| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K080620 |
05/19/2008 |
MODIFICATION TO 3M TEGADERM CHG DRESSING |
3M COMPANY-3M HEALTH CARE |
MARIA RUIZ |
| K063723 |
05/30/2008 |
IMPELLA RECOVER LP 2.5 PERCUTANEOUS CARDIAC SUPPORT SYSTEM |
ABIOMED, INC. |
ROBERT T KUNG |
| K080401 |
05/09/2008 |
SHELL CAGE, WAVE CAGE, LOOP CAGE |
ADVANCED MEDICAL TECHNOLOGIES AG |
J.D. WEBB |
| K080590 |
05/06/2008 |
AOS PROXIMAL HUMERAL PLATE |
ADVANCED ORTHOPAEDIC SOLUTIONS, INC. |
PAUL DONER |
| K080584 |
05/09/2008 |
METHA SHORT STEM HIP SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
KATHY A RACOSKY |
| K080547 |
05/23/2008 |
ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 |
AESCULAP IMPLANT SYSTEM, INC. |
MATTHEW M HULL |
| K071983 |
05/01/2008 |
AESCULAP PEEK INTERVERTEBRAL BODY FUSION SYSTEM: A SPACE, CESPACE, PROSPACE, T-SPACE |
AESCULAP IMPLANT SYSTEMS, INC. |
MATTHEW M HULL |
| K081031 |
05/05/2008 |
ENDOSCOPIC CLIP APPLIERS WITH CLIP MAGAZINE |
AESCULAP, INC. |
Lisa Boyle |
| K081104 |
05/02/2008 |
AESKULISA ANA HEP-2, REF 30-7115US |
AESKU.DIAGNOSTICS |
JIM RADFORD |
| K081251 |
05/13/2008 |
MODIFICATION TO AESKULISA DS DNA G |
AESKU.DIAGNOSTICS |
SASCHA PFEIFFER |
| K080994 |
05/16/2008 |
AMPLATZER TORQVUE EXCHANGE SYSTEM |
AGA MEDICAL CORP. |
MICHELLE NIVALA |
| K063583 |
05/09/2008 |
ALCON VISION SYSTEM |
ALCON |
TERRY J DAGNON |
| K072564 |
05/23/2008 |
ALMA LASERS HARMONY XL MULTI-APPLICATION PLATFORM |
ALMA LASERS LTD. |
ANNE WORDEN |
| K072258 |
05/16/2008 |
BI-RADS COMPANION |
ALMEN LABORATORIES, INC. |
ROGER H SCHNEIDER |
| K080699 |
05/21/2008 |
NOVEL SPINAL SPACER SYSTEM |
ALPHATEC SPINE, INC. |
MARY STANNERS |
| K073078 |
05/30/2008 |
RAPID TOX CUP |
AMERICAN BIO MEDICA CORP. |
RICH REILLY |
| K080397 |
05/06/2008 |
AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM |
AMERICAN DENTAL IMPLANT CORPORATION |
GINA HENNON |
| K080400 |
05/13/2008 |
ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT |
ANGIODYNAMICS, INC. |
TERI JUCKETT |
| K081220 |
05/28/2008 |
MODIFICATION TO ANGIOSCULPT PTA SCORING BALLOON CATHETER |
ANGIOSCORE, INC. |
KIMBERLEY KLINE |
| K080587 |
05/15/2008 |
EZ MANAGER MAX DIABETES MANAGEMENT SOFTWARE |
ANIMAS CORP. |
JENNIFER BOSLEY |
| K071915 |
05/14/2008 |
CPAP MASK |
ARCIMED LABORATORIES LLC |
PAUL DRYDEN |
| K072582 |
05/30/2008 |
PROVOX MICRON HME |
ATOS MEDICAL AB |
PAUL DRYDEN |
| K081154 |
05/23/2008 |
ULTRASOUND SCANNER FLEX FOCUS, MODEL 1202 |
B-K MEDICAL APS |
JENS RASMUSSEN |
| K081109 |
05/02/2008 |
CORONIS 5MP MAMMO SL, MODEL MDMG 6121 |
BARCOVIEW, MEDICAL IMAGING SYSTEMS |
NEIL PHILLIPS |
| K063532 |
05/30/2008 |
BARD E LUMINEXX BILIARY STENT |
BARD PERIPHERAL VASCULAR, INC. |
LINDSAY K PACK |
| K072595 |
05/09/2008 |
OMNI-TIGHT |
BASIC DENTAL IMPLANT SYSTEMS, INC. |
RICH WEISKOPF |
| K073326 |
05/28/2008 |
NRG TRANSSEPTAL NEEDLE |
BAYLIS MEDICAL CO., INC. |
MEGHAL KHAKHAR |
| K080869 |
05/23/2008 |
ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC |
BECKMAN COULTER, INC. |
DAVID M IKEDA |
| K080998 |
05/12/2008 |
DORIPENEM 10UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
JANINE MATLAK |
| K080012 |
05/08/2008 |
PLATELIA LYME IGG ASSAY |
BIO-RAD |
FRAN WHITE |
| K080911 |
05/02/2008 |
VARIANT NBS SICKLE CELL PROGRAM REAGENT KIT, VARIANT NBS NEWBORN SCREENING SYSTEM AND VARIANT NBS WORKSTATION WITH |
BIO-RAD LABORATORIES INC., CLINICAL SYSTEMS DIVISI |
J.B BARTILSON |
| K081143 |
05/02/2008 |
BIOMERS TRANSLUCENT ORTHODONTIC WIRE |
BIOMERS PRODUCT, LLC |
GEORGE ALIPHTIRAS |
| K081067 |
05/09/2008 |
FRACTURE/RECONSTRUCTION SYSTEM (TRAUMAONE) |
BIOMET MICROFIXATION, INC. |
KIM REED |
| K080646 |
05/02/2008 |
C-TEK MAXAN ANTERIOR CERVICAL PLATE SYSTEM |
BIOMET SPINE |
JACQUELYN A HUGHES |
| K080374 |
05/15/2008 |
BIOSYAG MEDICAL SYSTEM |
BIOS S.R.L. |
ALESSANDRO FRANCHI |
| K080988 |
