FDA 510(k) Applications Received During August, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
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
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 08/11/2008 EVIS MD PLATINUM RED LIGHT THERAPY AGELESS BEAUTY CORPORATION JILL CREASY
K082226 08/18/2008 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
K082438 08/23/2008 BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH TRUDY ESTRIDGE
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
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 08/13/2008 ASCENSION SILICONE PIP ASCENSION ORTHOPEDICS, INC. DEBBIE STEARNS
K082174 08/05/2008 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 08/29/2008 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
K082125 08/13/2008 N-DEX FREE NIGHTHAWK BLACK NITRILE MEDICAL EXAMINATION GLOVE, POWDER -FREE, MODEL# 7700PFT BEST GLOVE, INC NEIL DOW
K082190 08/13/2008 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 08/20/2008 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
K081787 08/28/2008 CAMLAB CRANIAL ORTHOSIS HELMET BIOSCULPTOR CORPORATION MARK MAZLOFF
K082293 08/12/2008 SURGVIEW INTEGRATED VISUALIZATION SYSTEM BIOVISION TECHNOLOGIES, LLC
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
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 08/05/2008 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
K081088 08/12/2008 MYRAY SKYVIEW CEFLA S.C. BERTHOIN CLAUDE
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
K082289 08/11/2008 PRINEO SKIN CLOSURE SYSTEM CLOSURE MEDICAL CORP. BRUCE KRATTENMAKER
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 08/15/2008 TRUFILL DCS SYRINGE CORDIS NEUROVASCULAR, INC. AMARILYS MACHADO
K082322 08/13/2008 AIR ASSISTED SPRAYER, MODELS: AIRSPRAYUS01 AND AIRSPRAYUS COVIDIEN VIRGINIA VETTER
K082454 08/27/2008 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 08/11/2008 THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 DALE MEDICAL PRODUCTS, INC. ROSINA ROBINSON
K082097 08/06/2008 DEMETECH POLYDIOXANONE SYNTHETIC MONOFILAMENT (PDO) ABSORBABLE SUTURE DEMETECH CORP. ANTHONY J DIMERCURIO
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 08/11/2008 STA SATELLITE AUTOMATED MULTI-PARAMETER ANALYZER DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K082049 08/11/2008 LIAISON ANTI-HAV ASSAY, LIAISON CONTROL ANTI-HAV DIASORIN, INC. CAROL A DEPOUW
K082050 08/11/2008 LIAISON HAV IGM ASSAY, LIAISON CONTROL HAV IGM DIASORIN, INC. CAROL A DEPOUW
K082001 08/18/2008 DIAZYME LIQUID STABLE ENZYMATIC LITHIUM ASSAY, MODEL DZ116B DIAZYME LABORATORIES ABHIJIT DATTA
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
K082410 08/21/2008 MASTER3DS E-WOO TECHNOLOGY CHARLIE MACK
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 08/19/2008 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
K082380 08/19/2008 VICARDIO 12B ENERGY-LAB TECHNOLOGIES GMBH GEORGE MYERS
K082121 08/04/2008 EASYMAX SELF MONITORING GLUCOSE TEST SYSTEM, MODEL # EPS08005 EPS BIO TECHNOLOGY CORP. Y.C. LEI
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 08/14/2008 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 08/11/2008 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
K082126 08/19/2008 RHAPSODY MRI GRANTADLER CORPORATION ARTHUR WARD
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 08/11/2008 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
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
K082338 08/15/2008 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
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
K081505 08/04/2008 THERAGEM PROFESSIONAL T1002 MEDICA HEALTH, LTD TERRI CMOREY
K082458 08/26/2008 P3T ABDOMEN MEDRAD, INC. FORTUNATO ALDAPE
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
K082385 08/19/2008 CHAPERON GUIDING CATHETER MICROVENTION, INC. FLORIN TRUUVERT
K081033 08/18/2008 MIROXI MIR MEDICAL INTL. RESEARCH SRL SIMON FOWLER
K082354 08/26/2008 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 08/15/2008 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
K082242 08/07/2008 ICON, MODEL C3 OSYPKA MEDICAL, INC. MARKUS OSYPKA
K082314 08/28/2008 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
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
K082182 08/01/2008 AP 34 MULTI-THERAPY INFUSION PUMP Q-CORE, LTD ASHER KASSEL
K082240 08/18/2008 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
K082116 08/04/2008 HEMOSTASYL PASTE SATELEC RICK ROSATI
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
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 08/11/2008 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 08/05/2008 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 08/15/2008 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 08/13/2008 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
K082110 08/22/2008 DUAL SYRINGE HOLDER SURGIN SURGICAL INSTRUMENTATION, INC. GRACE HOLLAND
K082276 08/11/2008 SYNTHEMED DEVICE SYNTHEMED, INC. ELI PINES
K082335 08/14/2008 SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM SYNTHES (USA) AMNON TALMOR
K081715 08/20/2008 FORA TD-4244 & TD-4245 BLOOD GLUCOSE MONITORING SYSTESM TAIDOC TECHNOLOGY CORPORATION YUHUA CHEN
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 08/27/2008 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
K082269 08/15/2008 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 08/11/2008 S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM VOLCANO CORPORATION MAMTA VATS
K082356 08/21/2008 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
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
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 08/11/2008 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


Search | Companies | Product Codes | Device Names | Contacts | Applications | Decisions | Contact