| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K094007 |
04/08/2010 |
UNICEM |
3M ESPE AG DENTAL PRODUCTS |
DESI W SOEGIARTO |
| K094064 |
04/30/2010 |
ILUMA VISION MODEL VERSION 2.2 |
3M IMTEC |
GINGER CANTOR, RAC |
| K100145 |
04/13/2010 |
A&E ZIRCONIA BLANKS MODEL EZBUCT02, EZBUCT04, EZBUCT25, EZBUCT31, EZBUST07, EZBUST08, EZBUTT05, EZBUTT06 |
A&E BIOCERAMIC CO., LTD. |
MARZ CHIU |
| K093305 |
04/02/2010 |
ENHANCED ULTRA VIT PROBE |
ALCON RESEARCH, LTD. |
MARTIN A KAUFMAN |
| K094041 |
04/07/2010 |
ALPHA ORTHOPAEDICS AT3 SYSTEM |
ALPHA ORTHOPAEDICS |
GINA TO |
| K093186 |
04/16/2010 |
AMBU ASCOPE AND MONITOR |
AMBU A/S |
SANJAY PARIKH |
| K100108 |
04/14/2010 |
AMEDICA DRUG TEST THC, COC, OPI, AMP, MET, PCP, BAR, BZO, MDMA, OXY, TCA |
AMEDICA BIOTECH, INC. |
Jeff Chen |
| K093014 |
04/16/2010 |
AMERICAN DENTAL PRODUCTS SE BONDEASY |
AMERICAN DENTAL PRODUCTS, INC. |
GEORGE NICOLAE |
| K092066 |
04/12/2010 |
PHASER LIPOPLASTY SYSTEM (DUR-01), PHASER DISPOSABLE KIT (DIS-01), PHASER WASTE COLLECTION KIT (WAS-01), PHASER CANNULAE |
ANDREW TECHNOLOGIES, LLC |
JONATHAN S KAHAN |
| K100747 |
04/14/2010 |
CONTREX PLUS LOW CONTROL SOLUTION |
APEX BIO TECHNOLOGY CORP |
THOMAS Y.S. SHEN |
| K100959 |
04/22/2010 |
SPECIMEN RETRIEVAL SYSTEM |
APPLIED MEDICAL RESOURCES |
FRANS VANDENBROEK |
| K100120 |
04/02/2010 |
ALEXIS ORTHOPAEDIC WOUND RETRACTOR |
APPLIED MEDICAL RESOURCES CORP. |
FRANS VANDENBROEK |
| K100215 |
04/07/2010 |
ARCHIMED REMEDY CERVICAL PLATE |
ARCHIMED, INC. |
BARRY AIKEN |
| K091472 |
04/27/2010 |
URITEST 50 AND URITEST 500 URINE ANALYZER |
ARJ MEDICAL, INC. |
AARON BEHAR |
| K092472 |
04/15/2010 |
NON STERILE POWDER-FREE, NATURAL OR AQUA LANO-E NITRILE EXAMINATION GLOVES, WITH OR WITHOUT CITRUS/ PEPPERMINT SCENT |
ASCEND EAGLE, INC. |
JANNA TUCKER |
| K093780 |
04/16/2010 |
ATLANTIS ABUTMENT FOR DENTSPLY IMPLANT, ATLANTIS GEMINI ABUTMENT, ATLANTIS GEMINI + ABUTMENT |
ASTRA TECH, INC. |
BETSY A BROWN |
| K093431 |
04/20/2010 |
CLEARWAY OTW MODEL 85912 |
ATRIUM MEDICAL CORP. |
RAYMOND KELLY |
| K092031 |
04/16/2010 |
VAPOR-CLEAR, MODEL 100 |
AXON MEDICAL, INC. |
JOSEPH ORR |
| K100334 |
04/22/2010 |
DIACAP POLYSULFONE HIFLO 23 HEMODILAYZER , MODEL 72036811 |
B. BRAUN AVITUM AG |
ANGELA J CARAVELLA |
| K100241 |
04/16/2010 |
CONTIPLEX D CONTINUOUS NERVE BLOCK SET, MODEL 331687, 331686, 331685, 331680 |
B. BRAUN MEDICAL, INC. |
LISA GIAQUINTO |
| K100005 |
04/15/2010 |
BD PEN NEEDLE |
BECTON, DICKINSON AND CO. |
James Haynes |
| K090301 |
04/14/2010 |
BINAXNOW PBP2A TEST, MODEL 890-000 |
BINAX, INC. |
SUZANNE VOGEL |
| K094018 |
04/16/2010 |
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES |
BIOCOMPATIBLES U.K. LIMITED |
JOHN GREENBAUM |
| K093321 |
04/02/2010 |
BIOHORIZONS LASER-LOK 3.0 IMPLANT SYSTEM |
BIOHORIZONS IMPLANT SYSTEMS, INC. |
MICHAEL DAVIS |
| K100155 |
04/20/2010 |
TRUVUE WIRELESS AMBULATORY ECG MONITORING SYSTEM |
BIOMEDICAL SYSTEMS CORP. |
MICHAEL KROEHNKE |
| K093235 |
04/30/2010 |
RINGLOC + HYBRID ACETABULAR SYSTEM |
BIOMET, INC. |
GARY BAKER |
| K100264 |
04/09/2010 |
T-FORM EXTREMITY IMMOBILIZER, MODEL RT-6060 |
BIONIX DEVELOPMENT CORP. |
JAMES HUTTNER |
| K092048 |
04/19/2010 |
ONE STEP EDDP (METHADONE METABOLITE) TEST STRIP |
BIOSITE INCORPORATED |
Lisa Chicorka |
| K100701 |
04/08/2010 |
SMARTEST PERSONA BLOOD GLUCOSE TEST SYTEM MODEL: 6277 |
Biotest Medical Corp. |
MAGGIE CHU |
| K100892 |
04/12/2010 |
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX |
BOSTON SCIENTIFIC CORP. |