05/07/2008 |
SCOUTPRO CS LEAD INTRODUCER SYSTEM |
BIOTRONIK, INC. |
Jon Brumbaugh |
| K081253 |
05/15/2008 |
ZIRDENT CAD/CAM BLOCKS |
C5 MEDICAL WERKS, INC. |
HOMER GREGORY |
| K080954 |
05/16/2008 |
T34L SYRINGE DRIVER |
CAESAREA MEDICAL ELECTRONICS LTD. |
EVA PARTAS |
| K072456 |
05/08/2008 |
DESARA MESH SLING, MODEL CAL-DS01 |
CALDERA MEDICAL, INC. |
CHRISTINE EMANUEL |
| K080726 |
05/14/2008 |
CALYPSO 4D LOCALIZATION SYSTEM |
CALYPSO MEDICAL TECHNOLOGIES INC |
ERIC MEIER |
| K081257 |
05/29/2008 |
CG-6108 ACT-3L CONTINUOUS ECG MONITOR & ARRHYTHMIA DETECTOR |
CARD GUARD SCIENTIFIC SURVIVAL, LTD. |
ALEX GONOROVSKY |
| K073207 |
05/08/2008 |
OLYMPUS ESG-100, MODEL WB991046; OLYMPUS AFU-100, MODEL WB950167 |
CELON AG MEDICAL INSTRUMENTS |
LAURA STORMS-TYLER |
| K073213 |
05/28/2008 |
THERABOND ANTIMICROBIAL BARRIER SYSTEMS |
CHOICE THERAPEUTICS |
HOWARD M HOLSTEIN |
| K080452 |
05/15/2008 |
COLLAGEN TENDON WRAP |
COLLAGEN MATRIX, INC. |
PEGGY HANSEN |
| K080386 |
05/30/2008 |
COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE |
COLUMBIA SCIENTIFIC DEVELOPMENT LLC |
STEPHEN SHULMAN |
| K080752 |
05/14/2008 |
CONCEIVEX LATEX-FREE SEMEN COLLECTOR |
CONCEIVEX INC. |
BLIX WINSTON |
| K080936 |
05/12/2008 |
CONFORMIS TOTAL KNEE REPIAR SYSTEM (ITOTAL) TIBIAL COMPONENT: 6.0 MM THICKNESS |
CONFORMIS, INC. |
S. MICHAEL SHARP |
| K080946 |
05/20/2008 |
CONMED AXCESS PAPILLOTOME MODELS AX4535, AX4535FX |
CONMED ENDOSCOPIC TECHNOLOGIES, INC. |
BETH ZIS |
| K073454 |
05/05/2008 |
FINGERTIP PULSE OXIMETER, MODEL CMS-50C |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K080383 |
05/02/2008 |
AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING |
CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. |
MARILYN KONICKY |
| K080359 |
05/09/2008 |
EVOLUTION ESOPHAGEAL STENT SYSTEM |
COOK IRELAND LTD |
NOREEN BARRY |
| K080967 |
05/02/2008 |
TRUFILL DCS ORBIT DETACHABLE COIL AND TRUFILL DCS SYRINGE OR TRUFILL DCS SYRINGE II, ALSO KNOWN AS THE TRUFILL DCS ORBIT |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
| K081169 |
05/23/2008 |
AUTOSUTURE VERSAPORT PLUS BLADLESS TROCAR; BLADELESS TROCAR |
COVIDIEN LP, FORMERLY REGISTERED AS UNITED STATES |
TIM LOHNES |
| K080860 |
05/29/2008 |
CREASPINE SUPSTANCE SMALL VERTEBRAL BODY REPLACEMENT SYSTEM |
CREASPINE |
CYNTHIA J NOLTE |
| K080605 |
05/05/2008 |
SURE-LOCK ELECTRODE CLIP, MODEL CL-34, CL-A60, CL-HW, CL-TL |
CURBELL ELECTRONICS INC. |
MICHAEL J WINTER |
| K080281 |
05/01/2008 |
PATHWAY |
CUSTOM SPINE, INC. |
SAAD ATTIYAH |
| K081181 |
05/05/2008 |
SMART CO2 (SMART US 20D / ULTRASPEED, SMART CLINIC AND PERIOPULSE) SURGICAL LASER |
CYNOSURE, INC. |
GEORGE CHO |
| K080738 |
05/13/2008 |
DENTRON SENSOR |
DENTRON SYSTEMS LLC |
CLAUDE D BERTHOIN |
| K081291 |
05/22/2008 |
PRE-CEMENTED ORTHODONTIC BRACKET SYSTEM EXTENSION |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K073281 |
05/02/2008 |
CAIS STAPLE |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
RUTH C FORSTADT |
| K081163 |
05/14/2008 |
SMARTSET GMV GENTAMICIN BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K081155 |
05/14/2008 |
SMARTSET MV BONE CEMENT |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K081252 |
05/30/2008 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K080313 |
05/08/2008 |
MODIFICATION TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K073562 |
05/15/2008 |
MODIFICATION TO VIPER SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K080568 |
05/01/2008 |
X-MESH EXPANDABLE CAGE SYSTEM |
DEPUY SPINE, INC. |
HANDE TUFAN |
| K081162 |
05/08/2008 |
TEMPTOUCH DERMAL THERMOMETER |
DIABETICA SOLUTIONS, INC. |
J.S. ALLINSON |
| K070104 |
05/07/2008 |
PROLYTE ELECTROLYTE ANALYZER |
DIAMOND DIAGNOSTICS, INC. |
RANDOLPH QUINN |
| K072290 |
05/29/2008 |
PEGASO V, NEGAVENT RESPIRATOR, MODEL: DA-3 PLUS |
DIMA ITALIA SRL |
