| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K082188 |
08/04/2008 |
TYMPANOSTOMY TUBE |
ACCLARENT, INC. |
KERI YEN |
| K082459 |
08/26/2008 |
ACRYDERM ABSORBENT OXYGEN DRESSING |
ACRYMED, INC. |
BRUCE GIBBINS |
| K082392 |
08/19/2008 |
EVOTECH ENDOSCOPE CLEANER AND REPROCESSOR |
ADVANCED STERILIZATION PRODUCTS |
JOSEPH ASCENZI, PH.D. |
| K082232 |
08/07/2008 |
EVIS MD PLANTIUM BLUE |
AGELESS BEAUTY CORPORATION |
JILL CREASY |
| K082247 |
08/08/2008 |
EVIS MD PLATINUM RED LIGHT THERAPY |
AGELESS BEAUTY CORPORATION |
JILL CREASY |
| K082226 |
08/07/2008 |
S40 CREATINE KINASE (CK) |
ALFA WASSERMANN DIAGNOSTIC TECHNOLOGIES, INC. |
DENNIS TASCHEK |
| K082328 |
08/14/2008 |
GLUCODR PLUS SYSTEM, MODEL AGM-3000 |
ALL MEDICUS CO., LTD |
MARGARET KIM |
| K082284 |
08/11/2008 |
AERO TRACHEOBRONCHIAL STENT TECHNOLOGY SYSTEM |
ALVEOLUS, INC |
TONY ALEXANDER |
| K082333 |
08/14/2008 |
ASAP WOUND DRESSING GEL |
AMERICAN BIOTECH LABS |
JAMES S TURNER |
| K082387 |
08/19/2008 |
APOGEE AND PERIGEE SYSTEMS WITH INTEPRO LITE AND INTEXEN LP, PART OF THE AMS; PELVIC FLOOR REPAIR SYSTEM |
AMERICAN MEDICAL SYSTEMS |
SARAH PETERSON |
| K082266 |
08/11/2008 |
DIGITAL CLINICAL THERMOMETER MODEL V9XX |
AMPEROR-ELECTRONIC(SZ) CO., LTD |
LARRY YANG |
| K082180 |
08/01/2008 |
PERMA FIBER,MODEL 441; PERMA MESH, MODEL 440 |
ANGELUS INDUSTRIA DE PRODUCTOS ODONTOLOGICOS |
LINDA K SCHULZ |
| K082457 |
08/26/2008 |
MICRO-TOUCH NITRATEX STERILE NITRILE POWDER-FREE BLUE EXAMINATION GLOVES (CHEMOTHERAPY USE) |
ANSELL HEALTHCARE PRODUCTS, INC. |
CYNTHIA A INGRAM |
| K082325 |
08/14/2008 |
APEXUM ABLATOR |
APEXUM LTD. |
IDAN TOBIS |
| K082436 |
08/25/2008 |
EXTT-101 |
APIMEDS, INC |
Kevin Walls |
| K082504 |
08/29/2008 |
APOLLO ANTERIOR CERVICAL PLATE SYSTEM |
APOLLO SPINE, INC. |
PAMELA PAPINEAU, RAC |
| K082217 |
08/06/2008 |
RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM |
ARIZANT HEALTHCARE INC. |
DAVID WESTLIN |
| K082417 |
08/22/2008 |
GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 |
ARKRAY Factory USA, Inc. |
TOM SPEIKERS |
| K082323 |
08/14/2008 |
ARTHROCARE ARTHROWANDS |
ARTHROCARE CORP. |
VALERIE DEFIESTA-NG |
| K082231 |
08/07/2008 |
ASCENSION SILICONE PIP |
ASCENSION ORTHOPEDICS, INC. |
DEBBIE STEARNS |
| K082174 |
08/01/2008 |
Y-ADAPTER |
ASTHMATX, INC. |
CARTER NAVARRO |
| K082199 |
08/04/2008 |
SPIRALFUSE PERIPHERAL INFUSION SYSTEM |
BACCHUS VASCULAR, INC. |
BOB MCRAE |
| K082202 |
08/05/2008 |
HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K082473 |
08/27/2008 |
BAUSCH & LOMB STELLARIS MICROSURGICAL SYSTEM |
BAUSCH & LOMB, INC. |
NED L LUCE |
| K082486 |
08/28/2008 |
GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE |
BAYER HEALTHCARE, LLC |
ROGER SONNENBURG |
| K082251 |
08/08/2008 |
SYNCHRON SYSTEMS MICROALBUMIN (MA) REAGENT, MODEL 475100 |
BECKMAN COULTER, INC. |
MARINE BOYAJIAN |
| K082271 |
08/11/2008 |
FLUCONAZOLE 25UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
JANINE MATLAK |
| K082272 |
08/11/2008 |
VORICONAZOLE 1UG BBL SENSI-DISC |
BECTON DICKINSON & CO. |
JANINE MATLAK |
| K082315 |
08/13/2008 |
EC50 MICRO+ SMOKERLYZER |
BEDFONT SCIENTIFIC LTD. |
GLEN HILLSLEY |
| K082487 |
08/28/2008 |
M-50 SERIES SPO2 SENSOR |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
LEI CHEN |
| K082428 |
08/22/2008 |
N-DEX BWC PINK NITRILE MEDICAL EXAMINATION GLOVE, NON STERILE |
BEST GLOVE, INC |
NEIL DOW |
| K082190 |
08/04/2008 |
BAXOLVE XP CONDUCTIVE GARMENT ACCESSORY & LUMBAR SUPPORT KIT, MODELS 297, 298 |
BIO-MEDICAL RESEARCH, LTD. |
ANNE-MARIE KEENAN |
| K082383 |
08/19/2008 |
FORTOSS VITAL |
BIOCOMPOSITES LTD. |
MARIE WHALLEY |
| K082381 |
08/19/2008 |
GENEX |
BIOCOMPOSITES LTD. |
SIMON FITZER |
| K082225 |
08/06/2008 |
15W CERALAS D 1470NM DIODE LASER, MODEL D1470 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K082263 |
08/08/2008 |
CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K082346 |