Scott Sepple |
| K100663 |
04/16/2010 |
CONTOUR EMBOLIZATION PARTICLES, MODELS M0017600121, M0017600221, M0017600321 |
Boston Scientific Corporation |
DEBBIE MCINTIRE |
| K100528 |
04/23/2010 |
BREATHE TECHNOLOGIES VENTILATOR AND ACCESSORIES BT-V2S |
BREATHE TECHNOLOGIES, INC. |
SUZON LOMMEL |
| K100229 |
04/21/2010 |
VENTRIO HERNIA PATCH |
C.R. BARD, INC. |
MICHELLE GODIN |
| K100362 |
04/14/2010 |
CAMBRIDGE HEART OEM |
CAMBRIDGE HEART, INC. |
JOHN GREENBAUM |
| K100266 |
04/29/2010 |
ACTIWAVE 1E, ACTIWAVE2E, ACTIWAVE2M, ACTIWAVE4E, ACTIWAVE CARDIO MODEL 08-514, 08-521, 08-536, 08-557, 08-603 |
CAMNTECH, LTD |
HOWARD SMITH |
| K100994 |
04/30/2010 |
PRELOADED TISSUE MARKER DEVICE |
CARBON MEDICAL TECHNOLOGIES, INC. |
TINA M WITTCHOW |
| K092484 |
04/02/2010 |
HELIOX LOW FLOW SENTRY BLENDER |
CARDINAL HEALTH 207, INC. |
MONTHER ABUSHABAN |
| K093288 |
04/08/2010 |
CARDIONET AMBULATORY ECG MONITOR WITH ARRHYTHMIA DETECTION |
CARDIONET, INC |
KENT SAYLER |
| K094045 |
04/22/2010 |
MODIFICAITON TO: CARDO MEDICAL HIP SYSTEM |
CARDO MEDICAL CORP. |
DAVE LAMB |
| K093229 |
04/08/2010 |
CATHETER CONNECTIONS DUALCAP |
CATHETER CONNECTIONS, INC. |
DONALD D SOLOMON |
| K100723 |
04/30/2010 |
DISPOSABLE CIRCULAR STAPLER, DISPOSABLE CIRCULAR STAPLER MODEL KYGW-25.5, KYGW-28.5 |
CHANGZHOU KANGDI MEDICAL STAPLER CO., LTD. |
CHARLIE MACK |
| K093977 |
04/22/2010 |
ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX |
CHESTNUT MEDICAL TECHNOLOGIES, INC. |
DANIEL CHER |
| DEN090005 |
04/30/2010 |
PRINEO SKIN CLOSURE SYSTEM |
CLOSURE MEDICAL CORP. |
BRUCE KRATTENMAKER |
| K090744 |
04/15/2010 |
CLARO |
CLRS TECHNOLOGY CORPORATION |
MAUREEN O'CONNELL |
| K100400 |
04/22/2010 |
PRESTODR PORTABLE |
CMT MEDICAL TECHNOLOGIES, LTD. |
SHLOMI DINES |
| K093243 |
04/07/2010 |
COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM |
COAGUSENSE, INC |
DOUGLAS PATERSON |
| K092391 |
04/01/2010 |
MOBILEAED, MOBILEALS, MOBILEAED+ AND ADVANTAGEAED |
CONCORD MEDICAL PRODUCTS |
RANDALL FINCKE |
| K083785 |
04/02/2010 |
VITALA CONTINENCE CONTROL DEVICE |
CONVATEC |
MARILYN KONICKY |
| K100283 |
04/23/2010 |
VERSATUBE TAPERED TRACHEOSTOMY TUBE WITH DISPOSABLE INNER CANNULA, MULTIPLE, PREFIXES C-VT, C-VTIC |
COOK, INC. |
SUSANNE GALIN |
| K092076 |
04/02/2010 |
AEGIS & AEGIS II SPINAL SYSTEM |
CORENTEC CO., LTD |
ROBERT SCHIFF |
| K083312 |
04/05/2010 |
MINIHIP STEM |
CORIN U.S.A. |
ASHLEA BOWEN |
| K092198 |
04/15/2010 |
CORMET CEMENTLESS RESURFACING FEMORAL HEAD |
CORIN USA |
ASHLEA BOWEN |
| K100548 |
04/26/2010 |
VERSAPORT BLADELESS LOW PROFILE TROCAR MODEL NB3SHFLP, NB5SHFLP, NB5STFLP |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
ANGELA VAN ARSDALE |
| K093871 |
04/22/2010 |
PERIOPHIL B-TCP |
CYTOPHIL INC |
VICTOR M BOWERS |
| K100633 |
04/01/2010 |
INFINITAS MINI-IMPLANT MODEL: DB10-0009, DB10-0010,DB10-0012,DB10-0015,DB10-0016 |
D B ORTHODONTICS LTD |
ANNA DYSON |
| K100378 |
04/28/2010 |
1 SERIES MODEL 1 SERIES T2, 1 SERIES X2, 1 SERIES T4, 1 SERIES X4 |
DAAVLIN DISTRIBUTING CO. |
MICHELE THIEL |
| K100012 |
04/30/2010 |
GRYPHON T BR DS ANCHOR W/ORTHOCORD, GRYPHON T BR ANCHOR W /ORTHOCORD, GRYPHON P BR DS ANCHOR W/ORTHOCORD, GRYPHON P BR A |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
Ruth Forstadt |
| K090975 |
04/12/2010 |
DEROYAL NON-LOCKING BONE FIXATION SYSTEM |
DEROYAL INDUSTRIES, INC. |
GRACIE GREENWAY |
| K093371 |
04/05/2010 |
MODEL DGH 6000 SCANMATE A |
DGH TECHNOLOGY, INC. |
M. LUTHER DETWEILER |
| K100312 |