LEWIS WARD |
| K073070 |
05/16/2008 |
DIO BIOTITE-H IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
STEVE CHANG |
| K080129 |
05/30/2008 |
SECURE IMPLANT SYSTEM (2.5/3.0MM) |
DIO DEPARTMENT DSI, INC. |
HYUNGICK KIM |
| K080128 |
05/14/2008 |
SM-EXTRA WIDE (RBM) IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
HYUNGICK KIM |
| K080479 |
05/21/2008 |
DENTAL CERAMIC |
DMG USA, INC. |
PAMELA PAPINEAU |
| K080480 |
05/30/2008 |
NANOCOMPOSITE RESTORATIVE KIT |
DMG USA, INC. |
PAMELA PAPINEAU |
| K080385 |
05/13/2008 |
CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR |
E1 ENT., INC. |
JACK CHENG |
| K073415 |
05/23/2008 |
NEMUS SYSTEM; NEMUS PC PERIPHERAL |
EB NEURO, S.P.A. |
Allison Scott |
| K073711 |
05/30/2008 |
MUCOGRAFT COLLAGEN MATRIX |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER S REICHERTZ |
| K072399 |
05/23/2008 |
DEL SOL RED LIGHT THERAPY SYSTEM |
EDGE SYSTEMS, INC. |
GARY MOCNIK |
| K081093 |
05/01/2008 |
3-D IMAGING WORKSTATION |
EIGEN LLC |
MARK A HOFFMAN |
| K080250 |
05/13/2008 |
LEKSELL SURGIPLAN, MODEL 1006947 |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
| K072536 |
05/07/2008 |
ESA BIOSCIENCES INC. VITAMIN D HPLC TEST |
ESA BIOSCIENCES INC. |
HAROLD ASP |
| K080839 |
05/21/2008 |
ECHELON GRAY CARTRIDGE, MODEL ERC45M |
ETHICON ENDO-SURGERY, LLC |
RUTH ANN WOOD |
| K071512 |
05/15/2008 |
GYNECARE PROLIFT +M* PELVIC FLOOR REPAIR SYSTEMS |
ETHICON, INC. |
BRYAN A LISA |
| K081274 |
05/28/2008 |
SURESKIN SILVER BANDAGES |
EUROMED, INC. |
SUBHASH CHANDER |
| K080980 |
05/06/2008 |
EXACTECH NOVATION ELEMENT PRESS-FIT FEMORAL STEMS |
EXACTECH, INC. |
XAVIER SARABIA |
| K073675 |
05/08/2008 |
T-PUMP LOCALIZED TEMPERATURE THERAPY PUMP |
GAYMAR INDUSTRIES, INC. |
BETHANY J GILBERT |
| K071889 |
05/19/2008 |
DATEX-OHMEDA S/5 CRITICAL CARE MONITOR WITH L-ICU05 AND L-ICU05A SOFTWARE |
GE HEALTHCARE |
JOEL C KENT |
| K081105 |
05/09/2008 |
GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) |
GE HEALTHCARE |
ANDREW MENDEN |
| K073543 |
05/02/2008 |
OEC 9900 ELITE |
GE OEC MEDICAL SYSTEMS |
MARIA C FRAME |
| K080662 |
05/15/2008 |
GENZYME CYSTATIN C REAGENT ANF GENZYME CYSTATIN C CALIBRATOR |
GENZYME CORPORATION |
ERIC LAWSON |
| K081195 |
05/28/2008 |
REVERE UNIPLANAR SCREWS |
GLOBUS MEDICAL INC. |
KELLY J BAKER |
| K080937 |
05/23/2008 |
POWDER FREE NITRILE EXAMINATION GLOVE, ORANGE |
GX CORPORATION SDN BHD |
FOO K PU |
| K080093 |
05/02/2008 |
PKS PLASMA MORCELLATOR, MODELS 962000PK, 3620PK |
GYRUS ACMI, INC. |
TERRENCE E SULLIVAN |
| K080818 |
05/15/2008 |
HEMCON BANDAGE, HEMCON BANDAGE OTC, HEMCON CHITOFLEX-SURGICAL DRESSING |
HEMCON MEDICAL TECHNOLOGIES, INC. |
KEVIN HAWKINS |
| K081179 |
05/09/2008 |
MAMMOSITE CAVITY EVALUATION DEVICE |
HOLOGIC, INC. |
RANDALL J COVILL |
| K081278 |
05/29/2008 |
OMEGA 3 TROCHANTERIC STABILIZING PLATE |
HOWMEDICA OSTEONICS CORP. |
ANDREA DWYER |
| K081217 |
05/22/2008 |
HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEM |
HYCOR BIOMEDICAL, INC. |
P. NARAYAN NAYAK |
| K080424 |
05/28/2008 |
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 |
HYGIA HEALTH SERVICES, INC. |
JEROME JAMES |
| K080007 |
05/13/2008 |
GRADUATED ADAPTER WITH CLAVE |
ICU MEDICAL, INC |
TRACY BEST |
| K080989 |
05/02/2008 |
UNIVERSAL VIAL ACCESS SPIKE |
ICU MEDICAL, INC |
TRACY BEST |
| K080762 |
05/15/2008 |
IB NEURO, VERSION 1.0 |
IMAGING BIOMETRICS, LLC |
MICHAEL SCHMAINDA |
| K080713 |
05/16/2008 |
REACTIVE DENTAL IMPLANT SYSTEM |
IMPLANT DIRECT LLC |
THOMAS GOTTENBOS |
| K081347 |
05/28/2008 |
ILUMA VISION |
IMTEC CORP. |
BRAD VANCE |
| K073217 |
05/14/2008 |
INCLUSIVE IMPLANT ABUTMENTS |
INCLUSIVE DENTAL SOLUTIONS |
KEITH D ALLRED |
| K081136 |
05/08/2008 |
LYRIC HEARING AID |
INSOUND MEDICAL INC. |
SUSAN WHICHARD |
| K081186 |
05/23/2008 |
CONCAVE RN HEALING CAP |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K081005 |
