FDA 510(k) Decisions During October, 2008  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K080466 10/21/2008 ALCOHOL PAD 122 CORPORATION DONALD CANAL
K073645 10/21/2008 SIMPLER MINI DENTAL IMPLANT: SM 3002 2.5 X 10MM, SM 3003 2.5 X 13MM, SM 3004 2.5 X 15MM 659543 BC LTD. HAROLD BERGMAN
K082717 10/30/2008 AUDIT MICROCV TUMOR MARKERS LINEARITY SET, MODEL K719M-5 AALTO SCIENTIFIC LTD. BRANDON J PEREZ
K082032 10/06/2008 SEQUOIA SPINAL SYSTEM (MODEL 3306), SPEEDLINK TRANSVERSE CONNECTOR (MODELS 3308, 3309, 3310) ABBOTT SPINE, INC. DAVID PADGETT
K081127 10/17/2008 ACCIN TOTAL KNEE SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K082071 10/02/2008 ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT ADPHARMA, INC. VIVEK RAMANA
K081545 10/02/2008 ONE SERIES ULTRA CARTRIDGE, MODEL 1VIPR30 ADVANCED MEDICAL OPTICS, INC. KIM REGIS
K081681 10/08/2008 VITRECTOMY CUTTER AND ACCESSORIES ADVANCED MEDICAL OPTICS, INC. Evelyn De La Vega
K081650 10/23/2008 AERONEB GO NEBULIZER AEROGEN (IRELAND) LTD FRANK ENRIGHT
K082232 10/15/2008 EVIS MD PLANTIUM BLUE AGELESS BEAUTY CORPORATION JILL CREASY
K082247 10/08/2008 EVIS MD PLATINUM RED LIGHT THERAPY AGELESS BEAUTY CORPORATION JILL CREASY
K080348 10/09/2008 OXISCAN II DATA MANAGEMENT SYSTEM AIRSEP CORP. PETER WEISERBORN
K081935 10/07/2008 STEREOTACTIC HEAD AND NECK LOCALIZER, MODEL 50-100 AKTINA MEDICAL PHYSICS CORP. TONY SPACCAROTELLA
K081710 10/15/2008 APOGEE AND PERIGEE SYSTEMS WITH PC COATED INTEPRO LITE AMERICAN MEDICAL SYSTEMS DENISE THOMPSON
K082006 10/20/2008 AMS SPECTRA CONCEALABLE PENILE PROSTHESIS AMERICAN MEDICAL SYSTEMS, INC. STEPHANIE GEORGE
K082831 10/23/2008 AMSELF CLOSED CATHETERIZATION SYSTEM AMSINO INTERNATIONAL, INC. CHING CHING SEAH
K080851 10/10/2008 A/C PORTABLE ENZYMATIC HOMOCYSTEINE ASSAY ANTICANCER INC YUYING TAN
K080254 10/31/2008 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES JEFF RYBERG
K081724 10/30/2008 HYDROLYZED COLLAGEN WITH 10% CHONDROITIN SULFATE (PSGAG, POLYSULFATED GLYCOSAMINOGLYCAN) WOUND GEL APPLIED NUTRITIONALS ANITA PETITO
K082839 10/24/2008 DISTAL RADIO-ULNAR JOINT IMPLANT APTIS MEDICAL, LLC. BRYAN BABB
K081312 10/31/2008 ARAGON ONESHOT SYSTEM ARAGON SURGICAL INC. ALAN CURTIS
K082217 10/06/2008 RANGER RAPID FLOW BLOOD/FLUID WARMING SYSTEM ARIZANT HEALTHCARE INC. DAVID WESTLIN
K082417 10/21/2008 GLUCOCARD 01-MINI BLOOD GLUCOSE MONITORING SYSTEM, MODEL 73110 ARKRAY Factory USA, Inc. TOM SPEIKERS
K082666 10/15/2008 ARTHROCARE CONTROLLER (SYSTEM 12000), ARTHROCARE PATIENT CABLE, FOOT CONTROL, POWER CORD, WANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K081893 10/01/2008 OPUS MAGNUM SPEEDSCREW KNOTLESS FIXATION DEVICE, MODEL OM-6500 ARTHROCARE CORP. LAURA KASPEROWICZ
