| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
Contact |
| K083672 |
12/11/2008 |
P.D SOFTWARE |
.DECIMAL, INC. |
DANIEL BENNETT |
| K080395 |
02/13/2008 |
SUNIVF DISHES |
INTL., INC. |
MICHAEL D CECCHI |
| 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 |
| 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 Culture Vials |
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 |
| K083821 |
12/22/2008 |
VITAL SIGNS MONITOR |
EDAN INSTRUMENTS, INC. |
WILLIAM STERN |
| K083623 |
12/08/2008 |
CARPENTIER-MCCARTHY-ADAMS IMR ETLOGIX ANNULOPLASTY RING, MODEL 4100 |
EDWARDS LIFESCIENCES, LLC. |
ERICA WALTERS |
| K083648 |
12/09/2008 |
GOTFRIED PHYSIOLOGICAL HIP (PH) NAIL |
EFRATGO, LTD. HI TECH BIO-SURGICAL |
GEORGE J HATTUB |
| K080422 |
02/15/2008 |
5 MEGAPIXEL MONOCHROME LCD MONITOR, MODEL RADIFORCE GS520 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K080457 |
02/20/2008 |
COLOR LCD MONITOR, MODEL RADIFORCE RX211 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K080392 |
02/13/2008 |
EndoWave Infusion System |
EKOS CORP. |
JOCELYN KERSTEN |
| K080355 |
02/11/2008 |
LEKSELL STEREOTACTIC SYSTEM WITH REUSABLE FIXATION SCREWS |
ELEKTA INSTRUMENT AB |
PETER LOWENDAHL |
| K083629 |
12/08/2008 |
SMOOTHSHAPES |
ELEME MEDICAL, INC. |
MICHAIL PANKRATOV |
| K080423 |
02/15/2008 |
INTEGRE, MODEL LP581 |
Ellex Medical Pty. Ltd. |
KEVIN HOWARD |
| K083555 |
12/02/2008 |
PICTURE ARCHIVING AND COMMUNICATION SYSTEM (PACS), PETAVISION |
EMSOMA CO., LTD. |
WEONBUM LEE |
| K080402 |
02/14/2008 |
ENCORE SHOULDER PRIMARY HUMERAL STEM, MODEL 500-00, ENCORE SHOULDER HUMERAL HEAD, MODEL 520-38 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K083651 |
12/09/2008 |
REVELATION STEM, MODEL 427-21/42-080/180 |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K083788 |
12/19/2008 |
ENDO OPTIKS UROLOGICAL CATHETER FOR ENDOSCOPY, MODEL SESSR |
ENDO OPTIKS, INC. |
DONALD R WATSON |
| K083833 |
12/23/2008 |
ENABLER-P CATHETER, 1000 PART NUMBER:1160 |
ENDOCROSS, LTD. |
JOHN SMITH |
| K080360 |
02/11/2008 |
ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER |
ENDOLOGIX, INC. |
ANNALIZA VICTORIA |
| K083608 |
12/05/2008 |
ERBE HYBRID KNIFE |
ERBE USA, INC. |
JOHN TARTAL |
| K083882 |
12/29/2008 |
MYLABFIVE |
ESAOTE EUROPE B.V. |
JAMIE AUSTIN |
| K080329 |
02/07/2008 |
CAP PLUS, EQUIVABONE, CAP/DBM |
ETEX CORP. |
PAMELA W ADAMS |
| K080299 |
02/05/2008 |
RESPIFIT S, MODEL RS-LR1001004 |
EUMEDICS MEDIZINTECHNIK UND MARKETING GMBH |
DAVID LEVINE |
| K083850 |
12/24/2008 |
EUROIMMUN ANCA IFA EUROPLUS GRANULOCYTE BIOCHIP MOSAIC TEST SYSTEMS |
EUROIMMUN US INC |
KATHRYN KOHL |
| K083615 |
12/08/2008 |
EUROIMMUN ANTI BP 180-4X ELISA (IGG) |
EUROIMMUN US INC |
KATHRYN KOHL |
| K083669 |
12/11/2008 |
OBI |
EUROTEKNIKA |
EMMANUEL MONTINI |
| K083670 |
12/11/2008 |
UNIVERSAL, AESTHETICA, NATEA, NATURA |
EUROTEKNIKA |
EMMANUEL MONTINI |
| K083793 |
12/22/2008 |
STEERABLE GUIDE CATHETER |
EVALVE INC |
KARUNA VELUSAMY |
| K083870 |
12/29/2008 |
EXSALT SD7 WOUND DRESSING |
EXCITON TECHNOLOGIES INC. |
SANDRA REIS |
| K083825 |
12/22/2008 |
EOI SPINAL SYSTEM |
EXPANDING ORTHOPEDICS, INC. |
