 07/26/2011 VITEK(R) 2 STREPTOCOCCUS CLINDAMYCIN BIOMERIEUX, INC. JOLYN TENLLADO
K111893 07/05/2011 VITEK(R) 2 STREPTOCOCCUS TETRACYCLINE BIOMERIEUX, INC. JOLYN TENLLADO
K111908 07/18/2011 BIOMET MICROFIXATION STERNAL CLOSURE SYSTEM BIOMET MICROFIXATION, INC. KIM REED
K112014 07/14/2011 ZYSTON STRAIGHT SPACER SYSTEM BIOMET SPINE JULIE A RYAN
K111957 07/11/2011 POLARIS SPINAL SYSTEM BIOMET SPINE (EBI LLC) VIVIAN KELLY, RAC
K112191 07/29/2011 HEALEX BIOSPONGE WOUND DRESSING BIONOVA MEDICAL, INC DEBORAH LAVOIE GRAYESKI
K112007 07/14/2011 CARTO 3 EP NAVIGATION SYSTEM, VERSION 2.2 BIOSENSE WEBSTER, INC. WAYNE R HOHMAN
K112050 07/18/2011 SOUNDSTAR ECO DIAGNOSTIC ULTRASOUND CATHETER BIOSENSE WEBSTER, INC. MARINA GUEVREKIAN
K112118 07/25/2011 DREAMBOND BISCO, INC. MICHELLE SCHILTZ-TAING
K112103 07/22/2011 INTERLOCK-35 FIBERED IDC OCCLUSION SYSTEM BOSTON SCIENTIFIC CORP. HARLAN JONES
K111963 07/11/2011 BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER BRIDGEPOINT MEDICAL JILL MUNSINGER
K112051 07/18/2011 LUNGPOINT PLANNING AND VIRTUAL BRONCHOSCOPIC NAVIGATION (VBN) SOFTWARE BRONCUS TECHNOLOGIES, INC. MAHTAB FATEMI
K112137 07/26/2011 COMFORTGLIDE INTERMITENT CATHETER C.R. BARD, INC. STACCI CRONK
K111924 07/06/2011 FINESSE PERSONAL INSULIN DELIVERY PATCH CALIBRA MEDICAL, INC. RICHARD J MEADER
K111878 07/01/2011 PROTEXIS LATEX BLUE WITH NEU-THERA POWDER-FREE SURGICAL GLOVES CARDINAL HEALTH, INC. TATYANA BOGDAN
K111868 07/01/2011 STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING CARDINAL HEALTH-MEDICAL PRODUCTS AND SERVICES TATYANA BOGDAN
K112052 07/18/2011 CAREFUSION NICOLET EDX CAREFUSION 209, INC. ROBERT BURDGE
K112034 07/15/2011 TECA ELITE DISPOSABLE CONCENTRIC NEEDLES CAREFUSION 209, INC. GLEN HERMANSON
K112184 07/28/2011 CIRRUS PHOTO CARL ZEISS MEDITEC INC JUDITH A BRIMACOMBE
K112067 07/19/2011 NAVIGATOR DELIVERY SYSTEM (NAVIGATOR DS) CARTICEPT MEDICAL INC TANYA EBERLE
K112141 07/26/2011 SMARTEPIL,DEPILASE YAG LASE PLUS CASTLE LASER SYSTEMS, LIMITED RAYMOND R BLANCHE
K111941 07/08/2011 CHOYANG THERMAL MASSAGER CHOYANG MEDICAL INSTRUMENT CO., LTD. SHIN KUK YOO
K111937 07/08/2011 CLEARFLASH AC2100 COSMETIC SYSTEM CLEARFLASH TECHNOLOGIES, INC. JOSEPH NEEV
K112095 07/22/2011 ACCULIF TL-PEEK IBF CAGE COALIGN INNOVATIONS, INC. JUSTIN EGGLETON
K111881 07/01/2011 VIRTUE MALE SLING SYSTEM AND ALEXIS(R) WOUND RETRACTOR KIT COLOPLAST A/S JANELL A COLLEY
K112168 07/28/2011 COMPONEER COLTENE/WHALEDENT AG MARK VAN METER
K112096 07/22/2011 IMAGELINK COMPUTER PROGRAMS AND SYSTEMS, INC. MICHAEL HUNT
K111916 07/06/2011 CONFORMIS IUNI UNICONDYLAR KNEE REPLACEMENT SYSTEM CONFORMIS, INC. AMITA S SHAH
K112099 07/22/2011 CONTOUR HEALER CONTOUR HEALER, LLC ALLEN HARDIN WHITE