K082515 10/03/2008 ASAHI REXEED-SX/LX DIALYZERS, MODELS: 13SX, 15SX, 18SX, 21SX, 25SX, 13LX, 15LX, 18LX, 21LX ASAHI KASEI MEDICAL CO., LTD. DAVID L WEST
K082174 10/20/2008 Y-ADAPTER ASTHMATX, INC. CARTER NAVARRO
K081666 10/07/2008 ATLANTIS, ATLANTIS GEMINI, ATLANTIS GEMINI+ ABUTMENTS FOR ASTRA OSSEOSPEED 3.0 IMPLANTS ASTRA TECH, INC. BETSY A BROWN
K081880 10/02/2008 ATLAS SPINE SPACER ATLAS SPINE INC. JEANNETTE G DAILEY
K081820 10/06/2008 AVALON ELITE BI-CAVAL DUAL LUMEN CATHETER, 13FR, 16FR, 19FR, 20FR, 23FR, 27FR, 31FR AVALON LABORATORIES, LLC DAVID C FURR
K081933 10/03/2008 AVALON ELITE MULTI-PORT VENOUS FEMORAL CATHETER, 20FR, 22FR, 24FR, 26FR, 28FR AVALON LABORATORIES, LLC LEE WIRTH
K082199 10/17/2008 SPIRALFUSE PERIPHERAL INFUSION SYSTEM BACCHUS VASCULAR, INC. BOB MCRAE
K082202 10/08/2008 HALO360 ENERGY GENERATOR, MODELS 1100C-115B AND 1100C-230B BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K082944 10/16/2008 CRYSTALSERT CRYSTALENS DELIVERY SYSTEM BAUSCH & LOMB, INC. DAVID THOMAS
K081717 10/10/2008 TRICOS A RESORBABLE BONE SUBSTITUTE BAXTER HEALTHCARE CORP. VALERIE FOLLOWELL
K082486 10/08/2008 GLUCOFACTS EXPRESS DIABETES MANAGEMENT SOFTWARE BAYER HEALTHCARE, LLC ROGER SONNENBURG
K082271 10/06/2008 FLUCONAZOLE 25UG BBL SENSI-DISC BECTON DICKINSON & CO. JANINE MATLAK
K082272 10/02/2008 VORICONAZOLE 1UG BBL SENSI-DISC BECTON DICKINSON & CO. JANINE MATLAK
K083066 10/30/2008 CHROMOPHARE E 778 AND E 558 BERCHTOLD HOLDING GMBH SILKE GORAL
K073368 10/10/2008 5.0 X 5.0MM DENTAL IMPLANT AND 6.0 X 5.0 DENTAL IMPLANT BICON, LLC VINCENT J MORGAN
K080003 10/23/2008 BINAXNOW G6PD TEST BINAX, INC. Anne Jepson
K073307 10/29/2008 MAX-FACE MAXILLOFACIAL OSTEOSYNTHESIS SYSTEM BIO-TECHNOLOGY USA, INC. IAN GORDON
K082263 10/24/2008 CERALAS E 980NM DIODE LASER, MODELS E15/980 AND E30/980 BIOLITEC, INC. JONATHAN S KAHAN
K082564 10/20/2008 HYPERQ SYSTEM BIOLOGICAL SIGNAL PROCESSING, LTD. GEORGE J HATTUB
K080194 10/09/2008 VIDAS CEA (S) ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K080979 10/31/2008 STAGEONE SELECT CEMENT SPACER MOLDS FOR TEMPORARY HIP REPLACEMENT BIOMET MANUFACTURING CORP. GARY BAKER
K082826 10/24/2008 VANGUARD CR STEM HOUSINGS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K081952 10/07/2008 SYNERGY SPINAL SYSTEM (6.35 POLARIS) BIOMET SPINE VIVIAN KELLY
K082446 10/15/2008 BIOMET METAL-ON-METAL HIP SYSTEMS- EXPANDED CONTRAINDICATIONS BIOMET, INC. BECKY EARL
K081478 10/06/2008 RNA MEDICAL GLUCOSE AND B-KETONE CALIBRATION VERIFICATION CONTROLS BIONOSTICS, INC. KATHLEEN STORRO
K082757 10/01/2008 MODIFIED STERILE PLATE & SCREW KIT CONFIGURATIONS FOR USE WITH BIOPLATE TITANIUM FIXATION SYSTEM BIOPLATE, INC. JESUS T FARINAS
