| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| 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 |
| K101594 |
10/08/2010 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES, BLUE |
BETTER CARE PLASTIC TECHNOLOGY CP., LTD |
JIE LIU\ |
| 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 |
| 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 |
| 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 |
| K102092 |
10/06/2010 |
PRO GEAR N95 PARTICULATE FILTER RESPIRATOR & SURGICAL MASK, REGULAR SIZE MODEL RP CERIES |
Prestige Ameritech |
BARARA MCCARTY |
| K101760 |
10/06/2010 |
ELEGANT BLUE, WHITE, PINK POWDER FREE, NITRILE EXAMINATION GLOVES |
PROFIT POINT MANUFACTURING SDN BHD |
ROBERT HILL |
| K101759 |
10/22/2010 |
QUANTUM RING FIXATION SYSTEM MODEL ISF |
QUANTUM MEDICAL CONCEPTS, LLC. |
ALEXANDER SHAEVITZ |
| K102477 |
10/04/2010 |
NO!NO! SKIN |
RADIANCY (ISRAEL) LTD. |
ROTHMAN JULIA |
| K092274 |
10/15/2010 |
RANDOX BENZODIAZEPINE ASSAY |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K101951 |
10/26/2010 |
LIGHT CURE RETAINER |
RELIANCE ORTHODONTIC PRODUCTS, INC. |
PAULA WENDLAND |
| K092407 |
10/08/2010 |
REMEL SPECTRA MRSA |
REMEL, INC. |
MARY ANN SILVIUS |
| K101859 |
10/13/2010 |
REL-K ARTIFICAL LIMB PROSTHESIS |
RIZZOLI ORTOPEDICA S.P.A. |
DIANE C TIERNAN, MS RAC |
| K093833 |
10/15/2010 |
KAPSS SPINAL SYSTEM |
ROBERT REID INC. |
KAREN E WARDEN |
| K101856 |
10/05/2010 |
ELECSYS CEA CALCHECK 5 |
Roche Diagnostics |
JASON FISHER |
| K102269 |
10/07/2010 |
ELECSYS IGE CALCHECK 5 |
Roche Diagnostics |
Sarah Baumann |
| K101365 |
10/05/2010 |
ELECSYS CA 19-9 CALCHECK 5 |
ROCHE DIAGNOSTICS CORP. |
KELLY O'MAINE ADAMS |
| K100903 |
10/05/2010 |
ANTI-HAV |
ROCHE PROFESSIONAL DIAGNOSTICS |
KELLY FRENCH |
| K100212 |
10/22/2010 |
DENTACENTER/EXPEDITION, MODEL SAF-430 |
SAFARI DENTAL, INC. |
ANDRE MATHIEU |
| K102161 |
10/08/2010 |
BLUE SAIL INNOVATION |
SHANDONG BLUE SAIL INNOVATION CO., LTD. |
YONGCHEN ZHANG |
| K102160 |
10/04/2010 |
STRETCH VINYL EXAMINATION GLOVE POWDER FREE |
SHANDONG BLUE SAIL INNOVATION CO., LTD. |
YONGCHEN ZHANG |
| K102023 |
10/19/2010 |
DIGITAL COLOR DOPPLER ULTRASOUND IMAGING SYSTEM, MODEL APOGEE 3500, CONVEX ARRAY TRANSDUCER, MODEL C3L60C |
SHANTOU I NSTITUTE OF ULTRASONIC INSTRUMENTS (SIUI |
BOB LEIKER |
| K102991 |
10/22/2010 |
M5 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
ZHAI PEI |
| K102920 |
10/15/2010 |
ELECTRONIC BLOOD PRESSURE MONITOR |
SHENZHEN PANGO ELECTRONIC CO., LTD |
Diana Hong |
| K102611 |
10/21/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG HYLAND PLASTIC CO., LTD |
CHU XIAOAN |
| K101347 |
10/01/2010 |
MAGNETOM AERA; MAGNETOM SKYRA |
SIEMENS MEDICAL SOLUTIONS USA INC. |
KIM RENDON |