K112185 07/29/2011 FOURSNARE VASCULAR RETRIEVAL SNARE COOK, INC. MOLLY BUSENBARK
K111966 07/11/2011 PROCLEAR, PROCLEAR TORIC, PROCLEAR MULTIFOCAL, PROCLEAR 1DAY, PROCLEAR XC COOPERVISION, INC. LISA HAHN
K112019 07/14/2011 BENCOX ID STEM, BENCOX METAL HEAD, BENCOX BIPOLAR CUP CORENTEC CO., LTD J.S. DANIEL
K111911 07/05/2011 CORIN OPTIMOM MODULAR HEAD CORIN U.S.A. LUCINDA GERBER
K112077 07/21/2011 HBIDB - HUMAN BRIAN INDEX SOFTWARE CORSCIENCE GMBH & CO. KG PATRIK R KAREM
K111917 07/06/2011 NUVANT, MOBILE CARDIAC TELEMETRY CORVENTIS, INC. MICHELE CHIN-PURCELL
K111887 07/01/2011 CLOSUREFAST RADIOFREQUENCY CATHETER COVIDIEN DANIEL CAMPION
K111933 07/08/2011 COVIDIEN NELLCOR RESPIRATION RATE SOFTWARE APPLICATION, VERSION 1.0 COVIDIEN JEAN SIMON
K111901 07/05/2011 ASA 'MPHI FAMILY DIODE LASER CYNOSURE, INC. ANTHONY BURNS
K111876 07/01/2011 Z BOND, PRELUDE ONE DANVILLE MATERIALS, INC. LINDSAY TILTON
K112045 07/18/2011 SIMPLELINE II ABUTMENT SYSTEM DENTIUM CO., LTD. JONGHYUN CHOI
K112152 07/27/2011 CERCON HT DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K112120 07/25/2011 DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SET DIAZYME LABORATORIES ABHIJIT DATTA
K112189 07/29/2011 THERMO PAL INFRARED EAR THERMOMETER DIGIO2 INTERNATIONAL CO., LTD. JENNIFER REICH
K111947 07/08/2011 DUET MAGNA DIREX SYSTEMS CORP. LARISA GERSHTEIN
K111583 07/25/2011 FLAATZ 560 DRTECH CORP. CHOUL-WOO SHIN
K111996 07/18/2011 ELITECH CLINICAL SYSEMS ISE CONTROL 1 AND 2 ELITECHGROUP DEBRA K HUTSON
K111960 07/11/2011 ELITECH CLINICAL SYSTEMS CARBON DIOXIDE ELECTRODE, ELITECH CLINICAL SYSTEMS ISE CALIBRATORS ELITECHGROUP DEBRA K HUTSON
K112029 07/15/2011 ELITECH CLINICAL SYSTEMS ELICAL 2, ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL II MODEL CALI-05 ELITECHGROUP DEBRA K HUTSON
K112069 07/25/2011 RSP GLENOID BASEPLATE POROUS COATED ENCORE MEDICAL, L.P. WILLIAM GARZON
K112121 07/25/2011 ERGOSELECT/GE ERGOLINE GMBH ANDREA PECSI
K112033 07/15/2011 ENSEAL G2 TISSUS SEALERS ETHICON ENDO-SUGERY, LLC DONOVAN MAY
K112056 07/19/2011 ECHELON 60 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ECR60T, ECHELON 45 ENDOSCOPIC LINEAR CUTTER RELOAD, BLACK MODEL ETHICON ENDO-SURGERY, LLC ASIFA VONHOF
K112074 07/20/2011 EVERYWAY TRACTION UNIT, MODEL EVER-TRAC ET-800 EVERYWAY MEDICAL INSTRUMENTS CO., LTD. JAY MANSOUR
K112097 07/22/2011 GIBRALT SPINE SYSTEMS FACET SCREW 04.0,04.5 EXACTECH, INC. VLADISLAVA ZAITSEVA
K111939 07/08/2011 M/29TM - PRESSURE INJECTABLE FLEXICATH LTD. TALI HAZAN
K112193 07/29/2011 ARROW REVERSE SHOULDER SYSTEM FOURNITURES HOSPITALIERES INDUSTRIE PATRICIA DONNARD
K112126 07/25/2011 GENUINE FIRST AID CPR MASK GENUINE FIRST AID LLC GARY LEHNUS