K082797 10/17/2008 BLACKSTONE PEDICLE SCREW SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K082906 10/30/2008 UNITY BETA ANCHOR SYSTEM BONUTTI RESEARCH, INC. PATRICK G BALSMANN
K081733 10/27/2008 10MM X 40MM UNCOVERED WALLFLEX BILLIARY RX STENT SYSTEM, MODEL M00570890 BOSTON SCIENTIFIC CORP. WING NG
K082928 10/16/2008 STRAIGHT FIRE HOLMIUM LASER FIBER BOSTON SCIENTIFIC CORP. LAUREN B ANDERSON
K082109 10/02/2008 BOVIE ICON GENERAL PURPOSE RF GENERATOR BOVIE MEDICAL RICHARD A KOZLOFF
K081187 10/08/2008 BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001 BRIDGEPOINT MEDICAL MICHAEL A DANIEL
K082687 10/17/2008 COLLAMEND FM IMPLANT C.R. BARD, INC. KEVIN G STEVENS
K082305 10/31/2008 G2 EXPRESS FILTER SYSTEM - FEMORAL AND JUGULAR/SUBCLAVIAN DELIVERY KITS C.R. BARD, INC. GENEVIEVE BALUTOWSKI
K082681 10/15/2008 VACORA VACUUM ASSISTED BIOPSY SYSTEM C.R. BARD, INC. CINDY MOSS
K080944 10/23/2008 X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER C.R. BARD, INC. TERRI MORRIS
K082260 10/17/2008 INTEGRA CERVICAL AND PETRA PLIF LUMBAR CAGES CALVARY SPINE LLC J.D. WEBB
K081670 10/09/2008 THE ADVANTAGE SERIES NON-VENTED (NV) FULL FACE MASK CARDINAL HEALTH 207, INC. ANDRE VON MULLER
K082981 10/31/2008 DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM WITH VIPERSLIDE LUBRICANT CARDIOVASCULAR SYSTEMS, INC. DAVID D BROOKE
K080906 10/17/2008 CDB CLIP CDB CORPORATION JENS RUMSFELD
K073022 10/01/2008 CLAREBLEND LED PROBES MODEL# 7201-415, 7204-631, 7205-830 CLAREBLEND, INC. JILL CREASY
K073000 10/01/2008 LUMAPROBE CLAREBLEND, INC. JILL CREASY
K080632 10/15/2008 CLEAR1-DAY HIOXIFILCON DAILY DISPOSABLE SOFT CONTACT LENS CLEARLAB SG PTE LTD. MARTIN DALSING
K082599 10/17/2008 NON-INVASIVE CONTINUOUS BLOOD PRESSURE MONITORING SYSTEM CNAP MONITOR 500I, 500AT CNSYSTEM MEDIZINTECHNIK AG SUMPER
K082640 10/17/2008 VIRTUE VENTRAL URETHRAL ELEVATION SLING SYSTEM COLOPLAST MANUFACTURING US, LLC ANGELA BYLAND
K081178 10/09/2008 OPTIMUM HR-1.51 (HIFLUFOCON A) AND HR-1.53 (HIFLUFOCON B) DAILY WEAR CONTACT LENSES CONTAMAC LTD. MARTIN DALSING
K082058 10/02/2008 DYNAMATRIX COOK BIOTECH, INC. DAVID J COLLETTE
K082536 10/27/2008 COOK WIRE GUIDES COOK UROLOGICAL, INC. CINDY FOOTE
K082051 10/16/2008 COSMAN G4 RADIOFREQUENCY GENERATOR, MODEL RFG-4 COSMAN MEDICAL, INC. LOUIS FALCONE
K082012 10/14/2008 COSMAN RF INJECTION ELECTRODES, MODELS CU, CUR, CCD, TCD, CP, CR, CN COSMAN MEDICAL, INC. LOUIS FALCONE
K082966 10/31/2008 PB 540 VENTILATOR COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. TINA O'BRIEN
K082258 10/16/2008 CROSSTEX ISOLITE AND ISOFLUID EARLOOP FACE MASKS AND ISOFLUID FOGFREE FACE MASKS WITH AND WITHOUT SPLASH VISOR CROSSTEX INTERNATIONAL RICHARD M ORMSBEE
K081413 10/24/2008 TWINLOTUS AND SHIELDS NATURAL RUBBER LATEX CONDOM DAILIAN LATEX COMPANY, LTD.
