FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
K112083 |
07/21/2011 |
LIFEGLOBAL TOTAL, TOTAL FOR FERTILIZATION, TOTAL W/HEPES, HTF TOTAL, HTF TOTAL W/HEPES |
INTL., INC. |
MICHAEL D CECCHI |
K111883 |
07/01/2011 |
SMARTLOC SPINAL FIXATION SYSTEM |
A-SPINE ASIA, CO., LTD |
FRANK HSU |
K112143 |
07/26/2011 |
AUDIT MICROCV T-UPTAKE LINEARITY |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
K111964 |
07/11/2011 |
AUDIT MICROCV URINE/FLUIDS CHEMISTRY LINEARITY |
AALTO SCIENTIFIC LTD. |
DESSI LYAKOV |
K111874 |
07/01/2011 |
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 |
07/27/2011 |
CMS-1000FM CENTRAL MONITORING SYSTEM |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
K112022 |
07/15/2011 |
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 |
K112187 |
07/29/2011 |
FM-1000 PLUS FETAL MONITOR |
ADVANCED INSTRUMENTATIONS, INC. |
JORGE MILLAN |
K111934 |
07/08/2011 |
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 |
K112165 |
07/28/2011 |
RHEA CUP |
APEX MEDICAL TECHNOLOGIES, INC. |
SCOTT HERRICK |
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 |
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 |
07/05/2011 |
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 |
K111996 |
07/13/2011 |
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 |
07/20/2011 |
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 |
K112122 |
07/25/2011 |
VENUE 40 |
GE HEALTHCARE |
BRYAN BEHN |
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 |
K111938 |
07/08/2011 |
IDS-ISYS IGFBP-3 CONTROL SET, IDS-ISYS HUMAN GROWTH HORMONE (HGH) CALIBRATION VERIFIERS, AND IDS-ISYS IGFBP-3 CAL... |
IMMUNODIAGNOSTIC SYSTEMS LTD. |
MICK FENTON |
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 |
07/11/2011 |
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 |
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 |
07/13/2011 |
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 |
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 |
K111972 |
07/11/2011 |
AFFINITY CP CENTRIFUGAL PUMP, RESTING HEART SYS.,MYOTHERM CARDIOPLEGIA DELIV.,AFFINITY HOLLOW FIBER OXYGENATOR,AAF |
MEDTRONIC INC. |
JESSICA SIXBERRY |
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 |
K112018 |
07/14/2011 |
SMART READ EZTEST STEAM |
MESA LABORATORIES, INC. |
WENDY ROYALTY |
K112181 |
07/28/2011 |
HYDROCOIL(R) EMBOLIC SYSTEM (HES) |
MICROVENTION, INC. |
VIN CUTARELLI |
K112162 |
07/27/2011 |
CONICAL CONNECTION IMPLANTS |
MIS IMPLANTS TECHNOLOGIES LTD. |
IMAN KHORSHID |
K112089 |
07/21/2011 |
BIOGEL ORTHOPOR BROWN SURGICAL GLOVE |
MOLNLYCKE HEALTHCARE, US LLC |
ANGELA L BUNN, RAC |
K112163 |
07/27/2011 |
MONICA IF24 |
MONICA HEALTHCARE |
IAN HOW |
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 |
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 |
07/19/2011 |
OBC BONE ANCHORED HEARING SYSTEM |
OTICON MEDICAL AB |
KAROLIN ISBERG JERNBY |
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 |
07/13/2011 |
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 |
07/08/2011 |
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 |
07/25/2011 |
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 |
K112153 |
07/07/2011 |
IROOT 100 MINI |
S-DENTI CO., LTD. |
PETER CHUNG |
K112188 |
07/29/2011 |
PIEZOTOME SOLO |
SATELEC - ACTEON, INC. |
RICK ROSATI |
K111915 |
07/06/2011 |
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 |
K112149 |
07/26/2011 |
WEIGHT AND BODY FAT SCALE SHINE BS0105 |
SHINE OVERSEAS MARKETING LIMITED |
CHARLIE MACK |
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 |
07/15/2011 |
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 |
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 |
07/05/2011 |
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 |
K112144 |
07/26/2011 |
AEQUALIS SHOULDER FRACTURE SYSTEM, AEQUALIS REVERSED SHOULDER PROSTHESIS, AEQUALIS REVERSED FRACTURE SHOULDER PROSTHESIS |
TORNIER |
SEVERINE BONNETON |
K111902 |
07/05/2011 |
AEQUALIS SHOULDER SYSTEM |
TORNIER |
SEVERINE BONNETON |
K111970 |
07/11/2011 |
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 |
07/26/2011 |
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 |
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 |