05/02/2008 |
P.004 NC CARES TITANIUM AND CERAMIC ABUTMENTS |
INSTITUT STRAUMANN AG |
ELAINE ALAN |
| K073377 |
05/04/2008 |
ACL TOP (WITH SYSTEM SOFTWARE V3.0.0) |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K072863 |
05/23/2008 |
ATRAMAT PGC25 POLY(GLYCOLIDE-CO-EPSILON-CAPROLACTONE) SURGICAL SUTURES |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
ALLAN P SCHWARTZ |
| K072859 |
05/23/2008 |
ATRAMAT PGLA90 POLY(GLYCOLIDE-CO-L-LACTIDE) SURGICAL SUTURES |
INTERNACIONAL FARMACEUTICA, S.A. DE C.V. |
ALAN P SCHWARTZ |
| K080598 |
05/21/2008 |
MINI DRIVE-LOCK DENTAL IMPLANT SYSTEM PROSTHETICS |
INTRA-LOCK INTERNATIONAL |
JEFFREY SAKOFF |
| K080575 |
05/13/2008 |
CORRIDOR4DM |
INVIA |
F. DAVID ROTHKOPF |
| K080427 |
05/23/2008 |
WATCH-PAT MODEL 100S-2 |
ITAMAR MEDICAL |
JONATHAN KAHAN |
| K080618 |
05/23/2008 |
DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID |
JAS Diagnostics, Inc. |
SAMUEL BURGOS |
| K080759 |
05/12/2008 |
THERMOFLASH LX-26 |
JXB CO. LTD GUANGZHOU (CHINA) |
TRAY CUI |
| K072410 |
05/09/2008 |
KSEA CLEARVISION II, MODEL 40334120 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K081120 |
05/01/2008 |
FUTAR (FUTAR, FUTAR D, FUTAR D FAST, FUTAR D SLOW, FUTAR SCAN BITE REGISTRATION MATERIALS |
KETTENBACH GMBH & CO KG |
MICHAELA ZINKE |
| K080159 |
05/22/2008 |
KRONUS TSH RECEPTOR AUTOANTIBODY (TRAB) ELISA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K080140 |
05/09/2008 |
LAURIMED SPINAL INJECTION SYSTEM |
LAURIMED LLC |
NANCY LINCE |
| K080158 |
05/02/2008 |
LB MEDICAL INFLATABLE TISSUE ELEVATOR/EXPANDER SYSTEM |
LB MEDICAL L.L.C. |
TERRY SHERIDAN POWELL |
| K080728 |
05/29/2008 |
LDR SPINE ROI-C IMPLANT |
LDR SPINE USA |
NOAH BARTSCH |
| K080569 |
05/07/2008 |
LDR SPINE ROI-T IMPLANT |
LDR SPINE USA |
NOAH BARTSCH |
| K080612 |
05/09/2008 |
LEICA FL800 |
LEICA MICROSYSTEMS (SCHWEIZ) AG |
COLLEEN BOSWELL |
| K080767 |
05/21/2008 |
CONQUEST SPINAL SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K080411 |
05/15/2008 |
PLATEAU SPACER SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K073411 |
05/13/2008 |
LITEDUO |
LIGHT INSTRUMENTS |
YORAM LEVY |
| K080029 |
05/16/2008 |
MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K080439 |
05/16/2008 |
SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE |
MALLINCKRODT DEVELOPPEMENT FRANCE |
TINA DREILING |
| K073592 |
05/07/2008 |
OPTISTAR ELITE INJECTION SYSTEM |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
DALE MOORE |
| K080238 |
05/12/2008 |
MASIMO RAINBOW SET RADICAL 7 PULSE CO-OXIMETER, MASIMO RAINBOW SET RAD 87 PULSE CO-OXIMETER |
MASIMO CORPORATION |
MARQUERITE THOMLINSON |
| K080764 |
05/06/2008 |
SUCCESS CECAL INTUBATION ASSIST, MODEL: 4100 |
MAX ENDOSCOPY INC. |
RICHARD M WOLF |
| K073467 |
05/23/2008 |
SPINEASSIST SYSTEM |
MAZOR SURGICAL TECHNOLOGIES LTD. |
AHAVA STEIN |
| K080742 |
05/09/2008 |
VERISUITE 1.6, VERISUITE-PARTICLE 1.6 |
MEDCOM GMBH |
STEFAN WALTER |
| K081066 |
05/05/2008 |
BRACHYTHERAPY SOURCE DEVICE, MODEL 9011 |
MEDI-PHYSICS, INC., DBA GE HEALTHCARE |
DAVID RISLEY |
| K071642 |
05/02/2008 |
MEDIAID M960 SERIES, VITAL SIGNS MONITOR AND MEDIAID M900 SERIES, PULSE OXIMETER |
MEDIAID INC. |
JAYESH PATEL |
| K080582 |
05/15/2008 |
MEDICATECH, MODEL DDR MAK-800, DDT MAK-1000 FS, DDR MAK-1100 FA |
MEDICATECH USA |
DANIEL KAMM |
| K073051 |
05/30/2008 |
MEDRAD CONTINUUM MR INFUSION SYSTEM WITH WIRELESS REMOTE ACCESSORY |
MEDRAD, INC. |
LESLIE S O'NAN |
| K080509 |
05/05/2008 |
CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE |
MEDTRONIC INC. |
PREETI JAIN |
| K081082 |
05/07/2008 |
U-CLIP UNI-FIRE, MODEL M65 |
MEDTRONIC INC. |
DAVID D COX |
| K080824 |
05/07/2008 |
BIO-CONSOLE 560 |
MEDTRONIC PERFUSION SYSTEMS |
PREETI JAIN |
| K080462 |
05/13/2008 |
PROGENIX DBM PUTTY |
MEDTRONIC SOFAMOR DANEK |