K082241 10/30/2008 THE DALE ACE CONNECTOR (ACCESS CONTROLLER FOR ENTERAL), MODEL H84104751 DALE MEDICAL PRODUCTS, INC. ROSINA ROBINSON
K082784 10/07/2008 JUMAO MANUAL WHEELCHAIR DANYANG JUMAO HEALTHCARE EQUIPMENT CO.,LTD. QING WANG
K072752 10/31/2008 BP LIMBO XL, BPTANGO XL, BP SALSA XL DATADANCER MEDICAL SYSTEMS MICHAEL KOHUT
K081842 10/03/2008 ENGSTROM CARESTATION, ENGSTROM PRO DATEX-OHMEDA, INC. ADRIENNE LENZ
K081010 10/07/2008 BARD 3DMAX MESH DAVOL INC., SUB. C.R. BARD, INC. STEPHANIE BAKER
K073582 10/15/2008 VRIICU SYSTEM DEEP BREEZE LTD. JEFF BAETZ
K082198 10/29/2008 DURASHIELD PLUS DENTSPLY INTL., INC. HELEN LEWIS
K082942 10/31/2008 MODFICATION TO: EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. FRANK JURCZAK
K082675 10/10/2008 STA-R EVOLUTION AUTOMATED MULTI-PARAMETRIC ANALYZER DIAGNOSTICA STAGO, INC. UMBERTO V PARROTTA
K081447 10/08/2008 FOURTH GAS MODULE WITH CO2 FOR PRIMUS US APOLLO DRAEGER MEDICAL AG & CO. KG KARIN LUEBBERS
K080559 10/09/2008 DIO SM IMPLANT SYSTEM DSI, INC. HYUNGICK KIM
K081382 10/23/2008 DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786 DUCKWORTH & KENT, LTD. MARTIN LOCK
K082410 10/31/2008 MASTER3DS E-WOO TECHNOLOGY CHARLIE MACK
K081385 10/09/2008 URESTA PESSARY EASTMED INC. SHIRLEY FURESZ
K082139 10/23/2008 EDWARDS BOVINE PERICARDIAL PATCH, MODEL 4700 EDWARDS LIFESCIENCES, LLC. DARYL RICHARDSON
K082663 10/06/2008 COLOR LCD MONITOR EIZO NANAO CORPORATION HIROAKI HASHIMOTO
K082106 10/02/2008 ELCAM ANTIMICROBIAL CLOSED STOPCOCKS (DSS AND TSS) ELCAM MEDICAL A.C.A.L. TALI HAZAN
K072603 10/23/2008 ABC SYRINGE INFUSION PUMP, MODEL 4100 ELIXIR CORPORATION WILLIAM M VONDERSMITH
K081408 10/17/2008 ELLIPSE MULTIFLEX ELLIPSE A/S OLE KOFOD
K082601 10/09/2008 INSTA-CLOT, INSTA-CLOT OTC EMERGENCY MEDICAL DEVICES, LLC JACK MENTKOW
K082398 10/15/2008 ENCORE HIP STEMS WITH CERAMIC HEADS AND UHMWPE LINERS ENCORE MEDICAL, L.P. TEFFANY HUTTO
K082420 10/08/2008 TRACHEOSCOPIC VENTILATION TUBE (TVT) ETVIEW YORAM LEVY
K082702 10/10/2008 EXACTECH EQUINOXE REVERSE SHOULDER SYSTEM+15MM HUMERAL ADAPTER TRAY EXACTECH, INC. SHING JEN TAI
K081741 10/31/2008 NEUROLINK IP, MODEL PK1113 EXCEL-TECH LTD. (XLTEK) GOLDY SINGH
K080793 10/16/2008 FIRMGRIP FLEXICATH LTD. TALI HAZAN
K082163 10/29/2008 FLOWMEDICA BENEPHIT INFUSION SYSTEMS FLOWMEDICA, INC. JEFF ELKINS
K082414 10/28/2008 OPTIFLUX F250NR, MODEL 0500325E FRESENIUS MEDICAL CARE NORTH AMERICA JANET KAY
K082092 10/15/2008 DISPO-BAG MANUAL RESUSCITATOR, DISPOSABLE ADJUSTABLE PEEP VALVE, DISPOSABLE FIXED PEEP VALVE GALEMED CORP. THOMAS LOESCHER
K082171 10/30/2008 GRADIA CORE GC AMERICA, INC MARK HEISS
K082768 10/21/2008 G-BOND PLUS GC AMERICA, INC. MARK HEISS