K112028 07/15/2011 SI-LOK SACROILIAC JOINT FIXATION SYSTEM GLOBUS MEDICAL, INC. WENDY S HILLS
K112060 07/19/2011 RADIANCE GMV AEROSPACE AND DEFENCE S.A. WILLIAM GREENROSE
K112071 07/20/2011 WONDFO COCAINE URINE TEST MODEL W10-CU, W10-P, WONDFO METHAMPHETAMINE URINE TEST MODEL W11-CU, W11-P GUANGZHOU WONDFO BIOTECH CO., LTD. JOE SHIA
K112006 07/13/2011 HAMILTON-TC1 HAMILTON MEDICAL AG RALPH AGUILA
K111999 07/13/2011 HEALGEN 11 REAGENT STRIP FOR URINALYSIS, HEALGEN 10 REAGENT STRIP FOR URINALYSIS, AND HEALGEN 4 REAGENT STRIP FOR URINAL HEALGEN SCIENTIFIC, LLC YONGQUAN WANG
K111988 07/13/2011 EASYSCAN MODEL 1.2 I-OPTICS BV WILLIAM GREENROSE
K111995 07/13/2011 XINGTM SPINE SYSTEM IMPLANOVA CO. LTD APRIL LEE
K112180 07/28/2011 I5 DIGITAL X-RAY IMAGING SYSTEM (WITH SDX-4336CP) INFIMED, INC. CATHERINE MULCAHY
K111985 07/12/2011 MYOGUIDE SYSTEM MODEL 8008 INTRONIX TECHNOLOGIES CORP. RICHARD VINCINS, CQA, RAC (US,EU)
K111931 07/08/2011 GLIASITE RTS ISORAY MEDICAL, INC. FREDRIC G SWINDLER
K111992 07/13/2011 CUROS PORT PROTECTOR IVERA MEDICAL, INC. DON CANAL
K111958 07/18/2011 TETRIC EVOCERAM BULK FILL IVOCLAR VIVADENT, INC. DONNA MARIE HARTNETT
K112110 07/22/2011 STERILE LUBRICATING JELLY JIANERKANG MEDICAL DRESSING COMPANY JORDON CHU
K112178 07/28/2011 JMS APHERESIS NEEDLE SET "WINGEATER(R)" V2 JMS NORTH AMERICA CORPORATION E.J. SMITH
K111948 07/08/2011 WINGEATER V2 JMS NORTH AMERICA CORPORATION E J SMITH
K112037 07/18/2011 RANGE SPINAL SYSTEM (MESA AND DENALI) K2M, INC. NANCY GIEZEN
K111997 07/13/2011 IMAGE1 GI CCU MODEL 22203020-114 KARL STORZ ENDOSCOPY-AMERICA, INC. WINKIE WONG
K112093 07/22/2011 CRYOMATIC CRYO CONSOLE, DISPOSABLE CRYO PROBE, DISPOSABLE PROBE ADAPTER KEELER INSTRUMENTS, INC. EUGENE R VANARSDALE
K111402 07/18/2011 KC200, SURGICAL MASK, KC200, PROCEDURE MASK, KC300, SURGICALMASK, FLUIDSHIELD, KC300, PROCEDURE MASK, FLUIDSHIELD MODEL KIMBERLY-CLARK ANN WATERHOUSE, RAC
K112064 07/19/2011 RESORB X-G KLS-MARTIN L.P. JENNIFER DAMATO
K112041 07/18/2011 KOO SMALL VOLUME NEBULIZER (SVN) KOO(SHANGHAI)INDUSTRIES CO., LTD. PAUL DRYDEN
K111956 07/11/2011 KRONUS VOLTAGE GATED CALCIUM CHANNEL (VGCC) ANTIBODY RIA ASSAY KIT KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. HEATHER VIELE
K112136 07/26/2011 TOP DRAPE STERILE, TOP DRAPE-NON STERILE, BOTTOM DRAPE- STERILE, BOTTOM DRAPE KUNSHAN JIEHONG NONWOVEN PRODUCT CO., LTD. GLEN FEYE
K111982 07/12/2011 CLEARFIL DC CORE PLUS KURARAY AMERICA, INC. KIYOYUKI ARIKAWA
K111980 07/12/2011 CLEARFIL TRI-S BOND PLUS KURARAY AMERICA, INC. KIYOYUKI ARIKAWA
K111975 07/12/2011 CLEARFIL TRI-S BOND PLUS SINGLE DOSE STANDARD / VALUE / INTRODUCTORY PACK KURARAY MEDICAL INC. MICHIO TAKIGAWA
