FDA 510(k) Applications Received During February, 2008

FDA 510(k) Number Submission Date Device Name Applicant Contact
K083672 12/11/2008 P.D SOFTWARE .DECIMAL, INC. DANIEL BENNETT
K080466 02/21/2008 ALCOHOL PAD 122 CORPORATION DONALD CANAL
K080513 02/25/2008 QLASER SYSTEM 2035, INC. Kevin Walls
K083903 12/29/2008 3M LITTMANN ELECTRONIC STETHOSCOPE, MODEL 3200 3M COMPANY JIZHONG JIN
K083610 12/08/2008 FILTEK SUPREME ULTRA UNIVERSAL RESTORATIVE 3M COMPANY SCOTT ERICKSON
K080514 02/25/2008 PECD-01 AND PECD QUICK-01 3M ESPE AG DENTAL PRODUCTS DESI W SOEGIARTO
K083894 12/29/2008 ALIF SPINAL TRUSS INTERBODY FUSION DEVICE 4-WEB SPINE, LLC RICHARD JANSEN
K083645 12/09/2008 RADSTAR FAMILY, MODELS: RADSTAR 4343 & VARIATIONS 5 STAR MEDICAL, INC. TERRY L ANCAR
K080395 02/13/2008 SUNIVF DISHES INTL., INC. MICHAEL D CECCHI
K083809 12/22/2008 CREATININE ABBOTT LABORATORIES LINDA MORRIS
K083713 12/15/2008 .035 LOC GUIDE WIRE EXTENSION Abbott Vascular NADINE SMITH
K083738 12/16/2008 HI-TORQUE FLEX-T GUIDE WIRE, MODELS 1012067-01, 02, 03, 04 AND 05 Abbott Vascular NADINE SMITH
K083706 12/15/2008 HI-TORQUE VERSACORE GUIDE WIRE Abbott Vascular NADINE SMITH
K083732 12/16/2008 TAD AND TAD II TAPERED GUIDE WIRES Abbott Vascular NADINE SMITH
K080264 02/01/2008 MODIFICATION TO: FOX PLUS PTA CATHETER ABBOTT VASCULAR-VASCULAR SOLUTIONS Ivalee Cohen
K080539 02/27/2008 ACCIN UNIPOLAR HEAD SYSTEM ACCELERATED INNOVATION, LLC MICHAEL KVITNITSKY
K083574 12/03/2008 RELIEVA STRATUS MICROFLOW SPACER ACCLARENT, INC. KERI YEN
K080545 02/27/2008 ACTITRAINER ACTIGRAPH, LLC JOHN SCHEIDER
K080500 02/25/2008 MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7 ACUMEN MEDICAL, INC. KEVIN MACDONALD
K083855 12/24/2008 MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59 ACUMEN MEDICAL, INC. KEVIN MACDONALD
K080503 02/25/2008 SILVER ALGINATE IV ANTIMICROBIAL WOUND DRESSING ADVANCED MEDICAL SOLUTIONS LIMITED CLAIRE RYAN
K080401 02/14/2008 SHELL CAGE, WAVE CAGE, LOOP CAGE ADVANCED MEDICAL TECHNOLOGIES AG J.D. WEBB
K083626 12/08/2008 DISTRACTABLE WAVE CAGE ADVANCED MEDICAL TECHNOLOGY, INC. J.D. WEBB
K080408 02/14/2008 EXTERNAL FIXATION CLAMP 5.0 MM PIN X9.5MM ROD, MODEL 1151-100, EXTERNAL FIXATON CLAMP, 9.5MM ROD ADVANCED ORTHOPAEDIC SOLUTIONS, INC. PAUL DONER
K083915 12/30/2008 ANGELITE FAMILY OF INTENSE PULSED LIGHT SYSTEMS, MODELS ANGELITE-DDC AND ANGELITE-SDC ADVANCED TECHNOLOGY LASER CO., LTD. Diana Hong
K083918 12/30/2008 ATL CO2 MEDICAL LASER SYSTEMS, MODELS ATL-150 AND ATL-250 ADVANCED TECHNOLOGY LASER CO., LTD. Diana Hong
K083772 12/18/2008 COLUMBUS REVISION KNEE SYSTEM AESCULAP IMPLANT SYSTEM, INC. LISA M BOYLE
K080547 02/28/2008 ORTHOPILOT NEXT GENERATION, MODEL FS101-FS106 AESCULAP IMPLANT SYSTEM, INC. MATTHEW M HULL
