| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K102377 |
11/18/2010 |
VENTIPLUS DISPOSABLE MANOMETER 0-60 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0-20 CM H2O; VENTIPLUS DISPOSABLE MANOMETER 0 |
A PLUS MEDICAL |
THOMAS C LOESCHER |
| K102234 |
11/24/2010 |
A-DEC 200 DENTAL SYSTEM |
A-DEC, INC. |
THOMAS H LOUISELL |
| K091052 |
01/15/2010 |
PICCOLO C-REACTIVE PROTEIN (CRP) TEST SYSTEM |
ABAXIS, INC. |
Dennis M Bleile |
| K103165 |
11/10/2010 |
BLOOD SAMPLING SET |
ACACIA, INC. |
FERGIE FERGUSON |
| K093022 |
01/20/2010 |
THE PICC WAND PEELABLE SAFETY INTRODUCER |
ACCESS SCIENTIFIC, INC. |
ALBERT MISAJON |
| K102650 |
11/17/2010 |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
| K093518 |
01/14/2010 |
ACE SURGICAL SECURE LOCATOR 3.25 IMPLANT SYSTEM |
ACE SURGICAL SUPPLY CO., INC. |
J. EDWARD CARCHIDI |
| K093657 |
01/15/2010 |
ADAGIO RETRACTING ECG LEAD WIRES |
ACIST MEDICAL SYSTEMS, INC. |
AL SAALABI |
| K093143 |
01/28/2010 |
MISSION BREATH ALCOHOL DETECTOR |
ACON LABORATORIES, INC. |
RICHARD LENART |
| K101794 |
11/29/2010 |
ASC TRIPORT LAPAROSCOPIC ACCESS DEVICE MODEL TPRT-02-01 (WA58000T), ASC QUADPORT LAPAROSCOPIC ASSCESS DEVICE QPRT-01 (WA |
ADVANCED SURGICAL CONCEPTS |
ROSINA ROBINSON |
| K092655 |
01/19/2010 |
C. ALBICANS PNA FISH |
ADVANDX, INC. |
PAULA E BULGER |
| K102240 |
11/10/2010 |
NIVO NEBULIZER SYSTEM |
AEROGEN IRELAND, LTD. |
CAITRIONA CONNEELY |
| K102505 |
11/24/2010 |
HTO PLATING SYSTEM |
AESCULAP IMPLANT SYSTEMS, LLC |
KATHY A RACOSKY |
| K103003 |
11/09/2010 |
AESCULAP- MEITHKE PROGAV PROGRAMMABLE SHUNT SYSTEM |
AESCULAP, INC. |
KATHY A RACOSKY |
| K101755 |
11/22/2010 |
AIDI DENTAL IMPLANT SYSTEM |
AIDI BIOMEDICAL LLC |
WILLIAM Y.S. HUNG |
| K101285 |
11/12/2010 |
CONSTELLATION VISION SYSTEM |
ALCON MANUFACTURING, LTD. |
MARTIN KAUFMAN |
| K102820 |
11/05/2010 |
APPLIANCE, FIXATION, SPINAL INTERVERTEBRAL BODY |
ALPHATEC SPINE, INC. |
KARLA SCHAFFNER |
| K093825 |
01/13/2010 |
AMBU NEUROLINE DISPOSABLE INOJECT NEEDLE ELECTRODE |
AMBU A/S |
SANJAY PARIKH |
| K091278 |
01/28/2010 |
VALEO SPACER SYSTEM |
AMEDICA CORP. |
ROBERT M WOLFARTH |
| K101654 |
11/10/2010 |
IMPROVIS IMAGING SYSTEM |
AMERICAN DENTAL PARTNERS, INC |
TIMOTHY RODENBERGER |
| K093495 |
11/19/2010 |
OTOSCOPE AND OPHTHALMOSCOPE DIAGNOSTIC INSTRUMENT KITS |
AMERICAN DIAGNOSTIC CORP. |
MICHAEL FALCO |
| K101220 |
11/05/2010 |
EXPLORER 4D TREATMENT PLANNING SYSTEM |
AMERICAN RADIOSURGERY, INC. |
DAN OLIVER |
| K093588 |
01/11/2010 |
EXPLORER 4D TREATMENT PLANNING SYSTEM |
AMERICAN RADIOSURGERY, INC. |
DAN OLIVIER |
| K102690 |
11/24/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
| K102930 |
11/03/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
| K100014 |
01/29/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-557 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K092811 |
01/13/2010 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODELS KD-7035B, KD-7921, KD-7903 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K102631 |
11/04/2010 |
KD-931D FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR |
ANDON HEALTH CO.,LTD |
LIU YI |
| K100199 |
11/26/2010 |
ANGIODYNAMICS, INC., PERCUTANEOUS INTRODUCER AND VENACUREEVLT PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K103282 |
11/16/2010 |
LAPAROSCOPIC DISSECTOR |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K101291 |
11/23/2010 |
SCANVIEW HER2/NEU FISH SYSTEM |
APPLIED SPECTRAL IMAGING, LTD. |
DAN LAOR |
| K093075 |
01/21/2010 |
ARAGON SURGICAL RF SYSTEM TELEO INSTRUMENT |
ARAGON SURGICAL INC. |
ALAN CURTIS |
| K101574 |
11/23/2010 |
ARK GABAPENTIN ASSAY, ARK GABEPENTIN CALIFRATOR, AND ARK GABAPENTIN CONTROL MODEL5025-0001-00, 5025-0002-00, 5025-0003-0 |
ARK DIAGNOSTICS,INC |
JOHNNY VALDEZ |
| K091674 |
01/15/2010 |
ARTHROCARE COBLATOR IQ SYSTEM |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K103057 |
11/19/2010 |
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K092047 |
01/14/2010 |
ASCENSION METAL GREAT TOE SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K101174 |
11/12/2010 |
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 |
ATRICURE, INC. |
JAMES LUCKY |
| K100076 |
01/26/2010 |
ATRIUM C-QUR OVT MESH |
ATRIUM MEDICAL CORP. |
Jacqueline Emery |
| K091863 |
01/21/2010 |
AWBAT-S PLUS, AWBAT-D PLUS, AWBAT-M PLUS |
AUBREY, INC. |
AUBREY WOODROF |
| K101882 |
11/03/2010 |
PRONTOSAN ANTIMICROBIAL WOUND GEL |
B. BRAUN MEDICAL, INC. |
MATTHEW J HOMA |
| K091387 |
01/22/2010 |
BTI DENTAL IMPLANT 5.5-6.5 |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
ALFREDO GOMEZ |
| K102146 |
11/18/2010 |
BAHADIR STERILIZATION TRAYS |
BAHADIR USA CORP. |
ISMAIL KILIC |
| K093855 |
01/15/2010 |
HALO 360 & SIZING BALLOON, MODEL 3441C |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K093008 |
01/08/2010 |
HALO ABLATION CATHETER, MODEL 90-9100 |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K100607 |
11/18/2010 |
COULTER 4C-EX 300 CELL CONTROL |
BECKMAN COULTER, INC. |
LOURDES COBA |
| K093972 |
01/21/2010 |
BD MICROTAINER MAP MICROTUBE FOR AUTOMATED PROCESS, MODEL 363706 |
BECTON DICKINSON & CO. |
JULIE T WING |
| K093013 |
01/08/2010 |
BLOOD PRESSURE MONITOR, MODEL MD200A |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEE FU |
| K092652 |
01/08/2010 |
FINGERTIP PULSE OXIMETER, MODEL MD300CA ND300CA |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K102073 |
11/08/2010 |
MED-RX TRANSFER SET, MODELS 10-1227TS, 10-1300TS, 10-1305TS AND 10-1306TS |
BENLAN, INC. |
E.J. Smith |
| K101105 |
11/10/2010 |
POWDER-FREE, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEPF1 |
BEST PUTRA GLOVES SDN BHD |