K111884 07/01/2011 OVER-THE-WIRE EXPANDABLE LEMAITRE VALVULOTOME LEMAITRE VASCULAR, INC. ANDREW HODGKINSON
K112098 07/22/2011 TBD LENSAR, INC. SHIRLEY MCGARVEY
K111953 07/11/2011 NAUTILUS SPINAL SYSTEM LIFE SPINE RANDY LEWIS
K112091 07/21/2011 H-MAX S FEMORAL STEMS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K112158 07/27/2011 MODULUS STEMS, MODULUS NECKS, MODULAR FEMORAL HEADS, CEMENTED CUPS, LOCK BIPOLAR HEADS LIMACORPORATE S.P.A. CHERYL HASTINGS
K111987 07/19/2011 FIBERNET EMBOLIC PROTECTION DEVICE LUMEN BIOMEDICAL, INC. MICHELLE STRAIGHT
K112114 07/25/2011 MAQUET FLOW-I C20, MAQUET FLOW-I C30, MAQUET FLOW-I C40 MAQUET CRITICAL CARE AB WHITNEY TORNING
K112078 07/21/2011 ENDOCEM MTA (MINERAL TRIOXIDE AGGREGATE) MARUCHI PRISCILLA CHUNG
K111888 07/01/2011 MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS MASIMO CORPORATION ANIL BHALANI
K112115 07/25/2011 MECTACER BIOLOX(R) DELTA FEMORAL HEADS MEDACTA INTERNATIONAL ADAM GROSS
K112169 07/28/2011 APTUS WRIST ARTHRODESIS PLATES MEDARTIS AG KEVIN A THOMAS
K112190 07/29/2011 PATIENT MONITOR MEDIANA CO., LTD. CHARLIE MACK
K111651 07/06/2011 SPLIT CATH III MEDICAL COMPONENTS INC JEAN CALLOW
K112132 07/26/2011 KRYSTALRAD 660 DIGITAL RADIOGRAPHIC PORTABLE RETROFIT SYSTEM MEDICATECH USA DANIEL KAMM
K111955 07/11/2011 MEDLINE PNEUMOPERITONEUM NEEDLE MEDLINE, INDUSTRIES, INC. MATT CLAUSEN
K112156 07/27/2011 CODMAN CERTAS PROGRAMMABLE VALVE SYSTEM, CODMAN CERTAS THERAPY MANAGEMENT SYSTEM MEDOS INTERNATIONAL SARL JOCELYN RAPOSO
K112086 07/21/2011 MEDRAD MARK 7 ARTERION (PEDESTAL SYSTEM / TABLE MOUNT SYSTEM), MEDRAD MARK 7 ARTERION SYRINGE MEDRAD, INC. MIKE BURNSIDE
K111942 07/08/2011 TSRH SPINAL SYSTEMS MEDTRONIC SOFAMOR DANEK USA, INC LILA JOE
K112125 07/25/2011 ILLUMIGENE GROUP B STREPTOCOCCUS ,EXTERNAL CONTROL KIT MERIDIAN BIOSCIENCE, INC. SUSAN D ROLIH
K112048 07/18/2011 IMMUNOCARD C. DIFFICILE GDH MERIDIAN BIOSCIENCE, INC. SUSAN BOGAR
K112162 07/27/2011 CONICAL CONNECTION IMPLANTS MIS IMPLANTS TECHNOLOGIES LTD. IMAN KHORSHID
K112089 07/25/2011 BIOGEL ORTHOPOR BROWN SURGICAL GLOVE MOLNLYCKE HEALTHCARE, US LLC ANGELA L BUNN, RAC
K112163 07/27/2011 MONICA IF24 MONICA HEALTHCARE IAN HOW
K111802 07/06/2011 SV BRAIN ARRAY, SIEMENS 3T MRI INTERVENTIONS, INC. E.F. WADDELL
K112024 07/15/2011 TI-MAX X450 NAKANISHI, INC. DIANE RUTHERFORD
K111949 07/08/2011 AC WOUND TREATMENT SYSTEM NANO VIBRONIX, INC. E J SMITH
K112124 07/25/2011 MICROCATHETER NAVILYST MEDICAL, INC. WANDA CARPINELLA
K111906 07/05/2011 XCELA HYBRID PICC WITH PASV VALVE TECHNOLOGY NAVILYST MEDICAL, INC. LORRAINE M HANLEY
K112131 07/26/2011 NEODYNE DRESSING NEODYNE BIOSCIENCES, INC. PEGGY MCLAUGHLIN