JANICE M HOGAN |
| K083690 |
12/12/2008 |
FEMVUE(TM) CATHETER SYSTEM |
FEMASYS INC. |
MARC FINCH |
| K080278 |
02/04/2008 |
TABATABA COTESTER |
FIM MEDICAL |
DANIEL KAMM |
| K083832 |
12/23/2008 |
ZEST NASAL MASK |
FISHER & PAYKEL HEALTHCARE, LTD. |
TINA MASON |
| K083838 |
12/23/2008 |
SCALEMAN BODY FAT SCALES, MODEL: FS-148BW1 SERIES |
FOOK TIN TECHNOLOGIES LIMITED |
JOHN CHAI |
| K083889 |
12/29/2008 |
FOTONA QX ND:YAG/KTP LASER SYSTEM FAMILY |
FOTONA D.D. |
STOJAN TROST |
| K080270 |
02/01/2008 |
MANUAL RIGID MOBILITY WHEELCHAIR |
FREEDOM DESIGNS, INC. |
BOB GARDNER |
| K080273 |
02/01/2008 |
AB-TROL AND PRIVATE LABEL GLUCOSE CONTROL SOLUTION |
FUJIREBIO DIAGNOSTICS TEXAS, INC. |
JOHN GORMLEY |
| K083697 |
12/15/2008 |
FUKUDA DENSHI DYNASCOPE MODEL DS-7000 SERIES PATIENT MONITOR, MODEL DS-7000//7000M/7210/7210M |
FUKUDA DENSHI USA, INC. |
DOUG BLAKELY |
| K080519 |
02/25/2008 |
PRISMAFLEX M150 SET |
GAMBRO RENAL PRODUCTS, INC. |
KAE MILLER |
| K080478 |
02/22/2008 |
GRADIA FORTE |
GC AMERICA, INC. |
MARK HEISS |
| K083750 |
12/17/2008 |
CAPNOSTAT / CAPNOFLEX CO2 SYSTEM |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
ROBERT L CASARSA |
| K083639 |
12/09/2008 |
MUSE CARDIOLOGY INFORMATION SYSTEM WITH VMWARE |
GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES |
LARRY LEPLEY |
| K083683 |
12/12/2008 |
ATS SIMULUS SEMI-RIGID MITRAL ANNULOPLASTY RING, MODEL 800SC |
Genesee BioMedical, Inc. |
JOHN T.M. WRIGHT |
| K083752 |
12/17/2008 |
GLUSEAL 90, MODEL GLU9010 |
GLUSTITCH, INC. |
DON BLACKLOCK |
| K083717 |
12/15/2008 |
POWDER FREE NITRILE EXAMINATION GLOVES, BUBBLE GUM SCENTED, PINK |
GX CORPORATION SDN BHD |
FOO KHON PU |
| K080421 |
02/15/2008 |
HEART SYNC, MODELS C-100 AND T-100 |
HEART SYNC LLC |
STEPHEN SHULMAN |
| K080560 |
02/28/2008 |
HENKE SASS WOLF OF AMERICA ARTHROSCOPE |
HENKE SASS WOLF OF AMERICA, INC. |
LYNETTE HOWARD |
| K080338 |
02/07/2008 |
CUTTERSIL ACTIVATOR UNIVERSAL PLUS |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
| K083652 |
12/09/2008 |
IBOND TOTAL ETCH |
HERAEUS KULZER GMBH |
CHERYL ZIMMERMAN |
| K083552 |
12/01/2008 |
MAXMORESPINE TOM STICK |
HOOGLAND SPINE PRODUCTS GMBH |
BORIS MIKLITZ |
| K083899 |
12/29/2008 |
REVLITE Q-SWITCHED ND:YAG LASER SYSTEM |
HOYA CONBIO, INC |
LIZA BURNS |
| K083824 |
12/22/2008 |
HUMANSCAN M5S-D ULTRASOUND TRANSDUCER |
HUMANSCAN COMPANY, LTD. |
GARY ALLSEBROOK |
| K080322 |
02/06/2008 |
HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200 |
HYCOR BIOMEDICAL, INC. |
P. NARAYAN NAYAK |
| K080424 |
02/15/2008 |
HYGIA HEALTH SERVICES REPROCESSED LNCS SENSORS, MODELS HHS-1858, HHS-1862, HHS-1860 AND HHS-1861 |
HYGIA HEALTH SERVICES, INC. |
JEROME JAMES |
| K080275 |
02/01/2008 |
NPD 1000 NEGATIVE PRESSURE WOUND THERAPY SYSTEM |
IASIS MEDICAL, INC. |
JOHN BUAN |
| K080538 |
02/26/2008 |
IDEAL LIFE POD (MODEL ILP 0001) |
IDEAL LIFE INC. |
Diane Horwitz |
| K080325 |
02/06/2008 |
IGROK |
IGROK, LLC |
ROBERT J RIKER |
| K083591 |
12/04/2008 |
IKOENGELO, VERSION 2 |
IKOETECH, LLC. |
HUIMIN CHAO |
| K080554 |
02/28/2008 |
INAREX, MODEL 2D-LX |
INAREX CORPORATION |
BRANDON CHOI |