08/15/2008 |
VITEK 2 GRAM NEGATIVE DORIPENEM |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K082446 |
08/25/2008 |
BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS |
BIOMET, INC. |
BECKY EARL |
| K082395 |
08/19/2008 |
GLUCOSE METER-CHECK CONTROL SOLUTION FOR BAYER ASCENSIA BLOOD GLUCOSE METER, MODEL: MC002 |
BIONOSTICS, INC. |
KATHLEEN STORRO |
| K082175 |
08/01/2008 |
MOFICATION TO: MODIFIED PLATE DESIGN FOR BIOPLATE ZIP CRANIOTOMY FIXATION |
BIOPLATE, INC. |
JESUS T FARINAS |
| K082432 |
08/22/2008 |
CORE VISION DIGITAL SPECIMEN RADIOGRAPHY (DSR) SYSTEM |
BIOPTICS, INC. |
PATRICIA WADE |
| K082293 |
08/12/2008 |
SURGVIEW INTEGRATED VISUALIZATION SYSTEM |
BIOVISION TECHNOLOGIES, LLC |
|
| K082449 |
08/25/2008 |
BISCEM TRANSLUCENT, MODEL D-45011; BISCEM OPAQUE, MODEL D-45012 |
BISCO, INC. |
Michelle Schiltz-Taing |
| K082235 |
08/07/2008 |
BLACKSTONE PILLAR XL PEEK SPACERS |
BLACKSTONE MEDICAL, INC. |
WHITNEY G TORNING |
| K082253 |
08/08/2008 |
BODYSTAT 1500 BODY COMPOSITION MONITORING UNIT |
BODYSTAT LTD. |
I. J. MEEUWSEN |
| K082254 |
08/08/2008 |
MODIFICATION TO BODYSTAT 1500MDD BODY COMPOSITION MONITORING UNIT |
BODYSTAT LTD. |
I. J. MEEUWSEN |
| K082255 |
08/08/2008 |
QUADSCAN 4000 BODY BODY COMPOSITION, FLUID & ILLNESS/SEGMENTAL MONITORING UNIT |
BODYSTAT LTD. |
I J. MEEUWSEN |
| K082345 |
08/15/2008 |
OXYGEN DEMAND VALVE |
BPR MEDICAL, LTD. |
BEN JOHNSON |
| K082508 |
08/29/2008 |
FASTECT II BUP DRUG SCREEN DIPSTICK AND QUICKTOX BUP DRUG SCREEN DIPCARD |
BRANAN MEDICAL CORPORATION |
RAPHAEL WONG |
| K082297 |
08/12/2008 |
BUSSE SURGICAL DRAPE |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K082396 |
08/19/2008 |
DAVOL ABSORBABLE FASTENER SYSTEM, MODEL (S) 0113080,0113081, 0113082, 0113084, 0113086, 0113087 |
C.R. BARD, INC. |
STEPHANIE BAKER |
| K082305 |
08/13/2008 |
G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS |
C.R. BARD, INC. |
GENEVIEVE BALUTOWSKI |
| K082306 |
08/13/2008 |
POWERLOC CLEAR SAFETY INFUSION SET |
C.R. BARD, INC. |
HENRY BOLAND |
| K082207 |
08/05/2008 |
ORTHOCAD IQ |
CADENT, INC. |
LAURIE CLARKE |
| K082260 |
08/08/2008 |
INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES |
CALVARY SPINE LLC |
J.D. WEBB |
| K082425 |
08/22/2008 |
TANDEMHEART TRANSSEPTAL CANNULA- EF 72 |
CARDIAC ASSIST, INC. |
ROBERT BOLLINGER |
| K082173 |
08/01/2008 |
Q-STRESS AND HEARTSTRIDE, MODELS QSTRESS/Q40 AND H4/H4S |
CARDIAC SCIENCE CORPORATION |
BEVERLY MAGRANE |
| K082191 |
08/04/2008 |
CARDIOMEMS ENDOSURE S2 PRESSURE SENSOR WITH DELIVERY SYSTEM, MODEL S2-2080 |
CARDIOMEMS INC |
GRACE POWERS |
| K082245 |
08/07/2008 |
AOC, OSTENE, AOC IMPLANT MATERIAL, CERETENE, OSTENE LUBE, AOC-LV |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K082491 |
08/28/2008 |
OSTENE CT SOLUBLE BONE HEMOSTASIS IMPLANT MATERIAL, AOC CT, AOC, OSTENE, OSTEOTENE & CERETENE |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K082480 |
08/28/2008 |
CONTEC POCKET FETAL DOPPLER |
CONTEC MEDICAL SYSTEM CO., LTD. |
Diana Hong |
| K082319 |
08/13/2008 |
INJEKT FILIFORM INJECTION NEEDLE |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K082324 |
08/14/2008 |
TRUFILL DCS SYRINGE |
CORDIS NEUROVASCULAR, INC. |
Amarilys Machado |
| K082322 |
08/13/2008 |
AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS |
COVIDIEN |
VIRGINIA VETTER |
| K082454 |
08/26/2008 |
MICROMYST APPLICATOR, MODEL 20-5000 |
COVIDIEN |
VIRGINIA VETTER |
| K082296 |
08/12/2008 |
COPA AMD |
COVIDIEN LP, FORMERLY REGISTERED AS TYCO HEALTHCAR |
JAMES WELSH |
| K082258 |
08/08/2008 |
CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR |
CROSSTEX INTERNATIONAL |
RICHARD M ORMSBEE |
| K082400 |
08/20/2008 |
DEIONIZER AND CARBON EXCHANGE SERVICE FOR HEMODIALYSIS |
CULLIGAN SOFT WATER SERVICE CO. |
MIKE JABLONSKI |
| K082241 |
08/07/2008 |
THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 |