K083730 12/16/2008 ISOLAZ AESTHERA CORPORATION PAMELA M BUCKMAN
K080348 02/11/2008 OXISCAN II DATA MANAGEMENT SYSTEM AIRSEP CORP. PETER WEISERBORN
K083761 12/18/2008 ALATECH POWDER FREE LATEX EXAMINATION GLOVE ALATECH HEALTHCARE, LLC. NEIL ANDERSON
K083628 12/08/2008 GLUCODR AUTO SYSTEM ALL MEDICUS CO., LTD MARGARET KIM
K083812 12/22/2008 REFRESH OPTIVE LENS COMFORT REWETTING DROPS ALLERGAN, INC. BEVERLEY D VENUTI
K083826 12/23/2008 LAGUNA POLYAXIAL PEDICLE SCREW SYSTEM ALLEZ SPINE, LLC HARTMUT LOCH
K080318 02/06/2008 ALMA LASER NIR MODULE ALMA LASERS LTD. TATIANA EPSTEIN
K083848 12/24/2008 ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM ALMA LASERS LTD. TATIANA EPSTEIN
K080463 02/20/2008 ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES ALMA LASERS LTD. ANNE WORDEN
K083625 12/08/2008 AERO DV TRACHEOBRONCHIAL STENT SYSTEM ALVEOLUS, INC TONY ALEXANDER
K083549 12/01/2008 ABT GLUCOSE CONTROL SOLUTION AMERICAN BIOLOGICAL TECHNOLOGIES, INC. JOHN GORMLEY
K080397 02/13/2008 AMERICAN DENTAL IMPLANT ABUTMENT SYSTEM AMERICAN DENTAL IMPLANT CORPORATION GINA HENNON
K080290 02/04/2008 XVIEWNET AMERICAN RADIOLOGIST NETWORK, INC. IAN GORDON
K080468 02/21/2008 LIASYS WITH MODELS LIASYS AMS S.R.L. ANALYZER MEDICAL SYSTEM STEFANO CORRADI
K080326 02/06/2008 KD-391 SEMI AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD
K080319 02/06/2008 KD-591 FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR ANDON HEALTH CO.,LTD MS. MONA
K080400 02/13/2008 ANGIODYNAMICS, INC., DURAMAX HEMODIALYSIS CATHETER AND PROCEDURE KIT ANGIODYNAMICS, INC. TERI JUCKETT
K080287 02/04/2008 ONCOBIONIC BIPOLAR ELECTRODE ANGIODYNAMICS, INC. TERI JUCKETT
K080451 02/19/2008 UNIBLATE ELECTROSURGICAL DEVICE ANGIODYNAMICS, INC. BRIAN KUNST
K083686 12/12/2008 BAIXIN DISPOSABLE SYRINGE, MULTIPLE SIZES ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. BIAN WEI QIANG
K083687 12/12/2008 BAIXIN INTRAVASCULAR ADMINISTRATION SET ANHUI KANGDA MEDICAL PRODUCTS CO., LTD. BIAN WEI QIANG
K083729 12/16/2008 HEMOCLOT QUANTI- V-L, FACTOR V-L CALIBRATOR, BIOPHEN V-L CAL (UNDILUTED), BIOPHEN ACT. PC-R CONTROL PLASMA AND BIOPHEN ANIARA DIAGNOSTICA ,LLC OLA ANDERSON
K080536 02/27/2008 MICRO-TOUCH NITRAFREE ANSELL HEALTHCARE PRODUCTS LLC LON D MCIIVAIN
K080564 02/28/2008 SCANSCOPE XT SYSTEM APERIO TECHNOLOGIES JEFF RYBERG
K083656 12/10/2008 APEX MEDICAL XT AUTO CPAP 9S-005200 APEX MEDICAL CORP. ALAN CHANG
K083617 12/08/2008 APIERON INSIGHT ENO SYSTEM APIERON, INC. NINA PELED
K080467 02/21/2008 BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC, APPLIED DNA TECHNOLOGIES, INC. FENG YU-LEE
K083638 12/09/2008 FIXATION TROCARS APPLIED MEDICAL RESOURCES CORP.