MICHELLE OBENAUER |
| K073285 |
05/15/2008 |
PEEK PREVAIL CERVICAL INTERBODY DEVICE |
MEDTRONIC SOFAMOR DANEK USA, INC. |
MICHAEL SCOTT |
| K080257 |
05/22/2008 |
MICROFRANCE LAPAROSCOPIC MANUAL SURGICAL INSTRUMENTS |
MEDTRONIC XOMED, INC. |
JAYME WILSON |
| K072251 |
05/08/2008 |
MERETE TOEMOBILE ANATOMICAL GREAT TOE RESURFACING SYSTEM |
MERETE MEDICAL GMBH |
DONNA COLEMAN |
| K080556 |
05/02/2008 |
ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES |
MERZ DENTAL GMBH |
RICHARD G HUNTER, M.S., RAC |
| K080981 |
05/02/2008 |
EAR THERMOMETER, MODELS ST66 AND ST67 |
MESURE TECHNOLOGY CO.,LTD. |
JOHN CHEN |
| K080655 |
05/09/2008 |
CHRYSALIS |
META IMAGING SOLUTIONS, LLC |
ROBERT J STAAB |
| K080337 |
05/13/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K080437 |
05/08/2008 |
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K080328 |
05/14/2008 |
MPS ACACIA ENTERAL FEEDING TUBE |
MPS ACACIA |
FERGIE FERGUSON |
| K080168 |
05/16/2008 |
SHUNTCHECK - CSF SHUNT FLOW DETECTOR |
NEURO DIAGNOSTIC DEVICES |
FREDERICK J FRITZ |
| K072259 |
05/06/2008 |
OPHTHALMOSCOPE F-10 |
NIDEK CO., LTD. |
PAUL SUMNER |
| K080177 |
05/09/2008 |
WRIST BLOOD PRESSURE MONITOR, MODEL WS-1100/WS-1100PV |
NIHON SEIMITSU SOKKI CO., LTD. |
KOJI KOBO |
| K080255 |
05/23/2008 |
NONIN MEDICAL, INC., MODEL 7500 DIGITAL PULSE OXIMETER |
NONIN MEDICAL, INC. |
LORI M ROTH |
| K081118 |
05/02/2008 |
NORAS MR-BI320-PA 1.5T |
NORAS MRI PRODUCTS GMBH |
MARTIN HEMPEL |
| K080515 |
05/16/2008 |
FMRI HARDWARE SYSTEM |
NORDICNEUROLAB |
STIAN SCISLY SAGEVIK |
| K081009 |
05/20/2008 |
NEUTROPHASE |
NOVABAY PHARMACEUTICALS |
SHEILA W PICKERING |
| K080009 |
05/06/2008 |
NOVABONE PUTTY- BIOACTIVE SYNTHETIC GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
| K081281 |
05/20/2008 |
OCENTRA MASTERPLAN 3.1 (OCENTRA BRACHY) |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K080934 |
05/28/2008 |
VIENNA RING CT/MR APPLICATOR SET, ROUND POINT TITANIUM NEEDLE SET, TROCAR POINT TITANIUM NEEDLE SET |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K080115 |
05/30/2008 |
I-MINI DENTAL IMPLANT |
OCO BIOMEDICAL |
Kevin Walls |
| K081185 |
05/02/2008 |
MOBLVAC W.C. |
OHIO MEDICAL CORPORATION |
DAVID PLATT |
| K080187 |
05/09/2008 |
OLSEN MEDICAL SINGLE USE BAYONET BIPOLAR IRRIGATING FORCEPS |
OLSEN MEDICAL |
JOHN P WATERS |
| K080586 |
05/06/2008 |
OLYMPUS XCHF TYPE B180Y1 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORMS-TYLER |
| K080403 |
05/20/2008 |
XTJF TYPE Q160VF1 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORM-TYLER |
| K080065 |
05/02/2008 |
OSFERION |
OLYMPUS TERUMO BIOMATERIALS CORPORATION |
LAURA STORMS-TYLER |
| K080842 |
05/23/2008 |
APEX KNEE SYSTEM, MODEL KC-230XY, KC-240XY [ NO HOLES, 2 HOLES] |
OMNI LIFE SCIENCE, INC. |
WILLIAM MCCALLUM |
| K080202 |
05/08/2008 |
ONCOBIONIC SYSTEM WITH 6 PROBE OUTPUT |
ONCOBIONICS, INC. |
PAUL MIKUS |
| K080631 |
05/23/2008 |
CLEANSE.FRESHEN.GO; ALIGNER CLEANSING TOWELETTE AND DENTAL APPLIANCE CLEANSER |
ORAL HEALTH TECHNOLOGIES, LLC |
ROBERT E TRICCA |
| K080648 |
05/07/2008 |
TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE |
ORE-MEDIX, LLC |
DONALD F GRABARZ |
| K080694 |
05/15/2008 |
OSTEOMED MODULAR LOCKING FIXATION SYSTEM |
OSTEOMED L.P. |
PIEDAD PENA |
| K081035 |
05/30/2008 |
AESCULON C2, AESCULON CHF CLINIC C2, AESCULON HYPERTENSION CLINIC C2 AND AESCULON PACEMAKER CLINIC C2 |
OSYPKA MEDICAL, INC. |
MARKUS OSYPKA |
| K080654 |
05/08/2008 |
PAJUNK'S KIT FOR BALLOON AIDED LAPAROSCOPY |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K080674 |
05/09/2008 |
PAJUNK'S PRIMOCUT DISPOSABLE BIOPSY SYSTEM |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN QUASS |
| K081416 |
05/29/2008 |
PALOMAR ASPIRE LASER PLATFORM |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K080963 |
05/02/2008 |