EFFENDI TENANG |
| K101106 |
11/10/2010 |
POWDERED, NATURAL COLOR, LATEX EXAMINATION GLOVE MODEL: MEP1 |
BEST PUTRA GLOVES SDN BHD |
EFFENDI TENANG |
| K093386 |
01/28/2010 |
CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FST |
BFW, INC |
LYNN COOPER |
| K093758 |
11/17/2010 |
BGM GALECTIN -3 |
BG MEDICINE, INC. |
Carol Adiletto |
| K100246 |
11/24/2010 |
MAX-IF1000 |
BIO PROTECH, INC. |
JUDY BURTON |
| K100565 |
11/16/2010 |
DURA PADZ (REUSABLE ELECTRODE), DURA PADZ GEL (DISPOSABLE HYDROGEL) MODEL 8900-0300, 8900-0325 |
BIO-DETEK, INC. |
ROBERT MORSE |
| K100917 |
11/03/2010 |
FIDIS VASCULITIS ASSAY KIT AND ANALYZER AND CARIS SYSTEM |
BIOMEDICAL DIAGNOSTICS (BMD) SA |
COURIVAUD CHRISTELLE |
| K102668 |
11/17/2010 |
ETEST TOBRAMYCIN 0.016-256 UG/ML AND 0.064-1024 UG/ML |
BIOMERIEUX |
ASA KARLSSON |
| K101582 |
11/08/2010 |
CAM STRUCTSURE BARS |
BIOMET 3I, INC. |
JOSE E CABRERA |
| K083384 |
01/05/2010 |
THERMODILUTION CATHETER |
BIOSENSORS INTL. PTE. LTD. |
MOSES THAM |
| K092541 |
11/09/2010 |
INTERFACE |
BIOSTRUCTURES |
DAVE BALDING |
| K102527 |
11/05/2010 |
IMAGER II UROLOGY TORQUE CATHETER (C1 TIP); IMAGER II UROLOGY TORQUE CATHETER (C2 TIP; IMAGER II UROLOGY TORQUE CATHETER |
Boston Scientific Corporation |
DANIEL HOAR |
| K102880 |
11/19/2010 |
BRIGHTWAY TM BRAND NITRILE EXAMINATION GLOVES, POWDER FREE, NON-STERILE. (GREY COLOR) |
BRIGHTWAY HOLDINGS SDN. BHD. |
NADARAJAN VENUGOPAL |
| K102409 |
11/04/2010 |
DEFENDO DISPOSABLE AIR/WATER VALVE MODEL 100304 |
BYRNE MEDICAL INC. |
JOHN WILLIS |
| K102581 |
11/08/2010 |
DEFENDO DISPOSABLE SUCTION VALVE MODEL 100305 |
BYRNE MEDICAL INC. |
JOHN WILLIS |
| K102855 |
11/19/2010 |
UNIVERSAL IRRIGATION SOLUTION HYBRID |
BYRNE MEDICAL, INC. |
JOHN WILLIS |
| K092739 |
01/12/2010 |
MICROENDOSCOPE MODEL S-0001 SINGLE LIGHT SOURCE, MICROENDOSCOPE, MODEL D-0001 DUAL LIGHT SOURCE STERILE |
C-LINK MICRO IMAGING, INC |
MARY P GALLUP |
| K093659 |
01/14/2010 |
ECLIPSE FILTER SYSTEM-FEMORAL DELIVERY KIT, ECLIPSE FILTER SYSTEM-JUGULAR/SUBCLAVIAN DELIVERY KIT MODEL RF500F MODEL RF5 |
C.R. BARD, INC. |
Joni Creal |
| K102159 |
11/17/2010 |
POWERPICC SV CATHETERS |
C.R. BARD, INC. |
JESSICA AGNELLO |
| K093065 |
01/20/2010 |
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 |
CALIBRA MEDICAL, INC. |
RICHARD J MEADER |
| K092684 |
01/22/2010 |
LAPAROSCOPIC RETRACTORS |
CARDINAL HEALTH, INC. |
SHARON NICHOLS |
| K102500 |
11/04/2010 |
STERILE NEOPRENE POWDER-FREE SURGICAL GLOVES WITH NITRILE COATING |
CARDINAL HEALTH, INC. |
TATYANA BOGDAN |
| K102147 |
11/19/2010 |
CARDIOQUIP MODULAR COOLER-HEATER MODEL MCH-1000 |
CARDIOQUIP LLP |
DOUGLAS PLATT |
| K092890 |
01/13/2010 |
ASTHMA MONITOR AM3 |
CAREFUSION GERMANY 234 GMBH |
ELMAR NIDERMEYER |
| K103090 |
11/19/2010 |
SPECTRA OPTIA R APHERESIS SYSTEM |
CARIDIANBCT, INC. |
PATTI ARNDT |
| K101182 |
11/03/2010 |
IOLMASTER 500 |
CARL ZEISS MEDITEC AG |
JUDITH A BRIMACOMBE |
| K091182 |
01/07/2010 |
CHAMPIONS IMPLANTS GMBH MIMI 1-PIECE PRECISION IMPLANT, MODEL 1000 UP TO 6000 |
CHAMPIONS IMPLANTS GMBH |
MARCUS WEINACKER |
| K100721 |
11/23/2010 |
LOCKING BONE SCREW MODEL HCQ04, HCZ04 |
CHANGZHOU ORTHMAR MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K101400 |
11/09/2010 |
LOCKING COMPRESSION PLATE |
CHANGZHOU ORTHMED MEDICAL INSTRUMENT CO., LTD. |
Diana Hong |
| K102669 |
11/17/2010 |
DIODE LASER THERAPY SYSTEM |
CHINA DAHENG GROUP, INC. |
Diana Hong |
| K102204 |
11/15/2010 |
CHOICE SPINE STARFIRE PEDICLE SCREW SYSTEM |
CHOICE SPINE, LP |
TODD HAWKINS |
| K103215 |
11/15/2010 |
CIANNA S1, SINGLE LUMEN BALLOON APPLICATOR KIT |
CIANNA MEDICAL |
GARY MOCNIK |
| K093713 |
01/19/2010 |
ULTRASOUND GENERAL PURPOSE GUIDANCE SYSTEM |
CIVCO MEDICAL INSTRUMENTS |
ARTHUR WARD |
| K093223 |
01/15/2010 |
COMPUMEDICS GRAEL SYSTEM, MODELS: GRAEL, GRAEL ECG |
COMPUMEDICS LIMITED |
STUART KING |
| K102657 |
11/17/2010 |
CONCENTRIC BALLOON GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K101534 |
11/24/2010 |
CONMED ALTRUS THERMAL TISSUE FUSION SYSTEM |
CONMED CORP. |
SHAWN REIDEL |
| K102339 |
11/23/2010 |
CONMED LINVATEC SEQUENT MENISCAL REPAIR DEVICE |
CONMED LINVATEC |
JAN FLEGEAU |
| K090345 |
01/07/2010 |
MENDASIL TWG GEL ANTIMICROBIAL SKIN AND WOUND GEL |
CONSEAL INTERNATIONAL, INC. |
STEPHEN C PERRY |
| K093195 |
01/21/2010 |
ECHOTIP ULTRA ENDOBRONCHIAL HIGH DEFINITION ULTASOUND NEEDLE, MODEL: ECHO-HD-22-EBUS-O |
COOK IRELAND LTD |
Jacinta Kilmartin |
| K093469 |
01/08/2010 |
CIAGLIA BLUE DOLPHIN BALLOON PERCUTANEOUS TRACHEOSTOMY INTRODUCER, MODEL: MULTIPLE, PREFIX C-PTBS |
COOK, INC. |
SUSANNE GALIN |
| K091339 |
01/05/2010 |
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
COOPERVISION, INC. |
LISA HAHN |
| K093472 |
11/23/2010 |
TRINITY ACETABULAR SYSTEM |
CORIN U.S.A. |
ASHLEA BOWEN |
| K103052 |
11/10/2010 |
V-LOC(TM) NONABSORBABLE WOUND CLOSURE DEVICE |
Covidien LLC |
JENNIFER BRENNAN |
| K103263 |
11/22/2010 |
ENDO GIA SINGLEUSE DUET TRS RELOAD WITH TRI0STAPLE TECHNOLOGY |
COVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO H |
FRANK GIANELLI |
| K090427 |
01/29/2010 |
URSA ANGIOGRAPHIC CATHETER |
CURATIVE MEDICAL TECHNOLOGY, INC. |
AMY MCKINNEY |
| K102337 |
11/08/2010 |
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE |
CURON SCIENTIFIC CO., LTD |
PETER WANG |
| K092923 |
01/06/2010 |
CYTORI PUREGRAFT 250/PURE SYSTEM |
CYTORI THERAPEUTICS, INC. |
KENNETH K KLEINHENZ |
| K102236 |
11/18/2010 |
HOVERTRANS TRANSFORMER WITH POWER DRIVE MODEL HTT-650P |
D.T. DAVIS ENTERPRISES LTD. T/A HOVERTECH INT'L |
SUSAN PAVELKO |
| K100628 |
11/24/2010 |
PLASMALUXLS |
DAAVLIN DISTRIBUTING CO. |
MICHELE THIEL |
| K090341 |
01/06/2010 |