| K083728 |
12/16/2008 |
INVISION SYSTEM |
INNEROPTIC TECHNOLOGY, INC |
CAROLINE GREEN |
| K083908 |
12/30/2008 |
BLACK NITRILE EXAMINATION GLOVES |
INNOVATIVE GLOVES CO; LTD |
RAJEEV K SOOD |
| K083879 |
12/29/2008 |
INNOCOR ERGOSPIROMETRY SYSTEM (INN00010), THE BASIC INNOCOR INCLUDING BREATH-BY-BREATH SYSTEM (INN00400), NIBP(INN00500) |
INNOVISION A/S |
H. CARL JENKINS |
| K080484 |
02/22/2008 |
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
INO THERAPEUTICS |
DAVID TRUEBLOOD |
| K080280 |
02/04/2008 |
SUB-TALAR LOK, MODEL 7-11 MM |
INSTRATEK, INC. |
Jeff Seavey |
| K083861 |
12/24/2008 |
TITAN, TITAN SHOULDER BOX, TITAN CRADLE, TITAN PRINTER, TITAN IMP440, IMP440 MODULE, TITAN SUITE |
INTERACOUSTICS AS |
HANNE NIELSEN |
| K080291 |
02/04/2008 |
INTUITIVE SURGICAL DA VINCI ENDOSCOPIC INSTRUMENTS AND CONTROL SYSTEM AND ENDOWRIST STABILIZER |
INTUITIVE SURGICAL, INC. |
KAREN UYESUGI |
| K083751 |
12/17/2008 |
INVACARE TPOC PORTABLE CONCENTRATOR, MODEL TPOC100 |
INVACARE CORPORATION |
CARROLL MARTIN |
| K083919 |
12/31/2008 |
AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER |
INVATEC INNOVATIVE TECHNOLOGIES, S.R.L. |
STEVE CAMP |
| K080575 |
02/29/2008 |
CORRIDOR4DM |
INVIA |
F. DAVID ROTHKOPF |
| K083851 |
12/24/2008 |
INVIROBLUNT CANNULA WITH AND WITHOUT EZ WINGS, MODELS 120522 AND 120022 |
INVIRO MEDICAL DEVICES, INC. |
JIM BARLEY |
| K083590 |
12/04/2008 |
ISKRA MEDICAL GREEN IRF PRESTIGE |
ISKRA MEDICAL, D.O.O. |
MOJCA VALJAVEC |
| K080427 |
02/15/2008 |
WATCH-PAT MODEL 100S-2 |
ITAMAR MEDICAL |
JONATHAN KAHAN |
| K080555 |
02/28/2008 |
SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS) |
IVU IMAGING CORPORATION |
MARK L STRIBLING |
| K083854 |
12/24/2008 |
CARDIAC TRIGGER, MODEL: CTM300 |
IVY BIOMEDICAL SYSTEMS, INC. |
DICK LISTRO |
| K083559 |
12/02/2008 |
YUYUE OXYGENMAX OXYGEN CONCENTRATOR, MODELS: 7F-5A/7F-5B |
JIANGSU YUYUE MEDICAL EQUIPMENT & SUPPLY CO., LTD. |
NORMAN F ESTRIN |
| K080542 |
02/27/2008 |
DISTRAX |
JOHN W. KING |
EMILY B ROSSITER |
| K083753 |
12/17/2008 |
SMART-LOGIC AUTO DIGITAL UPPERARM BLOOD PRESSURE MONITOR, MODEL KP-7500, FULLY FUZZY AUTO DIGITAL UPPER ARM BLOOD PRESSU |
K-JUMP HEALTH CO., LTD. |
JASON CHENG |
| K080302 |
02/05/2008 |
CAYMAN BUTTRESS PLATE SYSTEM |
K2M, INC. |
RICHARD WOODS |
| K080410 |
02/14/2008 |
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE CHEN |
| K083598 |
12/05/2008 |
KARL STORZ VOICE1 SCB R-UI SPEECH CONTROL APPLICATION |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
CRYSTAL DIZOL |
| K083701 |
12/15/2008 |
PANASIL INITIAL CONTACT AND PANASIL TRAY |
KETTENBACH GMBH & CO KG |
KRISTI KISTNER |
| K083609 |
12/08/2008 |
KFX PEEK BONE ANCHOR WITH PRE-ATTACHED SUTURES AND INSERTER HANDLE |
KFX MEDICAL |
GAYLE HIROTA |
| K083801 |
12/22/2008 |
BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70 |
KHN SOLUTIONS, LLC |
DANIEL KAMM |
| K080537 |
02/27/2008 |
L-VARLOCK |
KISCOMEDICA S.A. |
J.D. WEBB |
| K080523 |
02/26/2008 |
KRONUS BLOCKING ACETYLCHOLINE RECEPTOR AUTOANTIBODY (ACHRAB) RIA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K080508 |
02/25/2008 |