K103022 07/19/2011 KIM NEOMEDIC INTERNATIONAL S.L. JEFFREY R SHIDEMAN
K112107 07/22/2011 BWIII EEG, BWIII EEG PLUS, BWIII PSG, BWIII PSG PLUS NEUROVIRTUAL USA, INC. EDUARDO FARIA
K111935 07/08/2011 TI-BASE ABUTMENT, 1 CONNECT ABUTMENT NT-TRADING GMBH AND CO KG WILLIAM GREENROSE
K111973 07/12/2011 VAGINAL CT / MR MULTI CHANNEL APPLICATOR SET NUCLETRON MICHAEL PAUL
K112133 07/26/2011 OASYS SURGICAL LIGHT CONTROLLER OASYS HEALTHCARE TANYA M O'BRIEN
K112176 07/28/2011 SILICONE SPHERES OCULO PLASTIK, INC. SYLVAIN DESROSIERS
K111914 07/06/2011 VIRTUAL SLIDE SYSTEM, OLYMPUS VS800 SYSTEM OLYMPUS AMERICA INC. / SCIENTIFIC EQUIPMENT GROUP SHERI L MUSGNUNG
K111936 07/08/2011 ORTHO DEVLOPMENT CERAMIC FEMORAL HEAD ORTHO DEVELOPMENT TOM HAUETER
K111965 07/11/2011 VUSION(R) OS ORTHO DEVELOPMENT TOM HAUETER
K112109 07/22/2011 THE KINEGRAPH VMA SOFTWARE, THE MOTION NORMALIZER PATIENT HANDLING AND DATA COLLECTION DEVICE ORTHO KINEMATICS, INC. JOHN J SMITH
K112053 07/21/2011 OBC BONE ANCHORED HEARING SYSTEM OTICON MEDICAL AB KAROLIN ISBERG JERNBY
K111232 07/08/2011 GAP ENDO-EXO MEDULLARY SYSTEM PEGA MEDICAL INC. ARIEL R DUJOVNE
K111919 07/07/2011 IMMUNOCAP SPECIFIC IGE ALLERGEN BUNDLE, 12 ALLERGEN COMPONENTS PHADIA US INC. MARTIN MANN
K111905 07/05/2011 INTELLIVUE GUARDIAN SOFTWARE MODEL 866009, INTELLIVUE CL SP02 POD MODEL 865215, INTELLIVUE CL NBP POD MODEL 865216 PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN MARKUS STACHA
K111944 07/08/2011 NB3D BONE VOID FILLER PIONEER SURGICAL TECHNOLOGY, INC. FLOYD G LARSON
K112101 07/22/2011 FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS POLYMED THERAPEUTICS, INC TERRI WALLACE
K111932 07/08/2011 IGLUCOSE SYSTEM POSITIVEID CORPORATION EDWARD VALDEZ
K112015 07/13/2011 PREMIER HB9210 HBA1C ANALYZER PRIMUS CORPORATION DBA TRINITY BIOTECH BRITT EINSPAHR
K111978 07/12/2011 SULCUS BLUE PRODUITS DENTAIRES PIERRE ROLLAND RICK ROSATI
K111929 07/06/2011 PSYCHEMEDICS CANNABINOIDS EIA PSYCHEMEDICS CORP. VIRGINIA HILL
K111925 07/06/2011 PSYCHEMEDICS COCAINE EIA PSYCHEMEDICS CORP. VIRGINIA HILL
K111927 07/06/2011 PSYCHEMEDICS METHAMPHETAMINE EIA PSYCHEMEDICS CORP. VIRGINIA HILL
K111926 07/06/2011 PSYCHEMEDICS OPIATES EIA PSYCHEMEDICS CORP. VIRGINIA HILL
K111928 07/06/2011 PSYCHEMEDICS PHENCYCLIDINE EIA PSYCHEMEDICS CORP. VIRGINIA HILL
K111923 07/07/2011 SKIN GUARD, POWDER FREE LATEX EXAMINATION GLOVES, NON-STERILE PT. INTAN HEVEA INDUSTRY DARWIN TANDJO
K112139 07/26/2011 THE CANARY SYSTEM QUANTUM DENTAL TECHNOLOGIES INC JOSH SILVERTOWN
K111993 07/19/2011 FRAMEWALKER QUANTUM MEDICAL CONCEPTS, LLC. ALICIA BACH
K112172 07/28/2011 QUIDEL MOLECULAR INFLUENZA A + B ASSAY QUIDEL CORP. RONALD LOLLAR
K112177 07/28/2011 SOFIA ANALYZER AND INFLUENZA A+B FIA QUIDEL CORP. JOHN D TAMERIUS