04/20/2010 |
DISTALOCK FEMORAL INTRAMEDULLARY NAIL SYSTEM |
DGIMED ORTHO, INC |
SCOTT P YOUNGSTROM |
| K093680 |
04/08/2010 |
DIAZYME CYSTATIN C ASSAY |
DIAZYME LABORATORIES |
Abhijit Datta |
| K092911 |
04/26/2010 |
SMART HBA1C ASSAY KIT, MODEL DZ168B-POC, SMART HBA1C ASSAY CONTROL KIT, MODEL DZ168B-CON, SMART HBAC1C ANALYZER |
DIAZYME LABORATORIES |
Abhijit Datta |
| K100838 |
04/23/2010 |
ERGO IMAGING SYSTEM |
DIGIRAD CORP. |
Joel Tuckey |
| K093010 |
04/01/2010 |
MACH LED MC |
DR. MACH GMBH & CO. KG |
RAINER ADAMS |
| K093009 |
04/01/2010 |
MACH LED SC |
DR. MACH GMBH & CO. KG |
RAINER ADAMS |
| K100941 |
04/23/2010 |
INFINITY MCABLE - MAINSTREAM CO2 |
DRAEGER MEDICAL AG & CO. KG |
ULRICH SCHROEDER |
| K093632 |
04/05/2010 |
INFINITY ACUTE CARE SYSTEM WORKSTATION NEONATAL CARE |
DRAGER MEDICAL AG & CO. KGAA |
JOYCE KILROY |
| K093728 |
04/29/2010 |
BE MICRO, TREA |
EB NEURO, S.P.A. |
JAMIE AUSTIN |
| K093880 |
04/16/2010 |
PEANUT GROWTH CONTROL PLATING SYSTEM |
EBI, L.P. |
MARGARET F CROWE |
| K093869 |
04/01/2010 |
SE-601 SERIES ELECTROCARDIOGRAPH |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K093554 |
04/13/2010 |
RETROFLEX DILATOR KIT |
EDWARDS LIFESCIENCES, LLC. |
JASON K LYON |
| K100230 |
04/02/2010 |
SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V |
ELEME MEDICAL, INC. |
William McGrail |
| K092033 |
04/30/2010 |
VIBROLITH AND VIBROLITH PLUS INTRACORPOREAL LITHOTRIPTOR |
ELMED USA |
JONATHAN WARD |
| K100377 |
04/22/2010 |
DIAMONDBACK SPINAL SYSTEM |
EMINENT SPINE |
KAREN WARDEN |
| K100224 |
04/07/2010 |
ESTECH COBRA BIPOLSR II |
ENDOSCOPIC TECHNOLOGIES, INC. D/B/A ESTECH |
TAMER IBRAHIM |
| K100670 |
04/05/2010 |
S-SCAN, MODEL 9800020010 |
ESAOTE, S.P.A. |
Allison Scott |
| K100597 |
04/07/2010 |
HARMONIC FOCUS SHEARS |
ETHICON ENDO-SURGERY, LLC |
MARCIA ARENTZ |
| K093899 |
04/29/2010 |
MAMMOTOME BIOPSY SYSTEM FOR MOLECULAR IMAGING |
ETHICON ENDO-SURGERY, LLC |
ASIFA VONHOF |
| K093932 |
04/09/2010 |
ETHICON PHYSIOMESH, FLEXIBLE COMPOSITE MESH |
ETHICON GMBH |
NEELU MEDHEKAR |
| K093845 |
04/07/2010 |
ETHICON SECURESTRAP 5MM ABSORBABLE STRAP FIXATION DEVICE, MODEL STRAP25 |
ETHICON, INC. |
JOSEPH KICEINA |
| K100789 |
04/21/2010 |
MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST |
EVALVE INC |
KARUNA VELUSAMY |
| K093770 |
04/28/2010 |
EXTREMITY MEDICAL SCREW SYSTEM |
EXTREMITY MEDICAL LLC |
JAMY GANNOE |
| K100662 |
04/07/2010 |
FEMVUE CORNUAL BALLOON CATHETER |
FEMASYS INC. |
LISA PEACOCK |
| K092579 |
04/02/2010 |
INTRAUTERINE INSEMINATION (IUI) CATHETER |
FERTILIGENT, LTD |
JOHN A STEEN |
| K094040 |
04/27/2010 |
F&P ICON SERIES CPAP |
FISHER & PAYKEL HEALTHCARE, LTD. |
JAMES THOMPSON |
| K100881 |
04/14/2010 |
SYNAPSE OBLIQUUS MIP/MPR/FUSION |
FUJIFILM MEDICAL SYSTEM U.S.A., INC. |
PETER ALTMAN |
| K092171 |
04/26/2010 |
VOLUX, DIGITAL EXTRAORAL SOURCE X-RAY SYSTEM |
GENORAY CO., LTD. |
JAE KIM |
| K092578 |
04/05/2010 |
LIFEGLOBAL PROTEIN SUPPLEMENT |
GENX INTL., INC. |
MICHAEL D CECCHI |
| K091958 |
04/30/2010 |
BELFORT-DILDY OBSTETRIC TAMPONADE SYSTEM |
GLENVEIGH SURGICAL, LLC |
PENNY NORTHCUTT |
| K093904 |
04/14/2010 |
GLENVEIGH VAGINAL TAMPONADE BALLOON CATHETER |
GLENVEIGH SURGICAL, LLC |
PENNY NORTHCUTT |
| K093343 |
04/22/2010 |
GRAFTY QUICKSET |
GRAFTYS |
ANTHONY LE NAOUR |
| K100046 |
04/08/2010 |
M SEIRES PATIENT MONITOR MODEL M66, M69, M8000, M9000, M7000 |
GUANGDONG BIOLIGHT MEDITECH CO., LTD. |
Diana Hong |
| K100135 |
04/16/2010 |
GDS-DC12 |
GUIDED DELIVERY SYSTEMS |