MANDREL GUIDEWIRES OR M-WIRE |
LAKE REGION MEDICAL |
KAREN MORTENSEN |
| K083815 |
12/22/2008 |
LANX FUSION SYSTEM |
LANX, INC. |
Alan Burkholder |
| K083581 |
12/04/2008 |
LANX SPINAL FIXATION SYSTEM |
LANX, INC. |
ANDREW LAMBORNE |
| K083822 |
12/22/2008 |
LASER TOUCHONE |
LASER HEALTH TECHNOLOGIES, LLC |
Patsy Trisler |
| K083909 |
12/30/2008 |
SPINAL INJECTION SYSTEM |
LAURIMED LLC |
SEVRINA CIUCCI |
| K080572 |
02/29/2008 |
LDR SPINE ROI-A IMPLANT |
LDR SPINE USA |
NOAH BARTSCH |
| K083857 |
12/24/2008 |
LDR SPINE ROI-C IMPLANT |
LDR SPINE USA |
NOAH BARTSCH |
| K080569 |
02/29/2008 |
LDR SPINE ROI-T IMPLANT |
LDR SPINE USA |
NOAH BARTSCH |
| K083580 |
12/03/2008 |
ANTI-WRINKLE LIGHT, MODEL 1302 AND PAIN THERAPY LIGHT, MODEL 1301 |
LED INTELLECTUAL PROPERTIES, LLC |
ROBERT T WAGNER |
| K080502 |
02/25/2008 |
MODIFICATION TO:PILOT SPINAL SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K083865 |
12/29/2008 |
PILOT SPINAL SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K080411 |
02/15/2008 |
PLATEAU SPACER SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K080353 |
02/11/2008 |
LTM-T SURGICAL MESH |
LIFECELL CORP. |
LORRAINE T MONTEMURRO |
| K083560 |
12/02/2008 |
EXPANDED SPECTRUM PHOTO THERAPY DEVICE, MODEL ESPT-3X |
LIGHTHOUSE TECHNICAL INNOVATIONS, INC. |
JEAN ASQUITH |
| K083733 |
12/16/2008 |
LUME 2 SYSTEM, MODEL GA0005000 |
LUMENIS, LTD. |
FRANCES HARRISON |
| K083845 |
12/24/2008 |
XTAG CF60 KIT V2 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K083846 |
12/24/2008 |
XTAG CYSTIC FIBROSIS 39 KIT V2, (CFTR 39 KIT V2), MODEL I027C0231, I027D0266, I027E0267 |
LUMINEX MOLECULAR DIAGNOSTICS, INC. |
GLORIA LEE |
| K080496 |
02/22/2008 |
MOSAIC ECO2 LASER SYSTEM |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K083891 |
12/29/2008 |
VALIDATE THYROID CALIBRATION VERIFICATION TEST SET, MODEL 901 |
MAINE STANDARDS CO. |
HOLLY CRESSMAN |
| K080368 |
02/12/2008 |
MAKO SURGICAL CORP. UNICONDYLAR KNEE IMPLANT SYSTEM II |
MAKO SURGICAL CORP. |
WILLIAM F TAPIA |
| K083644 |
12/09/2008 |
MAKO SURGICAL TACTILE GUIDANCE SYSTEM-HIP |
MAKO SURGICAL CORP. |
WILLIAM TAPIA |
| K080439 |
02/19/2008 |
SANDMAN INFO WITHOUT HUMIDIFIER/ SANDMAN AUTO WITHOUT HUMIDIFIER, MODEL M-114801-114802-US; SANDMAN INFO WITH INTERGRATE |
MALLINCKRODT DEVELOPPEMENT FRANCE |
TINA DREILING |
| K083684 |
12/12/2008 |
ENDO VIVE STANDARD REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX |
MANUFACTURING & RESEARCH, INC. |
SUZANNE DEW |
| K083794 |
12/22/2008 |
MECC SET WITH BIOLINE COATING |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K080470 |
02/21/2008 |
ROTA FLOW CENTRIFUGAL PUMP WITH BIOLINE COATING, MODELS BE-RF-32, BEQ-RF-32 |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWEKGLENKS |
| K080506 |
02/25/2008 |
MARTIN CHAIR, MODEL C4S1 |
MARTIN MANUFACTURING CO., LLC |
MICHAEL ZAPATA, III |
| K083719 |
12/15/2008 |
LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K083622 |
12/08/2008 |
LNCS OXIMETRY SENSORS |
MASIMO CORPORATION |
MARGUERITE THOMLINSON |
| K083872 |
12/29/2008 |
IMNS MEDACTA NAVIGATION SYSTEM |
MEDACTA INTERNATIONAL, SA |
NATLIE J KENNEL |