K083799 12/22/2008 TOPIRAMATE ASSAY, ARK TOPIRAMATE CALIBRATOR AND ARK TOPIRAMATE CONTROL, MODELS 5015-0001-000, 5015-0002-00, 5015-0003-00 ARK DIAGNOSTICS,INC JOHNNY VALDEZ
K083707 12/15/2008 ARTHREX DUAL WAVE ARTHROSCOPY FLUID MANAGEMENT DEVICE ARTHREX, INC. SALLY FOUST
K080282 02/04/2008 ARTHROCARE CONTROLLERS (SYSTEM 2000,1100,1200), MODEL H2076-00, H2079-00, H3000-00, H4000-00; ARTHROCARE CORP. VALERIE DEFIESTA-NG
K080482 02/22/2008 ARTHROCARE IRRIGATION PUMP, MODEL SIP001-00, SIP001-01 ARTHROCARE CORP. VALERIE DEFIESTA-NG
K083904 12/29/2008 ASAHI SUOH PTCA GUIDE WIRE ASAHI INTECC CO., LTD. YOSHI TERAI
K080294 02/04/2008 ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KIT ASTORIA-PACIFIC,INC. JASON REYNOLDS
K080396 02/13/2008 OSSEOSPEED NARROW ASTRA TECH AB FLOYD G LARSON
K083871 12/29/2008 ATLANTIS STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI STRAUMANN BONE LEVEL ABUTMENT, ATLANTIS GEMINI + STRAUMANN BONE ASTRA TECH, INC. BETSY A BROWN
K083780 12/19/2008 SUPERELELASTIC NITINOL PISTON, SUPERELASTIC NITINOL TRIMMABLE PISTON, MODEL SPL03.39/40/41/42 (DETAILS IN 510(K) ANNEX 2 AUDIO TECHNOLOGIES S.R.L. FRANCO BEONI
K083858 12/24/2008 BOND BONE AUGMA BIOMATERIALS, LTD. DAVID J COLLETTE
K083868 12/29/2008 ARCHITECT ANTI-CCP (100 TEST), ARCHITECT ANTI-CCP (500 TEST), MODELS 1P65-25, 1P65-35 AXIS-SHIELD DIAGNOSTICS, LTD. Claire Dora
K083667 12/11/2008 NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 B-K MEDICAL APS LARS OKSBY HANSEN
K083723 12/15/2008 A6 LUER ACCESS DEVICE B. BRAUN MEDICAL, INC. BONNIE J KINCAID, RAC
K083689 12/12/2008 INFUSOMAT SPACE VOLUMETRIC INFUSION PUMP SYSTEM B. BRAUN MEDICAL, INC. LINDA MORGAN
K080557 02/28/2008 BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K083737 12/16/2008 HALO ABLATION CATHETER BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K083711 12/15/2008 MODIFICATION TO: HALO COAGULATION CATHETER, MODELS 32041-18, 32041-20, 32041-22, 32041-25, 32041-28, 32041-31, 32041-34 BARRX MEDICAL, INCORPORATED VIORICA FILIMON
K083757 12/17/2008 BPZ02 MULTIPURPOSE SOLUTION BAUSCH & LOMB, INC. GLENN A DAVIES, O.D.