MICHIGAN CRANIAL RESHAPING ORTHOSIS |
DANMAR PRODUCTS, INC. |
KAY FULLER, RAC |
| K092864 |
01/12/2010 |
AESPIRE 7900, AESPIRE VIEW |
DATEX-OHMEDA INC., A DIVISION OF INSTRUMENTARIUM C |
ADRIENNE LENZ |
| K082097 |
01/08/2010 |
DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE |
DEMETECH CORP. |
ANTHONY J DIMERCURIO |
| K092833 |
01/07/2010 |
ENDOMAX CORDLESS ENDODONTIC HANDPIECE |
DENTAMERICA |
ERIC HUANG |
| K102308 |
11/22/2010 |
SIMPLELINE II MODEL SOFX483408R, SOFX483410R TOTAL 44 MODELS |
DENTIUM CO., LTD. |
EUNKYUNG SON |
| K102080 |
11/23/2010 |
DEPUY RECLAIM REVISION HIP SYSTEM |
DEPUY (IRELAND) |
RHONDA MYER |
| K091994 |
01/07/2010 |
MOUNTAINEER LAMINOPLASTY SYSTEM |
DEPUY SPINE, INC. |
DAPHNEY GERMAIN |
| K103100 |
11/17/2010 |
MOUNTAINEER OCT SPINAL SYSTEM |
DEPUY SPINE, INC. |
EUGENE BANG |
| K101762 |
11/15/2010 |
VIPER F2 FACET FIXATION SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K102638 |
11/30/2010 |
DIAZYME HOMOCYSTEINE ASSAY BUFFER BASED CALIBRATORS |
DIAZYME LABORATORIES |
Abhijit Datta |
| K092827 |
01/08/2010 |
DIMELA OBSTERICAL FORCEPS, MODEL 72.1 XX XX |
DIMEDA INSTRUMENTE GMBH |
ANDREA PECSI |
| K100100 |
11/10/2010 |
DIO STEADY EXTERNAL IMPLANT SYSTEM |
DIO CORPORATION |
TIMOTHY LEE |
| K093185 |
01/22/2010 |
OWL UNIVERSAL RF SYSTEM URF-3AP (ML) |
DIROS TECHNOLOGY, INC. |
GEORGE DARMOS |
| K093587 |
01/21/2010 |
DENTAL MERCURY |
DMG USA, INC. |
PAMELA PAPINEAU |
| K102603 |
11/17/2010 |
SA FLOWABLE ADHESIVE |
DMG USA, INC. |
PAMELA PAPINEAU |
| K102255 |
11/23/2010 |
DMP ETCHING GEL |
DMP LTD |
DIMITRIS PRANTSIDIS |
| K102254 |
11/23/2010 |
DMP SINGLE BONDING |
DMP LTD |
DIMITRIS PRANTSIDIS |
| K102257 |
11/19/2010 |
NANOCERAM- BRIGHT |
DMP LTD |
DIMITRIS PRANTSIDIS |
| K101133 |
11/18/2010 |
SENSOMETRICS SOFTWARE |
DPCOM AS |
CONSTANCE BUNDY |
| K101368 |
11/18/2010 |
D. HEART MEDICAL INTRAVASCULAR ADMINISTRATION SET, SAFETY ACCES DEVICE AND ACCESSORIES |
DRAGON HEART MEDICAL, INC. |
JINA YU |
| K092479 |
01/11/2010 |
SDX-SPIRODYNR'X RADIOTHERAPY BREATHING CONTROL |
DYN'R |
XAVIER ISNARD |
| K093172 |
01/20/2010 |
QUANTITATIVE ELECTROCARDIOGRAPHIC DETECTOR (QED 1000) |
DYNACARDIA, INC. |
|
| K092589 |
01/28/2010 |
THERMOTEX PLATINUM SYSTEM |
EAS CONSULTING GROUP LLC |
EDUARDO MARCH |
| K100487 |
11/29/2010 |
EQUINOX CO2 LASER SYSTEM |
ECLIPSEMED GLOBAL, INC |
Connie Hoy |
| K093465 |
01/05/2010 |
FUSION SYSTEM |
ECLIPSEMED GLOBAL, INC |
IGOR GRADOV |
| K102531 |
11/17/2010 |
MUCOGRAFT |
ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K090401 |
01/08/2010 |
ORTHOSS |
ED. GEISTLICH SOEHNE AG FUR CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K100797 |
11/10/2010 |
FETAL MATERNAL MONITOR MODEL F9 EXPRESS AND EXPRESS |
EDAN INSTRUMENTS, INC. |
JIGAR SHAH |
| K101539 |
11/24/2010 |
VITAL SIGNS MONITOR MODEL M3B |
EDAN INSTRUMENTS, INC. |
RANDY JIANG |
| K093911 |
01/21/2010 |
FOGARTY OCCLUSION CATHETER |
EDWARDS LIFESCIENCES, LLC. |
PATRICIA A MILBANK |
| K093730 |
01/14/2010 |
PORT ACCESS SYSTEMS ENDODIRECT ARTERIAL CANNULA MODEL ED24 (OLD CODE WAS-DFK24) |
EDWARDS LIFESCIENCES, LLC. |
SPENCER WALKER |
| K092330 |
01/08/2010 |
OC-SENSOR DIANA IFOB TEST |
EIKEN CHEMICAL CO., LTD. |
|
| K102200 |
11/04/2010 |
INTEGRITY MODEL 1014284 |
ELEKTA LTD. |
ANDREW HEDGES |
| K102343 |
11/23/2010 |
EMERGE MEDICAL CANNULATED SCREW FIXATION SYSTEM |
EMERGE MEDICAL |
CURTIS RAYMOND |
| K102202 |
11/23/2010 |
GS 3000 |
EMSI |
CHERITA JAMES |
| K101940 |
11/19/2010 |
EQUASHIELD SYSTEM PROTECTIVE PLUS |
EQUASHIELD MEDICAL LTD |
ELISSA BURG |
| K091259 |
01/15/2010 |
ETHICON ENDO-SURGERY FLEXIBLE BIPOLAR HEMOSTASIS FORCEPS |
ETHICON ENDO-SURGERY, INC. |
RENEE ROWE |
| K093681 |
01/26/2010 |
MERIDIAN GUIDEWIRE |
EV3 NEUROVASCULAR |
DEBORAH BAKER-JANIS |
| K093866 |
01/13/2010 |
EVALVE STEERABLE GUIDE CATHETER |
EVALVE INC |
SEVRINA CIUCCI |
| K102215 |
11/09/2010 |
KIRSCHNER WIRES, STEINMAN PINS |
EVERGREEN ORTHOPEDIC RESEARCH LAB |
WAYNE MORSE |
| K103012 |
11/10/2010 |
EXACTECH BIOLOXDELTA / BIOLOX FEMORAL HEADS, 28MM OD, 32MM OD, 36MM OD, EXACTECH BIOLOX OPTION ADAPTERS/FEMORAL HEADS |
EXACTECH, INC. |
LINDY KNISELY |
| K102951 |
11/04/2010 |
EXACTECH EQUINOX FIXED ANGLE REPLICATOR PLATE (0MM,1.5MM,4.5MM), HUMERAL HEAD-SHORT (44MM,47MM), GLENOSPHERE (38MM,42MM) |
EXACTECH, INC. |
GRAHAM L CUTHBERT |
| K092900 |
01/07/2010 |
EXACTECH EQUINOXE PLATFORM FRACTURE STEM AND REVISION PLATFORM FRACTURE STEM |
EXACTECH, INC. |
TARA R PATTERSON |
| K102975 |
11/05/2010 |
NOVATION CROWN CUP WITH INTEGRIP ACETABULAR SHELL, CLUSTER-HOLE |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
| K102487 |
11/08/2010 |
NOVATION FEMORAL STEM, TAPERED 12/14 , STANDARD/EXTENDED OFFSET, PLASMA COATED, PRESS-FIT, SIZE 19/20 |
EXACTECH, INC. |
VLADISLAVA ZAITSEVA |
| K093360 |
01/11/2010 |
OPTETRAK LOGIC TOTAL KNEE SYSTEM TRAPEZOIDAL TIBIAL TRAY, SIZES 2.5F/1.5T-3.5F/4.5T |
EXACTECH, INC. |
PATRICK HUGHES |
| K092172 |
01/04/2010 |
EXEL I.V. EXTENSION SET |
EXELINT INTL. CO. |
ARMAND HAMID |
| K092831 |
01/14/2010 |
DISPOSABLE HYPODERMIC NEEDLE |
FEEL TECH |
PETER CHUN |
| K092257 |
01/26/2010 |
JALOSKIN |
FIDIA ADVANCED BIOPOLYMERS SRL |
SHARON A SEGAL |
| K092846 |
01/27/2010 |
AIRVO SERIES HUMIDIFIERS |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
| K102519 |
11/22/2010 |
FLEXSTENT BILIARY SELF EXPANDING STENT SYSTEM MODEL FLX-DDLLL-BX |
FLEXIBLE STENTING SOLUTIONS, INC. |
JOSEPH C GRIFFIN, III |
| K102170 |
11/24/2010 |
SIMPLEXA FLU A/B & RSV |
FOCUS DIAGNOSTICS, INC. |
TARA VIVIANI |
| K102548 |
11/26/2010 |
FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE |
FOOTPRINT MEDICAL INC. |
CLYDE N BAKER |