| K083558 |
12/02/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - QUADRA C |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K083862 |
12/29/2008 |
MEDAPPS 2.0 REMOTE PATIENT MONITORING SYSTEM |
MEDAPPS, INC. |
KENT DICKS |
| K080544 |
02/27/2008 |
UNASSIGNED |
MEDCOMP |
JEAN CALLOW |
| K083765 |
12/18/2008 |
MAXGUARD ADVANCED LUER ACTIVATED DEVICE WITH ANTIMICROBIAL |
MEDEGEN MEDICAL MANUFACTURING SERVICES |
MATTHEW FRIED |
| K080357 |
02/11/2008 |
MEDELA INVIA WOUND THERAPY |
MEDELA AG |
BRUNO GRETLER |
| K083802 |
12/22/2008 |
SONOTIP II 25-GAUGE ULTRASOUND NEEDLE SYSTEM, MODELS GUS-01-18-025 AND GUS-01-27-025 |
MEDI-GLOBE CORPORATION |
SCOTT KARLER |
| K080404 |
02/14/2008 |
EASYQC - CHEMISTRY WITH ELECTROLYTES; CHEMISTRY; ELECTROLYTES KIT; CHEMISTRY CALIBRATOR, CREA-U CLAIBRATOR |
MEDICA CORP. |
Photios Makris |
| K080391 |
02/13/2008 |
DRIVE SOLSTICE OXYGEN CONCENTRATOR |
MEDICAL DEPOT |
ARTHUR WARD |
| K083658 |
12/10/2008 |
PACS PLUS 5TH EDITION |
MEDICAL STANDARD CO., LTD. |
BRANDON CHOI |
| K083803 |
12/22/2008 |
FIXIT HEADREST CLAMP SYSTEM |
MEDICON, E.G. |
JOACHIM SCHMID |
| K083798 |
12/22/2008 |
IMPIX ALIF LUMBAR IBF, IMPIX ALIF-D LUMBAR IBF, IMPIX TLIF LUMBAR IBF |
MEDICREA TECHNOLOGIES |
DONALD GUTHNER |
| K083810 |
12/22/2008 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K080473 |
02/21/2008 |
EMBRYOASSIST AND EMBRYOASSIST WITH PHENOL RED |
MEDICULT A/S |
RONALD G LEONARDI |
| K080297 |
02/04/2008 |
MEDRAD INTEGO PET INFUSION SYSTEM |
MEDRAD, INC. |
TROY A JACK |
| K083792 |
12/19/2008 |
WEDGELOC SUTURE ANCHOR WITH OPTI-FIBER SUTURES, MODEL 1000-01-055 |
MEDSHAPE SOLUTIONS |
JACK GRIFFIS |
| K080339 |
02/08/2008 |
MEDSOURCE ENDOTRACHEAL TUBE (WITH AND WITHOUT CUFF) |
MEDSOURCE INTERNATIONAL, LLC. |
HOWARD T COOPER |
| K080334 |
02/07/2008 |
INSTARAD |
MEDSPHERE TECHNOLOGIES PVT LTD. |
CARL ALLETTO |
| K083735 |
12/16/2008 |
ANSHA AUTONOMIC NERVOUS SYSTEM HEALTH ASSESSMENT PLUS |
MEDTECHS, LLC |
MEGHAN ATH |
| K080428 |
02/19/2008 |
ATTAIN COMMAND 6250 LEFT HEART DELIVERY SYSTEMS AND ATTAIN COMMAND 6250 GUIDE CATHETERS FOR LEFT HEART DELIVERY |
MEDTRONIC INC. |
MARLENE PETERSON |
| K080509 |
02/25/2008 |
CARDIOBLATE 68000 GNERATOR, BP2 SURGICAL ABLATION DEVICE, LP SURGICAL ABLATION DEVICE, GEMINI-SSURGICAL ABLATION DEVICE |
MEDTRONIC INC. |
PREETI JAIN |
| K080462 |
02/20/2008 |
PROGENIX DBM PUTTY |
MEDTRONIC SOFAMOR DANEK |
MICHELLE OBENAUER |
| K080429 |
02/19/2008 |
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LILA JOE |
| K080288 |
02/04/2008 |
TRAVEL PAL FOUR WHEEL SCOOTER, MODEL MM114 |
MEGA MOTION, INC. |
TOM AMICO |
| K080303 |
02/05/2008 |
EZ REGULAR |
MEINNTECH CO., LTD. |
DANIEL KAMM |
| K083702 |
12/15/2008 |
TRACH-ASSIST |
MERGENET MEDICAL |
PAUL DRYDEN |
| K083576 |
12/03/2008 |
MISER CONTRAST MANAGEMENT SYSTEM |
MERIT MEDICAL SYSTEMS, INC. |
STEPHANIE ERSKINE |
| K080556 |
02/28/2008 |
ARTBLOC TEMP, DIMENSION: 15.5 X19.39 MM V-CLASSIC SHADES AND BLEACH SHADES |
MERZ DENTAL GMBH |
RICHARD G HUNTER, M.S., RAC |
| K080305 |
02/05/2008 |
NEXCOMP AND META ETCHANT |
META BIOMED CO., LTD. |
TAE-HOON KIM |
| K080512 |