K080494 02/22/2008 BAXANO ULTRA LOW PROFILE RONGEUR BAXANO, INC. SHARON ROCKWELL
K083778 12/19/2008 XENIUM XPH, MODELS 110, 130, 150, 170, 190 AND 210 BAXTER HEALTHCARE CORPORATION DIANE RENNPFERD
K083718 12/15/2008 BEAU RX SCAR CARE GEL BEAU RX SOLUTIONS, LLC. THOMAS L MCGRAW
K080481 02/22/2008 ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS BECKMAN COULTER, INC. CHECHAMMA VARUGHESE
K083867 12/29/2008 ACCESS SEX HORMONE BINDING GLOBULIN REAGENT, ACCESS SEX HORMONE BINDING GLOBULIN CALIBRATORS AND ACCESS SEX HORMONE BIND BECKMAN COULTER, INC. TYLER FOUTCH
K083572 12/03/2008 BD BACTEC PLUS AEROBIC/F BLOOD CULTURE MEDIUM BECTON, DICKINSON & CO. DENNIS MERTZ
K083720 12/15/2008 OSSEODUO, SHAVER HANDPIECE S80 AND S120, MICROMOTOR 80K BIEN-AIR SURGERY SA HUGUES FROIDEVAUX
K083744 12/16/2008 BINAXNOW MALARIA POSITIVE CONTROL KIT, MODEL 665-010 BINAX, INC. Anne Jepson
K080471 02/21/2008 RADIO BIOAQUACARE BIOARTIFICIAL GEL TECHNOLOGIES (BAGTECH) INC JONATHAN KAHAN
K083681 12/12/2008 BIOLAND BLOOD PRESSURE MONITOR BIOLAND TECHNOLOGY LTD. DAVID LEE
K083595 12/05/2008 EZLASE BIOLASE TECHNOLOGY, INC. IOANA RIZOUI
K083927 12/31/2008 WATERLASE MD BIOLASE TECHNOLOGY, INC. IOANNA RIZOU
K083682 12/11/2008 180W CERELAS D 980NM DIODE LASER, MODEL D180 BIOLITEC, INC. JONATHAN S KAHAN
K080561 02/28/2008 VIDAS CA 125 II ASSAY BIOMERIEUX, INC. SANDRA L PERREAND
K080469 02/21/2008 VIDAS CA 15-3 ASSAY BIOMERIEUX, INC. NIKITA S MAPP
K080426 02/20/2008 MAESTRO WRIST FRACTURE IMPLANT BIOMET MANUFACTURING CORP. PATRICIA SANDBORN BERES
K083779 12/19/2008 MAK OSS KNEE FEMORAL COMPONENTS BIOMET MANUFACTURING CORP. PATRICIA S BERES
K083827 12/23/2008 ORTHOPEDIC SALVAGE SYSTEM (OSS) 9CM COBALT - CHROME TIBIAL BODIES BIOMET MANUFACTURING CORP. GARY BAKER
K083782 12/19/2008 REGENEREX PATELLA COMPONENTS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K080528 02/26/2008 E-POLY TIBIAL BEARINGS BIOMET ORTHOPEDICS, INC. MELISSA STEINWEDEL
K080361 02/11/2008 REGENEREX TIBIAL COMPONENTS BIOMET, INC. SUSAN ALEXANDER
K080330 02/06/2008 SEGMENTAL DISTAL FEMORAL COMPONENTS AND PROXIMAL FEMORAL BODIES WITH A COMPRESS FEMALE TAPER BIOMET, INC. PATRICIA S BERES
K080374 02/12/2008 BIOSYAG MEDICAL SYSTEM BIOS S.R.L. ALESSANDRO FRANCHI
K080308 02/05/2008 BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD BIOSCAFFOLD INTERNATIONAL PTE LTD ROGER GRAY
K080425 02/15/2008 CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 BIOSENSE WEBSTER, INC. Balaka Das
K080269 02/01/2008 TRIAGE CARDIOPROFILER AND PROFILER S.O.B. PANELS BIOSITE INCORPORATED DAWN A ALLENBY
K080529 02/26/2008 STEREOS WORKSTATION BIOSPACE MED JOHN J SMITH
K083674 12/11/2008 PK-141 PATIENT CABLE BIOTRONIK, INC. Jon Brumbaugh