| K102245 |
11/09/2010 |
CARE ZY5BA OXYGEN CONCENTRATOR |
FOSHAN CARE MEDICAL TECHNOLOGY CO., LTD. |
KATHY GUO |
| K093162 |
01/22/2010 |
FIDELIS PLUS III D, AT FIDELIS D, POWERLASE AT D / FIDELIS PLUS III, AT FIDELIS, POWERLASE AT / FIDELIS ER III D, HT FID |
FOTONA D.D. |
STOJAN TROST |
| K101817 |
11/22/2010 |
LIGHTWALKER AT, MODEL M021-5AF/1, LIGHTWALKER DT, MODEL M021-5AF/2, LIGHTWALKER ST-E, MODEL M002-6A/2, LIGHTWALKER ST-N |
FOTONA D.D. |
STOJAN TROST |
| K093599 |
11/24/2010 |
ARROW ANATOMICAL SHOULDER SYSTEM |
FOURNITURES HOSPITALIERES INDUSTRIE |
PATRICIA DONNARD |
| K093370 |
01/21/2010 |
FU HONG INDUSTRIES LIMITED SOOTHER TEETHER |
FU HONG INDUSTRIES LTD. |
KEVIN WALLS, RAC |
| K092780 |
01/07/2010 |
INF 4160 PLUS, MODEL D-FJ31F |
FUJI DYNAMICS LIMITED |
CHING KONG LEE |
| K093427 |
01/21/2010 |
FDR ACSELERATE SYSTEM, DR-ID 200 FLAT PANEL DETECTOR |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
DEBBIE PEACOCK |
| K093071 |
11/17/2010 |
FUNDUS PHOTO OPHTHALMIC DIGITAL IMAGING SYSTEM, MODEL CFD-440 |
FUNDUS PHOTO, LLC |
DALE BRODSKY |
| K100364 |
11/03/2010 |
GAMBRO CARTRIDGE BLOOD SET LOW WEIGHT- LOW VOLUME, MODEL 003422-520 |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K102388 |
11/04/2010 |
VIVID I DIAGNOSTIC ULTRASOUND SYSTEM |
GE MEDICAL SYSTEM ISRAEL LTD. |
BRYAN BEHN |
| K102393 |
11/05/2010 |
VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM |
GE MEDICAL SYSTEM ISRAEL LTD. |
BRYAN BEHN |
| K093982 |
01/08/2010 |
XELERIS 3 PROCESSING AND REVIEW WORKSTATION |
GE MEDICAL SYSTEMS F.I. HAIFA |
ELI WERNER |
| K102231 |
11/03/2010 |
DISCOVERY NM 750B |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
ELI WERNER |
| K092925 |
01/06/2010 |
3D ASL |
GE MEDICAL SYSTEMS, LLC |
YUAN MA |
| K102615 |
11/18/2010 |
WIRELESS DR IMAGING OPTION-WDR1 |
GE MEDICAL SYSTEMS, LLC |
JOHN L SCHMIDT |
| K102015 |
11/19/2010 |
OSTEON, OSTEON SINUS, OSTEON LIFTING |
GENOSS CO., LTD. |
EUNKYUNG SON |
| K102048 |
11/09/2010 |
ATRAUMATIC VASCULAR CLAMPS |
GEOMED MEDIZIN- TECHNIK GMBH & CO. KG |
HARALD JUNG |
| K093125 |
01/27/2010 |
ALPHAXENON LIGHT 180 W AND 300 W |
GIMMI GMBH |
ULRICH HENZLER |
| K093368 |
01/27/2010 |
BUTTERFLY TONER MODEL GYM070 |
GLOBAL MARKETING PARTNERS DBA GYMMAX USA |
NICOLAAS BESSELING |
| K101784 |
11/26/2010 |
MOBICATH BI-DIRECTIONAL GUIDING SHEATH MODEL 1000182-XXX |
Greatbatch Medical |
Kristi Fox |
| K102540 |
11/16/2010 |
PTFE PORTABLE INTRODUCER |
Greatbatch Medical |
Kristi Fox |
| K103041 |
11/09/2010 |
VACUETTE BLOOD COLLECTION TUBE WITH LITHIUM HEPARIN AND GEL SEPARATOR |
GREINER BIO-ONE NORTH AMERICA, INC. |
Judi Smith |
| K091717 |
01/25/2010 |
ANY PLUS SPINAL FIXATION SYSTEM |
GS MEDICAL CO., LTD. |
WILLIAM F GREENROSE |
| K102074 |
11/02/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) |
GX CORPORATION SDN BHD |
CHO S FONG |
| K092447 |
01/07/2010 |
DIGITAL THERMOMETER (WITH DISPOSABLE THERMOMETER COVER), DT SERIES |
HANGZHOU HUA'AN MEDICAL & HEALTH INSTRUMENTS CO., |
JI BO |
| K092772 |
01/06/2010 |
PORTABLE X-RAY SYSTEM, MODEL HAND-RAY |
HANJIN DIGI-X CO., LTD. |
SHIN KUK YOO |
| K093807 |
01/08/2010 |
HARDYDISK AST TELAVANCIN,30UG |
HARDY DIAGNOSTICS |
WENDY PHILIPS |
| K093823 |
01/22/2010 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL888V, FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868JM |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K102546 |
11/17/2010 |
CHITOGAUZE |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KENDRA RATHKEY |
| K101547 |
11/22/2010 |
HENKE- SASS, WOLF PISTON SYRINGE (NORM-JET) |
HENKE-SASS WOLF, GMBH. |
LYNETTE HOWARD |
| K094016 |
11/19/2010 |
NEXT GENERATION INFUSED (R) OR TOWEL (HEMED), NEXT GENERATION INFUSED (R) OR TOWEL (WITH BINDING) MODEL HUCKCR17X27MH, H |
HINSON AND HALE MEDICAL TECHNOLOGIES, INC |
JEFFREY O STULL |
| K103184 |
11/10/2010 |
SILK'N FLASH N GO |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN |
| K103104 |
11/22/2010 |
SPECIAL ORTHOPAEDIC SOLUTIONS GLENOID SHOULDER COMPONENT |
HOWMEDICA OSTEONICS CORP |
AVITAL MERL-MARGULIES |
| K093433 |
01/28/2010 |
VARIAX ELBOW SYSTEM PLATE LINE EXTENSION |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
| K103118 |
11/19/2010 |
REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR |
HOYA PHOTONICS, INC. |
DONNA TEMPLEMAN |
| K101912 |
11/10/2010 |
THE INFRARED FOREHEAD THERMOMETER, MODEL FS-300&301 |
HUBDIC CO., LTD |
PETER CHUNG |
| K092828 |
01/29/2010 |
STATNET, MODEL 3100 |
HYDRODOT, INC |
KATHLEEN PRINCIPE |
| K102360 |
11/29/2010 |
ICESENCE 3 |
ICECURE MEDICAL LTD. |
ELISABETH SADKA |
| K102791 |
11/23/2010 |
EASYSUITE SURGICAL LIGHT CONTROL (ESLC) |
IMAGE STREAM MEDICAL, INC. |
BETH CYR |
| K103268 |
11/23/2010 |
OMNI EXPRESS |
INFINIUM MEDICAL |
JOHN OBRIEN |
| K082275 |
01/14/2010 |
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 |
INFOPIA CO., LTD |
MARIA F GRIFFIN |
| K092388 |
01/21/2010 |
DURAGEN PLUS DURAL REGENERATION MATRIX- SPINAL MATRIX, MODEL DP2013SM, INTEGRA SPINAL MEND DURAL REGENERATION MATRIX, MO |
INTEGRA LIFESCIENCES CORPORATION |
PETER ALLAN |
| K102802 |
11/23/2010 |
INTEGRA ELECTRODE TUNNELING NEEDLE |
INTEGRA LIFESCIENCES CORPORATION |
DEREK CAO |
| K093968 |
01/22/2010 |
OSV II LOW FLOW LOW PRO VALVE |
INTEGRA LIFESCIENCES CORPORATION |
DONNA MILLISKY |
| K093217 |
01/21/2010 |
5 MM HARMONIC ACE INSTRUMENT (USED WITH DA VINCI IS1200 & IS2000/IS3000 SYSTEM) |
INTUITIVE SURGICAL, INC. |
KAREN UYESUGI |
| K093331 |
01/28/2010 |
SR PHONARES NHC |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K102372 |
11/03/2010 |
OBS DISPOSABLE ELECTROSURGICAL PADS, MONOPOLAR, BIOPOLAR, MODELS GBS-DM, GBS-DB |