DALE MEDICAL PRODUCTS, INC. |
ROSINA ROBINSON |
| K082408 |
08/21/2008 |
LEDEX, MODEL: WL-070 |
DENTMATE TECHNOLOGY CO., LTD. |
CHENG-FENG CHOU |
| K082198 |
08/04/2008 |
DURASHIELD PLUS |
DENTSPLY INTL., INC. |
HELEN LEWIS |
| K082282 |
08/11/2008 |
HEALIX TI ANCHOR |
DEPUY MITEK, A JOHNSON & JOHNSON CO. |
KRISTINE CHRISTO |
| K082300 |
08/12/2008 |
ANATOMIC LOCKING PLATING SYSTEM |
DEPUY ORTHOPAEDICS, INC. |
SUZANA OTANO |
| K082239 |
08/07/2008 |
DEPUY C-STEM AMT |
DEPUY ORTHOPAEDICS, INC. |
RHONDA MYER |
| K082500 |
08/29/2008 |
DEPUY SIGMA CR-F FEMORAL COMPONENT |
DEPUY ORTHOPAEDICS, INC. |
NANCY FRIDDLE |
| K082195 |
08/04/2008 |
MODIFICATIONS TO EXPEDIUM SPINE SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K082273 |
08/11/2008 |
UNIPLATE ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
FRANK JURCZAK |
| K082248 |
08/08/2008 |
STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER |
DIAGNOSTICA STAGO, INC. |
UMBERTO V PARROTTA |
| K082462 |
08/27/2008 |
GEMLYTE ELECTROLYTE ANALYZER NA+/K+/CL-/CA++/LI+ |
DIAMOND DIAGNOSTICS, INC. |
LIANN VOO |
| K082368 |
08/18/2008 |
CARDIUS-1, -2, -3, AND CARDIUS 1,2,3 XPO SPECT IMAGING SYSTEMS, 2020TC SPECT IMAGING SYSTEM |
DIGIRAD CORP. |
Joel Tuckey |
| K082246 |
08/08/2008 |
DIGNITY 100 |
DIGNITY MEDICAL DEVICES, INC |
CHARMAINE SUTTON |
| K082512 |
08/29/2008 |
INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER |
DIMENSIONAL DOSING SYSTEMS, INC. |
EJ Smith |
| K082261 |
08/08/2008 |
DXRAD MODELS DX800 OR DX808 DIGITAL DIAGNOSTIC RADIOGRAPHIC SYSTEMS |
DXRAD SOLUTIONS LTD. |
DANIEL KAMM |
| K082410 |
08/21/2008 |
MASTER3DS |
E-WOO TECHNOLOGY |
CHARLIE MACK |
| K082465 |
08/27/2008 |
EVERON |
EARLYSENSE LTD. |
DALIA ARGAMAN |
| K082187 |
08/04/2008 |
BIOMET ANTERIOR LUMBAR PLATE |
EBI, L.P. |
VIVIAN KELLY MS, RAC |
| K082406 |
08/21/2008 |
EXPANDABLE PEEK-OPTIMA IMPLANT |
EBI, L.P. |
VIVIAN KELLY |
| K082369 |
08/18/2008 |
CADENCE, CADENCE DUAL, CADENCE II FETAL MONITOR |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K082308 |
08/13/2008 |
MODIFICATION TO VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR |
EDWARDS LIFESCIENCES, LLC. |
JASON SMITH |
| K082341 |
08/15/2008 |
DSA 2000EX |
EIGEN LLC |
ANIMESH KHEMKA |
| K082421 |
08/22/2008 |
HEARTSUITE HEMODYNAMICS 7.10 |
EMAGEON INC. |
|
| K082398 |
08/20/2008 |
ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K082233 |
08/07/2008 |
VIKY |
ENDOCONTROL |
CARINE HUGUEL |
| K082339 |
08/14/2008 |
ENABLER-P SUPPORT CATHETER |
ENDOCROSS, LTD. |
JOHN J SMITH |
| K082409 |
08/21/2008 |
SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083 |
ENDOPHOTONIX, INC |
KIRK S HONOUR |
| K082380 |
08/19/2008 |
VICARDIO 12B |
ENERGY-LAB TECHNOLOGIES GMBH |
GEORGE MYERS |
| K082278 |
08/11/2008 |
MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS |
ETHICON ENDO-SUGERY, LLC |
CAROL HUBBARD |
| K082216 |
08/06/2008 |
TBD ETHICON MESH |
ETHICON INC. |
BRYAN A LISA |
| K082420 |
08/22/2008 |
TRACHEOSCOPIC VENTILATION TUBE (TVT) |
ETVIEW |
YORAM LEVY |
| K082307 |
08/13/2008 |
EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT |
EVENFLO COMPANY, INC. |
AMY NEFF |
| K082291 |
08/11/2008 |
A-LAP SET (A-LAP, EZAXESS, TROCAR) |
EZSURGICAL |
Kevin Walls |
| K082414 |
08/21/2008 |
OPTIFLUX F250NR, MODEL 0500325E |
FRESENIUS MEDICAL CARE NORTH AMERICA |
JANET KAY |
| K082171 |
08/01/2008 |
GRADIA CORE |
GC AMERICA, INC |
MARK HEISS |
| K082434 |
08/25/2008 |
GDLS-200 |
GC AMERICA, INC. |
MARK HEISS |
| K082318 |
08/13/2008 |
CENTRICITY PACS IW |
GE HEALTHCARE DYNAMIC IMAGING SOLUTIONS |
JILLIAN M REED |
| K082374 |
08/18/2008 |
VIVID I AND VIVID Q |
GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. |
ISRAEL CITRON |
| K082185 |
08/01/2008 |
GE LOGIQ E9 DIAGNOSTIC ULTRASOUND SYSTEM, MODELS 5205000, 5205000-2 |
GE MEDICAL SYSTEMS ULTRASOUND AND PRIMARY CARE DIA |
NICOLE LANDREVILLE |
| K082488 |
08/28/2008 |