| K102150 |
10/05/2010 |
SYNGO DYNAMICS, VERSION 9.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
YURI IKEDA |
| K102671 |
10/12/2010 |
SYNGO RT THERAPIST CONNECT WORKSPACE, V4.2 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
CHRISTINE DUNBAR |
| K100152 |
10/22/2010 |
SIRONA CAD/CAM SYSTEM |
SIRONA DENTAL SYSTEMS GMBH |
FRITZ KOLLE |
| K092723 |
10/04/2010 |
AKRO VU VIDEOSCOPIC CARPAL TUNNEL RELEASE (VCTR) SYSTEM |
SKELETAL DYNAMICS, LLC |
JOSEPH M AZARY |
| K102069 |
10/05/2010 |
JOURNEY UNICONDYLAR TIBIAL BASEPLATES |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K092256 |
10/20/2010 |
THERA- HEAT HEATED HUMIDIFIER, MODEL RC70000, RC70072, RC70075, RC70077, RC70012 |
SMITHS MEDICAL ASD, INC. |
PAT MCLEISH |
| K100077 |
10/07/2010 |
NELLCOR COMPATIBLE REUSABLE SPO2 SOFT-FINGER SENSOR, MODEL T100A-090103 |
SOLARIS MEDICAL TECHNOLOGY, INC. |
RACHEL CHENG |
| K101586 |
10/05/2010 |
XTRA AUTOTRANSFUSION SYSTEM |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K093562 |
10/14/2010 |
ENDOSSEOUS DENTAL IMPLANT |
SOUTHERN IMPLANTS, INC. |
MICHAEL KEHOE |
| K101848 |
10/14/2010 |
SAPPHIRE ANTERIOR CERVICAL PLATE SYSTEM |
SPINAL ELEMENTS, INC. |
BENJAMIN A KIMBALL |
| K102721 |
10/18/2010 |
LIVEWIRE ELECTOPHYSIOLOGY CATHETER |
ST. JUDE MEDICAL |
NICOLE BOWDEN |
| K101955 |
10/15/2010 |
ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 |
ST. JUDE MEDICAL |
WENDY PINOR |
| K102006 |
10/06/2010 |
CRYOMEGA |
STC CONSULTING LLC |
R. SAM NIEDBALA |
| K101718 |
10/26/2010 |
OSSEOCONDUCT |
STEINER LABORATORIES DIV OF STEINER HEALTHCARE LLC |
GREGORY G STEINER |
| K102529 |
10/07/2010 |
D2RF DIGITAL DYNAMIC REMOTE SYSTEM |
STEPHANIX RADIOLOGICAL SYSTEMS |
DANIEL KAMM |
| K101992 |
10/01/2010 |
3D SCANNER, MODEL 1230 |
SUN NUCLEAR CORP. |
NOEL DOWNEY |
| K102604 |
10/07/2010 |
I-LOGIC INREACH SYSTEM |
SUPERDIMENSION, LTD. |
JONATHAN KOVACH |
| K102041 |
10/13/2010 |
AIXPLORER |
SUPERSONIC IMAGINE |
JACQUES SOUQUET |
| K102608 |
10/08/2010 |
SECURMARK BIOPSY SITE MARKING SYSTEM |
SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY |
ALYSSA M LOBO |
| K102096 |
10/04/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES, BLUE |
SYNTEX HEALTHCARE PRODUCTS CO. LTD. |
KATHY LIU |
| K102431 |
10/04/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN FUQIANG GLOVE CO., LTD. |
CHU XIAOAN |
| K102559 |
10/21/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K102570 |
10/21/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN KANGJIE GLOVE CO., LTD. |
CHU XIZOAN |
| K102569 |
10/21/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN KANGYUAN GLOVE CO., LTD. |
CHU XIAOAN |
| K102088 |
10/20/2010 |
JOURNEY INCLINED PLATFORM LIFT AND SUPRA CURVED INCLINE PLATFORM LIFT |