JIANGMEN CITY XINHUI BAISHENG MEDICAL EQUIPMENT CO |
CHEN XI |
| K100590 |
11/10/2010 |
EDGE CO2 LASER SYSTEM |
JM SYSTEM CO., LTD. |
SU-GUN LEE |
| K093054 |
11/15/2010 |
SCALP DURA RETRACTOR, MODEL KS00474 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K102994 |
11/03/2010 |
K-SHIELD ARTERIAL VENOUS FISTULA SET WITH ANTINEEDLE STICK PROTECTOR |
KAWASUMI LABORATORIES, INC. |
JACK PAVLO |
| K100720 |
11/18/2010 |
K-SHIELD PORT ACCESS INFUSION SET WITH HIGH PRESSURE TUBING |
KAWASUMI LABORATORIES, INC. |
SUZAN ONEL |
| K093445 |
01/19/2010 |
KEELER APPLANATION TONOMETER; T-TYPE KAT, K-TYPE KAT, (KAT) |
KEELER LTD. |
EUGENE R VANARSDALE |
| K093484 |
01/27/2010 |
PREMISE FLOWABLE MODIFIED |
KERR CORPORATION |
Wendy Garman |
| K092176 |
01/28/2010 |
TAKE 1 ADVANCED RIGID TRAY |
KERR CORPORATION |
Wendy Garman |
| K102666 |
11/09/2010 |
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
| K102349 |
11/24/2010 |
AERODR SYSTEM |
KONICA MINOLTA MEDICAL & GRAPHIC, INC. |
RUSSELL MUNVES |
| K093182 |
01/27/2010 |
SET GRI-FILL 3.0 |
LABORATORIOS GRIFOLS, S.A. |
SEBASTIAN GASCON |
| K100888 |
11/15/2010 |
MODIFICATION TO LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM |
LANX, INC. |
WILLIAM SANDUL |
| K102083 |
11/18/2010 |
VELSCOPE VX |
LED DENTAL INC. |
DAVID MORGAN |
| K101382 |
11/09/2010 |
DPL NUVE |
LED TECHNOLOGIES, LLC |
LEWIS WARD |
| K093231 |
01/14/2010 |
ALBOGRAFT VASCULAR PROSTHESIS |
LEMAITRE VASCULAR, INC. |
ERIN DALY |
| K093832 |
01/13/2010 |
LEVITRONIX CENTRIMAG PRIMARY AND BACKUP CONSOLES |
LEVITRONIX LLC. |
SUSAN K HAMANN |
| K100407 |
11/05/2010 |
LIFE SPINE INTERSPINOUS FIXATION SYSTEM |
LIFE SPINE |
CHARLES P GILL |
| K093200 |
01/19/2010 |
LIFE SPINE LUMBAR PLATE SYSTEM |
LIFE SPINE |
CHARLES GILL |
| K102484 |
11/09/2010 |
SEQURE SNARE SYSTEM |
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
SHI XIAOLI |
| K082586 |
01/04/2010 |
LIGHTWAVE PROFESSIONAL DELUXE |
LIGHTWAVE TECHNOLOGIES LLC |
MARIA F GRIFFIN |
| K093596 |
01/12/2010 |
LUMOS, MODEL R 72B |
LUMOS, INC |
DANIEL KAMM |
| K092555 |
01/05/2010 |
UNO NARROW IMPLANT |
M.I.S. IMPLANTS TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K101031 |
11/18/2010 |
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K090637 |
01/07/2010 |
CARDIO-WRAP |
MAST BIOSURGERY USA INC. |
KENNETH K KLEINHENZ |
| K093944 |
01/21/2010 |
MEDACTA TOTAL HIP PROTHESIS SYSTEM-AMISTEN H , QUADRA H, QUADRA S |
MEDACTA INTERNATIONAL, SA |
HEATHER NEELY |
| K102237 |
11/23/2010 |
PVS MODEL 1.0 |
MEDCOM GMBH |
STEFAN WALTER |
| K091954 |
01/08/2010 |
MICRO-STICK SET |
MEDCOMP |
Susan Pileggi |
| K091583 |
01/28/2010 |
MEDEFIL'S NORMAL SALINE I.V. FLUSH SYRINGE |
MEDEFIL, INC. |
PRADEEP AGGARWAL |
| K091557 |
01/04/2010 |
LUNG FLUTE THERAPEUTIC |
MEDICAL ACOUSTICS |
NICOLAAS J SMIT |
| K093364 |
01/25/2010 |
SOLO MICROPUMP INSULIN DELIVERY SYSTEM |
MEDINGO LTD. |
ARAVA HACOHEN |
| K093849 |
01/19/2010 |
ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
KYUNG-AM SHIM |
| K093349 |
01/07/2010 |
MEDLINE CURAD WOUND DRESSINGS |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K092250 |
01/21/2010 |
MEDLINE RED RUBBER URETHRAL CATHETER |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K102010 |
11/19/2010 |
VACUETTE PREMIUM SAFETY BLOOD COLLECTION SET |
MEDPRO SAFETY PRODUCTS, INC. |
H. CARL JENKINS |
| K102114 |
11/22/2010 |
MEDRANGE ELECTROSURGICAL GENERATOR |
MEDRANGE CORPORATION |
HARRY WOODS |
| K101808 |
11/08/2010 |
SHAPELOC-CL (CRUCIATE LIGAMENT) SOFT TISSIE FASTNER, SHAPELOC-ST (TENODESIS) SOFT TISSUE FASTNER |
MEDSHAPE SOLUTIONS |
JACK GRIFFS |
| K093593 |
01/20/2010 |
CELOX PRO, CELOX PRO OTC, CELOX HEMOSTATIC GRANULES, CELOX PRO HEMOSTATIC GRANULES, OMNI STAT PRO |
MEDTRADE PRODUCTS LIMITED |
JONATHAN RANFIELD |
| K093519 |
01/14/2010 |
MEDTRADE PRODUCTS CELOX VASCULAR TOPICAL HEMOSTATIC GRANULES ON SHEET |
MEDTRADE PRODUCTS LTD. |
JONATHAN D RANFIELD |
| K102953 |
11/04/2010 |
HEPARIN DOSE RESPONSE CARTRIDGE |
MEDTRONIC INC. |
JEFFERY L KOLL |
| K102555 |
11/17/2010 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
CHRIS MCKEE |
| K102807 |
11/17/2010 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK, INC. |
CHRIS MCKEE |
| K102072 |
11/03/2010 |
MEMOMETAL IMPLANTS (K-SNAP & TI-FUSE) |
MEMOMETAL TECHNOLOGIES |
GILLES AUDIC |
| K093947 |
01/21/2010 |
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM ENDOSCOPIC |
MERIT MEDICAL SYSTEMS, INC. |
CAROL HOLLOWAY, RAC |
| K092096 |
01/21/2010 |
ENDOFORM DERMAL TEMPLATE |
MESYNTHES LTD |
MARY MCNAMARA |
| K093520 |
01/05/2010 |
VIVOSIGHT TOPICAL OCT SYSTEM |
MICHELSON DIAGNOSTICS LTD. |
MARTIN JOHNS |
| K102365 |
11/18/2010 |
MICROPLEX COIL SYSTEM- COSMOS |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K093919 |
01/21/2010 |
MICROPLEX COIL SYSTEM-COSMOS MODEL 100933CSSR-V, 101036CSSR-V, 101141CSSR-V, 101245CSSR-V |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K093358 |
01/15/2010 |
MICROPLEX COIL SYSTEM-COSMOS, MODELS 81451CS-V, 181555CS-V, 16=81652CS-V |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K093111 |
01/05/2010 |
MIKRO-CATH, MODEL 825-0101 |
MILLAR INSTRUMENTS, INC. |
FATMA ALI |
| K091511 |
01/15/2010 |
MODERN MEDICAL RESECTOSCOPE ELECTRODES |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
EUGENE YEUNG |
| K101163 |
11/23/2010 |
BIOGEL ORTHOPRO INDICATOR UNDERGLOVE |
MOLNLYCKE HEALTH CARE USA |
ANGELA BUNN |
| K102923 |
11/19/2010 |
BARRIER N95 PARTICULATE RESPIRATOR |
MOLNLYCKE HEALTHCARE |
CAITLIN SENTER |
| K102433 |
11/18/2010 |
MOORVMS-PRES PRESSURE CUFF CONTROLLER |
MOOR INSTRUMENTS LTD. |
XIABING HUANG |
| K102112 |
11/18/2010 |
CRITICOOL PRO |