K080394 02/13/2008 BLACKSTONE ASCENT POSTERIOR OCCIPITAL CERVICO-THORACIC (POCT) SYSTEM BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K080407 02/14/2008 BLACKSTONE SFS PARALLEL ROD CONNECTORS BLACKSTONE MEDICAL, INC. WHITNEY G TORNING
K083715 12/15/2008 BELTBEAT WF-400 BONUS COMMUNICACIONES SRL BENNY ARAZY
K080272 02/01/2008 ATLANTIS PVIMAGING CATHETER, MODEL H749364560 BOSTON SCIENTIFIC CORP. JANICE BROWN
K080332 02/07/2008 POLYFLEX STENT SYSTEM WITH DELIVERY SYSTEM, MODEL M00514270, M00514280, 00514290, 00514300, 00514310, 00514320, 00514330 Boston Scientific Corporation ASHLEY PYLE
K083627 12/08/2008 WALLFLEX BILIARY RX FULLY-COVERED STENT SYSTEM, MODEL M00570500,M00570510, M00570520, M00570530, M00570540 Boston Scientific Corporation Marybeth Gamber
K083727 12/15/2008 STINGRAY GUIDEWIRE, STIFF, MODELS M-3003, M-3004, M-3011, M-3012 BRIDGEPOINT MEDICAL JILL MUNSINGER
K083869 12/29/2008 BT-TITE CV3, MINI IMPLANT, MINI SINGLE, SLOT IMPLANT, MODEL(S) DDDIII BTICV3, 1, AND DDDIIIBTISI BTLOCK SRL ESTHER BATTILANA
K083839 12/23/2008 AVAULTA SOLO SYNTHETIC SUPPORT SYSTEM, AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM C.R. BARD, INC. TERRI MORRIS
K083657 12/10/2008 CONQUEST PTA BALLOON DILATATION CATHETER C.R. BARD, INC. GENEVIEVE BALUTOWSKI
K083675 12/11/2008 POWER-TRIALYSIS TRIPLE LUMEN ACUTE DIALYSIS CATHETER C.R. BARD, INC. JESSICA AGNELLO
K083722 12/15/2008 ASCEND CALDERA MEDICAL, INC. MARA KORSUNSKY
K080333 02/07/2008 IMAGEGRID CANDELIS, INC. CARL ALLETTO
K083673 12/11/2008 CARESTREAM PACS, MODEL CARESTREAM PACS VII CARESTREAM HEALTH, INC. LINDA STEWART
K083892 12/29/2008 FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) CAS MEDICAL SYSTEMS, INC. RON JEFFREY
K080558 02/28/2008 STERITITE CONTAINER SYSTEM & MEDITRAY PRODUCTS CASE MEDICAL, INC. TANIA LUPU
K080276 02/04/2008 SELF-ADHESIVE ELECTRODES CATHAY HEALTHCARE EQUIPMENT MANUFACTURING, INC BRANDON CHOI
K083612 12/05/2008 APERFIX FEMORAL IMPLANT WITH INSERTER, 9,10,11 MM X 35MM AND X 29MM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K083607 12/05/2008 APERFIX IMPLANT WITH INSERTER, 8, 9, 10, 11, MM X30 MM CAYENNE MEDICAL, INC. KERESHMEH SHAHRIARI
K083876 12/29/2008 SFI-BAR SYSTEM COMPLETE 2-IMPLANT AND 4-IMPLANT CENDRES & METAUX SA PETER W FLEETWOOD
K080570 02/29/2008 CDC HUMAN INFLUENZA VIRUS REAL-TIME RT- PCR DETECTION AND CHARACTERIZATION PANEL CENTERS FOR DISEASE CONTROL AND PREVENTION STEPHEN LINDSTROM
K080507 02/25/2008 AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT CEREMED, INC. TADEUSZ WELLISZ
K083913 12/30/2008 CHESSON LABS LIQUID BANDAGE CHESSON LABORATORY ASSOCIATES, INC. SCOTT E NEUVILLE
K083640 12/09/2008 DIGITAL X-RAY IMAGING SYSTEM, MODEL: CXD-DR80D CHOONGWAE MEDICAL CORP. CHARLIE MACK
K080459 02/20/2008 CHROMESYTEMS TOXICOLOGY CALIBRATORS AND CONTROLS CHROMSYSTEMS INSTRUMENTS & CHEMICALS GMBH CATHY CAMBRIA