K082816 10/08/2008 GE BRIGHTSPEED DELIGHT CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC STEVEN KACHELMEYER
K082761 10/08/2008 GE LIGHTSPEED 7.2 CT SCANNER SYSTEM GE MEDICAL SYSTEMS, LLC TRACEY ORTIZ
K082960 10/17/2008 GE XTREME INJECTOR OPTION GE MEDICAL SYSTEMS, LLC STEVEN KACHELMEYER
K082442 10/07/2008 MODIFICATION TO MICROFUSE BONE VOID FILLER GLOBUS MEDICAL, INC. KELLY J BAKER
K082865 10/23/2008 MODIFICATION TO ZENIEVA GORBEC PHARMACEUTICAL SERVICES, INC. SANDRA R KIRCUS
K082298 10/23/2008 FLASH N' GO HOME SKINOVATIONS LTD. AMIR WALDMAN
K073309 10/17/2008 ABX PENTRA HBA1C WB, CALIBRATOR, CONTROL AND HEMOLYSIS REAGENT HORIBA ABX OLIVIER DUCAMP
K083019 10/22/2008 GEMSTAR SP INFUSION SYSTEM WITH GEMSTAR SP INFUSION SUITE SOFTWARE HOSPIRA, INC. Yuliya Matlin
K082567 10/03/2008 STRYKER COMPARTMENTAL KNEE SYSTEM LINE EXTENSION HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K082018 10/10/2008 T2 FLEXIBLE NAIL HOWMEDICA OSTEONICS CORP. FRANCISCO HARO
K081572 10/01/2008 SMARTSIGNS MINPULSE HUNTLEIGH HEALTHCARE LTD. ROBERT MCCARTHY
K080923 10/17/2008 CARESENS BLOOD GLUCOSE MONITORING SYSTEM; CARESENS II METER, MODEL GM505C; CARESENS POP METER, MODEL GM505EA OR GM505EB i-SENS, Inc. HYUN JOON OH
K080275 10/09/2008 NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM IASIS MEDICAL, INC. JOHN BUAN
K080909 10/17/2008 ICONOSCOPE ONCOFISH HER2 TEST SYSTEM, MODEL 2000 IKONISYS INC SYED ATAULLAH
K082402 10/16/2008 OSDX HIP BMD SYSTEM IMAGING THERAPEUTICS, INC. PATRICK HESS
K080825 10/03/2008 IMPEDIMED EXTRA CELLULAR FLUID ANALYSIS, MODEL L-DEX U400 IMPEDIMED PTY LTD. PHILIP S AUCKLAND
K080908 10/17/2008 INNERCOOL THERAPIES, INC., RAPIDBLUE SYSTEM INNERCOOL THERAPIES, INC.- A DELAWARE CORPORATION JENNIFER SPINELLA
K081248 10/27/2008 QUANTA LITE OMP PLUS ELISA INOVA DIAGNOSTICS, INC. ZAKERA SHUMS
K082545 10/17/2008 STRAUMANN NN CARES TITANIUM AND CERAMIC ABUTMENTS INSTITUT STRAUMANN AG ELAINE ALAN
K082764 10/01/2008 STRAUMANN WN CARES TITANIUM ABUTMENT INSTITUT STRAUMANN AG ELAINE ALAN
K081401 10/08/2008 MAYFIELD MR/X-RAY SKULL CLAMP INTEGRA LIFESCIENCES CORP. HELDER A SOUSA
K082250 10/10/2008 AURAGEN CORTICAL SURFACE ELECTRODES INTEGRA NEUROSCIENCES JON CAPAROTTA
K081436 10/22/2008 INVIROSTRIPE 3ML, 5ML, 10ML LUER LOCK SYRINGES INVIRO MEDICAL DEVICES, INC. ROBERT N CLARK
K082916 10/15/2008 HRB-127-32 HIGH RESOLUTION BRAIN COIL INVIVO JEFF WILKINSON
K082530 10/30/2008 APPLICATORS FOR AFTERLOADING BRACHYTHERAPY ISODOSE CONTROL B.V. HUB VAN DE BERGH
K081107 10/10/2008 CASPIAN SPINAL SYSTEM, SCREWS, RODS, HOOKS, ROD CONNECTORS K2M, INC. RICHARD W WOODS
K082046 10/10/2008 KARL STORZ PEDIATRIC FLEXIBLE CYSTO-URETHRO-FIBERSCOPE, MODEL 11278C1/ACUI AND CIRCON AUR-735 PEDIATRIC CYSTOURETHEROSCO KARL STORZ ENDOSCOPY-AMERICA, INC. MONIKA CAMPBELL