BONNIE L MCINERNEY |
| K092240 |
04/21/2010 |
ACUPUNCTURE NEEDLES |
HAENGLIM SEOWON MEDICAL CO. |
JEAN ASQUITH |
| K093241 |
04/27/2010 |
V7 PORTABLE SUCTION UNITS |
HERSILL, S.L. |
OSCAR JORDAN |
| K093889 |
04/22/2010 |
MODIFICATION TO: HG III ULTRA WIDE SYSTEM |
HIOSSEN INC. |
PATRICK LIM |
| K100745 |
04/15/2010 |
LIFEBED NETWORK PATIENT VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
Cindy Green |
| K100273 |
04/22/2010 |
INSTAFLO BOWEL CATHETER SYSTEM KIT |
HOLLISTER, INC. |
BENJAMIN LICHTENWALNER |
| K100692 |
04/06/2010 |
DIGITAL SPOT MAMMOGRAPHY SYSTEM |
HOLOGIC, INC. |
GAIL YAEKER-DAUNIS |
| K090882 |
04/23/2010 |
FLUSH SYRINGE FILLED WITH 0.9% SODIUM CHLORIDE |
HOSPIRA, INC. |
KEITH DUNN |
| K091955 |
04/02/2010 |
STRYKER SONICPIN SYSTEM |
HOWMEDICA OSTEONICS CORP |
AVITAL MERL-MARGULIES |
| K100475 |
04/30/2010 |
AXSOS LOCKED PLATING SYSTEM LINE EXTENSION OF 5MM LOCKING INSERTS |
HOWMEDICA OSTEONICS CORP. |
MELISSA A MATARESE |
| K100915 |
04/30/2010 |
INSPECTRA STO2 TISSUE OXYGENATION MONITOR, MODEL 650 |
HUTCHINSON TECHNOLOGY, INC. |
COLIN MCGRAW |
| K093706 |
04/02/2010 |
PROXISCAN MODEL 101 |
HYBRIDYNE IMAGING TECHNOLOGIES, INC |
BARRY S SALL, RAC |
| K100315 |
04/23/2010 |
12 LEAD GLOVE |
I NEEDMD, INC |
IRVING L WIESEN, ESQ |
| K093128 |
04/28/2010 |
ILLUMINA BEADXPRESS SYSTEM |
ILLUMINA, INC. |
DONALD R ELLIS |
| K093129 |
04/28/2010 |
ILLUMINA VERNCODE GENOTYPING TEST FOR FACOR V AND FACTOR II |
ILLUMINA, INC. |
DONALD R ELLIS |
| K091933 |
04/02/2010 |
ELECTRO-ACUPUNCTURE: ACULIFE/MODEL IDOC-01 |
INNO-HEALTH TECHNOLOGY, INC. |
TERRY C CHANG |
| K093922 |
04/15/2010 |
INOMAX DS |
INO THERAPEUTICS |
LARRY LEPLEY |
| K100517 |
04/29/2010 |
INSTRUMED FORCEPS OBSTERICAL, MODEL# 46-5XXX, OB-XXXX |
INSTRUMED INTERNATIONAL, INC. |
MICHAEL MASSONG |
| K100096 |
04/22/2010 |
LINAC COLLIMATOR ASSEMBLY HOUSING (LCAH) MODEL LCAHART |
INTEGRA RADIONICS, INC. |
HELDER A SOUSA |
| K100417 |
04/08/2010 |
XKNIFE 5 |
INTEGRA RADIONICS, INC. |
KEVIN J O'CONNELL |
| K100208 |
04/20/2010 |
IMC SURGICAL DRAPE |
INTERNATIONAL MEDSURG CONNECTION |
PETER KIM |
| K100921 |
04/30/2010 |
ADMIRAL XTREME PTA BALLOON DILATATION CATHETER |
INVATEC S.P.A. |
JOHN CLAY |
| K092335 |
04/09/2010 |
PEAK EXPIRATORY FLOW METER, KN-9710 |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K091486 |
04/29/2010 |
K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATOR |
KAMIYA BIOMEDICAL CO. |
SHAWN KAPLAN |
| K100526 |
04/22/2010 |
AMERITUS ENTRAL (TM) ENTERAL FEEDING TUBE |
KENTEC MEDICAL, INC. |
KEITH ROOKS |
| K100347 |
04/30/2010 |
OPTIBOND SE |
KERR CORPORATION |
Wendy Garman |
| K100803 |
04/22/2010 |
OLYMPUS FLUSHING PUMP OFP MODEL: OFP-1 |
KEYMED, INC. |
RONALD WARREN |
| K092765 |
04/07/2010 |
LANX ANTERIOR PLATING SYSTEM |
LANX, INC. |
MICHAEL FUNK |
| K100191 |
04/15/2010 |
LANX POSTERIOR CERVICOTHORACIC SPINAL FIXATION SYSTEM (PCFS) |
LANX, INC. |
ANDREW LAMBORNE |
| K093017 |
04/29/2010 |
STELLAR 300 |
LARSEN & TOUBRO LIMITED |
E.J. Smith |
| K100116 |
04/15/2010 |
LASERTOUCHONE (OTC) |
LASER HEALTH TECHNOLOGIES, LLC |
PATSY J TRISLER |
| K091987 |
04/23/2010 |
ANASTOCLIP MODELS 4001-01, 4000-02, 4000-03, 4000-04, 4004-01, 4004-02, ANASTOCLIP |
LEMAITRE VASCULAR, INC. |
ERIN E DALY |
| K094052 |
04/23/2010 |
LENSX 550 LASER SYSTEM. MODEL 550 |
LENSX LASERS, INC. |
Judy Gordon |
| K093857 |
04/30/2010 |
C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES |
LIGHTLAB IMAGING,INC. |
CHRISTINE BRAUER |
