| 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 |
| K103165 |
11/10/2010 |
BLOOD SAMPLING SET |
ACACIA, INC. |
FERGIE FERGUSON |
| K102650 |
11/17/2010 |
CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM |
ACCURAY INCORPORATED |
ANNE SCHLAGENHAFT |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K103057 |
11/19/2010 |
ASAHI ASTATO XS 20 PERIPHERAL GUIDE WIRE |
ASAHI INTECC CO., LTD. |
YOSHI TERAI |
| K101174 |
11/12/2010 |
ATRICURE BIPOLAR SYSTEM INCLUDING ISOLATOR SYNERGY DUAL ELECTRODE CLAMPS MODEL OLL2, OSL2, EMR2, EML2 |
ATRICURE, INC. |
JAMES LUCKY |
| K101882 |
11/03/2010 |
PRONTOSAN ANTIMICROBIAL WOUND GEL |
B. BRAUN MEDICAL, INC. |
MATTHEW J HOMA |
| K102146 |
11/18/2010 |
BAHADIR STERILIZATION TRAYS |
BAHADIR USA CORP. |
ISMAIL KILIC |
| K100607 |
11/18/2010 |
COULTER 4C-EX 300 CELL CONTROL |
BECKMAN COULTER, INC. |
LOURDES COBA |
| 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 |
| 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 |
| 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 |
| K102159 |
11/17/2010 |
POWERPICC SV CATHETERS |
C.R. BARD, INC. |
JESSICA AGNELLO |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K102337 |
11/08/2010 |
SYNTHETIC VINYL EXAMINATION GLOVES, POWDER FREE |
CURON SCIENTIFIC CO., LTD |
PETER WANG |
| 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 |
| 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 |
| 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 |
| K100100 |
11/10/2010 |
DIO STEADY EXTERNAL IMPLANT SYSTEM |
DIO CORPORATION |
TIMOTHY LEE |
| 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 |
| K100487 |
11/29/2010 |
EQUINOX CO2 LASER SYSTEM |
ECLIPSEMED GLOBAL, INC |
Connie Hoy |
| K102531 |
11/17/2010 |
MUCOGRAFT |
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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| K102231 |
11/03/2010 |
DISCOVERY NM 750B |
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING |
ELI WERNER |
| 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 |
| 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 |
| K102074 |
11/02/2010 |
POWDER FREE NITRILE EXAMINATION GLOVES, TESTED FOR USE WITH CHEMOTHERAPY DRUGS, BLUE (SG) |
GX CORPORATION SDN BHD |
CHO S FONG |
| 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 |
| 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 |
| 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 |
| K102802 |
11/23/2010 |
INTEGRA ELECTRODE TUNNELING NEEDLE |
INTEGRA LIFESCIENCES CORPORATION |
DEREK CAO |
| 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 |
| 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 |
| 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 |
| K100407 |
11/05/2010 |
LIFE SPINE INTERSPINOUS FIXATION SYSTEM |
LIFE SPINE |
CHARLES P GILL |
| K102484 |
11/09/2010 |
SEQURE SNARE SYSTEM |
LIFETECH SCIENTIFIC (SHENZHEN) CO., LTD. |
SHI XIAOLI |
| K101031 |
11/18/2010 |
MASIMO DISPOSABLE OXIMETRY EAR SENSOR, MODEL E1 |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K102237 |
11/23/2010 |
PVS MODEL 1.0 |
MEDCOM GMBH |
STEFAN WALTER |
| 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 |
| 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 |
| K102365 |
11/18/2010 |
MICROPLEX COIL SYSTEM- COSMOS |
MICROVENTION, INC. |
LARAINE PANGELINA |
| 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 |
| K091360 |
11/03/2010 |
CLEARFLUX DIALYZER REPROCESSING SYSTEM |
NOVAFLUX TECHNOLOGIES |
MOHAMED E LABIB |
| K102583 |
11/02/2010 |
MUCHECK, VERSION 9.0 |
ONCOLOGY DATA SYSTEMS, INC. |
VINCENT RUMINER |
| K093055 |
11/22/2010 |
CSTS SCREW |
ORTHOPRO LLC |
J.D. WEBB |
| 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 |
| K100598 |
11/19/2010 |
PENRITH ELETTRA ULTRASOUND SYSTEM |
PENRITH CORPORATION |
LAWRENCE ENGLE |
| 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 |
| 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 |
| K102757 |
11/05/2010 |
LIFENET SYSTEM |
PHYSIO-CONTROL, INC. |
TERESA DAVIDSON |
| K103269 |
11/23/2010 |
PATCHASSIST LARGE |
POLYTOUCH MEDICAL LTD |
LEO BASTA |
| K083746 |
11/10/2010 |
BIOSIGN FLU A+B |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K102620 |
11/22/2010 |
POWDERFREE BLACK NITRILE EXAMINATION GLOVES |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K102198 |
11/05/2010 |
COMPACT TOUCH STS |
QUANTEL MEDICAL S.A. |
MIKE JOHNSON M.D. |
| 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 |
| K101112 |
11/04/2010 |
RELIANCE SPINAL SCREW SYSTEM |
RELIANCE MEDICAL SYSTEMS |
BRET BARRY |
| 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 |
| 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 |
| 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 |
| 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 |
| K102093 |
11/03/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
KATHY LIU |
| K102097 |
11/17/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG GREAT VISION PLASTIC PRODUCTS CO., LT |
KATHY LIU |
| 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 |
| K100185 |
11/19/2010 |
SLEEP APP |
SLEEP MEDICINE NETWORK, INC. |
RICHARD MOORE |
| 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 |
| K102390 |
11/19/2010 |
SONOSITE NANOMAXX SERIES ULTRASOUND SYSTEM |
SONOSITE,INC. |
JESSICA R STENBERG |
| 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 |
| K102682 |
11/30/2010 |
STAXX(R) XD SYSTEM |
SPINE WAVE, INC. |
ROAIADA RIZKALLAH |
| 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 |
| K103124 |
11/19/2010 |
SERIES II X3 LARGE DIAMETER ACCETABULAR INSERTS |
STRYKER CORPORATION |
ESTELA CELI |
| K101183 |
11/09/2010 |
MODIFICATION TO: OASYS SYSTEM |
STRYKER SPINE |
PAULINE SHAND |
| K102207 |
11/23/2010 |
FIBER FORCE |
SYNCA MARKETING, INC. |
DAVE KIM |
| K101321 |
11/09/2010 |
EMATRIX CO2 |
SYNERON MEDICAL LTD. |
AVI HIRSHNZON |
| 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 |
| 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 |
| 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 |
| K102646 |
11/03/2010 |
SPIDER FLEX MONOPOLAR HOOK |
TRANSENTERIX, INC. |
BOBBI L HADERSBECK |
| K101244 |
11/18/2010 |
SKIN SENSOR PROBE, GENERAL PURPOSE PROBE, TYMPANIC PROBE |
TRUER MEDICAL INC. |
TIM TRUITT |
| K101590 |
11/29/2010 |
DIGITAL FLAT PANEL X-RAY DETECTOR |
VATECH CO., LTD. |
DAVE KIM |
| K102626 |
11/12/2010 |
VEGA MEDICAL SUCTION EQUIPMENT, MODEL SU-01/SU-DC01 |
VEGA TECHNOLOGIES, INC. |
JOSEPH LU |
| K100586 |
11/29/2010 |
VENUS FREEZE SYSTEM |
VENUS CONCEPT LTD |
YORAM LEVY |
| K103164 |
11/10/2010 |
VONFLEX HEAVY, VINFLEX LIGHT |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| 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 |
| 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 |
| 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 |