K083716 12/15/2008 FIRST RESPONSE EARLY RESULT PREGNANCY TEST (OTC) CHURCH & DWIGHT CO., INC. STEPHEN C KOLAKOWSKY
K080565 02/29/2008 MODIFICATION TO: SAVI APPLICATOR KIT CIANNA MEDICAL, INC. GARY MOCNIK
K083771 12/18/2008 RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP CLARITY MEDICAL SYSTEMS GARY A SEEGER
K080445 02/19/2008 LION SE ONE STEP ORTHODONTIC ADHESIVE CLASSONE ORTHODONTICS, INC. JUDY RIBORDY
K083596 12/05/2008 REEKROSS FAMILY OR OTW PTA CATHETERS CLEARSTREAM TECHNOLOGIES, LTD. FIONA N MHULLAIN
K083554 12/01/2008 CLINIQA LIQUIDQC IMMUNOASSAY CONTROL LEVEL 1, 2 & 3 CLINIQA CORPORATION DAWN GAST
K083567 12/03/2008 GII SPINAL FIXATION SYSTEM, GII-TI-POLY AXIAL SCREW CO-LIGNE AG DAVID W SCHLERF
K083783 12/19/2008 VF LIQUIGEL COAPT SYSTEMS, INC. LOUIS-PIERRE MARCOUX
K080363 02/11/2008 BAHA CORDELLE II COCHLEAR BONE ANCHORED SYSTEMS AB SEAN BUNDY
K083895 12/29/2008 CODMAN ISOCOOL BIPOLAR FORCEPS Codman & Shurtleff, Inc. EMILY E VALERIO
K080452 02/19/2008 COLLAGEN TENDON WRAP COLLAGEN MATRIX, INC. PEGGY HANSEN
K083742 12/16/2008 SYNOSS COLLAGEN SYNTHETIC MINERAL-COLLAGEN BONE GRAFT MATRIX COLLAGEN MATRIX, INC. PEGGY HANSEN
K083770 12/18/2008 COLOPLAST PERISTEEN ANAL IRRIGATION (PAI) SYSTEM COLOPLAST A/S JANELL A COLLEY
K080386 02/13/2008 COLUMBIA 600 ELECTRODE, COLUMBIA 06 LEADWIRE COLUMBIA SCIENTIFIC DEVELOPMENT LLC STEPHEN SHULMAN
K083624 12/08/2008 POWDER FREE NITRILE (BLUE AND WHITE) EXAMINATION GLOVES COMFORT RUBBER GLOVES IND. SDN. BHD. TAN K BENG
K083677 12/11/2008 PHYSIOGLOVE FOR USE WITH PHYSIOGLOVE ES1 COMMWELL LTD. JONATHAN KAHAN
K080298 02/05/2008 DERMABIOSAFE COMPLETE PRODUCT RESOURCES JOHN WALSH
K080531 02/26/2008 CONMED LINVATEC MICROFRACTURE INSTRUMENT STERILIZATION TRAY CONMED LINVATEC JON WARD
K080444 02/19/2008 CONMED LINVATEC OSPREY DRILL SYSTEM CONMED LINVATEC SUE F DAUTERMAN
K083785 12/19/2008 VITALA CONTINENCE CONTROL DEVICE CONVATEC MARILYN KONICKY
K080383 02/12/2008 AQUACEL HYDROFIBER WOUND DRESSING AND AG HYDROFIBER DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, L.L.C. MARILYN KONICKY
K080359 02/11/2008 EVOLUTION ESOPHAGEAL STENT SYSTEM COOK IRELAND LTD NOREEN BARRY
K080525 02/26/2008 COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W COOK UROLOGICAL, INC. CINDY FOOTE
K083814 12/22/2008 OUTBACK LTD RE-ENTRY CATHETER, MODEL: OTB42120 CORDIS CORP., A JOHNSON & JOHNSON CO. KAREN WILK
K083776 12/19/2008 CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1030AIV-LB-S CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083791 12/19/2008 CORFLO ANTI IV ENTERAL FEEDING SET, MODEL: 20-1060AIV-S CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083786 12/19/2008 CORFLO ANTI-IV ENTERAL FEEDING EXTENSION SET, MODELS 20-1006AIV-LB AND 20-1030AIV-LB CORPAK MEDSYSTEMS STEPHANIE WASIELEWSKI