| K093207 |
04/26/2010 |
ENDURAMESH, MODEL 762.XXX |
LUCERO MEDICAL, LLC |
JENNIFER PALINCHIK |
| K100415 |
04/21/2010 |
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM |
LUMENIS |
AHAVA STEIN |
| K100384 |
04/12/2010 |
FIBERLASE C02 LASER WAVEGUIDE |
LUMENIS, LTD. |
AHAVA STEIN |
| K100278 |
04/30/2010 |
QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING, MODELS BE-HMOD 30000-USA, BEQ-HMOD 30000-USA |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K093806 |
04/08/2010 |
MYKNEE CUTTING BLOCKS |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K100673 |
04/06/2010 |
EASYLYTE NA/K/CL/LI ANALYZER, MODEL 2020 |
MEDICA CORP. |
Photios Makris |
| K092542 |
04/23/2010 |
M |
MEDISCITEC INC. |
Kevin Walls |
| K100284 |
04/09/2010 |
LIQUIBAND ULTIMA, LUT 003 |
MEDLOGIC GLOBAL LIMITED |
MICHAEL BROWNE |
| K100023 |
04/05/2010 |
PROFILE-V MEDTOXSCAN DRUGS OF ABUSE TEST SYSTEM AND 12 DRUGS TEST SYSTEM |
MEDTOX DIAGNOSTICS, INC. |
PHILLIP HARTZOG |
| K100470 |
04/21/2010 |
GTX 12 GIDEWIRE |
MEDTRONIC INC. |
COLLEEN MULLINS |
| K094025 |
04/26/2010 |
CRESCENT SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
JENNIFER HACKNEY |
| K091797 |
04/30/2010 |
TSRH SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
BRAD SHEALS |
| K093913 |
04/06/2010 |
MERCURY MEDICAL T-PIECE RESUSCITATOR |
MERCURY MEDICAL, INC. |
PAUL DRYDEN |
| K100319 |
04/28/2010 |
MERIT MANIFOLD WITH INTEGRATED TRANSDUCER, MODEL 203LTCHN-R; 503LTCHN-R; 203LTPHN-R,203LTCHWN-R; 503LTCHWN-R; 203L |
MERIT MEDICAL SYSTEMS, INC. |
JEFF CARLSTROM |
| K091716 |
04/02/2010 |
MERITS HEALTH PRODUCTS PROFIL Q601 SERIES OXYGEN FILLING ACCESSORY |
MERITS HEALTH PRODUCTS CO., LTD. |
STEVE CHAO |
| K100454 |
04/22/2010 |
HYDROCOIL EMBOLIC SYSTEM-HYDROFRAME MODEL 100931HFM-V, 101243HFM-V, 180827HFM-V, 181139HFM-V, 181445HFM-V, 181850HFM-V |
MICROVENTION, INC. |
LARAINE PANGELINA |
| K092387 |
04/05/2010 |
MEDIVATORS DSD EDGE ENDOSCOPE REPROCESSING SYSTEM |
MINNTECH CORP. |
RICHARD M ORMSBEE |
| K100449 |
04/23/2010 |
MINXRAY MODEL CMDR-2S |
MINXRAY, INC. |
DANIEL KAMM, P.E. |
| K100127 |
04/16/2010 |
ELI 230 ELECTROCARDIOGRAPH |
MORTARA INSTRUMENT, INC. |
CHARLES MORREALE |
| K100237 |
04/23/2010 |
DIALYSATE METER, MODEL D-6 |
MYRON L COMPANY |
RICHARD JAMES SPAHL |
| K100683 |
04/09/2010 |
NEUROLINK IP MODEL: PK1117 |
NATUS MEDICAL INCORPORATED |
GOLDY SINGH |
| K100195 |
04/21/2010 |
NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X |
NDS SURGICAL IMAGING |
JIM LENG |
| K092481 |
04/02/2010 |
HEMODIALYSIS CARBON EXCHANGE, DUAL BED DEIONIZER EXCHANGE, MIXED BED DEIONIZER EXCHANGE, MODEL .60MAW,1.2MAW,3.6MAW, 1.2 |
NEW AQUA LLC (DBA AQUA SYSTEMS) |
NEVIN RUDIE |
| K092382 |
04/26/2010 |
NEXUS PRESSURE RATED EXTENSION SETS |
NEXUS MEDICAL, LLC |
SUSAN CURRY |
| K093971 |
04/22/2010 |
DENTAL HANDPIECE |
NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. |
Diana Hong |
| K100335 |
04/08/2010 |
ORS VISUAL |
OBJECT RESEARCH SYSTEMS, INC. |
ERIC FOURNIER |
| K090845 |
04/07/2010 |
APEX ARC HIP STEM |
OMNI LIFE SCIENCE, INC. |
WILLIAM MCCALLUM |
| K091404 |
04/22/2010 |
IVUE, MODEL 100 |
OPTOVUE, INC. |
Azimun Jamal |
| K093611 |
04/15/2010 |
VITROS CHEMISTRY PRODUCTS CO2 DT SLIDES; VITROS CHEMMISTRY PRODUCTS DT CALIBRATOR KIT, MODELS CO2 DT SLIDES, 172 0002; |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K100618 |
04/20/2010 |
MAXLOCK EXTREME EXTREMITY PLATING SYSTEM WITH VARIABLE ANGLE TECHNOLOGY |
ORTHOHELIX SURGICAL DESIGNS, INC. |
DEREK LEWIS |