DIAZYME LP(A) ASSAY |
GENERAL ATOMICS |
Abhijit Datta |
| K082317 |
08/13/2008 |
GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION |
GENERAL ELECTRIC CO. |
JAMES P RASKOB |
| K082243 |
08/07/2008 |
PRECISION RXI ANALOG AND DIGITAL X-RAY SYSTEMS |
GENERAL MEDICAL MERATE S.P.A. |
Kevin Walls |
| K082484 |
08/28/2008 |
ACCELAWAVE SYSTEM |
GENESIS BIOSYSTEMS, INC. |
BRIAN BUSS |
| K082205 |
08/05/2008 |
FACTOR VIII ANTIBODY SCREEN |
GENETIC TESTING INSTITUTE |
MICHELLE A STAPLETON |
| K082210 |
08/06/2008 |
TOTAL BILIRUBIN L3K, MODEL 295-10 AND 295-30 |
GENZYME DIAGNOSTICS P.E.I. INC. |
PENNY J WHITE |
| K082403 |
08/21/2008 |
MEDOS HILITE OXYGENATOR, MODEL 7000 & 7000 LT |
GISH BIOMEDICAL, INC. |
HARVEY KNAUSS |
| K082252 |
08/08/2008 |
INDEPENDENCE SPACER |
GLOBUS MEDICAL, INC. |
KELLY BAKER |
| K082442 |
08/25/2008 |
MODIFICATION TO MICROFUSE BONE VOID FILLER |
GLOBUS MEDICAL, INC. |
KELLY J BAKER |
| K082286 |
08/11/2008 |
BIOACTYS |
GRAFTYS |
ANTHONY LE NAOUR |
| K082498 |
08/29/2008 |
GRAFTYS HBS |
GRAFTYS |
ANTHONY LE NAOUR |
| K082455 |
08/26/2008 |
RECTANGULAR MULTIPLACE HYPERBARIC CHAMBER |
GULF COAST HYPERBARICS, INC. |
JAMES W MCCARTHY |
| K082312 |
08/13/2008 |
PRIME ECG SYSTEM (WITH ENHANCED DIAGNOSTIC ALGORITHM) |
HEARTSCAPE TECHNOLOGIES LTD |
PAUL PHILLIPS |
| K082206 |
08/05/2008 |
BLOM-SINGER DUAL VALVE INDWELLING VOICE PROSTHESIS, MODELS DV-1600 SERIES, DV-2000 SERIES |
HELIX MEDICAL, LLC |
CYNTHIA ANDERSON |
| K082366 |
08/18/2008 |
LIFEBED PATIENT VIGILANCE SYSTEM |
HOANA MEDICAL, INC. |
NANCY GERTLAR |
| K082483 |
08/28/2008 |
QUANTRA |
HOLOGIC, INC. |
CATHERINE A WILLIAMS |
| K082298 |
08/12/2008 |
FLASH N' GO |
HOME SKINOVATIONS LTD. |
AMIR WALDMAN |
| K082450 |
08/25/2008 |
IDR |
ICRCO INC. |
THOMAS CHANEY |
| K082496 |
08/29/2008 |
PACSMATE MMD-3213M MONITOR |
IEI TECHNOLOGY CORP. |
SHALLY CHEN |
| K082402 |
08/20/2008 |
OSDX HIP BMD SYSTEM |
IMAGING THERAPEUTICS, INC. |
PATRICK HESS |
| K082196 |
08/04/2008 |
STATIC VESSEL ANALYZER |
IMEDOS GMBH |
HANS STROMEYER |
| K082275 |
08/11/2008 |
CLOVER A1C/GLYCOSYLATED HEMOGLOBIN MONITOR & BLOOD GLUCOSE MONITOR, MODEL IGM-0023 |
INFOPIA CO., LTD |
MARIA F GRIFFIN |
| K082384 |
08/19/2008 |
HAV-LOK BUNION CORRECTION SYSTEM |
INSTRATEK, INC. |
Jeff Seavey |
| K082250 |
08/08/2008 |
AURAGEN CORTICAL SURFACE ELECTRODES |
INTEGRA NEUROSCIENCES |
JON CAPAROTTA |
| K082256 |
08/08/2008 |
LIFE SUPPORT FOR TRAUMA AND TRNSPORT (LSTAT) G6 LITE |
INTEGRATED MEDICAL SYSTEMS, INC. |
RENATE A MACLAREN |
| K082470 |
08/27/2008 |
SODIUM HYPOCHLORITE 3 & 6% SOLUTION AND 6% WITH WETTING AGENTS TO LOWER SURFACE TENSION MARKETED AS CHLOR-XTRA |
INTER-MED, INC. |
GEORGE HORVAT |
| K082419 |
08/22/2008 |
REOSS POWDER, REOSS PUTTY, REOSS GEL, MODELS R-1,RP-1, RG-1 |
INTRA-LOCK INTERNATIONAL, INC. |
JEFFREY SAKOFF |
| K082497 |
08/29/2008 |
INTUITIVE SURGICAL ENDOWRIST ONE HOT SHEARS INSTRUMENT |
INTUITIVE SURGICAL, INC. |
JAMES FARNWORTH |
| K082416 |
08/21/2008 |
IBA PROTON THERAPY SYSTEM- PROTEUS 235 |
ION BEAM APPLICATIONS S.A. |
JOHN REISS |
| K082349 |
08/15/2008 |
JARIT HULKA UTERINE TENACULUM FORCEPS |
J. JAMNER SURGICAL INSTRUMENTS, INC. |
JENNIFER BOSLEY |
| K082288 |
08/11/2008 |
HAIDA HD21 |
JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD. |
JUNNATA CHANG |
| K082274 |
08/11/2008 |
HAIDA MODEL HD11 MANUAL WHEELCHAIR |
JIANGYIN EAST CHINA MEDICAL TECHNOLOGY CO., LTD. |
JUNNATA CHANG |
| K082177 |
08/01/2008 |
KIMGUARD ONE-STEP STERILIZATION WRAP |
KIMBERLY-CLARK CORP. |
LISA PEACOCK |
| K082505 |
08/29/2008 |
KLS MARTIN ELECTROSURGICAL INSTRUMENTS |
KL MARTIN L.P. |
TOM FAUCETT |
| K082347 |
08/15/2008 |
DIGITAL RADIOGRAPHY, FLEXDR C30 |
KONICA MINOLTA TECHNOPRODUCT CO., LTD. |
RUSSEL MUNVES |
| K082509 |
08/29/2008 |
EOS SPINAL SYSTEM |
KOREA BONE BANK CO., LTD |
JUNG BAE BANG |
| K082399 |
08/20/2008 |
PECTUS STRUT |
KOROS USA, INC. |