02/25/2008 |
REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT |
METRO OPTICS OF AUSTIN, INC. |
MARTIN DALSING |
| K080337 |
02/08/2008 |
MICROLIFE UPPER ARM AUTOMATIC DIGITAL BLOOD PRESSURE MONITOR, MODEL BP3MQ1-2D |
MICROLIFE CORP. |
SUSAN D GOLDSTEIN-FALK |
| K083691 |
12/12/2008 |
BONEVUE |
MICROMRI, INC. |
RICHARD ELRATH |
| K083922 |
12/31/2008 |
MICRUS MICROCATHETER, COURIER FLEX, MODEL MSF 170000-00 |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K080437 |
02/15/2008 |
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 CERECYTE, MODEL CDF |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K080379 |
02/13/2008 |
MICRUS MICROCOIL SYSTEM, DELTAPAQ 10 STRETCH RESISTANT |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K083646 |
12/09/2008 |
MICRUS MICROCOLI SYSTEM, DELTAPLUSH, MODELS CPL, DPL |
MICRUS ENDOVASCULAR CORPORATION |
PATRICK LEE |
| K083659 |
12/10/2008 |
SILVER WOUND PAD |
MILLIKEN & CO. |
MARY MCNAMARA-CULLINANE |
| K083796 |
12/22/2008 |
MILTEX ASPIRATING SYRINGE, MILTEX PETITE ASPIRATING SYRINGE, MILTEX SELF-ASPIRATING SYRINGE, MILTEX LIGHTWEIGHT |
MILTEX, INC. |
JENNIFER J BOSLEY |
| K083754 |
12/17/2008 |
MINI LAP ELECTROCAUTERY INSTRUMENTS |
MINI LAP TECHNOLOGIES INC. |
JOSEPH AZARY |
| K080393 |
02/13/2008 |
MODIFICATION TO REBOUND HRD |
MINNESOTA MEDICAL DEVELOPMENT, INC. |
JULIE BULVER |
| K080550 |
02/28/2008 |
MEGACHANNEL ENDOSCOPIC OVERTUBE, MODEL OT22 |
MINOS MEDICAL |
TOM COLONNA |
| K080458 |
02/20/2008 |
MIS CREST WIDENER |
MIS - IMPLANT TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K080328 |
02/07/2008 |
MPS ACACIA ENTERAL FEEDING TUBE |
MPS ACACIA |
FERGIE FERGUSON |
| K083685 |
12/12/2008 |
ENDOVIVE LOW PROFILE REPLACEMENT GASTROSTOMY TUBE, MODEL 82XX, 8283, 8284, 8285 |
MRI MANUFACTURING AND RESEARCH, INC. |
SUZANNE DEW |
| K083840 |
12/24/2008 |
MSI MEDSERV INTERNATIONAL-RIGID ENDOSCOPE |
MSI MEDSERV INTERNATIONAL DEUTSCHLAND GMBH |
CHRISTINE STROBEL |
| K083662 |
12/10/2008 |
CRITICOOL |
MTRE ADVANCED TECHNOLOGY LTD. |
IFAT OREN |
| K080399 |
02/14/2008 |
DBX DEMINERALIZED BONE MATRIX PUTTY, DBX DEMINERALIZED BONE MATRIX PASTE |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY B JOY |
| K080405 |
02/14/2008 |
SYGNAL DBM |
MUSCULOSKELETAL TRANSPLANT FOUNDATION |
NANCY BENNEWITZ JOY |
| K080320 |
02/06/2008 |
PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 |
NDS SURGICAL IMAGING |
JIM LANG |
| K083916 |
12/30/2008 |
LCD3090WQXI OR MD304MC 29.8 INCH DIAGNOSTIC IMAGING LCD MONITOR, MODEL L307TD |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K083907 |
12/30/2008 |
MD212MC 21.3 DIAGNOSTIC IMAGING LCD MONITOR-L217TG |
NEC DISPLAY SOLUTIONS, LTD. |
ANGUS HSU |
| K083561 |
12/02/2008 |
NEOSS PROACTIVE IMPLANT |
NEOSS, LTD. |
CHERITA JAMES |
| K083603 |
12/05/2008 |
I-PORTAL 4D VIDEO OCULOGRAPHY EYE TRACKING SYSTEM (VOG), I-PORTAL VIDEO NYSTAGMOGRAPHY SYSTEM (VNG), I-PORTAL NEURO OTOL |
NEURO KINETICS |
Aura Kullmann |
| K080261 |
02/01/2008 |
IMPULSE IQ ADJUSTING INSTRUMENT |
NEUROMECHANICAL INNOVATIONS, LLC |
CHRISTOPHER J COLLOCA |
| K083818 |
12/22/2008 |
UNIVERSAL ELECTRODES |