| K090436 |
04/16/2010 |
AIRWAYEASE MAS |
ORTHOPLANT DENTAL LAB |
CHRISTOPHER KELLY |
| K100599 |
04/05/2010 |
CAS FIXATION PIN 3.2 DIA X 180 MM STR, CAS FIXATON PIN 3.2 DIA X 80 MM STR, CAS FIXATON PIN 3.2 DIA X 150 MM |
ORTHOSOFT, INC. |
CHRISTOPHER MCLEAN |
| K093974 |
04/22/2010 |
ESENOR FII-FV-MTHFR GENOTYPING TEST, ESENOR FII-FV GENOTYPING TEST, ESENOR FII GENOTYPING |
OSMETECH MOLECULAR DIAGNOSTICS |
ROBERT S DICHECK |
| K093205 |
04/01/2010 |
PADCHECK |
PADTEST, LLC |
JAMES R GREENWOOD |
| K092984 |
04/07/2010 |
PANPAC UTERINE INECTOR, MODEL UI-4.0, UI-2.0 |
Panpac Medical Corporation |
Yen-Ming Pan |
| K100164 |
04/05/2010 |
MR INSPIRE WITH EXTENDED KIT |
PARAMED SRL |
JOE OUELLETTE |
| K093695 |
04/13/2010 |
PEAK PLASMABLADE 3.OS TISSUE DISSECTION DEVICE |
PEAK SURGICAL, INC. |
LOIS NAKAYAMA |
| K100272 |
04/14/2010 |
INTELLIVUE CLINICAL INFORMATION PORTFOLIO |
PHILIPS MEDICAL SYSTEMS |
TERESA SCHMIDT |
| K100939 |
04/30/2010 |
INTELLIVUE PATIENT MONITOR MODEL: MP2, MP5, MP5T, MP20, MP30, MP40, MP50, MP60, MP70, MP75, MP80 AND MP90 |
PHILIPS MEDIZINSYSTEME BOEBLINGEN GMBH, CARDIAC AN |
ANDREAS SUCHI |
| K093618 |
04/23/2010 |
BILI-MIRROR MODEL BLM-1 |
PHYSICIAN ENGINEERED PRODUCTS, INC. |
ROB ROSE, MD |
| K100292 |
04/30/2010 |
CAAS QVA 3D, CAAS QCA 3D |
PIE MEDICAL IMAGING B.V. |
SASKIA LLOYD |
| K100361 |
04/22/2010 |
NANOSS BONE VOID FILLER |
PIONEER SURGICAL TECHNOLOGY |
DAVID J COLLETTE, MD |
| K100104 |
04/14/2010 |
HYBERNITE RAINOUT CONTROL SYSTEM |
PLASTIFLEX GROUP NV |
WILLIAM GREENROSE |
| K092348 |
04/08/2010 |
POLY FIT HIGH HYDRATING ANTIMICROBIAL DRESSINGS |
POLYREMEDY, INC. |
GARY MOCNIK |
| K092351 |
04/08/2010 |
POLY FIT + ABSORBING AND HIGH ABSORBING ANTIMICROBIAL DRESSINGS |
POLYREMEDY, INC. |
GARY MOCNIK |
| K093333 |
04/02/2010 |
PRIMUS STEAM STERILIZER PSS8-AA (16X16X26 MULTI FUNCTIONAL STERILIZER), LAB/LO STERILIZER,PRIMUS STEAM STERILIZER PSS8 |
PRIMUS STERILIZER COMPANY, LLC. |
CONNIE MANSFIELD |
| K100343 |
04/23/2010 |
PAP-CAP |
PUR-SLEEP, INC. |
PAUL DRYDEN |
| K093697 |
04/13/2010 |
VASHE WOUND THERAPY SOLUTION |
PURICORE INC. |
DENNIS MAHONRY |
| K093263 |
04/30/2010 |
STRETCH VINYL EXAMINATION GLOVE, POWDER FREE, YELLOW/WHITE |
QINGDAO LANG HUI IMPORT & EXPORT CO., LTD |
MARSHAL MA |
| K094038 |
04/22/2010 |
COMPACT TOUCH |
QUANTEL S.A. |
MIKE JOHNSON |
| K092901 |
04/28/2010 |
EPICAGE INTERBODY FUSION DEVICE |
R TREE INNOVATIONS |
RICHARD JANSEN |
| K100084 |
04/12/2010 |
MULTI FRAME WHEELCHAIR |
R82 A/S |
KIRK MACKENZIE |
| K100733 |
04/30/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
RAYEN SAFETY PRODUCTS LIMITED |
CHU XIAOAN |
| K091791 |
04/07/2010 |
PROVANT SYSTEM, MODEL 4201 |
REGENESIS BIOMEDICAL, INC. |
RICHARD ISENBERG |
| K093377 |
04/27/2010 |
POLARIS CONTACT LENS CASE |
RELIANCE DESIGN & MANUFACTURING CORP. |
TRAVIS HSU |
| K093555 |
04/02/2010 |
COBAS U411 TEST SYSTEM |
Roche Diagnostics |
JENNIFER TRIBBETT |
| K100810 |
04/26/2010 |
ELECSYS C-PEPTIDE CALCHECK 5 |
Roche Diagnostics |
KELLY ADAMS |
| K094031 |
04/27/2010 |
ELECSYS FOLATE III CALCHECK 5 |
Roche Diagnostics |
KELLY COLEEN O'MAINE ADAMS |
| K100594 |
04/01/2010 |
ELECSYS TROPONIN I CALCHECK 5 |
Roche Diagnostics |
Sarah Baumann |
| K093836 |
04/15/2010 |
ELECSYS TSH CALCHECK 5 |
Roche Diagnostics |
KELLY COLLEEN O'MAINE ADAMS |
| K093421 |
04/23/2010 |
ELECSYS TESTOSTERONE II IMMUNOASSAY |
ROCHE DIAGNOSTICS CORP. |
Sarah Baumann |
| K092530 |
04/02/2010 |
SPRYTIE, MODELS ST001, ST002 AND ST003 |