TIBOR KOROS |
| K082338 |
08/14/2008 |
POLYBONE GRANULE & BLOCK |
KYUNGWON MEDICAL CO., LTD. |
JUNG BAE BANG |
| K082194 |
08/04/2008 |
LAURIMED PERCUTANEOUS DISCECTOMY SYSTEM, MODEL FG-000002 |
LAURIMED LLC |
NANCY LINCE |
| K082262 |
08/08/2008 |
LDR SPINE ROI INTERBODY FUSION SYSTEM |
LDR SPINE USA |
NOEL BARTSCH |
| K082351 |
08/15/2008 |
NEPTUNE HYPERBARIC VENTILATOR |
LEVEL-5, INC. |
HOWARD M HOLSTEIN |
| K082367 |
08/18/2008 |
INFANT SLEEP BEANIE |
LIFE INNOVATIONS LLC |
JANE SCOTT |
| K082176 |
08/01/2008 |
LTM-BPS SURGICAL MESH |
LIFECELL CORP. |
LORRAINE T MONTEMURRO |
| K082460 |
08/26/2008 |
CENEFOM PVA SURGICAL SPEAR |
LONGTEK SCIENTIFIC CO., LTD. |
JOSEPH J CHANG |
| K082348 |
08/15/2008 |
FIBERNET EMBOLIC PROTECTION SYSTEM |
LUMEN BIOMEDICAL, INC. |
MARIA E BRITTLE |
| K082172 |
08/01/2008 |
MAKO MODULAR KNEE COMPARTMENTAL IMPLANT SYSTEM |
MAKO SURGICAL CORPORATION |
WILLIAM F TAPIA |
| K082237 |
08/07/2008 |
PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST |
MALLINCKRODT DEVELOPPEMENT FRANCE |
TINA DREILING |
| K082212 |
08/06/2008 |
SYRINGE WITH HANDI-FIL |
MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS |
DALE MOORE |
| K082218 |
08/06/2008 |
MAX ADJUSTING INSTRUMENT |
MANNA OMNI INTERNATIONAL INC. |
STEPHEN TSAI |
| K082412 |
08/21/2008 |
VENOUS BUBBLE TRAP, MODEL VBT 160; VENOUS BUBBLE TRAP WITH BIOLINE COATING, MODEL BE-VBT 160, BEQ-VBT 160 |
MAPQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K082472 |
08/28/2008 |
VIROCULT, MODEL MW950 |
MEDICAL WIRE & EQUIPMENT COMPANY (BATH) LTD |
DAVID ELLIS |
| K082511 |
08/29/2008 |
MEDIGARD BLOOD COLLECTION DEVICE |
MEDIGARD LIMITED |
EJ Smith |
| K082458 |
08/26/2008 |
P3T ABDOMEN |
MEDRAD, INC. |
FORTUNATO ALDAPE |
| K082464 |
08/27/2008 |
PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 |
MEDTRONIC INC. |
JEANMARIE SALES |
| K082475 |
08/28/2008 |
REVEAL XT INSERTABLE CARDIAC MONITOR, MODEL 9529, REVEL DX INSERTABLE CARDIAC MONITOR, MODEL 9528 |
MEDTRONIC INC. |
DEBBIE KIDDER |
| K082236 |
08/07/2008 |
CD HORIZON SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
BRAD SHEALS |
| K082342 |
08/15/2008 |
MODIFICATION TO CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRIS MCKEE |
| K082463 |
08/27/2008 |
PROGENIX |
MEDTRONIC SOFAMOR DANEK |
RYAN MASSEY |
| K082249 |
08/08/2008 |
MORPHEUS |
MEIBACH TECH LTDA |
STUART L FRIEDEL |
| K082357 |
08/18/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). |
MICROLIFE INTELLECTUAL PROPERTY GMBH |
SUSAN D GOLDSTEIN-FALK |
| K082461 |
08/27/2008 |
BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B |
MICROVENTION, INC. |
FLORIN TRUUVERT |
| K082385 |
08/19/2008 |
CHAPERON GUIDING CATHETER |
MICROVENTION, INC. |
FLORIN TRUUVERT |
| K082354 |
08/15/2008 |
STEREO NAVIGATOR ACCESSORY, STN-1000 |
NAVISCAN PET SYSTEMS |
HEATHER JALISI |
| K082203 |
08/05/2008 |
NUMERIS COAGULATION SYSTEM WITH VISITRAX, MODEL(S) CSK-021;CSK-022; CSK-023; CSK-025 |
NCONTACT SURGICAL, INC. |
JANE RICUPERO |
| K082493 |
08/29/2008 |
MEDICAL DISPLAY, MD205MG-1 |
NEC DISPLAY SOLUTIONS, LTD. |
SHUICHI KINO |
| K082238 |
08/07/2008 |
NEOMED POLYURETHANE FEEDING TUBE |
NEOMED, INC. |
PENNY NORTHCUTT |
| K082223 |
08/06/2008 |
NEUTROLUMENPN SYSTEM, MODEL 1000 |
NEUROLUMEN, LLC |
SHELLY HENRY |
| K082485 |
08/28/2008 |
MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
| K082336 |
08/14/2008 |
XR-EXPRESS |
NEW MEXICO SOFTWARE, INC. |
NEAL KOLBER |
| K082373 |
08/18/2008 |
NORAS MR-BI320-PA 3T |
NORAS MRI PRODUCTS GMBH |
PATRICIA KRAPF |
| K082441 |
08/25/2008 |
NORDICICE SOFTWARE |
NORDICIMAGINGLAB AS |
STIAN SCISLY SAGEVIK |
| K082332 |
08/14/2008 |
NUVASIVE SPHERX SYSTEM |
NUVASIVE, INC. |
LAETITIA COUSIN |
| K082468 |
08/27/2008 |
APEX HIP SYSTEM BIPOLAR HEAD, MODEL H3-822XX AND H3-828YY, XX=OD IN [MM] (38-43), YY=OD IN [MM](44-60) |
OMNI LIFE SCIENCE, INC. |
WILLIAM MCCALLUM |
| K082268 |