THYSSENKRUPP CETECO SRL |
FABRIZIO FEDELE |
| K100172 |
10/21/2010 |
TOKUYAMA SHIELD FORCE |
TOKUYAMA DENTAL CORPORATION |
KEITH BARRITT |
| K102758 |
10/26/2010 |
TRULIGHT 5520 AND TRULIGHT 5320 |
TRUMPF KREUZER MEDIZIN SYSTEME GMBH + CO.KG |
LINDSEY RONNENBERG |
| K100456 |
10/28/2010 |
CVUE ADVANCED DEFINITIVE |
UNILENS CORP., USA |
MARTIN DALSING |
| K101670 |
10/08/2010 |
UNITED U2 BIPOLAR IMPLANT |
UNITED ORTHOPEDIC CORP. |
FANG-= YUAN HO |
| K101847 |
10/21/2010 |
URGENT PC STIMULATOR; URGENT PC LEAD SET |
UROPLASTY, INC. |
MICHAEL MORRELL |
| K102916 |
10/20/2010 |
G-CATH TISSUE ANCHOR DELIVERY CATHETER |
USGI MEDICAL |
MARY L MOONEY |
| K102024 |
10/15/2010 |
RPM RESPIRATORY GATING SYSTEM |
VARIAN MEDICAL SYSTEMS |
VY TRAN |
| K102124 |
10/22/2010 |
DENTAL COMPUTED TOMOGRAPHY X-RAY SYSTEM |
VATECH CO., LTD. |
DAVE KIM |
| K103121 |
10/26/2010 |
ECO-S |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| K102277 |
10/06/2010 |
INTERFUSE T INVERTEBRAL BODY FUSION DEVICE |
VERTEBRAL TECHNOLOGIES, INC. |
SURESH GHAI |
| K102476 |
10/07/2010 |
TELERADPRO |
VIDAR SYSTEMS CORP. |
CARRIE L BRANCART |
| K100687 |
10/16/2010 |
VITALOGRAPH HAND HELD SPIROMETER, MODEL 2120 |
VITALOGRAPH(IRELAND) LTD. |
TOM J HEALY |
| K102347 |
10/29/2010 |
GRANDTEC |
VOCO GMBH |
T GERKENSMEIER |
| K102450 |
10/08/2010 |
IONOLUX PRO |
VOCO GMBH |
MANFRED T PLAUMANN |
| K101104 |
10/21/2010 |
REMIN PRO |
VOCO GMBH |
M. TH PLAUMANN |
| K102104 |
10/01/2010 |
GE VIVID P3 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
WIPRO GE HEALTHCARE PRIVATE, LTD. |
BRYAN BEHN |
| K101571 |
10/26/2010 |
XPER INFORMATION MANAGEMENT AND FLEX CARDIO PHYSIOMONITORING SYSTEMS |
WITT BIOMEDICAL CORP |
JAMES LUKER |
| K101035 |
10/29/2010 |
WMI REPROCESSED DVT WRAP, WMI REPROCESSED THERMAL WRAP MODEL: RD-1000F, RD-1000C, RT 2000A, RT 2000B, RT 2000KF, RT 2000 |
WMI ENTERPRISES LLC |
MIKE WILFORD |
| K092809 |
10/19/2010 |
HRV ACQUIRE |
WR MEDICAL ELECTRONICS CO. |
Gary Syring |
| K100443 |
10/28/2010 |
DEFINITIVE, FLEXLENS - SILICONE HYDROGEL |
X-CEL CONTACTS, INC. |
MARTIN DALSING |
| K091989 |
10/01/2010 |
PERFADEX AND PERFADEX WITH THAM |
XVIVO PERFUSION AB |
KJELL KJORK |
| K093837 |
10/01/2010 |
ATHENA MULTI-LYTE TREPONEMA PALLIDUM IGG PLUS TEST SYSTEM |
ZEUS SCIENTIFIC, INC. (ZEUS) |
EWA NADOLCZAK |
| K101880 |
10/01/2010 |
TAPERED SCREW-VENT T IMPLANT, TAPERED SCREW-VENT P IMPLANT |
ZIMMER DENTAL INC. |
MELISSA BURBAGE |
| K101622 |
10/01/2010 |
ZIMMER NATURAL NAIL SYSTEM RETROGRADE FEMORAL NAILS |
ZIMMER, INC. |
DANIEL J WILLIMAN |
| K101987 |
10/12/2010 |
COOL LINE CATHETER, MODEL CL-2295A, ICY CATHETER, MODEL IC-3893A AND QUATTRO CATHETER, MODEL IC-4593 |
ZOLL CIRCULATION |
SAM NANAVATI |