NEUROMETRIX, INC. |
RAINER MAAS |
| K083877 |
12/29/2008 |
FLYING DIAGNOSTIC ULTRASOUND SYSTEM |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
| K080540 |
02/27/2008 |
NEUSOFT SPIRAL CT SCANNER SYSTEM, MODEL NEUVIZ VERSION 2.0 |
NEUSOFT MEDICAL SYSTEMS CO., LTD. |
TIAN YANFANG |
| K080342 |
02/08/2008 |
NIHON KOHDEN BEDSIDE MONITOR, MODEL BSM-6000S SERIES |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K080546 |
02/28/2008 |
NIHON KOHDEN EEG-1200A SERIES NEUROFAX, MODEL EEG-1200A |
NIHON KOHDEN AMERICA, INC. |
JACK COGGAN |
| K083578 |
12/03/2008 |
NORAS CPC MULTIFUNCTIONAL COIL |
NORAS MRI PRODUCTS GMBH |
ZAHED SEDIGHIANI |
| K080515 |
02/25/2008 |
FMRI HARDWARE SYSTEM |
NORDICNEUROLAB |
STIAN SCISLY SAGEVIK |
| K083583 |
12/04/2008 |
XPRESSE INJECTION SYSTEM |
NORDSON EFD |
JEFF PEMBROKE |
| K080438 |
02/19/2008 |
DENTAL UNIT WITH CHAIR |
NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. |
DIANA HONG |
| K080365 |
02/11/2008 |
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR |
NOUVAG AG |
ERICH FORSTER |
| K080340 |
02/08/2008 |
COMPAT DUALFLO ENTERAL DELIVERY PUMP SET WITH SPIKERIGHT PIERCING SPIKE AND 1000 ML WAER BAG |
NOVARTIS NUTRITION CORP. |
THOMAS A DOLD |
| DEN080015 |
12/24/2008 |
NUCLEUS-X PTV CATHETER |
NUMED, INC. |
NICHELLE LAFLESH |
| K083594 |
12/05/2008 |
EZ HSG CATHETER.FOAMSEAL CATHETER |
OBG PRODUCTS |
AL MUZZAMMEL |
| K080435 |
02/19/2008 |
OLYMPUS DIRECT BILIRUBIN REAGENT, MODEL OSR6X181 |
OLYMPUS LIFE SCIENCE RESEARCH EUROPA GMBH (EUROPA) |
STEPHANIE G DONNELLY |
| K080403 |
02/14/2008 |
XTJF TYPE Q160VF1 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
LAURA STORM-TYLER |
| K080289 |
02/04/2008 |
1500 PRO |
OMRON HEALTHCARE, INC. |
PAUL DRYDEN |
| K080376 |
02/12/2008 |
ONCOBIONIC SYSTEM |
ONCOBIONIC INCORPORATED |
PAUL MIKUS |
| K080460 |
02/20/2008 |
SPECTRAL OCT/SLO |
OPKO HEALTH, INC. |
JANE HSIAO |
| K083680 |
12/12/2008 |
VITROS CHEMISTRY PRODUCTS K+DT SLIDES: VITROS CHEMISTRY PRODUCTS DT CALIBRATOR KIT, MODEL K+DT SLIDES: 153 2258 |
Ortho-Clinical Diagnostics, Inc. |
MARLENE A HANNA |
| K083726 |
12/15/2008 |
PEDINAIL INTRAMEDULLARY NAILING SYSTEM |
ORTHOPEDIATRICS, CORP. |
GARY BARNETT |
| K083830 |
12/23/2008 |
OSCAR BONE RESECTOR |
ORTHOSONICS, LTD. |
MICHAEL J YOUNG |
| K083633 |
12/08/2008 |
HS II SHORT FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K080387 |
02/13/2008 |
HU II / HS II FIXTURE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MIN JOO KIM |
| K080511 |
02/25/2008 |
PLEXUR-P |
OSTEOTECH, INC. |
CHRIS TALBOT |
| K083618 |
12/08/2008 |
PACS SCAN |
PACSGEAR, INC. |
IAN GORDON |
| K083745 |
12/16/2008 |
THE IC-PRO SYSTEM, MODEL VERSION 3.2 |
PAIEON, INC. |
SHAHAR MANDELBOIM |
| K083900 |
12/29/2008 |
ERBIUM FRACTIONAL HANDPIECE |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K080567 |
02/29/2008 |
PALOMAR ASPIRE LASER PLATFORM |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K083619 |
12/08/2008 |
PARCUS TINTANIUM INTERFERENCE SCREW, MODELS: 10001-10012, 10014-10016, 10018-10020 |
PARCUS MEDICAL, LLC |
BARTON BRACY |
| K080549 |
02/27/2008 |
DURAFINISH ALL-CURE, MODEL S296 |