08/11/2008 |
CAPNOSTREAM20 WITH INTEGRATED PULMONARY INDEX |
ORIDION CAPNOGRAPHY, INC. |
RACHEL WEISSBROD |
| K082445 |
08/25/2008 |
CURATIVE980 DIODE LASER |
OROSCIENCE, INC. |
PHIL HOULE |
| K082375 |
08/18/2008 |
ORTHOPEDIATRICS PEDIFLEX FLEXIBLE NAIL SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K082213 |
08/06/2008 |
GS III FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K082242 |
08/07/2008 |
ICON, MODEL C3 |
OSYPKA MEDICAL, INC. |
MARKUS OSYPKA |
| K082314 |
08/13/2008 |
BRAVORACER PEDIATRIC MANUAL WHEELCHAIR |
OTTO BOCK HEALTH CARE, LP |
WILLIAM JACKSON |
| K082183 |
08/01/2008 |
PAJUNK'S GENERIC CONVENIENCE TRAY FOR REGIONAL ANESTHESIA: CSF |
PAJUNK GMBH MEDIZINTECHNOLOGIE |
CHRISTIAN G. H. QUASS |
| K082228 |
08/07/2008 |
PLANISIGHT LINASYS |
PATHFINDER THERAPEUTICS, INC. |
JAMES D STEFANSIC |
| K082186 |
08/01/2008 |
MODIFICATION TO PATHWAY PV ATHERECTOMY SYSTEM |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K082290 |
08/11/2008 |
NEURON DELIVERY CATHETER 070 |
PENUMBRA, INC. |
THERESA BRANDNER-ALLEN |
| K082280 |
08/11/2008 |
SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR |
PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO. |
MARY KRUITWAGEN |
| K082301 |
08/12/2008 |
GRIND NO MORE |
PLACONTROL INC. |
JONATHAN S KAHAN |
| K082474 |
08/28/2008 |
PMT SUBDURAL CORTICAL ELECTRODES |
PMT CORP. |
ERIC CAILLE |
| K082382 |
08/19/2008 |
ANGIOJET ULTRA AVX THROMBECTOMY SET, MODEL 105039 |
POSSIS MEDICAL, INC. |
MARK STENOIEN |
| K082415 |
08/21/2008 |
PRODIGY NPWT SYSTEM MODEL PRODIGY 800V |
PREMCO MEDICAL SYSTEMS, INC. |
HAROLD JACOBS |
| K082391 |
08/19/2008 |
PRIMAEVA MEDICAL RENESIS SYSTEM |
PRIMAEVA MEDICAL, INC. |
BRIAN GRIGSBY |
| K082330 |
08/14/2008 |
PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR IRRIGATION |
PRIMARY CARE SOLUTIONS, INC. |
RON MADDIX |
| K082302 |
08/12/2008 |
POWDER FREE NITRILE PATIENT EXAMINATION GLOVES WITH CHEMO LABELING CLAIM |
PT. MEDISAFE TECHNOLOGIES |
ANIL TANEJA |
| K082182 |
08/01/2008 |
AP 34 MULTI-THERAPY INFUSION PUMP |
Q-CORE, LTD |
ASHER KASSEL |
| K082240 |
08/07/2008 |
SNTRYPACS |
QSTAR TECHNOLOGIES, INC. |
HERMAN OOSTERWIJK |
| K082423 |
08/22/2008 |
NO!NO! SKIN |
RADIANCY (ISRAEL) LTD. |
ZVI LADIN |
| K082221 |
08/06/2008 |
RAYDOSE |
RAYSEARCH LABORATORIES AB |
ANDERS MURMAN |
| K082197 |
08/04/2008 |
RHYTEC, INC., PORTRAIT PSR |
RHYTEC INCORPORATED |
Robert Zoletti |
| K082443 |
08/25/2008 |
DISPOSABLE SYNTHETIC EXAMINATION GLOVES, POWDER FREE |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K082447 |
08/25/2008 |
DISPOSABLE VINYL EXAMINATION GLOVE, POWDER FREE |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K082444 |
08/25/2008 |
DISPOSABLE VINYL EXAMINATION GLOVE, POWDERED |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K082448 |
08/25/2008 |
DISPOSABLE VINYL SYNTHETIC EXAMINATION GLOVES, POWDERED |
RICH MOUNTAIN MEDICAL PRODUCTS, INC. |
MICHELLE SHIH |
| K082340 |
08/15/2008 |
ROCHE ELECSYS FOLATE III, ROCHE ELECSYS RBC FOLATE HEMOLYSING REAGENT, ROCHE ELECSYS FOLATE III CALSET, ROCHE ELECSYS |
ROCHE DIAGNOSTICS CORP. |
KATHIE J GOODWIN |
| K082407 |
08/21/2008 |
MODIFICATION TO ULTRALIGHT II ND: YAG LASER SYSTEM |
SANDSTONE MEDICAL TECHNOLOGIES, LLC |
MARK ROHRER |
| K082208 |
08/05/2008 |
DOCTORS CHOICE SLOW HEALING BANDAGE WITH SPRAY ON REMOVER |
SCIVOLUTIONS, INC. |
ARTHUR WARD |
| K082309 |
08/13/2008 |
CAMBRIA |
SEASPINE, INC. |
JEFF BRITTAN |
| K082310 |
08/13/2008 |
HOLLYWOOD, PACIFICA, REDONDO, VENTURA |
SEASPINE, INC. |
JEFF BRITTAN |
| K082227 |
08/07/2008 |
MINICAP HEMOGLOBIN(E) KIT, MODEL 2207, 2227 |
SEBIA |
KAREN ANDERSON |
| K082388 |
08/19/2008 |
MINICAP IMMUNOTYPING, MODEL: 2300 |
SEBIA |
KAREN ANDERSON |
| K082192 |
08/04/2008 |
INFRARED EAR THERMOMETER, MODEL ET-101A |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
REN YUNHUA |
| K082264 |
08/11/2008 |
CONTURA LUMEN MARKER |