RUSSELL B. WALTHER |
RUSSELL B WALTHER |
| K100173 |
04/16/2010 |
IYUNNI 3ID TRI-FUNNEL FEEDING TUBE KIT |
SAINATH INTELLECTUAL PROPERTIES, LLC |
CHRISTOPHER PARADIES |
| K100410 |
04/28/2010 |
PIEZOELECTRIC SYSTEM |
SATELEC |
RICK ROSATI |
| K092521 |
04/13/2010 |
ZUMA-C |
SEASPINE, INC. |
ETHEL BERNAL |
| K100268 |
04/26/2010 |
SECHRIST MONOPLACE HYPERBARIC OXYGEN CHAMBER |
SECHRIST INDUSTRIES, INC. |
VICTOR ARELLANO |
| K100113 |
04/22/2010 |
VANGUARD BREAST MRI AUXILIARY TABLE WITH 16 CHANNEL COIL ARRAY FOR GE 3T MRI SYSTEM, MODEL 4000451-51 |
SENTINELLE MEDICAL, INC. |
JOAN MEDLEY |
| K100394 |
04/15/2010 |
MULTI-PARAMETER PATIENT MONITOR, MODEL# PMS8210A |
SHANGHAI 3F ELECTRONICS CO LTD |
CHARLES MACK |
| K090510 |
04/29/2010 |
DOPPLER FETAL HEARTBEAT RATE DETECTOR |
SHENZHEN BESTMAN INSTRUMENT CO., LTD. |
KATHY GUO |
| K093394 |
04/08/2010 |
BC-3200 AUTO HEMATOLOGY ANALYZER,M-30D DILUENT, M-30R RINSE, M-30CFL LYSE, M-30E-Z CLEANSER, M-30PROBE CLEANSER, BC-3D C |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN GOLDSTEIN |
| K101041 |
04/30/2010 |
DC-7 DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
MENG XIANJUN |
| K091772 |
04/08/2010 |
POWDER-FREE VINYL EXAM GLOVES |
SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD. |
Kevin Walls |
| K091770 |
04/06/2010 |
VINYL PATIENT EXAM GLOVES PRE-POWERED, CLEAR |
SHIJIAZHUANG HUIJINGYUAN PLASTIC CO, LTD. |
Kevin Walls |
| K093441 |
04/07/2010 |
DIMENSION VISTA LOCI DIGOXIN FLEX REAGENT CARTRIDGE (DIGXN), MODEL K6435 |
SIEMENS HEALTHCARE DIAGNOSTICS |
FRANCES A DILLON |
| K093790 |
04/05/2010 |
SIMONDR DRP |
SIMONDR, INC. |
VALERIE LOHR |
| K091720 |
04/09/2010 |
SKLARLITE RIGID STERILIZATION CONTAINER SYSTEM |
SKLAR CORP. |
NATALYA VALERIO |
| K100159 |
04/19/2010 |
SMITH AND NEPHEW TWINFIX ULTRA TI SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
CHRISTINA FLORES |
| K093991 |
04/15/2010 |
SLR-PLUS STANDARD AND LATERAL FEMORAL STEMS |
SMITH & NEPHEW, INC. |
SHEREEN MYERS |
| K093935 |
04/05/2010 |
SMITH & NEPHEW FOOTPRINT RCX PK SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
CHRISTINA FLORES |
| K090982 |
04/21/2010 |
SMITH & NEPHEW HIP SYSTEMS WITH HA |
SMITH & NEPHEW, INC. |
MANDY COE |
| K093844 |
04/01/2010 |
SMITH & NEPHEW TWINFIX ULTRA HA SUTURE ANCHOR |
SMITH & NEPHEW, INC. |
CHRISTINA FLORES |
| K092748 |
04/26/2010 |
SURESHOT TAN NAILS AND ACCESSORIES |
SMITH & NEPHEW, INC. |
DAVID HENLEY |
| K093746 |
04/14/2010 |
VERILAST WEAR CLAIMS FOR THE LEGION PRIMARY KNEE SYSTEM |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K093422 |
04/29/2010 |
VITAL SYNC MODEL 5000 SERIES |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K092611 |
04/28/2010 |
SONARMED AIRWAY MONITORING SYSTEM, MODEL 0901 |
SONARMED, INC. |
LAURA LYONS |
| K100252 |
04/09/2010 |
MASTER-VU A-SCAN, MV4500 |
SONOMED, INC. |
CHARLES O'NEAL |
| K093511 |
04/16/2010 |
SORING MBC200/BCC140 |
SORING GMBH MEDIZINTECHNIK |
JAN SCHUELLER-IWERSEN |
| K100710 |
04/28/2010 |
ROLL-X GUIDEWIRE |
ST. JUDE MEDICAL |
Jennifer Zwiefelhofer |
| K093858 |
04/02/2010 |
PSA CABLE, MODELS 4160 AND 4161 AND PSA CABLE ADAPTER, MODEL 4053A |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
Beena Flynn |
| K093176 |
04/06/2010 |
MED-LOK |
STA-MED, LLC |
GREG HOLLAND |
| K091022 |
04/12/2010 |
MODIFICATION TO RESERT XL HLD HIGH LEVEL DISINFECTANT |
STERIS Corporation |
JOHN SCOVILLE JR. |
| K090036 |
04/05/2010 |
SYSTEM 1.5 STERILE PROCESSING SYSTEM |
STERIS Corporation |
PETER BURKE |
