| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K093169 |
11/12/2009 |
SURGIPLUS STANDARD SURGICAL GOWN (STERILE) ( NON STERILE), REINFORCED SURGICAL GOWN (STERILE) (NON STERILE) |
A PLUS INTERNATIONAL, INC. |
SOLOMON CHEN |
| K092687 |
11/23/2009 |
VENTI.PLUS HYPERINFLATION BAG SYSTEM WITH PRESSURE MANOMETER |
A PLUS MEDICAL |
THOMAS LOESCHER |
| K082534 |
11/02/2009 |
ETEST VORICONAZOLE 0.002-32 UG/ML |
AB BIOMERIEUX |
ANETTE ENGELHARDT |
| K090730 |
11/13/2009 |
AKITA JET |
ACTIVAERO AMERICA, INC. |
PAUL DRYDEN |
| K092503 |
11/19/2009 |
RADAR VASCULAR COMPRESSION DEVICES |
ADVANCED VASCULAR DYNAMICS |
MATTHEW SEMLER |
| K092166 |
11/23/2009 |
S. AUREUS/CNS PNA FISH, MODEL KT005 |
ADVANDX, INC. |
PAULA E BULGER |
| K092669 |
11/06/2009 |
DX-D IMAGING PACKAGE |
AGFA HEALTHCARE N.V. |
JEFFERY A JEDLICKA |
| K093488 |
11/20/2009 |
ALOKA PROSOUND ALPHA 6 DIAGNOSTIC ULTRASOUND SYSTEM |
ALOKA CO., LTD. |
RICHARD CEHOVSKY |
| K092568 |
11/17/2009 |
SPARTAN S3 FACET SYSTEM |
AMENDIA, INC. |
RICHARD JANSEN |
| K092826 |
11/12/2009 |
ASAP ANTIMICROBIAL SILVER WOUND DRESSING GEL |
AMERICAN BIOTECH LABS |
MIRIAM PROVOST |
| K092735 |
11/09/2009 |
GREENLIGHT XPS LASER SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
DARLENE-CROCKET BILLIG |
| K093387 |
11/27/2009 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR MODEL KD-5961, KD-5962, KD-5902 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K093296 |
11/05/2009 |
ALEXIS LAPAROSCOPIC SYSTEM |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K091653 |
11/02/2009 |
ARK LEVETIRACETAM ASSAY, ARK LEVETIRACETAM CALIBRATOR AND ARK LEVETIRACETAM CONTROL, MODELS 5024-0001-00, 5024-0002-00 |
ARK DIAGNOSTICS,INC |
JOHNNY VALDEZ |
| K092104 |
11/24/2009 |
ASSURE PLATINUM BLOOD GLUCOSE MONITORING SYSTEM |
ARKRAY Factory USA, Inc. |
HAMID IDRISSI |
| K092133 |
11/05/2009 |
ARTHROCARE TITANIUM SUTURE ANCHOR, MODEL 22-9055,22-9055N, 22-9065, 22-9065N |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K092440 |
11/05/2009 |
ASCENSION CANNULATED SCREW SYSTEM |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K092597 |
11/12/2009 |
CENTROS CHRONIC HEMODIALYSIS CATHETER SET |
ASH ACCESS TECHNOLOGY, INC. |
ROLAND WINGER |
| K093187 |
11/05/2009 |
MODIFICATION TO THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM |
AVANTIS MEDICAL SYSTEMS, INC. |
ELAINE APLAON |
| K092959 |
11/27/2009 |
AVITA RADAR THERMO IR THERMOMETER, MODEL NT 152 |
AVITA CORPORATION |
JENNIFER REICH |
| K092313 |
11/04/2009 |
PERFUSOR SPACE INFUSION SYRINGE PUMP SYSTEM |
B. BRAUN MEDICAL, INC. |
SUSAN OLINGER |
| K092487 |
11/10/2009 |
HALOFLEX ENERGY GENERATOR, MODELS 1190A-115A AND 1190A-230A |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K083757 |
11/18/2009 |
BPZ02 MULTIPURPOSE SOLUTION |
BAUSCH & LOMB, INC. |
GLENN A DAVIES, O.D. |
| K092877 |
11/17/2009 |
INDISCAL ASPIRATION DEVICE AND ACCESSORIES |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K091724 |
11/13/2009 |
BD PROBETEC CHLAMYDIA TRACHOMATIS (CT) Q AMPLIFIED DNA ASSAY |
BECTON DICKINSON & CO. |
SABA MODJARRAD |
| K091730 |
11/13/2009 |