SENORX, INC. |
EBEN GORDON |
| K082352 |
08/16/2008 |
SERIM DISINTEK OPA TEST STRIP |
SERIM RESEARCH CORP. |
PATRICIA A RUPCHOCK |
| K082439 |
08/25/2008 |
DISPOSABLE ANGIOGRAPHIC SYRINGE, MODEL(S) CT-200-NE, CT-200-MA, CT-200+200-MA, CT-200-LF, CT -100-NE, CT-200NE, CT-50+CT |
SHANDONG WEIGAO MEDICAL POLYMER CO., LTD |
Diana Hong |
| K082224 |
08/06/2008 |
DIAGNOSTIC ULTRASOUND SYSTEM SARANO, ECHO VIEW, SHIMASONIC |
SHIMADZU MEDICAL SYSTEMS |
DON KARLE |
| K082430 |
08/22/2008 |
SYNGO IMAGING XS |
SIEMENS AG, MEDICAL SOLUTIONS |
SABINE SCHROEDEL |
| K082503 |
08/29/2008 |
DIMENSION VISTA LG LIGHT CHAINS, TYPE KAPPA, DIMENSION VISTA LG LIGHT CHAINS, TYPE LAMBDA, DIMENSION VISTA PROTEIN 1 CAL |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA MARIE KATHLEEN ENNIS |
| K082220 |
08/06/2008 |
SOMATOM FLASH DS |
SIEMENS MEDICAL SOLUTIONS USA INC. |
CORRINE MCLEOD |
| K082331 |
08/14/2008 |
MAGNETOM C! |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
JUDITH CAMPBELL |
| K082506 |
08/29/2008 |
SYMBIA, VERSION 4.0 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
GUNHILD PAULSEN |
| K082427 |
08/22/2008 |
SYNGO MR B17 |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ELIZABETH LAZARO |
| K082479 |
08/28/2008 |
SKLAR SURGICAL GOWN |
SKLAR CORP. |
NATALYA VALERIO |
| K082370 |
08/18/2008 |
POWDER FREE NITRILE EXAMINATION GLOVE (BLUE) |
SMART GLOVE CORP. SDN BHD |
FOO KHON PU |
| K082215 |
08/06/2008 |
OSTEORAPTOR SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIVISION |
JULIE ACKER |
| K082211 |
08/06/2008 |
RENASYS-F NEGATIVE PRESSURE WOUND THERAPY FOAM DRESSING KITS |
Smith & Nephew, Inc |
LAURA KREJCI |
| K082267 |
08/11/2008 |
PIGALILEO CAS, VERSION 4.0 AND TKR BASE, VERSION 2.1 |
SMITH & NEPHEW, INC. |
RISHI SINHA |
| K082426 |
08/22/2008 |
RENASYS EZ |
SMITH & NEPHEW, INC. |
LAURA KREJCI |
| K082371 |
08/18/2008 |
SMITH & NEPHEW SL-PLUS MIA STANDARD AND LATERAL FEMORAL HIP STEM |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K082358 |
08/18/2008 |
SMITH & NEPHEW, INC. PATIENT MATCHED TECHNOLOGY |
SMITH & NEPHEW, INC. |
MEGAN BEVILL |
| K082200 |
08/04/2008 |
KLOCKNER ESSENTIAL DENTAL IMPLANTS SYSTEM, MODEL ESSENTIAL CONE 1.5 |
SOADCO, S.L. |
MARIA MITJANETA |
| K082453 |
08/25/2008 |
4CIS SOLAR AND APOLLON SPINE SYSTEMS |
SOLCO BIOMEDICAL CO., LTD. |
SAEYOUNG AHN |
| K082327 |
08/14/2008 |
INVOS CEREBRAL/SOMATIC OXIMETER SYSTEM, MODEL: 5100C |
SOMANETICS CORP. |
RONALD A WIDMAN |
| K082344 |
08/15/2008 |
STOCKERT S5 SYSTEM, STOCKERT ELECTRICAL VENOUS OCCLUDER (EVO) |
SORIN GROUP DEUTSCHLAND GMBH |
ROSINA ROBINSON |
| K082353 |
08/15/2008 |
MERCURY SPINAL SYSTEM |
SPINAL ELEMENTS, INC. |
KERRI DIMARTINO |
| K082467 |
08/27/2008 |
ENSITE FUSION DYNAMIC REGISTRATION TOOL |
ST. JUDE MEDICAL |
KAREN J MCKELVEY |
| K082279 |
08/11/2008 |
EPICOR ABLATION CONTROL SYSTEM, MODEL ACS-US-2, ACS-EUR-2 |
ST. JUDE MEDICAL |
DONNA R LUNAK |
| K082304 |
08/13/2008 |
ROLL-X GUIDEWIRE |
ST. JUDE MEDICAL |
JEFF STURM |
| K082435 |
08/22/2008 |
AMSCO EVOLUTION MEDIUM STEAM STERILIZER |
STERIS Corporation |
ROBERT F SULLIVAN |
| K082451 |
08/25/2008 |
STRYKER VIDEOSCOPE |
Stryker Endoscopy |
DESIREE CRISOLO |
| K082209 |
08/05/2008 |
DEVILBISS DV5M SMARTLINK SYSTEM |
SUNRISE MEDICAL |
JOSEPH E OLSAVSKY |
| K082386 |
08/19/2008 |
INREACH PLANNING LAPTOP |
SUPERDIMENSION, LTD. |
MARGARET DEPUYDT |
| K082276 |
08/11/2008 |
SYNTHEMED DEVICE |
SYNTHEMED, INC. |
ELI PINES |
| K082335 |
08/14/2008 |
SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K082482 |
08/28/2008 |
FORA TD-4251/U-RIGHT TD-4252/U-RIGHT TD-4254 BLOOD GLUCOSE MONITORING SYSTEM, MODEL TD-4251/TD-4252A/TD-4252B/TD-4254 |
TaiDoc Technology Corporation |
SOPHIE LIN |
| K082169 |
08/01/2008 |
PRO GLUCOSE TEST STRIP |
TaiDoc Technology Corporation |
Yuhua Chen |
| K082499 |
08/29/2008 |
C. DIFF QUIK CHEK COMPLETE |
TECHLAB, INC. |