K082767 10/21/2008 KOWA NONMYD ALPHA-DIII KOWA CO. LTD. AKIHIRO FUJITA
K081587 10/24/2008 KRELL WEIGHT & BODY FAT MONITORING SCALE, MODEL BFA-8530 KRELL PRECISION (YANG ZHOU) CO., LTD. CHARLIE MACK
K082900 10/28/2008 KYMCO FORU, MODEL EQ10 KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K082901 10/28/2008 KYMCO FORU, MODEL EQ20 KWANG YANG MOTOR CO., LTD. JUNNATA CHANG
K082338 10/16/2008 POLYBONE GRANULE & BLOCK KYUNGWON MEDICAL CO., LTD. JUNG BAE BANG
K082774 10/21/2008 LANX CERVICAL INTERVERTEBRAL BODY FUSION DEVICE LANX, LLC Alan Burkholder
K082592 10/08/2008 LDR SPINE EASYSPINE SYSTEM LDR SPINE USA NOAH BARTSCH
K082802 10/09/2008 MIPUMP SINGLE ELECTRIC/BATTERY BREAT PUMP & MIPUMP DOUBLE ELECTRIC/BATTERY BREAST PUMP & MIPUMP DELUXE DOUBLE ELECTRIC/B LEARNING CURVE BRANDS INC. THE FIRST YEARS SUPRAVAN KHONGKRUAPHAN
K083017 10/24/2008 LEVO C3 LEVO AG THOMAS RABER
K082923 10/24/2008 PRLONG, MODELS PL50, PL100, PL-40C, PL-50C, PL-100C, PL-150C, PLT-40C, PLT-50C, PLT-100C, PLT-150C LIFE-TECH, INC. JEFF KASOFF
K082103 10/08/2008 LTM WOUND DRESSING LIFECELL CORP. MANAL MORCOS
K081438 10/17/2008 MATRACELL DECELLULARIZED PULMONARY ARTERY PATCH ALLOGRAFT LifeNet Health ALYCE LINTHURST JONES
K082513 10/22/2008 ONETOUCH VITA BLOOD GLUCOSE MONITORING SYSTEM LIFESCAN, INC. Oyinkan Donaldson
K072926 10/15/2008 HELONTIX VENT LINDE GAS THERAPEUTICS ANN-CATHRIN JAREMAN
K080901 10/02/2008 LBI EMBOLECTOMY SYSTEM LUMEN BIOMEDICAL, INC. MARIA E BRITTLE
K082096 10/08/2008 POWERLIPO LASER SYSTEM LUTRONIC CORPORATION MAUREEN O'CONNELL
K081884 10/08/2008 MAJOR.BASE 20 MAJOR PRODOTTI DENTARI S.P.A. MONICA FUNAI
K082088 10/22/2008 MAKO SURGICAL CORP. PATELLOFEMORAL KNEE IMPLANT SYSTEM II MAKO SURGICAL CORP. WILLIAM F TAPIA
K082081 10/15/2008 MAKO SURGICAL CORPORATION UNICONDYLAR KNEE IMPLANT SYSTEM III MAKO SURGICAL CORP. WILLIAM F TAPIA
K082237 10/09/2008 PURITAN BENNETT, SANDMAN DUO AND SANDMAN DUO ST MALLINCKRODT DEVELOPPEMENT FRANCE TINA DREILING
K082520 10/02/2008 SEALGUARD EVAC ENDOTRACHEAL AND ENDOTRACHEAL TUBES MALLINCKRODT MEDICAL SCOTT D DICKERHOFF
K082544 10/03/2008 QUART ARTERIAL FILTER WITH BIOLINE COATING MAQUET CARDIOPULMONARY AG KATRIN SCHWENKGLENKS
K082703 10/14/2008 MRDH BANDAGE MARINE POLYMER TECHNOLOGIES, INC. SERGIO FINKIELSZTEIN
K082052 10/10/2008 MASIMO RAINBOW SET RADCHECK PULSE CO-OXIMETER, RADCHECK, RAD 57 SPOT CHECK MASIMO CORPORATION MARGUERITE THOMLINSON
K082856 10/15/2008 CARAPASTE ORAL WOUND DRESSING MCGRATH PHARMACEUTICALS, INC. PATRICK D MCGRATH
K081023 10/22/2008 EVOLIS TOTAL KNEE SYSTEM MEDACTA INTERNATIONAL, SA NATALIE J KENNEL