BD PROBETEC NEISSERIA GONORRHOEAE (GC) QX AMPLIFIED DNA ASSAY |
BECTON, DICKINSON & CO. |
SABA MODJARRAD |
| K091272 |
11/10/2009 |
BESMED JET NEBULIZER BOTTLE SET |
BESMED HEALTH BUSINESS CORP. |
Ke-Min Jen |
| K092549 |
11/16/2009 |
OXIPROBE, MODELS BM-100, BM-200, BM-400, BM-300, BM-300S, BM-600P |
BIO MEDICAL TECHNOLOGIES CO., LTD |
CATHRYN CAMBRIA |
| K091248 |
11/30/2009 |
MAXEMS, MODELS 1000 AND 2000 |
BIO PROTECH, INC. |
JUDY BURTON |
| K092732 |
11/25/2009 |
PROPENCIL ESU PENCIL |
BIO PROTECH, INC. |
KEVIN HAN |
| K092761 |
11/24/2009 |
PROPLATE, MODELS 9641C, 9641F, P9641C, P9641F, 9642C, 9642F AND P9642C |
BIO PROTECH, INC. |
JUDY BURTON |
| K093224 |
11/09/2009 |
DENSICHECK PLUS |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K092341 |
11/30/2009 |
LOW PROFILE ABUTMENTS - INTERNAL AND EXTERNAL CONNECTION |
BIOMET 3I, INC. |
JOSE E CABRERA |
| K091914 |
11/06/2009 |
OMNIS HEALTH EMBRACE GLUCOSE CONTROL SOLUTION |
BIONOSTICS, INC. |
MINNA RANNIKKO |
| K093032 |
11/13/2009 |
TRIAGE TOTAL 3 CONTROLS AND CALIBRATION VERIFICATION SET |
BIOSITE INCORPORATED |
MARA CALER |
| K091815 |
11/16/2009 |
SUPERCHECK 1 BLOOD GLUCOSE MONITORING SYSTEM, MODEL 6268 |
Biotest Medical Corp. |
DIANE MANDELL HORWITZ |
| K093303 |
11/20/2009 |
SCOUTPRO 7F LONG CATHETERS |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K092009 |
11/06/2009 |
MODIFICATION TO: LEVEEN SUPERSLIM NEEDLE ELECTRODES, MODELS M001262260, M001262270, M001262280, M001262290 |
Boston Scientific Corporation |
JENNIFER KIMBALL |
| K093423 |
11/17/2009 |
LUNGPOINT PROCEDURE PLANNING |
BRONCUS TECHNOLOGIES, INC. |
NANCY ISAAC |
| K092191 |
11/25/2009 |
EXILIS, MODEL 5000 |
BTL INDUSTRIES LTD |
RICHARD VINCINS |
| K092090 |
11/30/2009 |
ERBELIFT HAND PUMP AND FLEXIBLE PROBE |
BYRNE MEDICAL INC. |
CHRIS HIERHOLZER |
| K092429 |
11/19/2009 |
ENDOGATOR |
BYRNE MEDICAL, INC. |
DON BYRNE |
| K092607 |
11/20/2009 |
AJUST ADJUSTABLE SINGLE INCISION SLING |
C.R. BARD, INC. |
JOHN C KNORPP |
| K090739 |
11/10/2009 |
BARD SACROCOLPOPEXY GRAFT |
C.R. BARD, INC. |
TERRI MORRIS |
| K093068 |
11/10/2009 |
FINESSE ULTRA BREAST BIOSPY SYSTEM DRIVER - BLUE, PINK, PROBE FO1BLU, FOIPNK, F14105US |
C.R. BARD, INC. |
CINDY MOSS |
| K083273 |
11/19/2009 |
MICRODOT XTRA |
CAMBRIDGE SENSORS LIMITED |
WARREN REEVES |
| K090915 |
11/18/2009 |
STERILE WATER FOR INHALATION FLEX BAG, USP |
CARDINAL HEALTH, INC. |
KIMBERLY SOUTHWELL |
| K093521 |
11/25/2009 |
GDXPRO |
CARL ZEISS MEDITEC INC |
JUDY A BRIMACOMBE |
| K090584 |
11/24/2009 |
INTRABEAM SYSTEM WITH BALLOON APPLICATOR AND CBG SETS |
CARL ZEISS SURGICAL GMBH |
MARK W SHEEHAN |
| K092868 |
11/20/2009 |
CELLAVISION DM1200 AUTOMATED HEMATOLOGY ANALYZER, MODEL XU-10127 |
CELLAVISION AB |
CONSTANCE G BUNDY |
| K092384 |
11/04/2009 |
LIQUICORD |
CENTRIX, INC. |
ROGER MASTRONY |
| K093134 |
11/27/2009 |
CERNER CAREAWARE IBUS |
CERNER CORP. |
SHELLEY S LOOBY |
| K091531 |
11/02/2009 |
CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER |
CHOICE SPINE, LLP |
G.TODD HAWKINS |
| K080459 |
11/17/2009 |
CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS |
CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH |
CATHY CAMBRIA |
| K092362 |
11/02/2009 |
SLEEPWEAVER NASAL CPAP MASK |
CIRCADIANCE LLC |
DAVID GROLL |
| K092619 |
11/13/2009 |
ETRAX NEEDLE SYSTEM, ETRAX VARIABLE ANGLE NEEDLE GUIDANCE SYSTEM, VIRTUTRAX UNIVERSAL TRACKER |
CIVCO |
JAMES LEONG |
| K090326 |
11/25/2009 |
RET CAM II, RETCAM 3 AND RETCAM SHUTTLE AND PORTABLE OPHTHALMIC IMAGING SYSTEMS |
CLARITY MEDICAL SYSTEMS |
GARY A SEEGER |
| K093184 |
11/06/2009 |
ENVOY GUIDING CATHETERS |
Codman & Shurtleff, Inc. |
KATHRYN LAROSE |
| K083770 |
11/23/2009 |
COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM |
COLOPLAST A/S |
JANELL A COLLEY |
| K092160 |
11/27/2009 |
POWDERFREE NITRILE (DARK BLUE) EXAMINATION GLOVES |
COMFORT RUBBER GLOVES IND. SDN. BHD. |
TAN KENG BENG |
| K093389 |
11/17/2009 |
CSI MODEL 5K MANAGED HEALTH SYSTEM KIOSK |
COMPUTERIZED SCREENING, INC. |
SAM KUMAR |
| K092298 |
11/05/2009 |
MODIFICATION TO MODIFIED HD GUIDE CATHETER |
CONCENTRIC MEDICAL, INC. |
KIRSTEN VALLEY |
| K092954 |
11/06/2009 |
CADSTREAM VERSION 5 |
CONFIRMA, INC. |
BRENT LEWIS |
| K092359 |
11/02/2009 |
ECHO TIP ULTRA HIGH DEFINITION ULTRASOUND ACCESS NEEDLE, MODEL: ECHO-HD-19A |
COOK IRELAND LTD |
TRACY MORIARTY |
| K092730 |
11/20/2009 |
COSMEDENT BRUSHABLE COMPOSITE |
COSMEDENT, INC. |
JAMES L SANDRIK |
| K092364 |
11/03/2009 |
MODEL 220 PATIENT MAGNET |
CYBERONICS, INC. |
KAREN STUEBER |
| K092473 |
11/25/2009 |
EXPEDIUM SPINE SYSTEM |
DEPUY SPINE,INC |
LISA GILMAN |
| K092317 |
11/02/2009 |
DEROYAL NON-STERILE LOCKING COMPRESSION PLATE SYSTEM |
DEROYAL INDUSTRIES, INC. |
GRACIE GREENWAY |
| K091309 |
11/05/2009 |
REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX |
DGIMED ORTHO, INC |
SCOTT YOUNGSTROM |
| K092113 |
11/13/2009 |
STA - FREE PS CALIBRATOR |
DIAGNOSTICA STAGO, INC. |
UMBERTO V PARROTTA |
| K091382 |
11/16/2009 |
KRYPTONITE BONE CEMENT |
DOCTORS RESEARCH GROUP, INC. |
JUSTIN EGGLETON |
| K092999 |
11/24/2009 |
NBP CUFF |
DRAEGER MEDICAL AG & CO. KG |
JOYCE KILROY |
| K092670 |
11/19/2009 |
BIODRIVE MICRO SCREW SYSTEM |
EBI,LLC D/B/A BIOMET TRAUMA |
SHIKHA GOLA |
| K092997 |
11/10/2009 |
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K090682 |
11/19/2009 |
EDWARDS AQUARIUS SYSTEM, MODEL GE-F098-00 |
EDWARDS LIFESCIENCES SERVICES GMBH |
NEIL R ARMSTRONG |
| K092741 |
11/10/2009 |
COLOR LCD MONITOR, MODEL RADIFORCE MX241W |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K090796 |
11/25/2009 |
MULTI-BITE HOT BIOPSY FORCEPS |
ENDO-THERAPEUTICS, INC. |
MARK R WADDELL |
| K092400 |
11/06/2009 |
ENDOGASTRIC SOLUTIONS ESOPHYX2 SYSTEM WITH SEROSAFUSE FASTENER AND ACCESSORIES, MODEL 2.7.5 |
ENDOGASTRIC SOLUTIONS, INC. |
STEVE HOFFMAN |
| K091607 |
11/02/2009 |
ALPHA-BSM, BETA-BSM, GAMMA-BSM, EQUIVABONE |
ETEX CORP. |
CHRISTOPHER KLACZYK |
| K091824 |
11/27/2009 |
ETHICON ENDO-SURGERY ROTATING ENDOSCOPIC SCISSORS, MODEL IN2507 |
ETHICON ENDO-SURGERY, INC. |
GLENDA MARSH |
| K093236 |
11/10/2009 |
ETHICON ENDO-SURGERYOPTICAL DILATOR |
ETHICON ENDO-SURGERY, INC. |
RENEE ROWE |
| K091657 |
11/19/2009 |
IMMUNOSCAN CCPLUS |