MTRE ADVANCED TECHNOLOGY LTD. |
IFAT OREN |
| K091425 |
01/21/2010 |
QUANTUM M COMPOSITE NAILING SYSTEM |
N.M.B. MEDICAL APPLICATIONS, LTD. |
JONATHAN S KAHAN |
| K091428 |
01/27/2010 |
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM |
NDD MEDIZITECHNIK AG |
GERARD MASIELLO |
| K093781 |
01/22/2010 |
MODIFIED: NEWDEAL HALLU PLATES |
NEWDEAL SAS |
STEPHEN BEIER |
| K091936 |
01/19/2010 |
BLADE ANTERIOR CERVICAL PLATE SYSTEM |
NEXXT MEDICAL INC |
KAREN E WARDEN |
| K093308 |
01/14/2010 |
MARK 5 NUVO 8 OCSI, MARK 5 NUVO 8 STD |
NIDEK MEDICAL PRODUCTS, INC. |
JENNIFER MCWILLIAMS |
| K093985 |
01/22/2010 |
NIPRO SAFETOUCH LOCKTAIL SAFETY FISTULA NEEDLE |
NIPRO MEDICAL CORP. |
JESSICA OSWALD |
| K092845 |
01/26/2010 |
RESPISENS |
NOMICS |
PIERRE ANSAY |
| K093693 |
01/19/2010 |
NORAS OR HEAD HOLDER S17000-MQ/ NORAS OR HEAD COIL 3T 7230-PH MODEL S1700-MQ/ 7230-PH |
NORAS MRI PRODUCTS GMBH |
ZAHED SEDIGHIANI |
| K091547 |
01/15/2010 |
NOVA MAX PLUS BLOOD GLUCOSE AND B-KETONE MONITOR SYSTEM, NOVA MAX PLUS B-KETONE CONTROL SOLUTIONS, NOVA MAX BLOOD GLUCOS |
NOVA BIOMEDICAL CORP. |
PAUL MACDONALD |
| K091360 |
11/03/2010 |
CLEARFLUX DIALYZER REPROCESSING SYSTEM |
NOVAFLUX TECHNOLOGIES |
MOHAMED E LABIB |
| K092224 |
01/25/2010 |
TIGR SURGICAL MESH , MODEL WK-6 |
NOVUS SCIENTIFIC PTE LTD |
KELVIN KOH |
| K092636 |
01/07/2010 |
POGS, MODEL 65/130 |
ON SITE GAS SYSTEMS, INC. |
GUY HATCH |
| K102583 |
11/02/2010 |
MUCHECK, VERSION 9.0 |
ONCOLOGY DATA SYSTEMS, INC. |
VINCENT RUMINER |
| K093923 |
01/19/2010 |
CEROX MODEL 3210 |
OR-NIM MEDICAL LTD. |
MICHAL BALBERG, PHD |
| K093055 |
11/22/2010 |
CSTS SCREW |
ORTHOPRO LLC |
J.D. WEBB |
| K092118 |
01/13/2010 |
ANGIOGRAPHIC CATHETER, MODEL ANGIOS |
Oscor Inc. |
MILA DOSKOCIL |
| K102326 |
11/15/2010 |
PARCUS 3.5MM PEEK CF PUSH-IN SUTURE ANCHOR |
PARCUS MEDICAL, LLC |
BARION BRACY |
| K102162 |
11/10/2010 |
PARCUS PEEK CF PUSH-IN SUTURE ANCHOR |
PARCUS MEDICAL, LLC |
BARTON BRACY |
| K093918 |
01/21/2010 |
JETSTREAM G3 L SYSTEM MODEL PV31400 (JETSTREAM G3 L CATHETER WITH CONTROL POD); PVCN100 (PV CONSOLE) |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIT BAIRD |
| K100598 |
11/19/2010 |
PENRITH ELETTRA ULTRASOUND SYSTEM |
PENRITH CORPORATION |
LAWRENCE ENGLE |
| K093970 |
01/15/2010 |
PICA CATHETER |
PENUMBRA, INC. |
SETH A SCHULMAN |
| K102790 |
11/29/2010 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVE, BLUE COLORED NON-STERILE (LOW DERAMATITIS POTENTIAL AND CHEMOTHERAPY DRUG |
PERUSAHAAN GETAH ASAS SDN BHD |
S F CHO |
| K092978 |
01/19/2010 |
IMMUNOCAP RAPID READER, MODEL 12-3600-10 |
PHADIA US INC. |
MARTIN MANN |
| K101538 |
11/05/2010 |
HANDHELD MANUAL BREAST PUMP (AVENT MANUAL BREAST PUMP) |
PHILIPS ELECTRONICS UK LIMITED |
DIANA KORDA HEWITT |
| K102344 |
11/09/2010 |
MDIXON SOFTWARE OPTION FOR INTERA 1.5T, ACHIEVA 1.5T & ACHIEVA 3.0T MR SYSTEMS |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LYNN HARMER |
| K093355 |
01/08/2010 |
PCR ELEVA 1.2 |
PHILIPS MEDICAL SYSTEMS, INC. |
LYNN HARMER |
| K102757 |
11/05/2010 |
LIFENET SYSTEM |
PHYSIO-CONTROL, INC. |
TERESA DAVIDSON |
| K093925 |
01/12/2010 |
LIFENET SYSTEM |
PHYSIO-CONTROL, INC. |
TERESA DAVIDSON |
| K103269 |
11/23/2010 |
PATCHASSIST LARGE |
POLYTOUCH MEDICAL LTD |
LEO BASTA |
| K090953 |
01/21/2010 |
TOTAL KNEE SURGETICS NAVIGATION SYSTEM WITH IBLOCK |
PRAXIM MEDIVISION, SA |
SEBASTIEN BURTIN |
| K083746 |
11/10/2010 |
BIOSIGN FLU A+B |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K090271 |
01/14/2010 |
HYDROCOAT MESH |
PROMETHEAN SURGICAL DEVICES, INC. |
KENNETH K KLEINHENZ |
| K092263 |
01/21/2010 |
ENDURAVENT-5 VENTILATOR |
PROVIDENCE GLOBAL MEDICAL, INC. |
HELEN REDD |
| K092878 |
01/15/2010 |
PRUTECT TOPICAL OINTMENT, MODELS 45 GRAM TUBE, 90 GRAM TUBE |
PRUGEN IP HOLDINGS, INC |
ROBERT L KNECHTEL |
| K102620 |
11/22/2010 |
POWDERFREE BLACK NITRILE EXAMINATION GLOVES |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K082805 |
01/20/2010 |
PAGUAMEDICINA STRUCTURAL HYDROGEL PEDIATRIC URETERAL STENT, MODEL NP330-XXX |
Q UROLOGICAL CORPORATION |
SCOTT M EPSTEIN |
| K093667 |
01/28/2010 |
SHOULDER SPEEDER COIL |
QUALITY ELECTRODYNAMICS |
CHRISTIE ZYDYK |
| K102198 |
11/05/2010 |
COMPACT TOUCH STS |
QUANTEL MEDICAL S.A. |
MIKE JOHNSON M.D. |
| K100050 |
01/29/2010 |
R & D SYSTEMS XERET HEMATOLOGY CONTROL |
R & D SYSTEMS, INC. |
NANCY RING |
| K091506 |
01/08/2010 |
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K102849 |
11/23/2010 |
ACCULMAING |
RADIOLOGY INFORMATION SYSTEMS, INC. |
E.J. Smith |
| K092273 |
11/01/2010 |
RANDOX ETHANOL ASSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K092258 |
11/09/2010 |
RANDOX METABOLITE (EDDP) ASSAY |
RANDOX LABORATORIES, LTD. |
P. ARMSTRONG |
| K092272 |
11/18/2010 |
RANDOX METHADONE ASSAY |
RANDOX LABORATORIES, LTD. |
PAULINE ARMSTRONG |
| K094020 |
01/25/2010 |
GRIND NO MORE GENERATION II |
RANIR LLC |
JONATHAN S KAHAN |
| K092933 |
01/14/2010 |
SAF (SELF ADJUSTING FILE) |
REDENT-NOVA LTD. |
JONATHAN S KAHAN |
| K101112 |
11/04/2010 |
RELIANCE SPINAL SCREW SYSTEM |
RELIANCE MEDICAL SYSTEMS |
BRET BARRY |
| K093658 |
01/14/2010 |
RENU MEDICAL VASOPRESS CALF , THIGH GARMENTS- ALL SIZESD, RENU MEDICAL VASOPRESS FOOT GARMENTS |
RENU MEDICAL, INC. |
L. BRUCE PIERSON |
| K092818 |
01/22/2010 |
BIPAP AVAPS VENTILATORY SUPPORT SYSTEM |
RESPIRONICS, INC. |
ZITA A YURKO |
| K093416 |
01/29/2010 |
TRILOGY 200 VENTILATOR |
RESPIRONICS, INC. |
ZITA YURKO |
| K102068 |
11/16/2010 |
MINIATURIZE CHEST COMPRESSOR (MCC) |
RESUSCITATION INTERNATIONAL |
ROBYN SCOPIS |
| K102043 |
11/18/2010 |
ULTRASTREAM CHRONIC HEMODIALYSIS CATHETER |
REX MEDICAL |