K082587 10/02/2008 AUTO-SAFETY INJECTOR-2 (ASI-2) MEDICAL HOUSE PRODUCTS LIMITED ROSE Y GUANG
K082969 10/23/2008 LUMINEX INFRARED LAMP SYSTEM MEDICAL LASER SYSTEMS INC MIKI KOLTON
K082798 10/28/2008 DIGITAL DIAGNOSTIC X-RAY SYSTEM, MODELS MAK 1500, MAK 2000 AND MAK 3000 MEDICATECH USA DANIEL KAMM
K082069 10/03/2008 PASS 2 SPINAL SYSTEM MEDICREA TECHNOLOGIES J.D. WEBB
K082577 10/03/2008 PASS LP SPINAL SYSTEM MEDICREA TECHNOLOGIES J D WEBB
K082514 10/21/2008 TENS/EMS COMBO, EMS, TENS MEDIHIGHTEC MEDICAL CO., LTD. MU-SHENG HUNG
K082657 10/08/2008 RTX RESPIRATOR MEDIVENT LIMITED SHAHAR HAYEK
K081594 10/17/2008 MEDLINE POWDER-FREE NITRILE EXAMINATION GLOVE WITH ALOE MEDLINE INDUSTRIES, INC. MATT CLAUSEN
K082458 10/17/2008 P3T ABDOMEN MEDRAD, INC. FORTUNATO ALDAPE
K080339 10/27/2008 MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) MEDSOURCE INTERNATIONAL, LLC. HOWARD T COOPER
K082464 10/27/2008 PROSTIVA RF THERAPY HAND PIECE, MODEL 8929 MEDTRONIC INC. JEANMARIE SALES
K082236 10/10/2008 CD HORIZON SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK BRAD SHEALS
K082732 10/16/2008 MODIFICATION TO: CAPSTONE SPINAL SYSTEM MEDTRONIC SOFAMOR DANEK USA, INC. CHRIS MCKEE
K081475 10/17/2008 ELECTRIC DRILL SYSTEM [XPS 4000 SYSTEM, MIDAS REX LEGEND EHS SYSTEM, INTEGRATED POWER CONSOLE (IPC)] MEDTRONIC XOMED, INC. ANTOINE KOUCHAKJY
K082707 10/01/2008 MEDX LPT 200 TETHERED LASER & MEDX LPS 200 (ORALASE) PORTABLE LASER MEDX ELECTRONICS, INC. ANITA SALTMARCHE
K081791 10/21/2008 E-Z CLEAN ELECTROSURGICAL ELECTRODE MEGADYNE MEDICAL PRODUCTS, INC. RONDA K MAGNESON
K082149 10/06/2008 LYMPHA PRESS OPTIMAL, MODEL# 1201AP MEGO AFEK AC LTD AHAVA STEIN
K082063 10/15/2008 PRELUDE SHORT SHEATH INTRODUCER MERIT MEDICAL SYSTEMS, INC. JERRIE HENDRICKSON
K082357 10/29/2008 MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODELWATCHBP OFFICE (TWIN200). MICROLIFE INTELLECTUAL PROPERTY GMBH SUSAN D GOLDSTEIN-FALK
K080786 10/03/2008 ML830TP MICROLIGHT CORPORATION OF AMERICA FRED A SIMPSON
K082461 10/02/2008 BARE PLATINUM FRAMING COIL, MODEL(S) 100408BPFC-V,100412BPFC-V,100515BPFC-V100518BPFC-V,100522BPFC-V,100618BPFC-V100622B MICROVENTION, INC. FLORIN TRUUVERT
K082739 10/17/2008 MICRUS MICROCOIL DELIVERY SYSTEM MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K081965 10/27/2008 MPOWRX SNORING SOLUTION MPOWRX HEALTH AND WELLNESS PRODUCTS INC. JEAN ASQUITH
K080399 10/10/2008 DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE MUSCULOSKELETAL TRANSPLANT FOUNDATION NANCY B JOY
K082493 10/23/2008 MEDICAL DISPLAY, MD205MG-1 NEC DISPLAY SOLUTIONS, LTD. SHUICHI KINO
K082238 10/01/2008 NEOMED POLYURETHANE FEEDING TUBE NEOMED, INC. PENNY NORTHCUTT
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