DSS STABILIZATION SYSTEM |
PARADIGM SPINE |
JUSTIN EGGLETON |
| K073362 |
05/23/2008 |
MROPEN |
PARAMED SRL |
MICHAEL A DOUGLAS |
| K080549 |
05/13/2008 |
DURAFINISH ALL-CURE, MODEL S296 |
PARKELL, INC. |
DANIEL R SCHECHTER, ESQ |
| K080161 |
05/29/2008 |
PASPORT OPTICAL TROCAR, VORTEX SEAL, BLUNT TIP TROCAR, SHIELDED TROCAR, CANNULA ANCHOR |
PATTON SURGICAL CORP. |
MICHAEL PATTON |
| K072300 |
05/16/2008 |
POWDER FREE NATURAL RUBBER LOW MODULUS LATEX PATIENT EXAMINATION GLOVES WITH A PROTEIN LABELING CLAIM |
PERUSAHAAN PELINDUNG GETAH (M) SDN BHD |
THOMAS N TILLOTSON |
| K080999 |
05/09/2008 |
PAGEWRITER CARDIOGRAPH |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
| K081203 |
05/28/2008 |
OB TRACEVUE OBSTETRICAL INFORMATION MANAGEMENT SYSTEM WITH RELEASE F.00 |
PHILIPS MEDIZIN SYSTEME BOEBLINGEN GMBH |
MICHAEL ASMALSKY |
| K073477 |
05/09/2008 |
PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS |
PHOTONOVA OFSWEDEN AB |
Connie Hoy |
| K073177 |
05/13/2008 |
PIONEER INTERVERTEBRAL FUSION DEVICE SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K080165 |
05/14/2008 |
SMART SAVERS POWDER FREE NITRILE EXAMINATION GLOVE (BLUE, WHITE, PINK AND GRAY) |
PLATINUM GLOVE INDUSTRIES SDN.BHD. |
SO SOON CHEAW |
| K081030 |
05/02/2008 |
MODIFICATION TO PROFLU+ ASSAY |
PRODESSE, INC. |
KAREN HARRINGTON |
| K081040 |
05/20/2008 |
POWDERED LATEX EXAMINATION GLOVES, SMALL, MEDIUM, LARGE, X-LARGE |
PT. SHAMROCK MANUFACTURING CORP. |
EMMY TJOENG |
| K080256 |
05/09/2008 |
PULMODYNE CHF FLOW GENERATOR SYSTEM |
PULMODYNE |
PAUL DRYDEN |
| K080307 |
05/01/2008 |
PROCHEM INDICATOR TAPE |
RAVEN LABORATORIES |
WENDY ROYALTY-HANN |
| K070412 |
05/21/2008 |
ELEXOMA MEDIC |
REDPLANE AG |
JAEN LABUSCHAGNE |
| K070463 |
05/07/2008 |
REVERA WOUND CARE, MODEL MDW0060 |
REVALESIO CORPORATION |
GREG J ARCHAMBEAU |
| K080977 |
05/14/2008 |
3 CCD ENDOCAM 5550 |
RICHARD WOLF MEDICAL INSTRUMENTS CORP. |
NIELS SCHMIDT |
| K081256 |
05/27/2008 |
WIRELESS BODY TEMPERATURE MONITOR, MODELS BTM-DIC, D, E, F, G AND H |
RIO FLEXON TECHNOLOGY CO., LTD. |
CHI-HUNG LIAO |
| K080227 |
05/15/2008 |
ACCU-CHEK 360 DIABETES MANAGEMENT SYSTEM |
ROCHE DIAGNOSTICS CORP. |
Scott Thiel |
| K080607 |
05/12/2008 |
CALIBRATOR FOR AUTOMATED SYSTEMS (C.F.A.S.) PROTEINS WITH MODEL 11355279160 |
ROCHE DIAGNOSTICS CORP. |
KATHIE J CUNNINGHAM |
| K081194 |
05/29/2008 |
INTERPLATE PEEK CERVICAL INTERBODY FUSION DEVICE (IFD) |
RSB SPINE LLC. |
KAREN E WARDEN |
| K081142 |
05/16/2008 |
AUTO-BAND LIGATOR |
SCANDIMED INTERNATIONAL |
SALAH CHAMI |
| K080588 |
05/30/2008 |
SCIENT'X TRIBECA VBR |
SCIENT'X USA, INC. |
JOHN SANDERS |
| K081359 |
05/29/2008 |
GENESIS ECP |
SCOTTCARE CORPORATION |
RONALD J CLINES |
| K081079 |
05/02/2008 |
CONTURA MLB SOURCE APPLICATOR FOR BRACHYTHERAPY |
SENORX, INC. |
EBEN GORDON |
| K081170 |
05/28/2008 |
PROSTATE TISSUE MARKER |
SENORX, INC. |
EBEN GORDON |
| K080712 |
05/06/2008 |
SERIM HISENSE ULTRA 0.1, PART NUMBER 5167 |
SERIM RESEARCH CORP. |
PATRICIA RUPCHOCK |
| K081110 |
05/16/2008 |
SIUI CTS-900 DIGITAL ULTRASOUND IMAGING SYSTEM |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
BOB LEIKER |
| K073684 |
05/22/2008 |
SHEFFIELD PHARMACEUTICALS (STERILE) LUBRIGEL |
SHEFFIELD INDUSTRIES, DIV. OF FARIA LTD. |
KATHLEEN HACKU |
| K072696 |
05/02/2008 |
ANT ANGIOGRAPHIC SYRINGES, MODEL(S) 100101,102,103,100201,202,203,204,100301,200101,201,202, 203,200301,101,102,202,301 |
SHENZHEN ANT HI-TECH INDUSTRIAL CO., LTD |
Diana Hong |
| K081320 |
05/27/2008 |
DC-3, DC-3T DIAGNOSTIC ULTRASOUND SYSTEM |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN-FALK |
| K073192 |
05/02/2008 |
POWDERED VINYL PATIENT EXAMINATION GLOVES |
SHIJIAZHUANG PROSPEROUS PLASTIC CO., LTD |
CHU XIAOAN |
| K080701 |
05/14/2008 |
SHIMADZU MOBILE X-RAY SYSTEM MOBILEDART EVOLUTION |
SHIMADZU CORP. |
DON KARLE |
| K072749 |