SUSAN D GOLDSTEIN- FALK |
| K102086 |
11/01/2010 |
ELECSYS CA 125 II CALCHECK 5 |
Roche Diagnostics |
KELLY FRENCH |
| K103162 |
11/18/2010 |
ELECSYS PTH CALCHECK 5 |
Roche Diagnostics |
KELLY FRENCH |
| K102445 |
11/10/2010 |
ROSTAM SCENTED AND UNSCENTED BIODEGRADABLE PLASTIC APPLICATOR TAMPONS |
ROSTAM LTD. |
ROBERT J STAAB |
| K092540 |
01/27/2010 |
C-PS PEEK OPTIMA CERVICAL INTERBODY SPACER, L-PS PEEK OPTIMA LUMBAR INTERBODY SPACER |
RSB SPINE LLC. |
KAREN WARDEN |
| K100450 |
11/18/2010 |
I-ROOT |
S-DENTI CO., LTD. |
TAE KYE NAM |
| K101619 |
11/12/2010 |
WELCH ALLYN 1500 PATIENT MONITOR |
SCHILLER AG |
SERKAN SEZER |
| K100920 |
11/29/2010 |
MESA II OXYGEN CONCENTRATOR MODEL: T2000 SERIES |
SEQUAL TECHNOLOGIES CO., LTD |
CEARO HUANG |
| K092346 |
01/07/2010 |
SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 |
SERIM RESEARCH CORP. |
PATRICIA RUPCHOCK |
| K091950 |
01/15/2010 |
SMART-WELL EZTEST INCUBATOR |
SGM BIOTECH, INC. |
JOHN R GILLIS |
| K101822 |
11/19/2010 |
NON-STERILE POWDER-FREE BLUE NITRILE EXAMINATION GLOVES TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
SGMP CO., LTD. |
JANNA P TUCKER |
| K101436 |
11/17/2010 |
PEARLESCENT POWDER FREE NITRILE EXAMINATION GLOVE WITH ALOE VERA (YELLOW, RED, GREEN, BLACK, BLUE) |
SHEN WEI (USA), INC. |
ABLERT LI |
| K093560 |
01/28/2010 |
UPCERA ZIRCONIA BLANKS |
SHENYANG UPCERA CO., LTD. |
STUART R GOLDMAN |
| K092627 |
01/14/2010 |
CT2011 SONICSTIMU PAIN RELIEF DEVICE |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ZHIGNAG ZHAO |
| K100117 |
01/29/2010 |
LT3000 COMBO STIMULATOR, LT3001 TENS STIMULATORY, LT3002 EMS STIMULATOR |
SHENZHEN DONGDIXIN TECHNOLOGY CO, LTD. |
ZHIGANG ZHAO |
| K102865 |
11/03/2010 |
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM, DC-3/DC-3T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K102988 |
11/09/2010 |
ELECTRONIC BLOOD PRESURE MONITOR |
SHENZHEN PANGO ELECTRONIC CO., LTD |
Diana Hong |
| K093822 |
01/28/2010 |
DOCKING STATION,TEIRSTEIN EDGE,ANGIOASSIST COMBINATION DEVICE, ANGIOASSIST FAMILY |
SHEPHERD SCIENTIFIC INC |
PAUL TEIRSTEIN |
| K102097 |
11/17/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
KATHY LIU |
| K102093 |
11/03/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
KATHY LIU |
| K093703 |
01/19/2010 |
3DI |
SHINA SYSTEMS LTD. |
DAN LAOR |
| K091867 |
01/14/2010 |
ADVIA CENTAUR SHBG READYPACK, LOW AND HIGH CALIBRATORS AND MASTER CURVE MATERIAL, MODELS 06520781, 04819274 AND 06520773 |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K102904 |
11/23/2010 |
ENHANCED ESTRADIOL (EE2) MASTER CURVE MATERIAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K093626 |
11/29/2010 |
INNOVANCE D-DIMER, MODEL OPBP09 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KATHLEEN A DRAY-LYONS |
| K091949 |
01/26/2010 |
MICROSCAN MICROSTREP PLUS, MODEL B1027-201 |
SIEMENS HEALTHCARE DIAGNOSTICS |
SHANNON POPSON |
| K100185 |
11/19/2010 |
SLEEP APP |
SLEEP MEDICINE NETWORK, INC. |
RICHARD MOORE |
| K092754 |
01/19/2010 |
SBI FOOT AND ANKLE CANNULATED SCREW SYSTEM, MODEL 100-0061 |
SMALL BONE INNOVATIONS INC. |
JOHN MINIER |
| K093550 |
01/07/2010 |
MINI RAIL EXTERNAL FIXATOR SYSTEM |
SMALL BONE INNOVATIONS, INC. |
JOHN MINIER |
| K093363 |
01/26/2010 |
COCR AND OXINIUM FEMORAL HEADS AND R3 XLPE LINERS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K092508 |
01/28/2010 |
FAST-FIX 360 MENISCAL REPAIR SYSTEM, STRIAGHT, CURVED, REVERSE CURVED,FAST FIX 360 AB MENISCAL REPAIR SYSTEM, STRAIGHT, |
SMITH & NEPHEW, INC. |
JULIE ACKER |
| K092098 |
01/22/2010 |
PATIENT SPECIFIC ACETABULAR RECONSTRUCTION PROSTHESIS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K102122 |
11/22/2010 |
SMITH & NEPHEW MILTI-PURPOSE STERILIZATION TRAY MODEL 72202428 |
SMITH & NEPHEW, INC. |
CHRISTINA FLORES |
| K102967 |
11/04/2010 |
SMITH & NEPHEW, INC. SURESHOT DISTAL TARGETING SYSTEM V2.0.2 |
SMITH & NEWPHEW, INC |
SHEREEN MYERS |
| K101519 |
11/05/2010 |
PARIETEX PLUG AND PATCH |
SOFRADIM PRODUCTION |
JAMES MCMAHON |
| K092162 |
01/06/2010 |
4CIS PEEK, PLIF AND TLIF CAGE SYSTEM |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K092110 |
01/20/2010 |
WAVEON FRACTURE REPAIR SYSTEM (WAVEON RX) |
SONOMA ORTHOPEDIC PRODUCTS, INC. |
CARLOS GONZALEZ |
| K102390 |
11/19/2010 |
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM |
SONOSITE,INC. |
JESSICA R STENBERG |
| K091328 |
01/22/2010 |
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE |
SOPHYSA SA |
GUSTAVO KOBRIN |
| K092583 |
01/13/2010 |
SOPROLIFE |
SOPRO |
RICK ROSATI |
| K093882 |
01/15/2010 |
SORIN C5 SYSTEM MODEL 58-00-00 |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON, RN, MED, RAC |
| K093986 |
01/22/2010 |
AF 620 PH.I.S.I.O., AF 640 PH.I.S.I.O. ARTERIAL FILTERS |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K103202 |
11/23/2010 |
PREASSEMBLED SURGICAL WASH SET |
SORIN GROUP ITALIA S.R.L. |
BARRY SALL |
| K102983 |
11/01/2010 |
VASCUCLEAR PRECISION BIPOLAR |
SORIN GROUP USA, INC. |
SCOTT LIGHT |
| K102478 |
11/03/2010 |
OTC ELASTO-GEL MANUKA HONEY WOUND DRESSING |
SOUTHWEST TECHNOLOGIES, INC. |
EDWARD I STOUT |
| K094036 |
01/25/2010 |
TURBO-TANDEM SYSTEM MODEL 472-110 |
SPECTRANETICS CORP. |
MICHAEL K HANDLEY |
| K102682 |
11/30/2010 |
STAXX(R) XD SYSTEM |
SPINE WAVE, INC. |
ROAIADA RIZKALLAH |
| K093092 |
01/21/2010 |
ODYSSEY WORKSTATION |
STEREOTAXIS, INC. |
DENNIS POZZO |
| K092158 |
01/14/2010 |
REPROCESSED ELECTROPHYSIOLOGY DIAGNOSTIC CATHETERS |
STERILMED, INC. |
DENNIS TOUSSAINT |
| K102217 |
11/22/2010 |
SYSTEM 1E CHEMICAL INDICATOR |
STERIS Corporation |
ROBERT F SULLIVAN |
| K092745 |
11/19/2010 |