EURO-DIAGNOSTICA AB |
ANNIKA ANDERSSON |
| K093286 |
11/13/2009 |
POWERCROSS .018 OTW PTA DILATION CATHETER |
EV3 INC |
SARA BAKKER |
| K093301 |
11/06/2009 |
TURBOHAWK PERIPHERAL PLAQUE EXCISION SYSTEM |
EV3 INC |
BRENDA JOHNSON |
| K092271 |
11/17/2009 |
GE LOGIQ E9 BT2010 DIAGNOSTIC ULTRASOUND SYSTEM, MODEL 5205000-3, 5205000-4 |
GE HEALTHCARE |
NICOLE LANDREVILLE |
| K093348 |
11/25/2009 |
3.0T 16 CHANNEL HEAD NECK SPINE COIL |
GE HEALTHCARE COILS (USA INSTRUMENTS INC.) |
ELIZABETH MATHEW |
| K092231 |
11/24/2009 |
GEBDI TRIBOS 501 |
GEBDI DENTAL-PRODUCTS GMBH |
THOMAS BISKUPSKI |
| K092146 |
11/16/2009 |
XTEND ANTERIOR CERVICAL PLATE SYSTEM |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K091367 |
11/05/2009 |
GDS-DCS |
GUIDED DELIVERY SYSTEMS |
BONNIE MCINERNEY |
| K091643 |
11/02/2009 |
POWDER FREE LATEX EXAMINATION GLOVES, BLUE, TESTED FOR USE WITH CHEMOTHERAPY DRUGS |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K092072 |
11/04/2009 |
POWDER FREE NITRILE EXAMINATION GLOVE, GRAPE SCENTED, BLUE |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K092163 |
11/16/2009 |
FULL AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL168KB |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K093352 |
11/24/2009 |
HG III FIXTURE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K092406 |
11/04/2009 |
ABG II MODULAR HIP STEM |
HOWMEDICA OSTEONICS CORP. |
ESTELA CELI |
| K092178 |
11/20/2009 |
AXSOS STRYKER LOCKED PLATING SYSTEM LINE EXTENSION OF CABLE PLUGS |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
| K091061 |
11/13/2009 |
IMPLICITGUIDE SURGICAL SUTURE SYSTEM |
IMPLICITCARE, LLC |
STEVE REITZLER |
| K091963 |
11/06/2009 |
VIGILANT EEG MONITOR, VIGILANT 2.0 |
INFINITE BIOMEDICAL TECHNOLOGIES, LLC |
MANAN HATHI |
| K091157 |
11/17/2009 |
GLUCO LAB AUTO CODING, MODEL IGM-0022 |
INFOPIA CO., LTD |
Priscilla Chung |
| K090804 |
11/05/2009 |
NASAL AIRE II PEDIATRIC, MODEL 5 SIZES, MODEL TBD |
INNOMED TECHNOLOGIES INC./RESPCARE INC. |
LINDA MAGILL |
| K093564 |
11/25/2009 |
SVED WOUND TREATMENT SYSTEM |
INNOVATIVE THERAPIES, INC. |
JUDITH HARBOUR |
| K091743 |
11/02/2009 |
SEC VBR |
INNVOTEC SURGICAL, INC. |
JUSTIN EGGLETON |
| K091874 |
11/18/2009 |
INOMED ADHESIVE LARYNGEAL ELECTRODES, MODELS 530655, 530656 |
INOMED MEDIZINTECHNIK GMBH |
YOLANDA SMITH |
| K093399 |
11/19/2009 |
PRECISECORE 10 MM BIOPSY DEVICE- 14GA X 5 CM MODEL 670514, 671014, 670518 671018, 670520 |
INRAD |
MELISSA LALOMIA |
| K093256 |
11/17/2009 |
SELECTCORE VARIABLE THROW BIOPSY DEVICE MODEL 991014, 991514, 991018, 991518, 992018 |
INRAD |
MELISSA LALOMIA |
| K092591 |
11/20/2009 |
ORTHOPANTOMOGRAPH OP30 |
INSTRUMENTARIUM DENTAL, PALODEX GROUP OY |
JOUNI ONNELA |
| K092395 |
11/19/2009 |
OSV II LUMBAR VALVE SYSTEM AND OSV II LOW FLOW LUMBAR VALVE SYSTEM |
INTEGRA LIFESCIENCES CORP. |
DONNA MILLISKY |
| K091468 |
11/20/2009 |
IVD TECHNOLOGIES ACHRAB TEST KIT |
IVD TECHNOLOGIES |
Gary Lehnus |
| K090925 |
11/23/2009 |
MULTIPLE (APEX LOCATOR), MODEL RCM-7 |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K091686 |
11/13/2009 |
LEFORTE NEUROSYSTEM BONE SCREW |