K111897 07/05/2011 ABL90 RADIOMETER MEDICAL APS MARTIN GABLER
K112161 07/27/2011 AQT90 FLEX ANALYZER, AQT90 FLEX MYOGLOBIN TEST KIT, AQT90 FLEX LQC MULTI-CHECK, LVLS 1-3, AQT90 FLEX MYO CAL CARTRIDGE.. RADIOMETER MEDICAL APS JANA S HELLMANN
K112017 07/14/2011 RAUMEDIC ICP MONITORING SYSTEM RAUMEDIC AG REINER THIEM
K111940 07/14/2011 S 100 PEDICLE SCREW SYSTEM RENOVIS SURGICAL TECHNOLOGIES, LLC J.D. WEBB
K111885 07/01/2011 SIMPLYGO PORTABLE OXYGEN CONCENTRATOR RESPIRONICS INC. JOSEPH E OLSAVSKY
K112113 07/27/2011 ELECSYS MYOGLOBIN CALCHECK 5 ROCHE DIAGNOSTICS KELLY COLLEEN O'MAINE ADAMS
K112104 07/22/2011 ELECSYS N-MID OSTEOCALCIN CALCHECK 5 ROCHE DIAGNOSTICS JANE E PHILLIPS
K112073 07/20/2011 INFUSITE NEEDLELESS ACCES DEVICE (STERILE, BULK NON-STERILE) AND INFUSITE NEEDLELESS ACCESS DEVICE 'Y' ADAPTER (BULK... RX DEVICES LLC CHARLES HOKANSON
K111732 07/08/2011 AQUAMANTYS SBS 5.0 SHEATED BIOPOLAR SEALER SALIENT SURGICAL TECHNOLOGIES, INC. MARTIN J LEIGHTON
K112188 07/29/2011 PIEZOTOME SOLO SATELEC - ACTEON, INC. RICK ROSATI
K111483 07/07/2011 JOULE CLEARSENSE LASER SYSTEM SCITON, INC. JAY M PATEL
K111915 07/19/2011 MAGNESIUM ASSAY SEKISUI DIAGNOSTICS P.E.I. INC. PENNY J WHITE
DEN110011 07/13/2011 SYMPHONY DEVICE SENSORY MEDICAL, INC FRED BURBANK
K112112 07/25/2011 SENTINELLE BREAST MRI TABLETOP WITH 16 CHANNEL COIL ARRAY FOR SIEMENS 1.5/3T MRI SYSTEMS SENTINEL MEDICAL, INC. JOAN MEDLEY
K112002 07/13/2011 CAROTID COIL SHANGHAI CHENGUANG MEDICAL TECHNOLOGIES CO, LTD MEIJUAN CHEN
K111907 07/05/2011 DYNAMIC DU SERIES PORTABLE DENTAL UNIT SHANGHAI DYNAMIC INDUSTRY CO., LTD. DORIS DONG
K112057 07/19/2011 KDL SYRINGES AND NEEDLE SHANGHAI KINDLY ENTERPRISE DEV. GROUP CO., DIANA HONG
K112042 07/18/2011 KINGYIELD WRIST BLOOD PRESSURE MONITOR SHENZHEN KINGYIELD TECHNOLOGY CO., LTD. DACHENG GONG
K112154 07/27/2011 FEMTO LDV SIE AG,SURGICAL INSTUMENT ENGINEERING KEVIN WALLS
K112142 07/26/2011 DIMENSION VISTA LITHIUM FLEX REAGENT CARTRIDGE SIEMENS HEALTHCARE DIAGNOSTICS ROSE T MARINELLI
K111912 07/05/2011 MOBILETT MIRA SIEMENS MEDICAL SOLUTIONS USA, INC. PATRICIA D JONES
K112020 07/14/2011 SYNGO.CT VASCULAR ANALYSIS SIEMENS MEDICAL SOLUTIONS, INC. RALF HOFMANN
K112106 07/22/2011 NAVIAID ICVI-F,S,B,R DEVICE SMART MEDICAL SYSTEMS, LTD. ADVA YOSELZON
K112127 07/25/2011 PICO SINGLE USE NEGATIVE PRESSURE WOUND THERAPY SYSTEM SMITH & NEPHEW, INC. TERRY MCMAHON
K111994 07/13/2011 SMITH & NEPHEW CANNULATED SCREWS AND WASHERS SMITH & NEPHEW, INC. MAUREEN WHITSON
K112134 07/27/2011 TRUCLEAR OPERATIVE HYSTEROSCOPE SMITH & NEPHEW, INC. JANICE HASELTON
K112173 07/28/2011 SPEACELABS MULTIGAS MODULE SPACELABS HEALTHCARE THOMAS KROENKE