VIS-U-ALL LOW TEMPERATURE TYVEK STERILIZATION POUCH FOR ETHYLENE OXIDE, MODELS: SELF AND HEAT SEAL POUCHES, HEAT SEAL TU |
STERIS Corporation |
ROBERT F SULLIVAN |
| K091794 |
01/28/2010 |
CARE2 MEDICAL NEBULIZER, MODEL 101/102, 201/202 |
STEVE ISLAVA |
JIM BARLEY |
| K103124 |
11/19/2010 |
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS |
STRYKER CORPORATION |
ESTELA CELI |
| K092743 |
01/15/2010 |
THE LEIBINGER ADVANCE INTERNAL MIDFACE DISTRACTION SYSTEM |
STRYKER CRANIOMAXILLOFACIAL |
ROBERT YAMASHITA |
| K101183 |
11/09/2010 |
MODIFICATION TO: OASYS SYSTEM |
STRYKER SPINE |
PAULINE SHAND |
| K093070 |
01/26/2010 |
DEVILBISS INTELLIPAP/ SLEEPCUBE BILEVEL ST, DV56 ST SERIES |
SUNRISE MEDICAL |
BETTY LOU MILLER |
| K102207 |
11/23/2010 |
FIBER FORCE |
SYNCA MARKETING, INC. |
DAVE KIM |
| K101321 |
11/09/2010 |
EMATRIX CO2 |
SYNERON MEDICAL LTD. |
AVI HIRSHNZON |
| K090025 |
01/08/2010 |
MATRIX RF APPLICATOR |
SYNERON MEDICAL LTD. |
YONI IGER |
| K093464 |
01/25/2010 |
RAPIDSORB PLUS SCREW SYSTEM |
SYNTHES (USA) |
SUSAN LEWANDOWSKI |
| K092909 |
01/11/2010 |
SYNTHES 7.3 MM CANNULATED SLIPPED CAPITAL FEMORAL EPIPHYSIS SCREWS (SCFE) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K092106 |
01/25/2010 |
U-RIGHT TD-3132 BLOOD PRESSURE MONITOR, FORA P 20 BLOOD PRESSURE MONITOR, MODEL TD-3132, TD-3132 |
TaiDoc Technology Corporation |
ERICA LI |
| K102558 |
11/12/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (WHITE) |
TANGSHAN HENGDA PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K101943 |
11/08/2010 |
SYNTHETIC, POWDER-FREE NITRILE EXAMINATION GLOVES |
TANGSHAN JITENG PLASTIC PRODUCTS CO., LTD. |
FRANK LIU |
| K092942 |
01/13/2010 |
VITAL SLEEP |
THE SNORE RELIEVER COMPANY LLC |
NICOLAAS BESSELING |
| K102067 |
11/05/2010 |
ENDOSKELETON TO |
TITAN SPINE, LLC |
RICH JANSEN |
| K103007 |
11/09/2010 |
AFFINITI TOTAL AND HEMI-SHOULDER SYSTEM |
TORNIER, INC. |
BRAHIM HADRI |
| K100067 |
01/28/2010 |
MODEL VIAMO SSA-640A, VERSION 2.0 ULTRASOUND SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K093891 |
11/18/2010 |
AQUILION ONE VERSION 4.6 W/DUAL ENERGY SCAN SYSTEM, MODEL TSX-301A/2 |
TOSHIBA MEDICAL SYSTEMS CORPORATION |
PAUL BIGGINS |
| K092728 |
11/19/2010 |
20.1 INCH (51 CM) COLOR LCD MONITOR CCL208 (CDL2013A) |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K092124 |
01/21/2010 |
AXIALIF 2L, AXIALIF 2-LEVEL SYSTEM, AXIALIF APOLLO, AXIALIF II |
TRANS1 INCORPORATED |
CHERYL WAGONER |
| K102646 |
11/03/2010 |
SPIDER FLEX MONOPOLAR HOOK |
TRANSENTERIX, INC. |
BOBBI L HADERSBECK |
| K093080 |
01/22/2010 |
METAPHOR METABOLIC MONITOR |
TREYMED, INC. |
ROBERT H RICCIARDELLI |
| K090312 |
01/05/2010 |
TRIA ACNE TREATMENT SYSTEM, MODEL ATS-1 OTC |
TRIA BEAUTY, INC. |
JONATHAN S KAHAN |
| K101244 |
11/18/2010 |
SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE |
TRUER MEDICAL INC. |
TIM TRUITT |
| K092893 |
01/14/2010 |
TYTAN AUTOMATIC ANEROID SPHYGMOMANOMETER, MODEL A730 AND MANUAL DIGITAL LCD SPHYGMOMANOMETER, MODEL A830 SERIES |
TYTAN MEDICAL CORP. |
Ke-Min Jen |
| K093021 |
01/28/2010 |
ATLANTIS SLIT LAMP |
USOPTHALMIC, LLC |
AL WEISENBORN |
| K093502 |
01/07/2010 |
VARI-LASE ENDOVENOUS LASER CONSOLE |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K093817 |
01/07/2010 |
GELWEAVE BRANCHED VASCULAR GRAFTS WITH RADIOPAQUE MARKERS |
VASCUTEK LTD. |
KAREN KELSO |
| K101590 |
11/29/2010 |
DIGITAL FLAT PANEL X-RAY DETECTOR |
VATECH CO., LTD. |
DAVE KIM |
| K090467 |
01/08/2010 |
DIGITAL X-RAY IMAGING SYSTEM, MODEL PAX-UNI3D |
VATECH CO., LTD. |
VINCENT LEE |
| K102626 |
11/12/2010 |
VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
| K093503 |
01/06/2010 |
INTRAX FILM PROCESSOR |
VELOPEX INTERNATIONAL, INC. |
ANTHONY URELLA |
| K100586 |
11/29/2010 |
VENUS FREEZE SYSTEM |
VENUS CONCEPT LTD |
YORAM LEVY |
| K093995 |
01/27/2010 |
IG 4 IMAGE GUIDED SYSTEM |
VERAN MEDICAL TECHNOLOGIES, INC. |
SCOTT WRIGHTSTONE |
| K103164 |
11/10/2010 |
VONFLEX HEAVY, VINFLEX LIGHT |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| K093271 |
01/27/2010 |
EXTENSION SET (STANDARDBORE TUBING), EXTENSION SET (MINIBORE TUBING), IV ADMINISTRATION SET ( STANDARD |
VICTUS, INC. |
ILEANA YANES |
| K093809 |
01/07/2010 |
VIDAR DENTAL FILM DIGITIZER |
VIDAR SYSTEMS CORP. |
CARRIE L BRANCART |
| K091765 |
01/19/2010 |
EBCARRYON BLOOD GLUCOSE MONITORING SYSTEM |
VISGENEER, INC. |
EVONNE CHEN |
| K102351 |
11/02/2010 |
GRANDIO SO |
VOCO GMBH |
MANFIELD T PLAUMANN |
| K102354 |
11/08/2010 |
GRANDIO SO HEAVY FLOW |
VOCO GMBH |
T GERKENSMEIER |
| K102612 |
11/19/2010 |
VOCO IONOFIL MOLAR AC QUICK |
VOCO GMBH |
T GERKENSMEIER |
| K083811 |
01/14/2010 |
W&H HANDPIECE ANESTO, MODEL: RA-5 |
W & H DENTALWERK BUERMOOS GMBH |
JOHANN G SCHARL |
| K093500 |
01/19/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES, WHITE (NON-COLORED) OR BLUE (COLORED), NON-STERILE |
WEAR SAFE (MALAYSIA) SDN. BHD. |
S.H. TAN |
| K093950 |
01/22/2010 |
BIOFOAM BONE WEDGE MODEL ASSORTED |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELLEN HILLS |
| K102429 |
11/23/2010 |
ORTHOLOC 3DI ANKLE PLATING SYSTEM, ORTHOLOC BONE SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
MEGAN MCCAGH |
| K102171 |
11/16/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
WUXI BINGFA GAINLITE GLOVES CP., LTD |
CHENGYU SHEN |
| K092360 |
01/22/2010 |
ACP4 SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K101471 |
11/24/2010 |
AXLE INTERSPINOUS FUSION SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K102108 |
11/23/2010 |
CLICKFINE PEN NEEDLE |
YPSOMED AG |
MANFRED MADER |
| K102444 |
11/22/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO YINGBO MEDICAL PRODUCTS, INC. |
FRANK LIU |