05/14/2008 |
SIALO BALLOON DILATATION CATHETER |
SIALO TECHNOLOGY, LTD. |
AHAVA STEIN |
| K081074 |
05/23/2008 |
DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691 |
Siemens Healthcare Diagnostics Inc. |
YUK-TING LEWIS |
| K080578 |
05/16/2008 |
DIMENSION VISTA N-TERMINAL PRO-BRAIN NATRIURETIC PEPTIDE (PBNP) FLEX REAGENT CARTRIDGE (K6423A), DIMENSION VISTA |
Siemens Healthcare Diagnostics Inc. |
VICTOR M CARRIO |
| K081103 |
05/23/2008 |
LOCI THYROID CALIBRATOR WITH MODEL RC610 |
Siemens Healthcare Diagnostics Inc. |
YUK-TING LEWIS |
| K073551 |
05/21/2008 |
SMITH & NEPHEW INSTRUMENT TRAYS |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
JULIE ACKER |
| K072817 |
05/15/2008 |
ECHELON TITANIUM HIP SYSTEM |
SMITH & NEPHEW, INC. |
MARLON D RIDLEY |
| K080625 |
05/08/2008 |
SMITH & NEPHEW MIS HIP STEM WITH STIKTITE |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K080321 |
05/23/2008 |
SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM |
SNAP LABORATORIES, L.L.C. |
GIL RAVIV |
| K072904 |
05/21/2008 |
SONOCA 180/195 WOUND CARE SYSTEM |
SOERING GMBH |
CARL THOMAS |
| K081050 |
05/28/2008 |
PARIETEX PROGRIP MESH |
SOFRADIM PRODUCTION |
SHARON ALEXANDER |
| K080769 |
05/14/2008 |
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL 5100C |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K071442 |
05/01/2008 |
SUPRASORB A +AG |
SPECIALTY FIBRES AND MATERIALS LTD. |
COLIN LUDFORD |
| K080314 |
05/13/2008 |
SPINAL USA INTERBODY FUSION DEVICE |
SPINAL USA |
JEFFREY JOHNSON |
| K081228 |
05/12/2008 |
CAPSURE PS (R) SPINE SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K080050 |
05/06/2008 |
SPIRUS MEDICAL ENDO-EASE ENDOSCOPIC OVERTUBE |
SPIRUS MEDICAL, INC. |
PAMELA PAPINEAU |
| K072236 |
05/07/2008 |
DUREX PLAY TINGLING AQUEOUS BASED LUBRICANT |
SSL AMERICAS |
CHRIS ROBINSON |
| K080645 |
05/02/2008 |
STD MED PRIMO PORT POLY |
STD MED, INC. |
PAMELA PAPINEAU |
| K080750 |
05/12/2008 |
BROWNE RAPICIDE GLUTARALDEHYDE INDICATOR |
STERIS Corporation |
JOHN SCOVILLE |
| K073244 |
05/28/2008 |
VERIFY SELF-CONTAINED BIOLOGICAL INDICATOR FOR VH202 GASEOUS STERILIZATION PROCESSES |
STERIS Corporation |
JOHN R SCOVILLE |
| K081004 |
05/02/2008 |
PROTECTISCOPE CS COLONOSCOPE, NON-INTRAPULL |
STRYKER GI |
TIFFANI ROGERS |
| K072600 |
05/19/2008 |
INTRACYTOPLASMIC SPERM AND SPERMATID INJECTION, HOLDING, ZONE DRILLING, PARTIAL ZONE DISSECTION AND DENUDING PIPETTES |
SUNLIGHT MEDICAL, INC. |
DUNSONG YANG |
| K081034 |
05/30/2008 |
SYNERGEYES HYBRID CONTACT LENSES - DAILY WEAR, MODELS A, M, KC AND PS |
Synergeyes, Inc. |
RICHARD E LIPPMAN |
| K080153 |
05/14/2008 |
SYNTHES (USA) CURVILINEAR DISTRACTION SYSTEM |
SYNTHES (USA) |
ANDREA M TASKER |
| K080522 |
05/23/2008 |
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K081071 |
05/01/2008 |
SYNTHES 6.5MM MIDFOOT FUSION BOLT |
SYNTHES (USA) |
KARL J NITTINGER |
| K080020 |
05/23/2008 |
ARCOFIX |
SYNTHES SPINE CO.LP |
KIRSTEN STOWELL |
| K080887 |
05/02/2008 |
SYSMEX UF-1000I, AUTOMATED URINE PARTICLE ANALYZER WITH URINALYSIS WAM SOFTWARE |
SYSMEX AMERICA, INC. |
NINA GAMPERLING |
| K073622 |
05/14/2008 |
EASY GRIP DENTAL IMPLANT SYSTEM |
T.F.I. SYSTEM S.R.L |
DOTT. CLAUDIO MECHELLI |
| K073006 |
05/29/2008 |
OSTEOTRANS -MX BIOABSORBABLE BONE FIXATION SYSTEM |
TAKIRON CO., LTD |
KUNIHIRO HATA |
| K073311 |
05/13/2008 |
OSTEOTRANS-OT PIN |
TAKIRON CO., LTD |
KUMIHIRO HATA |
| K073312 |
05/13/2008 |
OSTEOTRANS-OT SCREW |
TAKIRON CO., LTD |
KUNIHIRO HATA |
| K080763 |
05/30/2008 |
TABLEGARD PRESSURE RELIEVING PATIENT WARMING MATTRESS, MODEL: TG 700 HT |
TALLEY MEDICAL |
JACK VAN DYKE |
| K071999 |
05/08/2008 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
TANGSHAN HONGYUN PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K071977 |
05/23/2008 |
TARRY MEDICAL TEMPERATURE PROBES |