JEIL MEDICAL CORPORATION |
SHIN KUK YOO |
| K092640 |
11/06/2009 |
CASPIAN SPINAL SYSTEM |
K2M, INC. |
RICHARD W WOODS |
| K092446 |
11/03/2009 |
INTRA LUX HEAD 3 LDSY |
KALTENBACH & VOIGT GMBH & CO. |
CLAUDIA ORTIZ |
| K092797 |
11/19/2009 |
ACUTE AND CHRONIC CATHETER REPAIR KIT |
KENDALL |
Daniel Campion |
| K091192 |
11/02/2009 |
KENSEY NASH P1076 COLLAGEN DENTAL MEMBRANE, MODEL 20655-XX |
KENSEY NASH CORP. |
Alyssa Schwartz |
| K092167 |
11/02/2009 |
KIMGUARD ONE-STEP STERILIZATION WRAP, MODELS KC100, KC200, KC300, KC400, KC500, KC600 |
KIMBERLY-CLARK CORP. |
THOMAS KOZMA |
| K082399 |
11/05/2009 |
PECTUS STRUT |
KOROS USA, INC. |
TIBOR KOROS |
| K092499 |
11/20/2009 |
LAGLOVE BRAND COLORED LATEX EXAMINATION GLOVES POWDERED, NON-STERILE (PINK/GREEN/VIOLET) |
LAGLOVE (M) SDN. BHD. |
G BASKARAN |
| K092498 |
11/20/2009 |
LAGLOVE BRAND NITRILE EXAMINATION GLOVES POWDERED, NON STERILE (PINK COLOR) |
LAGLOVE (M) SDN. BHD. |
G. BASKARAN |
| K092656 |
11/24/2009 |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
| K092153 |
11/20/2009 |
SKYLINE 55, MODEL VER 1 |
LARSEN & TOUBRO LIMITED |
SHAILESH BHOSALE |
| K091568 |
11/05/2009 |
LH-75 PHOTOTHERAPY SYSTEM |
LERNER MEDICAL DEVICES, INC. |
ZAFIRIOS F GOURGOULIATOS |
| K093499 |
11/23/2009 |
HAIRMAX LASERCOMB |
LEXINGTON INTERNATIONAL, LLC |
CHERITA JAMES |
| K091625 |
11/03/2009 |
EPICARE-DUO LASER SYSTEM |
LIGHT AGE, INC. |
ELIZABETH REDDINGTON |
| K091754 |
11/13/2009 |
LUNETTE MENSTRUAL CUP, MODELS 1 AND 2 |
LUNE GROUP LTD. |
MORRIS WAXLER |
| K091241 |
11/06/2009 |
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER; RAD 87 PULSE CO-OXIMETER |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K091263 |
11/19/2009 |
ZIMMER PATIENT SPECIFIC INSTRUMENTS, ZIMMER PATIENT SPECIFIC INSTRUMENTS PLANNER, MODEL 1.1 (4.3.0.35) |
MATERIALISE N.V. |
KARL VON BERGE |
| K083123 |
11/24/2009 |
MEDART MODEL 610 CO2 LASER SYSTEM & ACCESSORIES |
MEDART A/S |
OLAV BALLE-PETERSON |
| K093309 |
11/24/2009 |
PRO-LINE CT (BASIC TRAY) MODEL MR28036101 |
MEDCOMP (MEDICAL COMPONENTS) |
JEAN CALLOW |
| K092737 |
11/17/2009 |
EASYRA MG REAGENT, MODEL 10220 |
MEDICA CORP. |
Photios Makris |
| K092239 |
11/17/2009 |
ROSA SURGICAL DEVICE, MODEL ROSA 1.1 |
MEDTECH S.A. |
BERTIN NAHUM |
| K090780 |
11/20/2009 |
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC PASTE |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
| K091795 |
11/20/2009 |
MEDTRADE PRODUCTS CELOX TRAUMA GAUZE |
MEDTRADE PRODUCTS LTD. |
JONATHAN RANFIELD |
| K091813 |
11/17/2009 |
INTREPID SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
MIKE SCOTT |
| K093160 |
11/05/2009 |
HEADWAY 21 MICROCATHETER, MODEL: MC212150S |
MICROVENTION, INC. |
Naomi Gong |
| K092702 |
11/20/2009 |
MICRUS MICROCATHETER, MODEL COURIER 270 |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K083754 |
11/20/2009 |
MINI LAP ELECTROCAUTERY INSTRUMENTS |
MINI LAP TECHNOLOGIES INC. |
JOSEPH AZARY |
| K093337 |
11/17/2009 |
VERIGENE RESPIRATORY VIRUS NUCLEIC ACID TEST ON THE VERIGENE SP SYSTEM |
NANOSPHERE, INC |
GREGORY SHIPP |
| K093366 |
11/24/2009 |
NMI PICC II |
NAVILYST MEDICAL, INC. |
LORRAINE HANLEY |
| K090888 |
11/18/2009 |
NEWPORT HT70 FAMILY OF VENTILATORS |
NEWPORT MEDICAL INSTRUMENTS, INC. |
DANA RODRIGUEZ |
| K092899 |
11/10/2009 |
OPER SERIES OPEN TYPE PERMANENT-MAGNET MRI SYSTEM, MODEL: OPER-0.3, -0.35, -0.4 |
NINGBO XINGAOYI MAGNETISM CO., LTD. |
JIANG MOWEN |
| K092246 |
11/12/2009 |
NIPRO NEEDLELESS TRANSFER DEVICE, MODELS: M285503 AND M285505 |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K092501 |
11/12/2009 |
LIGHT-ACTIVATED LOW-STRESS THIOL-ENE COMPOSITE RESTORATIVE MATERIAL |
NOVOCOL, INC. |
STEVE RUDOLPH |
| K093451 |
11/20/2009 |
OMNIGUIDE BEAMPATH CO2 MARK III WAVEGUIDE FIBER WITH LOW PROFILE/LOW LOSS TIP |
OMNIGUIDE, INC. |
DOUGLAS W WOODRUFF |
| K092522 |
11/20/2009 |
ACU007S |
ONCOLOGY SYSTEMS, INC. |
JENNIFER WILLIAMS |
| K092374 |
11/17/2009 |
OIS EYESCAN PORTABLE MODULAR IMAGING SYSTEM, MODEL OIS EYESCAN |
OPHTHALMIC IMAGING SYSTEMS |
ANDREA AMBROSE |
| K090195 |
11/20/2009 |
PALOMAR LUX1540 HANDPIECE |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
Sharon Timberlake |
| K093307 |
11/06/2009 |
ASEPT PLEURAL DRAINAGE SYSTEM |
PFM MEDICAL, INC |
Salvadore Palomares, RAC |
| K092050 |
11/20/2009 |
IMMUNOCAP ALLERGEN D201, HOUSE DUST MITE, MODEL 4-4896-01 |
PHADIA AB |
MARTIN MANN |
| K091862 |
11/20/2009 |
NESSI SPACER |
PHARMACARIBE |
PAUL DRYDEN |
| K091176 |
11/13/2009 |
PHILIPS TELEMEDICINE SERVER/SYSTEM, MODEL 861441 |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
| K091927 |
11/03/2009 |
INTELLIVUE PATIENT MONITORS ,MODELS MP40, MP50, MP60, MP70, MP80, MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K091031 |
11/17/2009 |
PIONEER SURGICAL NANOSS BVF-E |
PIONEER SURGICAL TECHNOLOGY |
DAVID J COLLETTE |
| K091965 |
11/24/2009 |
POWDER FREE NITRILE EXAMINATION GLOVES BLACK; BLUE, GRAPE SCENTED |
PLATINUM GLOVE INDUSTRIES SDN.BHD. |
SO SOON CHEAW |
| K091053 |
11/20/2009 |
PROPARAFLU+ASSAY |
PRODESSE, INC. |
KAREN HARRINGTON |
| K092040 |
11/18/2009 |
PHEROCIOUS 10.5 FR (24 CM, 28 CM AND 32 CM), MODELS 430102440, 430102840, 430103240 |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K093089 |
11/13/2009 |
MAGNUM NAIL |
ROBERT REID INC. |
KAREN WARDEN |
| K092168 |
11/16/2009 |
ELECSYS HCG+B CALCHECK 5 |
Roche Diagnostics |
Sarah Baumann |
| K092320 |
11/03/2009 |
ELECSYS PRECICONTROL THYROAB |
Roche Diagnostics |
Sarah Baumann |
| K092888 |
11/10/2009 |
ELECSYS TOXO IGG CALCHECK 5 |
ROCHE DIAGNOSTICS CORP. |
JANE E PHILLIPS |
| K092858 |
11/10/2009 |
SAFERSONIC SONOGRAPHY COVER |
SAFERSONIC MEDIZINPRODUKTE GMBH |
Kevin Walls |
| K093253 |
11/12/2009 |
AMID STAPLER |
SAFESTITCH LLC |
STEWART DAVIS |
| K092685 |
11/24/2009 |
PNEUMOTHERML, MODEL: 5800 |
SALTER LABS |
TERRY NEWTON |
| K093453 |
11/30/2009 |
MODIFICATION TO COMPUTED ORAL RADIOLOGY SYSTEM |
SCHICK TECHNOLOGIES, INC. |
HOWARD FIDEL |
| K093512 |
11/20/2009 |
ENCOR BREAST BIOPSY SYSTEM |
SENORX, INC. |
EBEN GORDON |
| K093359 |
11/27/2009 |
1103 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1103, 1133 DIGITAL BLOOD PRESSURE MONITOR, MODEL LD 1133 |
SHANGHAI LITTLE DOCTOR CO. LIMITED |
JANUSUN WANG |
| K093100 |
11/24/2009 |
REVLON RVSP3501 SPA MOISTURESTAY PARAFFIN BATH (TYPE SPB3752EA) |
SHENZHEN COMFORT TECHNOLOGY CO., LTD. |
JEAN ASQUITH |
| K091664 |
11/16/2009 |
GSD INTENSE PULSED LIGHT SYSTEM, MODELS: GP666C4, GP666C |
SHENZHEN GSD TECH. CO., LTD. |
Diana Hong |
| K090578 |
11/06/2009 |
SHIMADZU COLLIMATOR R-30H |
SHIMADZU CORP. |
DON KARLE |
| K092993 |
11/20/2009 |
ADVIA CENTAUR CYCLOSPORINE MASTER CURVE MATERIAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K092401 |
11/17/2009 |
SINEXUS SINUS STENT GEN 2, MODEL 1999-25 |
SINEXUS, INC. |
AMY CONUEL |
| K091714 |
11/18/2009 |
ALCODIGITAL BREATHALYZER, MODEL AT576, AT577, AT578, AT579 |
SKYFINE INC. LIMITED |
MICHAEL LEE |
| K092386 |
11/03/2009 |
R3 MULTI-HOLE SHELLS AND 36MM XLPE ACETABULAR LINERS |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K092657 |
11/04/2009 |
EPIFUSE CATHETER CONNECTOR, MODEL: 4909E |
SMITHS MEDICAL ASD, INC. |
CINDY ENGELHARDT |
| K092463 |
11/05/2009 |
SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K093501 |
11/24/2009 |
ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATION |
SPACELABS MEDICAL INC. |
DAVID GERAGHTY |
| K092378 |
11/02/2009 |
SPECTRANETICS VISISHEATH DILATOR SHEATH |
SPECTRANETICS CORP. |
CHERYL HASTINGS |
| K092659 |
11/17/2009 |
SPINAL USA RCS ANTERIOR LUMBAR BUTRESS PLATE SYSTEM, MODEL 22-1001-25 |
SPINAL USA |
JEFFREY JOHNSON |
| K093170 |
11/04/2009 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K092420 |
11/19/2009 |
KRD1 PEDICLE SCREW SYSTEM |
SPINEFRONTIER, INC. |
JOHN SULLIVAN |
| K092464 |
11/09/2009 |
SPINEOLOGY FACET SCREW |
SPINEOLOGY, INC. |
Karen Roche |
| K091865 |
11/13/2009 |
SPORT-ELEC BODY CONTROL SYSTEM |
SPORT-ELEC |
KIMBERLY JONES |
| K093130 |
11/04/2009 |
ENGAGE TR INTRODUCER |
ST. JUDE MEDICAL |
LINH PHAM |
| K092368 |
11/03/2009 |
REPROCESSED PULSE OXIMETER SENSORS |
STERILMED, INC. |
GARRETT AHLBORG |
| K092490 |
11/04/2009 |
AMSCO EVOLUTION SERIES STEAM STERILIZER, MODEL: HC-2000 AND HC-3000 |
STERIS Corporation |
ROBERT F SULLIVAN |
| K092434 |
11/10/2009 |
STERNGOLD 2.2MM ANGLES MICRO ERA DENTAL IMPLANT SYSTEM |
STERNGOLD |
LEE CLERMONT |
| K093408 |
11/12/2009 |
V-LOC 180 ABSORBABLE WOUND CLOSURE DEVICE |
SURGICAL DEVICES, A DIVISION OF TYCO HEALTHCARE |
NISHITH DESAI |
| K093410 |
11/12/2009 |
AUTOSUTURE ENDO GIA SINGLE USE BLACK RELOAD WITH TRI-STAPLE TECHNOLOGY |
SURGICAL DEVICES, A DIVSION OF TYCO HEALTHCARE |
FRANK GIANELLI |
| K093402 |
11/12/2009 |
AUTOSUTURE EEA ORVIL |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT TYCO |
REBECCA RONNER |
| K092504 |
11/05/2009 |
SURGIQUEST AIRSEAL OPTICAL TROCAR AND CANNULA SYSTEM |
SURGIQUEST, INC. |
KOUROSH AZARBARZIN |
| K091650 |
11/24/2009 |
AXS-590 SERIES |
SWR INTERNATIONAL, LTD |
MARTIN J LEIGHTON |
| K090605 |
11/06/2009 |
CLAMPFIX |
SYNTHES (USA) |
JASON LIPMAN |
| K092556 |
11/17/2009 |
SYNTHES (USA) 2.4MM VA-LCP TWO-COLUMN NARROW VOLAR DISTAL RADIUS |
SYNTHES (USA) |
KARL J NITTINGER |
| K092609 |
11/17/2009 |
SYNTHES 3.5 MM AND 4.55 MM CURVED NARROW AND BROAD LOCKING COMPRESSION PLATES (LCP) |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K091814 |