| K092969 |
04/30/2010 |
H/S CATHETER SET 5 FRENCH, MODEL 61-5005F, H/S CATHETER SET 7 FRENCH, MODEL 61-5007F |
STERLING MEDICAL INC |
THOMAS TRIMNAL |
| K100737 |
04/12/2010 |
MODIFICATION TO: TRIO+SPINAL FIXATION SYSTEM |
STRYKER SPINE |
CURTIS TRUESDALE |
| K092554 |
04/30/2010 |
BLASTOMERE BIOPSY PIPETTES, POLAR BODY BIOPSY PIPETTES |
SUNLIGHT MEDICAL, INC. |
DUNSONG YANG |
| K100855 |
04/22/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
SUZHOU SHENGYUDA PLASTIC PRODUCTS CO., LTD. |
CHU XIAOAN |
| K093341 |
04/05/2010 |
CENTURY MODEL 105C |
SYBRON DENTAL SPECIALTIES, INC. |
CLAUDIA ORTIZ |
| K093361 |
04/14/2010 |
SYNTHES AIR PEN DRIVE (APD) SYSTEM |
SYNTHES (USA) |
JILL YELTON |
| K100676 |
04/08/2010 |
SYNTHES TOMOFIX(TM) MEIAL HIGH TIBIA PLATE, SMALL |
SYNTHES (USA) |
KARL J NITTINGER |
| K093940 |
04/23/2010 |
ADVOCATE REDI-CODE DASH BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4276 |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K093506 |
04/01/2010 |
CLEVER CHOICE AUTO-CODE PRO BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4267 |
TaiDoc Technology Corporation |
TELING HSU |
| K100392 |
04/13/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN JIAXING PLASTIC PRODUCTS CO., LT |
CHU XIAOAN |
| K100419 |
04/06/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN YONGKANG GLOVE CO., LTD |
CHU XIAOAN |
| K093705 |
04/23/2010 |
FUORECAM |
THERAPEUTIC TECHNOLOGIES, INC. |
BART COLLINS |
| K093799 |
04/22/2010 |
TORNIER SURGICAL MESH |
TORNIER, INC. |
HOWARD L SCHRAYER |
| K093478 |
04/26/2010 |
KODAK RVG 6500 SYSTEM AND KODAK RVG 6500 IPS SYSTEM |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K100301 |
04/29/2010 |
OPAL BOND FLOW |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K093400 |
04/01/2010 |
1ML UNITRACT INSULIN SYRINGE 27G X 1/2 AND 29G X 1/2 |
UNILIFE MEDICAL SOLUTIONS LIMITED |
MELISSA L DEHASS |
| K100081 |
04/12/2010 |
ENTEROSCOPY OVERTUBE, MODEL 00712140 |
UNITED STATES ENDOSCOPY GROUP, INC. |
BOB BISHUI |
| K100093 |
04/30/2010 |
VSI TORQUE DEVICE |
VASCULAR SOLUTIONS, INC. |
JENNIFER RUETHER |
| K092785 |
04/02/2010 |
COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SOFTWARE, 2301 |
VASOMEDICAL, INC. |
RICHARD GORDON |
| K093135 |
04/02/2010 |
VENNER PNEUX P.Y. (TM) TRACHEOSTOMY TUBE AND ENDO TRACHEAL TUBE |
VENNER MEDICAL (SINGAPORE) PTE LTD |
JUDY BURTON |
| K100383 |
04/20/2010 |
VITAPHONE. MODEL 100 BT |
VITASYSTEMS GMBH |
TILO BORCHARDT |
| K100930 |
04/30/2010 |
PRIMEWIRE PRESTIAGE PRESSURE GUIDE WIRE, MODELS 8185, 8185J, 8300, 8300J |
VOLCANO CORPORATION |
MARILYN POURAZAR |
| K093907 |
04/14/2010 |
WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE |
WELCH ALLYN, INC. |
HUY DOAN |
| K100258 |
04/28/2010 |
ELECTROSURGICAL PENCIL WITH ELECTRODE, WP200 |
WICKIMED SUPPLY LIMITED |
KIPSON FUNG |
| K100866 |
04/28/2010 |
PROFEMUR HIP SYSTEM MODULAR NECKS |
WRIGHT MEDICAL TECHNOLOGY, INC. |
GREGORY NEAL |
| K100250 |
04/08/2010 |
XCERAM |
XCERAMUSA |
DANIEL KAMM |
| K093279 |
04/07/2010 |
NAVIX ACCESS DEVICE |
XLUMENA |
WITNEY MCKIERNAN |
| K100436 |
04/30/2010 |
CLICKFINE PEN NEEDLE |
YPSOMED AG |
MANFRED MADER |
| K100111 |
04/12/2010 |
NCB PERIPROSTHETIC FEMUR POLYAXIAL LOCKING PLATE SYSTEM |
ZIMMER INC. |
ANTHONY FRANCALANICA, RAC |
| K093561 |
04/28/2010 |
ZIMMER TRABECULAR METAL MODULAR ACETABULAR SYSTEM |
ZIMMER, INC. |
BENJAMIN CURSON, CQE RAC |
| K093802 |
04/09/2010 |
ULTRAVIEW DM3 MONITOR |
ZOE MEDICAL, INC. |
JIM CHICKERING |