TARRY MEDICAL PRODUCTS, INC. |
JOSEPH M AZARY |
| K073532 |
05/01/2008 |
DISPOSABLE ADHESIVE SURFACE ELECTRODES, DISC ELECTRODES |
TECHNOMED EUROPE |
MAURICE ROOST |
| K073370 |
05/08/2008 |
TC MATRIX CLINICAL CHEMISTRY ANALYZER |
TECO DIAGNOSTICS |
JIM VAECHHES |
| K062273 |
05/22/2008 |
SPACER-G TEMPORARY HIP PROSTHESIS |
TECRES SPA |
AMNON TALMOR |
| K062274 |
05/22/2008 |
SPACER-K TEMPORARY KNEE SPACER WITH GENTAMICIN, MODELS SPK0021, SPK0121, SPK0221, SPK0321 |
TECRES SPA |
DIANA TAYLOR |
| K081045 |
05/28/2008 |
DESTINATION RENAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K081046 |
05/21/2008 |
PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K073295 |
05/29/2008 |
UREA/BUN, SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K073612 |
05/23/2008 |
URIC ACID (AOX), SCAL, NORTROL, ABTROL |
THERMO FISHER SCIENTIFIC OY |
PAIVI SORMUNEN |
| K081341 |
05/14/2008 |
REINFORCED CATHETER INTRODUCER SYSTEM (RCIS) |
THOMAS MEDICAL PRODUCTS, INC. |
TIM STOUDT |
| K080952 |
05/29/2008 |
15-INCH (38 CM) COLOR LCD MONITOR CDL1576A |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K080951 |
05/29/2008 |
19-INCH (48CM) 1.3M COLOR LCD MONITOR CDL1909A |
TOTOKU ELECTRIC CO., LTD |
MIKIO HASEGAWA |
| K080198 |
05/30/2008 |
TSO3 OZONE STERILIZATION WRAP |
TSO3 INC. |
CHARLES O HANCOCK |
| K073097 |
05/12/2008 |
TUTODENT DENTAL MEMBRANE |
TUTOGEN MEDICAL U.S., INC. |
TRAVIS AROLA |
| K080898 |
05/05/2008 |
AUTO SUTURE ENDO GIA STAPLERS WITH ENDO GIA SINGLE USE LOADING UNITS WITH STAPLE LINE REINFORCEMENT |
TYCO HEALTHCARE GROUP, LP |
SHARON ALEXANDER |
| K080660 |
05/13/2008 |
IV ADMINISTRATION SET |
U.S. SAFETY SYRINGES CO., INC. |
CHRISTINE SMITH |
| K080665 |
05/13/2008 |
NOVOLET |
U.S. SAFETY SYRINGES CO., INC. |
CHRISTINA SMITH |
| K081201 |
05/28/2008 |
WBR XPRESS3.CARDIAC |
ULTRASPECT LTD. |
DAN LAOR |
| K071130 |
05/14/2008 |
HEARTRAK AF |
UNIVERSAL MEDICAL, INC. |
STEVEN ADAMSKY |
| K080551 |
05/28/2008 |
UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE |
UNIVERSITY OF UTAH HOSPITALS AND CLINICS |
BRENT ALM |
| K081036 |
05/09/2008 |
4D INTEGRATED TREATMENT CONSOLE WITH PATIENT ACCESSORY VERIFICATION SYSTEM (PAVS) |
VARIAN MEDICAL SYSTEMS, INC. |
VY TRAN |
| K073694 |
05/30/2008 |
IVENT 2001 MRI CONDITIONAL |
VERSAMED MEDICAL SYSTEMS, INC. |
PAUL DRYDEN |
| K081102 |
05/29/2008 |
VSU - VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K080891 |
05/12/2008 |
REVOLUTION 45MHZ IVUS IMAGING CATHETER |
VOLCANO CORPORATION |
JENNIFER MOTTO |
| K073261 |
05/23/2008 |
VAR MONITOR |
VORTRAN MEDICAL TECHNOLOGY 1, INC. |
JAMES LEE |
| K073493 |
05/06/2008 |
HEPATOSTAT SET |
VYGON CORP. |
COURTNEY SMITH |
| K081069 |
05/30/2008 |
GORE INFINIT MESH |
W.L. GORE & ASSOCIATES,INC |
MICHAEL J TITUS |
| K081014 |
05/09/2008 |
SOYALA GEL VENTED |
WEINMANN GERATE FUR MEDIZIN GMBH + CO. KG |
RALF EGENOLF |
| K081090 |
05/15/2008 |
PROFEMUR LX 5/8 COATED HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN ROSS |
| K072276 |
05/16/2008 |
SUBDERMAL NEEDLE ELECTRODES |
XIAN FRIENDSHIP ELECTRONICS CO.,LTD. |
CHU XIAOAN |
| K072616 |
05/09/2008 |
AXXENT VAGINAL APPLICATOR |
XOFT, INC. |
ERIC HASHEMIAN |
| K081214 |
05/14/2008 |
STYLA MICROLASER AND STYLAORTHO |
ZAP LASERS, LLC |
JAY GOBLE |
| K080118 |
05/02/2008 |
ZELTIQ AESTHETICS CLN1 DERMAL COOLING DEVICE |
ZELTIQ AESTHETICS |
DONALD V JOHNSON |
| K072178 |
05/30/2008 |
ATHENA MULTI-LYTE HSV 1 & 2 IGG TEST SYSTEM |
ZEUS SCIENTIFIC, INC. |
EWA NADOLCZAK |
| K081084 |
05/14/2008 |
COLORISE RIGID |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K072084 |
05/08/2008 |
POWDERED VINYL PATIENT EXAMINATION GLOVES, CLEAR (NON-COLORED) |
ZIBO HONGYE SHANGQIN PLASTIC RUBBERT CO LTD |
CHU XIAOAN |
| K081007 |
05/06/2008 |
ZIMMER M/L TAPER HIP PROSTHESIS WITH KINECTIV TECHNOLOGY SYSTEM |
ZIMMER, INC. |
BENJAMIN C CURSON |