K112032 07/19/2011 8FR TURBO - TANDEM SYSTEM SPECTRANETICS CORP. SHELLEY WILCOX
K112025 07/15/2011 SURE LOK MINI POSTERIOR CERVICAL/UPPER THORACIC SYSTEM SPINAL USA FRANKIE CUMMINS
K111913 07/06/2011 CAPSURE(R) PS SYSTEM SPINE WAVE, INC. ROAIDA RIZKALLAH
K112108 07/22/2011 ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM SPINEART FRANK P ENNESI
K111880 07/01/2011 SPINEOLGY PEEK BULLET LUMBER INTERBODY FUSION DEVICE SPINEOLOGY INC. BRYAN BECKER
K111943 07/08/2011 AGILLS PF DELIVERY SYSTEM ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI GEENA GEORGE
K112055 07/19/2011 AMSCO CHIMERON MEDIUM STEAM STERILIZER STERIS CORPORATION ROBERT F SULLIVAN
K111870 07/01/2011 AMSCO WARMING CABINET STERIS CORPORATION ROBERT F SULLIVAN
K111798 07/06/2011 STERNIC IMPLANT 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM, 12.0MM / 4.1MM RN, 1.8MM, 14.0MM ... STERNGOLD DENTAL LLC. MARIA RAO
K112059 07/19/2011 T2 FEMORAL NAIL MODEL 1825-XXXXCP, 1828-XXXXCP STRYKER VALERIE GIAMBANCO
K111986 07/13/2011 LOGIC LAPAROSCOPIC INSTRUMENT SYSTEM SURGICAL INNOVATIONS PLC PAUL BIRTLES
K111891 07/05/2011 SYNTHES BRAINLAB TRAUMA COMPATIBLE INSTRUMENTS SYNTHES (USA) PRODUCTS LLC CHRISTOPHER HACK
K112085 07/21/2011 SYNTHES LCP PEDIATRIC PLATE SYSTEMS SYNTHES (USA) PRODUCTS LLC ANGELA F LASSANDRO
K112068 07/20/2011 SYNTHES ZERO-P VARIABLE ANGLE (VA) SYNTHES SPINE CO.LP STACEY BONNELL
K112030 07/15/2011 SYNTHES RADIAL HEAD PROSTHESIS SYSTEM SYNTHES USA, LLC ANGELA F LASSANDRO
K111890 07/01/2011 FORA DIAMOND PRIMA BLOOD GLUCOSE MONITORING SYSTEM, FORA DIAMOND MINI BLOOD GLUCOSE MONITORING SYSTEM TAIDOC TECHNOLOGY CORPORATION MEIRU LI
K111974 07/12/2011 ION HEALTH USB INSTA-SCAN THERMOMETER TAIDOC TECHNOLOGY CORPORATION TELING HSU
K111971 07/11/2011 SYNDE-LOCK SYNDESMOSIS REPAIR KIT TARSUS MEDICAL INC. NICHOLAS MOURLAS
K111900 07/11/2011 NEXTSTEP ANTEGRADE CHRONIC HEMODIALYSIS CATHETER TELEFLEX MEDICAL, INC. SUZANNE SCHORLE
K111946 07/08/2011 TEPHAFLEX MESH TEPHA, INC. MARY P LEGRAW
K111984 07/12/2011 SPI VARIO ANGLED ABUTMENT THOMMEN MEDICAL, AG LINDA K SCHULZ
K111902 07/05/2011 AEQUALIS SHOULDER SYSTEM TORNIER SEVERINE BONNETON
K111970 07/25/2011 KNEETEC PFJ&HLS KNEETEC PATELLAR COMPONENT TORNIER STEPHANIE BERNARD
K112003 07/13/2011 VANTAGE TITAN HSR TOSHIBA MEDICAL SYSTEMS CORPORATION PAUL BIGGINS
K112054 07/19/2011 INFINIX CF-I/SP AND INFINIX VF-I/SP MODEL INFX-8000V TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN PAUL BIGGINS
K112145 07/29/2011 MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MS33I2 TOTOKU ELECTRIC CO., LTD TSUKASA TASHIRO
K112008 07/13/2011 TOUCHPACS SUITE TOUCH MEDICAL SOLUTIONS INC. JAMES OWEN