CHARLES PENNINGTON |
| K082377 |
08/18/2008 |
TENSCARE ITOUCH MODEL(S) EASY AND PLUS |
TENSCARE LTD |
ANTHONY JANKEL |
| K082178 |
08/01/2008 |
TEPHAFLEX ABSORBABLE SUTURE |
TEPHA, INC. |
MARY P LEGRAW |
| K082321 |
08/13/2008 |
TERUMO ROCSAFE HYBRID PERFUSION SYSTEM |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARY A COURTNEY |
| K082362 |
08/18/2008 |
SURSHIELD SAFETY I.V. CATHETER |
TERUMO MEDICAL CORP. |
EILEEN DORSEY |
| K082311 |
08/13/2008 |
EXSUDEX WOUND DRAINAGE PUMP |
THE MEDICAL COMPANY |
HARM JAAP SMIT |
| K082510 |
08/29/2008 |
IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0 |
TOMTEC IMAGING SYSTEMS, GMBH |
INGE SCHEIDT |
| K082364 |
08/18/2008 |
IMAGENET PROFESSIONAL PC SOFTWARE SYSTEM OR IMAGENET PROFESSIONAL, OR IMAGENET PRO, OR DIGITAL IMAGING SOFTWARE FOR |
TOPCON CORP. |
BARBARA S FANT, PHARM.D. |
| K082494 |
08/29/2008 |
DRAD3000E/RADREX-I |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K082244 |
08/08/2008 |
PCA-8000A, MARK 11, PET / CT SYSTEM |
TOSHIBA AMERICA MEDICAL SYSTEMS, INC. |
PAUL BIGGINS |
| K082393 |
08/19/2008 |
CVUE ADVANCED (HIOXIFILCON D) SOFT (HYDROPHILIC) CONTACT LENS |
UNILENS CORP., USA |
ALAN J FRAZER |
| K082469 |
08/27/2008 |
UNITED U2 PATELLA |
UNITED ORTHOPEDIC CORP. |
RUDY CHEN |
| K082424 |
08/22/2008 |
UNITED U2 TOTAL KNEE SYSTEM |
UNITED ORTHOPEDIC CORP. |
RUDY CHEN |
| K082201 |
08/05/2008 |
G5 INFINITY BLODO GLUCOSE MONITORING SYSTEM WITH MODEL IGM, 0024A |
US DIAGNOSTICS, INC. |
JONATHAN J JOHNSON |
| K082337 |
08/14/2008 |
MINNIE SUPPORT CATHETER |
VASCULAR SOLUTIONS, INC. |
CHARMAINE SUTTON |
| K082481 |
08/28/2008 |
FLOWPICC CATHETER |
VASONOVA INC. |
TINA CHENG |
| K082350 |
08/15/2008 |
PAX-500 |
VATECH CO., LTD. |
DAVE KIM |
| K082204 |
08/05/2008 |
SERIES SY DISPOSABLE ELECTROSURGICAL PAD |
VENTLAB CORP. |
CHRISTINA NORRIS |
| K082456 |
08/26/2008 |
VERATHON INC. BLADDERSCAN ULTRASOUND SYSTEM, MODEL BVI 9600 |
VERATHON INCORPORATED |
RICHARD A ZEINE |
| K082466 |
08/27/2008 |
XYCOR SPINAL IMPLANT |
VERTEBRATION,INC |
BARBARA FANT |
| K082270 |
08/11/2008 |
OCTANE VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| K082329 |
08/14/2008 |
VIRAMED BIOTECH AG BORRELIA B31 IGM VIRASTRIPE |
VIRAMED BIOTECH AG |
BARRY E MENEFEE |
| K082269 |
08/11/2008 |
VISAGE PACS, VERSION 6.0/CS 3.1 |
VISAGE IMAGING, INC. |
STEFAN STROWICH |
| K082355 |
08/15/2008 |
VISIONSENSE STEREOSCOPIC VISION SYSTEM |
VISIONSENSE, LTD. |
GERARD J PRUD'HOMME |
| K082285 |
08/11/2008 |
EASY GLAZE |
VOCO GMBH |
THORSTEN GERKENSMEIER |
| K082229 |
08/07/2008 |
S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM |
VOLCANO CORPORATION |
MAMTA VATS |
| K082356 |
08/18/2008 |
GORE INTRODUCER SHEATH WITH SILICONE PINCH VALVE |
W. L. GORE & ASSOCIATES, INC. |
ALICIA HEMPHILL |
| K082404 |
08/21/2008 |
NAVIGATION PROBES |
WE SENSE LTD |
NABIL JADAON |
| K082478 |
08/28/2008 |
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 |
WELCH ALLYN, INC. |
JOHN SAWYER |
| K082294 |
08/12/2008 |
WESTAR SERIES DENTAL UNITS |
WESTAR MEDICAL PRODUCTS, INC. |
RUTH HALLER |
| K082299 |
08/12/2008 |
VERICORE IMPLANT ABUTMENTS |
WHIP-MIX CORP. |
DAVID J STEINBOCK |
| K082257 |
08/08/2008 |
ZENO AI ECO DISC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K082363 |
08/18/2008 |
COOK SYDNEY IVF BLASTOCYST VITRIFICATION (K-SIBV-5000), WARMING (K-SIBW-5000) KITS |
WILLIAM A. COOK AUSTRALIA PTY, LTD. |
GUS TADDEO |
| K082320 |
08/13/2008 |
DARCO SMALL SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| DEN080007 |
08/15/2008 |
ALLOMAP MOLECULAR EXPRESSION TESTING |
XDX |
ROSE ROMEO |
| K082230 |
08/07/2008 |
VECTRA PLUS LASER SYSTEM AND ACCESSORIES |
XINTEC CORPORATION |
MARILYN M CHOU |
| K082343 |
08/15/2008 |
VASCUTRAK 2, MODELS: V14 AND V18 |
YMED INC. |
THOMAS SCHROEDER |
| K082326 |
08/14/2008 |
ZONARE ULTRA ULTRASOUND SYSTEM |
ZONARE MEDICAL SYSTEMS, INC. |
LINDA J MOORE |