K083693 12/12/2008 PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840 COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT INC. KIM BLOOM
K080281 02/04/2008 PATHWAY CUSTOM SPINE, INC. SAAD ATTIYAH
K080300 02/05/2008 CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) CUTERA, INC. KATHY MAYNOR
K080530 02/26/2008 MODIFICATION TO CUTERA ER:YSGG LASER HANDPIECE CUTERA, INC. KATHY MAYNOR
K080406 02/14/2008 IPULSE, MODEL I400 CYDEN LIMITED MICHEAL KIERNAN
K083748 12/17/2008 IPULSE, MODEL: I150 CYDEN LIMITED MICHAEL KIERNAN
K083795 12/22/2008 CYNOSURE SMARTLIPO MPX LASER CYNOSURE, INC. GEORGE CHO
K080373 02/12/2008 TACAHE PC1350 POWER WHEELCHAIR DALTON MEDICAL CORP. WILL RIDGWAY
K083586 12/04/2008 I-FIX SYSTEM DENTIS CO. LTD. JUNG BAE BANG
K083841 12/24/2008 ADAPTABLE COMPOSITE RESIN RESTORATIVE MATERIAL DENTSPLY INTERNATIONAL, INC. HELEN LEWIS
K080311 02/06/2008 MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM DENTSPLY INTERNTIONAL HELEN LEWIS
K083805 12/22/2008 ANKYLOS C/X DENTAL IMPLANT SYSTEM DENTSPLY INTL., INC. HELEN LEWIS
K080352 02/11/2008 MICRO QA+ ANCHOR WITHT #3-0 ORTHOCORD SUTURE, MODEL 212843, MICROFIX AQ+ ANCHOR WITH #3-0 ORTHOCORD SUTURE DEPUY MITEK, A JOHNSON & JOHNSON COMPANY KRISTINE CHRISTO
K083789 12/19/2008 ACE FISCHER EXTERNAL FIXATION SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K083642 12/09/2008 DEPUY PINNACLE METAL-ON-METAL ACETABULAR CUP LINERS DEPUY ORTHOPAEDICS, INC. DAWN SINCLAIR
K083843 12/24/2008 LOCKING ANATOMIC & COMPOSITE PLATING SYSTEM DEPUY ORTHOPAEDICS, INC. SUZANA OTANO
K080313 02/06/2008 MODIFICATION TO EXPEDIUM SPINE SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K080568 02/29/2008 X-MESH EXPANDABLE CAGE SYSTEM DEPUY SPINE, INC. HANDE TUFAN
K080497 02/22/2008 DERMA SCIENCES CALCIUM ALGINATE DRESSING WITH ANTIMICROBIAL SILVER (ALGICELL AG) DERMA SCIENCES CANADA, INC. SHARMINI ATHERAY
K080315 02/06/2008 DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY DERMA SCIENCES, INC. MARY MCNAMARA-CULLINANE
K080351 02/11/2008 DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI DEXELA LTD BARRY SALL
K080485 02/22/2008 ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS DIASYS DIAGNOSTICS SYSTEMS GMBH STEPHANIE KLEIN
K083649 12/09/2008 CARDIUS 3 X-ACT DIGIRAD CORP. Joel Tuckey
K080382 02/13/2008 SELLAS DINONA CO., LTD. Kevin Walls
K083712 12/15/2008 WATER PURIFICATION COMPONENTS FOR HEMODIALYSIS DIPURE, LLC. TIM MARCO
K080479 02/22/2008 DENTAL CERAMIC DMG USA, INC. PAMELA PAPINEAU
K080480 02/22/2008 NANOCOMPOSITE RESTORATIVE KIT DMG USA, INC. PAMELA PAPINEAU
K080559 02/28/2008 DIO SM IMPLANT SYSTEM DSI, INC. HYUNGICK KIM
K080385 02/13/2008 CRUISER PP5500 CHALLENGER POWERED WHEELCHAIR E1 ENT., INC. JACK CHENG
K083769 12/18/2008 MODIFICATION TO URESTA PESSARY EASTMED INC. ROSHANA AHMED
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