K112010 07/14/2011 AEROCHAMBER PLUS FLOW-VU ANTI-STATIC VALVED HOLDING CHAMBER (VHC) TRUDELL MEDICAL INTL. DARRYL FISCHER
K112012 07/13/2011 NON-STERILE, POWDER-FREE BLUE, NITRILE EXAMINATION GLOVES UG HEALTHCARE (USA), INC. KEN STANTON
K112005 07/13/2011 NON-STERILE, POWDER-FREE, GREEN LATEX EXAMINATION GLOVES WITH PROTEIN CONTENT LABELING CLAIM (50 MICROGRAMS OR LESS) UG HEALTHCARE (USA), INC. KEN STANTON
K112148 07/27/2011 POWERED MUSCLE STIMULATOR VALMED, SA CARL MAGNELL
K112082 07/21/2011 GUIDELINER V2 CATHETER VASCULAR SOLUTIONS, INC. MATT NIENSTEDT
K112100 07/22/2011 M2 NAVIGATION CATHETER AND GUIDELINER NAVIGATION CATHETER VASCULAR SOLUTIONS, INC. MATT NIENSTEDT
K111872 07/01/2011 VIRTUOSO SYSTEM FOR IHC P53 (DO-7) VENTANA MEDICAL SYSTEMS, INC. TROY QUANDER
K111869 07/01/2011 VIRTUOSO SYSTEM FOR IHC PR (IE2) VENTANA MEDICAL SYSTEMS, INC. TROY QUANDER
K111892 07/05/2011 VITREAVIEW SOFTWARE 6.1 VITAL IMAGES, INC. IAN NEMEROV
K111922 07/06/2011 VOCARE MYHEALTH TABLET VOCARE, INC STEVE PEABODY
K112035 07/15/2011 VALET MICRO CATHETER VOLCANO CORPORATION LISA QUAGLIA
K112166 07/28/2011 ULTRALASE FLEXIBLE CO2 LASER WAVEGUIDE W AND R INVESTMENTS DBA LASER ENGINEERING ROBERT I RUDKO
K112167 07/28/2011 SOYALA SILKGEL FULL FACE MASK WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG RALF EGENOLF
K111781 07/06/2011 GYMFORM DUAL FLEX BELT MODEL WB-162 WELL BRAIN INTERNATIONAL, LTD. VICTOR K WAI
K112119 07/25/2011 CUNTHER TULIP(R) VENA CAVA FILTER SET FOR FEMORAL APPROACH, COOK CELECT(R) VENA CAVA FILTER FOR FEMORAL APPROACH WILLIAM COOK EUROPE APS JENNIFER BROWN
K111895 07/05/2011 ECHOTIP(R) ULTRA FIDUCIAL NEEDLE WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY MARGE WALLS-WALKER
K111910 07/05/2011 GLADIATOR HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. MATT PAUL
K112080 07/21/2011 PRESERVE HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. GREGORY NEAL
K112150 07/27/2011 PROFEMUR GLADIATOR HA HIP STEM WRIGHT MEDICAL TECHNOLOGY, INC. MATT PAUL
K112036 07/18/2011 CALIX PC SPINAL IMPLANT SYSTEM X-SPINE SYSTEMS, INC DAVID KIRSCHMAN
K112016 07/14/2011 L-SER KO LAMP YA-MAN LTD NELSON MARQUINA
K112102 07/22/2011 MICHELE SLEEP SCORING SYSTEMS YOUNES SLEEP TECHNOLOGIES MAGDY YOUNES
K112160 07/27/2011 TAPERED SCREW-VENT X IMPLANT ZIMMER DENTAL INC. JEREMY MARKOVICH
K111889 07/01/2011 ZIMMER DENTAL TAPERED SCREW-VENT M IMPLANT ZIMMER DENTAL INC. MELISSA BURBAGE
K111983 07/12/2011 VISTA-S DEVICE MODEL 08/06-401-XXXXX, 08/06-402-XXXXXX ZIMMER TRABECULAR METAL TECHNOLOGY KATHLEEN RUTHERFORD
K112174 07/28/2011 NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM ZIMMER, INC. STEPHEN H MCKELVEY


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact