| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K091354 |
05/08/2009 |
ACRYDERM SILVER ANTIMICROBIAL FOAM WOUND DRESSING |
ACRYMED, INC. |
CHARLES K GRIFFIN |
| K091326 |
05/05/2009 |
ACTIVAPATCH |
ACTIVATEK INC. |
JAMAL YANAKI |
| K091284 |
05/01/2009 |
VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORMAL AND ABNORMAL CONTROL PLASMA |
AFFINITY BIOLOGICALS INC. |
DENISE FOULON |
| K091363 |
05/08/2009 |
COMPRESSOR FILTER, MODELS AG1038831, HCF100,BF900,BF910,BF950, LL201, LL202, LL205, BACTERIA FILTER |
AG INDUSTRIES |
IAN GORDON |
| K091369 |
05/08/2009 |
ELECTROFLUIDGRAPH |
AKERN USA, LLC |
KEVIN WELLS |
| K091327 |
05/05/2009 |
ALDEN HP 54 SPHEE 7 HIP 54 TORIC CONTACT LENSES, ALDEN HP 54 MULTIFOCAL &HP 54 TORIC MULTIFOCAL CONTACT LENSES |
ALDEN OPTICAL LABS., INC. |
CHARLES CREIGHTON |
| K091413 |
05/13/2009 |
S-TEST CHOLESTEROL (CHO), MODEL RC0009, S-TEST HDL CHOLESTEROL (HDL), MODEL RC0015, S-TEST TRIGLYCERIDES (TG) |
ALFA WASSERMANN, INC. |
HYMAN KATZ |
| K091544 |
05/27/2009 |
S-TEST LACTATE DEHYDROGENASE (LD), MODEL RC 0017 |
ALFA WASSERMANN, INC. |
HYMAN KATZ |
| K091333 |
05/06/2009 |
S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022 |
ALFA WASSERMANN, INC. |
HYMAN KATZ |
| K091548 |
05/27/2009 |
AMCO REPLACEMENT BATTERY FOR PHILIPS MEDICAL MODELS BT1 AND M5070A |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEXANDER B HENDERSON |
| K091278 |
05/01/2009 |
VALEO SPACER SYSTEM |
AMEDICA CORP. |
ROBERT M WOLFARTH |
| K091460 |
05/18/2009 |
ABT GLUCOSE CONTROL SOLUTION LEVEL 1,2,3 MODEL, 2120083,2120086, 2120087 |
AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
JOHN GORMLEY |
| K091306 |
05/04/2009 |
AMSURE PVC INTERMITTENT CATHETER |
AMSINO INTERNATIONAL, INC. |
HOLIVEN JI |
| K091500 |
05/21/2009 |
MODIFICATION TO:FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-556 |
ANDON HEALTH CO.,LTD |
LIU YI |
| K091432 |
05/14/2009 |
XCLOSE TISSUE REPAIR SYSTEM, MODEL XC-200-01 |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K091472 |
05/18/2009 |
URITEST 50 AND URITEST 500 URINE ANALYZER |
ARJ MEDICAL, INC. |
AARON BEHAR |
| K091503 |
05/21/2009 |
MAGNUM MP FIXATION DEVICE |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K091406 |
05/12/2009 |
ATLAS SPINE SPACER |
ATLAS SPINE LLC |
JEANNETTE DAILEY |
| K091552 |
05/27/2009 |
SWITCH TRT |
AUDIFON GMBH & CO. KG |
JANE PERRONE |
| K091285 |
05/01/2009 |
AL T LASER, MODEL AVI HPLL-12 |
AVICENNA LASER TECHNOLOGY, INC. |
BRUCE COREN |
| K091387 |
05/11/2009 |
BTI DENTAL IMPLANT 5.5-6.5 |
B.T.I. BIOTECHNOLOGY INSTITUTE, S.L. |
ALFREDO GOMEZ |
| K091321 |
05/05/2009 |
OSTEOSELECT DEMINERALIZED BONE MATRIX PUTTY |
BACTERIN INTERNATIONAL INC. |
HOWARD J SCHRAYER |
| K091377 |
05/11/2009 |
BD FLU+ SYRINGE |
BECTON DICKINSON & CO. |
EILEEN HILLER |
| K091292 |
05/04/2009 |
BD VACUTAINER RAPID SERUM TUBE PLUS BLOOD COLLECTION TUBE, MODEL 368771 |
BECTON DICKINSON AND COMPANY (BD) |
MARY ANN ALSBERGE |
| K091489 |
05/20/2009 |
CLEARVIEW ADVANCED STREP A , MODEL 737-430 |
BINAX, INC. |
ERIN E KENALEY |
| K091317 |
05/04/2009 |
LUMBOFIX CONDUCTIVE GARMENT, MODEL 420 BACK |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K091303 |
05/04/2009 |
LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV |
Bio-Rad Laboratories |
SUZANNE S PARSONS |
| K091414 |
05/13/2009 |
VTRUST BLOOD PRESSURE MONITOR, MODEL VTRUST 701DH |
BIOCARE CORP. |
JUDY WEI |
| K091558 |
05/28/2009 |
BIOVISION DIGITAL SPECIMEN RADIOGRAPHY SYSTEM |
BIOPTICS, INC. |
CARLOS REYES |
| K091352 |
05/07/2009 |
SOUNDSTAR 3D DIAGNOSTIC CATHETER, MODEL M-5723-05 |
BIOSENSE WEBSTER, INC. |
Balaka Das |
| K091340 |
05/06/2009 |
THROUGH THE -PEG (TTP) JEJUNAL FEEDING TUBE KIT, MODEL M00566320,M00566330, M00566340, M00566350 |
BOSTON SCIENTIFIC CORP. |
Marybeth Gamber |
| K091510 |
05/22/2009 |
WALLFLEX ESOPHAGEAL FULLY COVERED STENT SYSTEM, MODELS M00516700, M00516710, M00516720, M00516730 |
Boston Scientific Corporation |
Marybeth Gamber |
| K091440 |
05/15/2009 |
LAPAROSCOPIC RESECTION DEVICE, MODEL SR326L |
BOVIE MEDICAL |
RICHARD KOZLOFF |
| K091370 |
05/08/2009 |
RADIA STEERABLE DIAGNOSTIC CATHETER |
C.R. BARD, INC. |
JULIA BRODERICK |
| K091324 |
05/05/2009 |
SHERLOCK 3CG TIP POSITIONING SYSTEM, SHERLOCK 3CG TIP POSITIONING SYSTEM STYLET |
C.R. BARD, INC. |
RICK GAYKOWSKI |
| K091418 |
05/13/2009 |
C.T.M. MOBILITY SCOOTER, MODEL HS-628, INVACARE ORION |
C.T.M. HOMECARE PRODUCT, INC. |
LINDA BOVARD |
| K091545 |
05/27/2009 |
DIGITAL RADIOGRAPHY CXDI-60C |
CANON INC. |
SHEILA DRISCOLL |
| K091435 |
05/14/2009 |
DIGITAL RADIOGRAPHY MODEL CXDI-55G |
CANON INC. |
SHEILA DRISCOLL |
| K091436 |
05/14/2009 |
DIGITAL RADIOGRAPHY, MODEL CXDI-55C |
CANON, INC. |
SHEILA DRISCOLL |
| K091300 |
05/04/2009 |
ASCENT PORCELAIN PRIMER, MODEL 006-00078, 00600079 |
CAO GROUP, INC. |
ROBERT LARSON |
| K091308 |
05/04/2009 |
ALARIS PC UNIT, MODELS 8000 AND 8015 |
CARDINAL HEALTH 303, INC. |
Michelle J Badal |
| K091461 |
05/18/2009 |
BERNOULLI MANAGEMENT SYSTEM, OXINET III AND LIFEGARD VUE |
CARDIOPULMONARY CORP. |
JORDAN SCHRECK |
| K091396 |
05/10/2009 |
CARDO MEDICAL ANTERIOR CERVICAL PLATE SYSTEM |
CARDO MEDICAL CORP. |
DENISE DUCHENE |
| K091471 |
05/18/2009 |
PATIENT EXAMINATION GLOVES, POWDER-FREE VINYL |
CARTAGLOVES S.A. |
SAM KAO |
| K091452 |
05/18/2009 |
FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) |
CAS MEDICAL SYSTEMS, INC. |
RON JEFFREY |
| K091380 |
05/11/2009 |
CORDCAP |
CENTRIX, INC. |
JOHN DISCKO |
| K091559 |
05/28/2009 |
MARKSMANN CATHETER |
CHESTNUT MEDICAL TECHNOLOGIES, INC. |
DANIEL CHER |
| K091531 |
05/26/2009 |
CHOICE SPINE CERVICAL INTERBODY SPACER SYSTEM CHOICE SPINE CERVICAL INTERBODY SPACER |
CHOICE SPINE, LLP |
G.TODD HAWKINS |
| K091346 |
05/07/2009 |
CODMAN HAKIM MICRO II VALVE |
Codman & Shurtleff, Inc. |
SHARON MCDERMOTT |
| K091287 |
05/01/2009 |
VS-SENSE TEST |
COMMON SENSE, LTD. |
NATASHA LESKOVSEK |
| K091315 |
05/04/2009 |
COVIDIEN EXTENDED TIP APPLICATOR |
CONFLUENT SURGICAL,INC |
SEAN REYNOLDS |
| K091355 |
05/08/2009 |
DEUCE POLYPECTOMY SNARE, MODELS 000995, 000996,000997, 000998 |
CONMED ENDOSCOPIC TECHNOLOGIES, INC. |
KAREN PROVENCHER |
| K091527 |
05/26/2009 |
ADVANCE 35LP LOW PROFILE PTA BALLOON DILATATION CATHETER |
COOK, INC. |
NATHAN SIMON |
| K091385 |
05/10/2009 |
APPROACH HYDRO ST WIRE GUIDE, MODEL HMW |
COOK, INC. |
KAREN BRADBURN |
| K091325 |
05/05/2009 |
TEN-YEAR FRACTURE RISK OPTION AND SIRI TABLE OPTION FOR NORLAND DXA BONE DENSITOMETERS |
COOPER SURGICAL |
THOMAS G WILLIAMS |
| K091339 |
05/06/2009 |
BIOMEDICS (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
COOPERVISION, INC. |
LISA HAHN |
| K091298 |
05/04/2009 |
LUBREASE FEMALE LUBRICANT |
CURVES LIMITED |
NILUFER SMITH |
| K091537 |
05/26/2009 |
CYNOSURE SMARTLIPO MULTIWAVELENGTH LASER WITH 1440NM WAVELENGTH |
CYNOSURE, INC. |
ANTHONY BURNS |
| K091482 |
05/19/2009 |
HUAYI K-SERIES LIGHTWEIGHT WHEELCHAIR K3/K4 |
DANYANG HUAYI MEDICAL SUPPLY & EQUIPMENT CO, LTD |
JIUGUANG (JOE) SONG |
| K091449 |
05/18/2009 |
DATASCOPE'S 8FR. 50CC INTRA-AORTIC BALLOON CATHETER AND ACCESSORIES, MODELS 0684,00-0498-01, 02 |
DATASCOPE CORP., CARDIAC ASSIST DIVISION |
DOLLY MISTRY |
| K091294 |
05/04/2009 |
LATERAL COLUMN LENGTH PLATE, MODEL 824073000-3, LOCKED FUSION PLATE, MODEL 824077010, COMPRESSION FUSION PLATE, |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K091453 |
05/18/2009 |
LPS UNIVERSAL TIBIAL HINGE INSERTS, MODEL 198727012-198727331 |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K091310 |
05/04/2009 |
ABLATION INSTRUMENT, MODEL 1635; ABLATION MULTIPLEX CATHETER, MODEL 1682 |
DFINE, INC. |
SANDEEP SABOO |
| K091309 |
05/04/2009 |
REVOLUTION FEMORAL INTRAMEDULLARY NAIL SYSTEM, MODEL DGOOXX |
DGIMED ORTHO, INC |
SCOTT YOUNGSTROM |
| K091455 |
05/18/2009 |
DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY KIT, MODEL DZ113C-X, DIAZYME LIQUID STABLE ENZYMATIC POTASSIUM ASSAY CAL |
DIAZYME LABORATORIES |
Abhijit Datta |
| K091430 |
05/14/2009 |
CARE PAL, MODEL CPW-10X |
DIGIO2 INTERNATIONAL CO., LTD |
JENNIFER REICH |
| K091382 |
05/11/2009 |
KRYPTONITE BONE CEMENT |
DOCTORS RESEARCH GROUP, INC. |
JUSTIN EGGLETON |
| K091358 |
05/08/2009 |
ECSCOPE 100 |
DYANSYS, INC. |
SRINI NAGESHWAR |
| K091397 |
05/12/2009 |
ECSCOPE 200 |
DYANSYS, INC. |
SRINI NAGESHWAR |
| K091305 |
05/04/2009 |
CLEARPATH |
EASYGLIDE LTD. |
PAUL DRYDEN |
| K091381 |
05/11/2009 |
IBEX SPINAL SYSTEM |
EBI, L.P. |
VIVIAN KELLY |
| K091513 |
05/22/2009 |
SMART ECG SERIES ELECTROCARDIOGRAPH, MODELS SE-3, SE-300A AND 300B, SE-6, SE-600, SE-12, SE-12 EXPRESS AND SE-1200 |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K091393 |
05/11/2009 |
ELEKTA NEUROMAG WITH MAXFILTER |
ELEKTA NEUROMAG OY |
DANIEL KAMM |
| K091497 |
05/20/2009 |
K-LASER K-1200, MODEL 12 W |
ELTECH, S.R.L. |
RICHARD ALBRIGHT |
| K091542 |
05/26/2009 |
ESTECH EASYFLOW CANNULA WITH GUIDEWIRE |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
| K091350 |
05/07/2009 |
ESTECH HAWKEYE INTRODUCER SYSTEMS |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
| K091336 |
05/06/2009 |
IVNOW MODULAR FLUID WARMER, 120V, MODEL IVNOW-1, IVNOW-2, IVNOW-3, IVNOW-6, IVNOW MODULAR FLUID WARMER 230V |
ENTHERMICS MEDICAL SYSTEMS, INC. |
EMALEE G MURPHY |
| K091481 |
05/19/2009 |
EASYPLUS MINI R13N SELF MONITORING BLOOD GLUCOSE SYSTEM |
EPS BIO TECHNOLOGY CORP. |
Y.C. LEI |
| K091322 |
05/05/2009 |
CONTOUR CURVED CUTTER STAPLER AND RELOADS, MODELS: CS40B, CS40G, CR40B, CR40G |
ETHICON ENDO-SURGERY, INC. |
ASIFA VONHOF |
| K091290 |
05/01/2009 |
ETHICON ENDO-SURGERY ROTATING HOOK KNIFE, MODEL IN2508 |
ETHICON ENDO-SURGERY, INC. |
TOM BOSTICCO |
| K091458 |
05/18/2009 |
HYPERGLIDE OCCLUSION BALLOON SYSTEM, HYPERFORM OCCLUSION BALLOON SYSTEM, MODEL 104-4112, 104-4113, 104-4127,104-4132,104 |
EV3 NEUROVASCULAR |
TOM DAUGHTERS |
| K091362 |
05/08/2009 |
CERAMIC PEDATRIC PREFORMED CROWN |
EZ-PEDO INC |
JEFFREY FISHER |
| K091488 |
05/19/2009 |
FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C |
FOOTPRINT MEDICAL |
CLYDE BAKER |
| K091533 |
05/26/2009 |
SLICKS SECTIONAL MATRIX AND MATRIX BANDS, MODELS SM100, SM150, SM175, SM200, SM300, SMH100, SMH150, SMH175 AND SMH200 |
GARRISON DENTAL SOLUTIONS |
JOSEPH AZARY |
| K091388 |
05/11/2009 |
GCUC-505 |
GC AMERICA, INC. |
MARK HEISS |
| K091374 |
05/11/2009 |
GE LOGIQ I/E & VIVID E COMPACT ULTRASOUND |
GE MEDICAL SYSTEMS CHINA CO., LTD. |
YALAN WU |
| K091536 |
05/26/2009 |
OPTIMA MR450W |
GE MEDICAL SYSTEMS, LLC |
MARK STAUFFER |
| K091405 |
05/12/2009 |
PILLCAM PLATFORM WITH PILLCAM SB CAPSULES WITH PILLCAM SENSORBELT |
GIVEN IMAGING LTD. |
Tim Thomas |
| K091359 |
05/08/2009 |
GSO PCT SPINAL SYSTEM |
GOLD STANDARD ORTHOPAEDICS, LLC |
DAVID BAUGHMAN |
| K091367 |
05/08/2009 |
GDS-DCS |
GUIDED DELIVERY SYSTEMS |
BONNIE MCINERNEY |
| K091519 |
05/22/2009 |
HAEMOBAND MULTI-LIGATOR |
HAEMOBAND SURGICAL LTD. |
PAUL DRYDEN |
| K091338 |
05/06/2009 |
COLLASORB COLLAGEN WOUND DRESSING |
HARTMANN-CONCO INC. |
E.J. Smith |
| K091390 |
05/11/2009 |
HDC STERILE SELF LIGATING SPIDER SCREW, MODEL SLI,SL2 |
HDC S.R.L. |
GUIDO BONAPACE |
| K091491 |
05/20/2009 |
HERO VASCULAR ACCESS DEVICE |
HEMOSPHERE INC |
W. ALLEN PUTNAM |
| K091494 |
05/20/2009 |
FLEXITIME FLOW |
HERAEUS KULZER, INC. |
CHERYL ZIMMERMAN |
| K091378 |
05/11/2009 |
MAMMOSITE II RADIATION THERAPY SYSTEM |
HOLOGIC, INC. |
JENNIFER SULLIVAN |
| K091368 |
05/08/2009 |
R2 DIGITALNOW HD(DIGITALNOW HD) |
HOLOGIC, INC. |
MICHAELA MAHL |
| K091529 |
05/22/2009 |
ICAD VERALOOK CTC CAD SOFTWARE |
ICAD, INC. |
JOHN A DELUCIA |
| K091522 |
05/22/2009 |
IMMULISA CELIAC G+ (GLIADIN) IGA AND IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K091520 |
05/22/2009 |
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K091556 |
05/27/2009 |
HEMOSIL ACUSTAR ANTI-B2 GLYCOPROTEIN-I; IGG, IGM, IGG CONTROLS, IGM CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K091302 |
05/04/2009 |
INTEGRA MOZAIK AND OS MOLDABLE MORSELS |
INTEGRA LIFESCIENCES CORPORATION |
PETER ALLAN |
| K091465 |
05/18/2009 |
MYOSURE ROD LENS HYSTEROSCOPE |
INTERLACE MEDICAL, INC. |
John Vozella |
| K091323 |
05/05/2009 |
MODIFIED INTERMEDIC DIODE LASER 980NM SYSTEM (MULTIDIODE SST 200) |
INTERMEDIC ARFRAN, S.A. |
ANNE WORDEN |
| K091539 |
05/26/2009 |
IQ 200 URINE ANALIZER BODY FLUIDS MODULE |
IRIS DIAGNOSTICS |
WILLIAM M DOUGHERTY |
| K091468 |
05/18/2009 |
IVD TECHNOLOGIES ACHRAB TEST KIT |
IVD TECHNOLOGIES |
Gary Lehnus |
| K091486 |
05/19/2009 |
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR |
KAMIYA BIOMEDICAL CO. |
SHAWN KAPLAN |
| K091499 |
05/21/2009 |
MEDEOR MATRIX, MODELS 30010-XX (HYDRATED); 30020-XX (DRY) |
KENSEY NASH CORP. |
Alyssa Schwartz |
| K091357 |
05/08/2009 |
MICROCOOL SURGICAL GOWN, BREATHABLE HIGH PERFORMANCE KC400 |
KIMBERLY-CLARK CORP. |
DAVID M LEE |
| K091562 |
05/28/2009 |
DOCTOR SMILE A-810 AND B-980 LASERS |
LAMBDA SCIENTIFIC SPA |
BOSCHI ALESSANDRO |
| K091366 |
05/08/2009 |
INSUFLOW DEWHEART |
LEXION MEDICAL, LLC. |
BERNARD HORWATH |
| K091301 |
05/04/2009 |
LIFE SPINE STAND-ALONE SPACER SYSTEM |
LIFE SPINE |
MICHAEL S BUTLER |
| K091534 |
05/26/2009 |
LIGHTLAS MODEL 532 |
LIGHTMED CORP. |
ANITA CHEN |
| K091549 |
05/27/2009 |
CONMED LINVATEC SOFT TISSUE TO BONE SYSTEM |
LINVATEC CORP. |
JOHN CUSACK |
| K091320 |
05/05/2009 |
SPECTRA SP II, SPECTRA DENTA II |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K091474 |
05/18/2009 |
EASY.TOUCH INSULIN SYRINGE |
MASTERS HEALTHCARE, LLC. |
DANIEL KAMM |
| K091280 |
05/01/2009 |
FREEDOM TOTAL KNEE CRUCIATE RETAINING (CR) FEMORAL COMPONENT |
MAXX ORTHOPEDICS, INC. |
MARY MCNAMARA-CULLINANE |
| K091518 |
05/22/2009 |
CUBESCAN BIOCON-500 DIAGNOSTIC ULTRASOUND SYSTEM |
MCUBE TECHNOLOGY CO., LTD. |
CHARLIE MACK |
| K091400 |
05/12/2009 |
MODIFICATION TO AVIE A1C TEST SYSTEM |
MEC DYNAMICS CORP |
EMMANUEL MPOCK |
| K091479 |
05/19/2009 |
APTUS FOOT SYSTEM |
MEDARTIS AG |
LINDA SCHULZ |
| K091466 |
05/18/2009 |
1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 |
MEDCOMP |
Susan Pileggi |
| K091557 |
05/27/2009 |
LUNG FLUTE THERAPEUTIC |
MEDICAL ACOUSTICS |
NICOLAAS J SMIT |
| K091454 |
05/18/2009 |
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM |
MEDTOX DIAGNOSTICS, INC. |
PHILLIP HARTZOG |
| K091312 |
05/04/2009 |
PS MEDICAL STRATA NSC LUMBOPERITONEAL VALVE AND SHUNT SYSTEM |
MEDTRONIC NEUROSURGERY |
JEFFERY HENDERSON |
| K091365 |
05/08/2009 |
VERTEX RECONSTRUCTION SYSTEM, VERTEX SELECT RECONSTRUCTION SYSTEM |
MEDTRONIC SOAFAMOR DANEK |
MELISA LANSKY |
| K091442 |
05/15/2009 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
BRAD SHEALS |
| K091445 |
05/15/2009 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K091540 |
05/26/2009 |
MTD 4000 |
METTLER ELECTRONICS CORP. |
ROBERT FLEMING |
| K091288 |
05/01/2009 |
MEDI-6000 MEDICAL IMAGE DIGITIZER |
MICROTEK INTERNATIONAL, INC. |
HUI-CHEN KAI |
| K091504 |
05/21/2009 |
MICRUS ASCENT OCCLUSION BALLOON CATHETER 4X7MM,6X9MM, MICRUS SUMMIT OCCLUSION BALLOON CATHETER 4X10MM,4X15, MODEL BRS 00 |
MICRUS ENDOVASCULAR CORPORATION |
TED RUPPEL |
| K091496 |
05/20/2009 |
MEP-90 HAIR GROWTH STIMULATION SYSTEM |
MIDWEST R.F. LLC. |
HELMUT KEIDL |
| K091511 |
05/22/2009 |
MODERN MEDICAL RESECTOSCOPE ELECTRODES |
MODERN MEDICAL EQUIPMENT MFG., LTD. |
EUGENE YEUNG |
| K091425 |
05/13/2009 |
QUANTUM M COMPOSITE NAILING SYSTEM |
N.M.B. MEDICAL APPLICATIONS, LTD. |
JONATHAN S KAHAN |
| K091428 |
05/14/2009 |
EASYONE PRO RESPIRATORY ANALYSIS SYSTEM |
NDD MEDIZITECHNIK AG |
GERARD MASIELLO |
| K091457 |
05/18/2009 |
NEXSTIM EXIMIA NAVIGATED BRAIN STIMULATION SYSTEM |
NEXSTIM OY |
CYNTHIA J NOLTE |
| K091553 |
05/27/2009 |
BLOOD PRESSURE MONITOR, MODEL WA400 FOR WRIST TYPE AND MODEL AA300 FOR UPPER ARM TYPE |
NINGBO DIAIER ELECTRONIC CO., LTD. |
LAO XIKUN |
| K091279 |
05/01/2009 |
NIPRO DISPOSABLE SYRINGE |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K091546 |
05/27/2009 |
NORAS OR HEAD COIL 3T, MODELS SI7200/SI72100/SI7220/SI7230 |
NORAS MRI PRODUCTS GMBH |
ZAHED SEDIGHIANI |
| K091547 |
05/27/2009 |
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 |
| K091484 |
05/19/2009 |
NOVABONE DENTAL PUTTY - BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GALSSER |
| K091515 |
05/22/2009 |
SPY SCOPE INTRA-OPERATIVE OPERATING SYSTEM |
NOVADAQ TECHNOLOGIES, INC. |
JOHN FENGLER |
| K091360 |
05/08/2009 |
CLEARFLUX DIALYZER REPROCESSING SYSTEM |
NOVAFLUX TECHNOLOGIES |
MOHAMED E LABIB |
| K091422 |
05/13/2009 |
NOVAPRO STRETCH VINYL EXAMINATION GLOVE POWDER FREE (YELLOW/WHITE) |
NOVAPRO CO., LTD. |
ZHENZHONG CHENG |
| K091421 |
05/13/2009 |
NOVAPRO VINYL EXAMINATION GLOVE POWDER FREE (NON-COLORED) |
NOVAPRO CO., LTD. |
ZHENZHONG CHENG |
| K091386 |
05/11/2009 |
MICROFUSE DUAL RATE INFUSER |
NUMIA MEDICAL TECHNOLOGY, LLC |
ERIC FLACHBART |
| K091502 |
05/21/2009 |
NUVASIVE SPHERX II SYSTEM |
NUVASIVE, INC. |
HAN FAN |
| K091364 |
05/08/2009 |
DICOMPACS, MODEL 5.2, DICOMPACS DX-R, MODEL 1.4 |
OEHM UND REHBEIN GMBH |
ALAN SCHWARTZ |
| K091444 |
05/15/2009 |
PERFSCAPE |
OLEA MEDICAL |
NEAL KOLBER |
| K091495 |
05/20/2009 |
SINGLE USE 3-LUMEN EXTRACTION BALLOON V, MODEL V B-V233P-A,B-V233P-B,B-V433P-A,B-V433P-B, BV243Q-A, B-V243Q-B, B-V443Q-A |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO |
| K091403 |
05/12/2009 |
MOD1T COMPENSATORS FOR RADIATION BEAM THERAPY |
ONCOLOGY TECH, LLC |
SEAN COMER |
| K091404 |
05/12/2009 |
IVUE, MODEL 100 |
OPTOVUE, INC. |
Azimun Jamal |
| K091564 |
05/28/2009 |
NBM-200MP PULSE OXIMETRY DEVICE |
ORSENSE LTD |
AHAVA STEIN |
| K091411 |
05/13/2009 |
KNEEALIGN SYSTEM |
ORTHALIGN, INC |
AMY WALTERS |
| K091493 |
05/20/2009 |
ORTHO SELECT BONE PLATES AND SCREW SYSTEM |
ORTHO SELECT IMPLANT TECHNOLOGY GESELLSCHAFT |
ANGELIKA SCHERP |
| K091398 |
05/12/2009 |
ARTHROSCOPE |
ORTHOPEDIC SCIENCES, INC |
JAMES K BRANNON |
| K091424 |
05/13/2009 |
OSTA MAXIGRO AND REGIGRO |
OSTA TECHNOLOGIES |
JAY MANSOUR |
| K091446 |
05/15/2009 |
MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
SHARON TIMBERLAKE, RAC, CCRA |
| K091509 |
05/22/2009 |
JETSTREAM G2 NXT SYSTEM, MODEL PV20300 |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIT BAIRD |
| K091478 |
05/19/2009 |
TREVAIR CHAIR |
PATMONT MOTOR WERKS, INC. |
STEVEN J PATMONT |
| K091512 |
05/21/2009 |
BUILD-IT LIGHT CURE |
PENTRON CLINICAL TECHNOLOGIES |
Wendy Garman |
| K091554 |
05/27/2009 |
PHARMAPAC PERSONAL LUBRICANT |
PHARMAPAC LLC |
TOM OTTO |
| K091395 |
05/11/2009 |
MP5 INTELLIVUE PATIENT MONITOR |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K091389 |
05/11/2009 |
EQUALSHIELD LUER LOCK CONNECTOR PAIR |
PLASTMED, LTD. |
ELISSA BURG |
| K091296 |
05/04/2009 |
POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09 |
POLYMAP WIRELESS |
PIERRE LANDAU |
| K091392 |
05/11/2009 |
TDS TITANIUM ABUTMENT FOR NOBEL BIOCARE BRANEMARK |
POU YU BIOTECHNOLOGY CO., LTD. |
DANIEL TSAO |
| K091281 |
05/01/2009 |
TAMPAX PEARL UNSCENTED TAMPONS, LIGHT, REGULAR, SUPER & SUPER PLUS, TAMPAX PEARL UNSCENTED TAMPONS, ULTRA |
PROCTER & GAMBLE CO. |
KIMBERLY A NEMETH |
| K091433 |
05/13/2009 |
R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL |
R & D SYSTEMS, INC. |
NANCY RING |
| K091506 |
05/21/2009 |
DURASPAN HEMODIALYSIS LONG-TERM CATHETER, MODELS 62152420, 621512820, 62153220, 62153620, 62154020, 62155520 |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K091517 |
05/22/2009 |
RALCO, MODEL R225 ACS |
RALCO S.R.L. |
DANIEL KAMM |
| K091507 |
05/21/2009 |
RAYNER SMALL INCISION SINGLE USE SOFT TIPPED INJECTOR, MODEL R-INJ-04/18 |
RAYNER INTRAOCULAR LENSES LTD. |
ROYNAN H KERNAGHAN |
| K091319 |
05/05/2009 |
REMSTAR AUTO A-FLEX |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA A YURKO |
| K091459 |
05/18/2009 |
PHILIPS NM3 MONITOR, MODEL 7900 |
RESPIRONICS NOVAMETRIX LLC |
KEVIN MADER |
| K091563 |
05/28/2009 |
RECRUIT MICROCATHETER |
REVERSE MEDICAL CORPORATION |
AMY ESKINA |
| K091409 |
05/13/2009 |
LIGHTCYCLER MRSA ADVANCED TEST FOR USE WITH THE LIGHTCYCLER 2.0 INSTRUMENT, MODEL 05205727 |
ROCHE MOLECULAR SYSTEMS, INC. |
LARRY PIETRELLI |
| K091331 |
05/05/2009 |
PIEZOTOME 2 |
SATELEC |
RICK ROSATI |
| K091283 |
05/01/2009 |
CAPILLARYS NEONAT HB (PN 2006) |
SEBIA |
KAREN ANDERSON |
| K091541 |
05/26/2009 |
MESA OXYGEN CONCENTRATOR, MODEL 2-6000 SERIES |
SEQUAL TECHNOLOGIES CO., LTD |
CEARO HUANG |
| K091408 |
05/12/2009 |
DISPOSABLE PRESSURE TRANSDUCER |
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD |
LEE FU |
| K091523 |
05/22/2009 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG CENTURY PLASTIC CO., LTD |
CHU XIAOAN |
| K091521 |
05/22/2009 |
POWERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG CENTURY PLASTIC CO., LTD |
CHU XIAOAN |
| K091429 |
05/13/2009 |
VINYL POWDER FREE EXAMINATION GLOVE |
SHUN DA (XINGHUA) CO., LTD |
ZHANG YAN |
| K091427 |
05/13/2009 |
VINYL POWDERED EXAMINATION GLOVE |
SHUN DA (XINGHUA) CO., LTD |
ZHANG YAN |
| K091383 |
05/11/2009 |
VINYL POWDER FREE EXAMINATION GLOVE |
SHUN TONG CO., LTD |
CHEE HOONG TAN |
| K091384 |
05/11/2009 |
VINYL POWDERED EXAMINATION GLOVE |
SHUN TONG CO., LTD |
CHEE HOONG TAN |
| K091289 |
05/01/2009 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K091361 |
05/08/2009 |
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM |
SIEMENS HEALTHCARE DIAGNOSTICS |
CAROLYN K GEORGE |
| K091373 |
05/11/2009 |
SYNGO TRUED |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JAMES E KUHN JR |
| K091286 |
05/01/2009 |
SYNGO US WORKPLACE |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K091467 |
05/18/2009 |
BABY QUASAR |
SILVER BAY, LLC |
DANIEL KAMM, P.E. |
| K091543 |
05/26/2009 |
LEGION POROUS PLUS HA PRIMARY FEMORAL COMPONENTS |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K091470 |
05/18/2009 |
RANASYS EZ NEGATIVE PRESSURE WOUND THERAPY SYSTEM, MODEL 66800059 |
SMITH & NEPHEW, INC. |
LAURA KREJCI |
| K091420 |
05/13/2009 |
FRAXEL RE: STORE LASER SYSTEM, MODEL SR1500 |
SOLTA MEDICAL, INC. |
HEATHER MACFALLS |
| K091328 |
05/05/2009 |
SIPHONX GRAVITATIONAL ANTISIPHON DEVICE |
SOPHYSA SA |
GUSTAVO KOBRIN |
| K091462 |
05/18/2009 |
SPECTRA MEDICAL SAFETY SCAPEL |
SPECTRA, INC. |
AGUSTIN TURRIZA |
| K091299 |
05/04/2009 |
SPECTRANETICS TURBO-TANDEM SYSTEM |
SPECTRANETICS CORP. |
GRACIE MURGUIA |
| K091410 |
05/13/2009 |
DISPOSABLE EMG NEEDLE ELECTRODES, MYOLINE, MYOLINE 2, MYOBOT, |
SPES MEDICA S.R.L. |
ALFREDO SPADAVECCHIA |
| K091291 |
05/01/2009 |
XIA 3 SPINAL SYSTEM, UNIPLANNER/REDUCTION SCREWS & VITALLIUM ROD |
STRYKER SPINE |
CURTIS TRUESDALE |
| K091439 |
05/14/2009 |
HEAD FIXATION ARC AND TABLE BASE |
SURGIVISION, INC. |
J. HARVEY KNAUSS |
| K091343 |
05/06/2009 |
MRI NEURO DRAPE |
SURGIVISION, INC. |
J. HARVEY KNAUSS |
| K091441 |
05/15/2009 |
SYNERGETICS ADJUSTABLE GAS PRESSURIZED INFUSION (AGPI) TUBE SET |
SYNERGETICS, INC. |
GARY OLIVEROS |
| K091313 |
05/04/2009 |
SYSMEX MODEL XT-4000I |
SYSMEX AMERICA, INC. |
SHARITA BROOKS |
| K091555 |
05/27/2009 |
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
ERICA LI |
| K091417 |
05/13/2009 |
SINGLE USE GUIDEWIRE, MODELS G-240-2527S, G-240-2545S, G-240-2527A, G-240-2545A, G-240-3527S, G-240-3545S & G-240-3527A |
TERUMO CORP. |
MARK UNTERREINER |
| K091329 |
05/05/2009 |
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K091490 |
05/20/2009 |
FAMILY OF THD DISPOSABLE ANOSCOPES/PROCTOSCOPES/RECTOSCOPES |
THD SPA |
GUIDO BONAPACE |
| K091419 |
05/13/2009 |
VICKS POWERSHOT DRY THROAT & MOUTH RELIEF |
THE PROCTER & GAMBLE CO. |
RICHARD J COOKE |
| K091295 |
05/04/2009 |
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM MODEL SSA-790A VERSION 4.0 |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K091332 |
05/06/2009 |
AIA-PACK RBC FOLATE |
Tosoh BioScience, Inc. |
CHARLES P GILL |
| K091415 |
05/13/2009 |
TRULY AUTOMATIC WRIST BLOOD PRESSURE MONITOR, MODEL DW100,DW200, DW500,DW700,DW703,DW701M.702M |
TRULY INSTRUMENT CO., LTD. |
YANG JIAN-HAO |
| K091434 |
05/13/2009 |
TRULY AUTOMATIC ARM BLOOD PRESSURE MONITORDB21,DB31,DB22,DB23,DB71M,DB32,DB61M, DB62M, DB63M |
TRULY INSTRUMENT CO., LTD. |
YANGJIAN HAO |
| K091391 |
05/11/2009 |
UROPLASTY RIGID ENDOSCOPIC NEEDLE, MRN-518 |
UROPLASTY, INC. |
MICHAEL MORRELL |
| K091492 |
05/20/2009 |
MODIFICATION TO ECLIPSE TREATMENT PLANNING SYSTEM |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K091345 |
05/06/2009 |
GOPHER GOLD CATHETER, MODEL 5620 |
VASCULAR SOLUTIONS, INC. |
LOUCINDA BJORKLUND |
| K091551 |
05/27/2009 |
VARI-LASE PLATINUM BRIGHT TIP LASER FIBER |
VASCULAR SOLUTIONS, INC. |
LOUCINDA BJORKLUND |
| K091426 |
05/13/2009 |
CERVICORE CORPECTOMY CAGE |
VERTICOR, LTD |
J.D. WEBB |
| K091412 |
05/13/2009 |
CLEAN PEAK FLOW METER |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K091505 |
05/21/2009 |
COR12+ |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K091498 |
05/20/2009 |
VITREA ENDOVASCULAR STENT PLANNING SOFTWARE |
VITAL IMAGES, INC. |
DARIN BUSCH |
| K091304 |
05/04/2009 |
VORTEX CANNULA |
VORTEX MEDICAL INC |
CHERYL BLAKE |
| K091516 |
05/22/2009 |
WELL LEAD SILICONE CATHETER WITH TEMPERATURE SENSOR |
WELL LEAD MEDICAL CO. LTD |
ARTHUR WARD |
| K091538 |
05/26/2009 |
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 |
WET NOSE TECHNOLOGIES, LLC |
JIM BARLEY |
| K091423 |
05/13/2009 |
PROFEMUR HIP SYSTEM MODULAR NECKS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN ROSS |
| K091431 |
05/13/2009 |
POWDER-FREE, YELLOW VINYL PATIENT EXAMINATION GLOVES |
ZIBO YUSHENG PLASTIC PRODUCTS CO., LTD. |
JOHN ZHAO |
| K091566 |
05/28/2009 |
ZIMMER NATURAL NAIL SYSTEM CEPHALOMEDULLARY NAILS |
ZIMMER GMBH |
DANIEL J WILLIMAN |
| K091508 |
05/22/2009 |
ZIMMER CONTINUUM ACETABULAR SYSTEM, ZIMMER TRILOGY IT ACETABULAR SYSTEM |
ZIMMER, INC. |
BENJAMIN C CURSON |
| K091561 |
05/28/2009 |
ZOLL AED PLUS VERSION 5.32 SOFTWARE RELEASE |
ZOLL MEDICAL CORPORATION |
CHARLES W KOLIFRATH |