11/20/2009 |
FORA D20 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM; TD-3263 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTE |
TaiDoc Technology Corporation |
ERICA LI |
| K093270 |
11/04/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN EXCELLENCE GLOVE CO., LTD. |
CHU XIAOAN |
| K093277 |
11/30/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN GREEN HEALTHCARE CO., LTD. |
CHU XIAOAN |
| K093272 |
11/30/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HUAMEI HEALTHCARE CO., LTD. |
CHU XIAOAN |
| K093276 |
11/04/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN KANGYUAN GLOVE CO., LTD. |
CHU XIAOAN |
| K092773 |
11/24/2009 |
CEMEX GENTA, GENTA SYSTEM AND GENTA SYSTEM FAST |
TECRES SPA |
CHRISTINE BRAUER |
| K092230 |
11/25/2009 |
MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01 |
TIME MEDICAL LIMITED |
Diana Hong |
| K091725 |
11/09/2009 |
PERFIX SPINAL SYSTEM, MODEL SNA4530-9610, SNM4530-9610, SN3020 (TOTAL: 549) |
U&I CORP. |
SUNG YOUN CHO |
| K093462 |
11/20/2009 |
SONIX ULTRASOUND SCANNER |
UltraSonix Medical Corporation |
CHAS YU |
| K092567 |
11/25/2009 |
MODIFICATION TO UNIGRAFT |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
| K092461 |
11/05/2009 |
IRRIGATION PUMP, IRRIGATION BIOPSY VALVE, ,MODEL 00711520, 00711139, 00711140 |
UNITED STATES ENDOSCOPY GROUP, INC. |
CRAIG MOORE |
| K092871 |
11/30/2009 |
TRILOGY MX |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K093291 |
11/17/2009 |
VARIAN INTERSTITIAL TITANIUM NEEDLES |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K092563 |
11/04/2009 |
GATOR CLIPSEAL PLUG |
VASCULAR SOLUTIONS, INC. |
LOUCINDA BJORKLUND |
| K091750 |
11/04/2009 |
GUIDELINER CATHETER, MODELS 5571, 5572, 5573 |
VASCULAR SOLUTIONS, INC. |
LOUCINDA BJORKLUND |
| K091924 |
11/18/2009 |
VPS CATHETER |
VASONOVA INC. |
KIM TOMPKINS |
| K093146 |
11/30/2009 |
IG4 IMAGE GUIDED SYSTEM, MODEL: SYS-0200 |
VERAN MEDICAL TECHNOLOGIES, INC. |
SCOTT WRIGHTSTONE |
| K092135 |
11/23/2009 |
MODIFICATION TO IVENT 101 |
VERSAMED MEDICAL SYSTEMS LTD. |
ADRIANNE LENZ |
| K092693 |
11/25/2009 |
VIRAMED BIOTECH AG BORRELIA B31 IGG VIRASTRIPE, MODEL V-BBSGUS |
VIRAMED BIOTECH AG |
BARRY MENEFEE |
| K092439 |
11/30/2009 |
CANON DIGITAL FLUOROSCOPY AND RADIOGRAPHY, MODEL CXDI-50RF |
VIRTUAL IMAGING, INC. |
DANIEL KAMM |
| K090532 |
11/13/2009 |
T.E.A.R. TECH3 |
VISION QUEST INDUSTRIES, INC. |
WALLACE FISCHER |
| K092822 |
11/03/2009 |
CAPRI APPLICATOR |
VIVARAY, INC. |
GEORGE HERMANN |
| K091752 |
11/12/2009 |
VIZTEK WL |
VIZTEK, INC. |
DANIEL KAMM |
| K092790 |
11/02/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
ZIBO BOXIANG PLASTIC & RUBBER CO., LTD. |
JOHN ZHAO |
| K092377 |
11/03/2009 |
PLASTIC TEMPORARY ABUTMENTS, MODELS: PT341S, PT344S, PT341A, PT344A, PT451S, PT454S, PT451A, PT454A, PT561S, PT564S |
ZIMMER DENTAL INC. |
WILLIAM FISHER |
| K091973 |
11/17/2009 |
METASUL TAPER LINERS, METASUL FEMORAL HEADS |
ZIMMER GMBH |
BENJAMIN C CURSON |
| K091003 |
11/24/2009 |
ZIMMER MMC CUP |
ZIMMER GMBH |
BENJAMIN C CURSON |