PARKELL, INC. |
DANIEL R SCHECHTER, ESQ |
| K083616 |
12/08/2008 |
PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS |
PATHOLASE, INC |
ANNE WORDEN |
| K083837 |
12/23/2008 |
JETSTREAM G2 SYSTEM, MODELS PV20300 (JETSTREAM G2 CATHETER AND CONTROL POD); PVCN100 (PV CONSOLE) |
PATHWAY MEDICAL TECHNOLOGIES, INC. |
BRIAN CLEARY |
| K083842 |
12/24/2008 |
ROTEM DELTA THROMBOELASTOMETRY SYSTEM |
PENTAPHARM GMBH |
VOLKER JOACHIM FRIEMERT |
| K083873 |
12/29/2008 |
PICC (CT RATED AND NON-RATED) |
PFM MEDICAL, INC |
SALVADORE PALOMARES |
| K080461 |
02/20/2008 |
STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0 |
PHILIPS MEDICAL SYSTEMS |
ZETY BILLARD |
| K080495 |
02/22/2008 |
SURESIGNS VM SERIES PATIENT MONITOR, MODELS VM4, VM6, VM8, VM3 AND VS3 |
PHILIPS MEDICAL SYSTEMS |
MARY KRUITWAGEN |
| K083740 |
12/16/2008 |
MAMMODIAGNOST VU |
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. |
LYNN HARMER |
| K080548 |
02/28/2008 |
HD7 DIAGNOSTIC ULTRASOUND SYSTEM |
PHILLIPS MEDICAL SYSTEMS |
NANCY BURKE |
| K083663 |
12/10/2008 |
PACP |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN GILBERT |
| K080504 |
02/25/2008 |
PIONEER LOWTOP SPINAL ROD SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K080518 |
02/25/2008 |
PIONEER SURGICAL TECHNOLOGY QUANTUM SPINAL SYSTEM |
PIONEER SURGICAL TECHNOLOGY |
JONATHAN M GILBERT |
| K083621 |
12/08/2008 |
MEDPOR CUSTOMIZED SURGICAL IMPLANT |
POREX SURGICAL, INC. |
JERRI L MANN |
| K083695 |
12/15/2008 |
TRAXODENT |
PREMIER DENTAL PRODUCTS CO. |
VINCENT D'ALESSANDRO |
| K080432 |
02/19/2008 |
MAPERSOL |
PRESERVATION SOLUTIONS, INC. |
NEIL BURRIS |
| K083746 |
12/17/2008 |
BIOSIGN FLU A+B |
PRINCETON BIOMEDITECH CORP. |
KYUNG-AH KIM |
| K083688 |
12/12/2008 |
PULMONETIC SYSTEMS LTV 1200 MR CONDITIONAL VENTILATOR |
PULMONETIC SYSTEMS, INC. |
ROBERT C SAMEC |
| K083883 |
12/29/2008 |
CHARTIS CATHETER |
PULMONX, INC. |
Roberta Hines |
| K083571 |
12/03/2008 |
ILLUSION POWDER FREE EXAM GLOVES, NATURAL COLOR WITH VANILLA SCENT, ORANGE COLOR WITH CITRIC SCENT AND PINK COLOR |
PURNABINA SDN BHD |
ROBERT HILL |
| K083749 |
12/17/2008 |
CARDIOVIEW32 REVIEW MODULE |
QRS DIAGNOSTIC, LLC. |
MARY KAY JENSEN |
| K083613 |
12/08/2008 |
QUANTA SYSTEM POLYSURGE DIODE LASER FAMILY |
QUANTA SYSTEM, S.P.A. |
ISABELLA CARRER |
| K080455 |
02/20/2008 |
RAPIDSENSE DRUGS OF ABUSE METHAMPHETAMINE (MET) 1000 DEVICE, MODEL 900-0050 |
QUANTRX BIOMEDICAL CORPORATION |
NATALIE J KENNEL |
| K080436 |
02/19/2008 |
RAPIDSENSE DRUGS OF ABUSE COCAINE (COC) 300 DEVICE, MODEL 900-0052 |
QUANTRX BIOMEDICAL CORPORATION |
NATALIE J KENNEL |
| K080431 |
02/19/2008 |
RAPIDSENSE DRUGS OF ABUSE PHENCYCLIDINE (PCP) 25 DEVICE WITH MODELS 900-0054 |
QUANTRX BIOMEDICAL CORPORATION |
NATALIE J KENNEL |
| K083931 |
12/05/2008 |
SYNTHETIC POWDER-FREE EXAM VINYL GLOVES, YELLOW/WHITE |
QUANTUM CO., LTD. |
LIJUAN WANG |
| K083600 |
12/05/2008 |
VINYL EXAMINATION GLOVE, POWDER-FREE, CLEAR (NON-COLORED) |
QUANTUM CO., LTD. |
LIJUAN WANG |
| K080381 |
02/13/2008 |
QUEST DIAGNOSTICS METHAMPHETAMINE MICRO-PLATE EIA |
QUEST DIAGNOSTICS, INC. |
LIUMING YU |
| K083878 |
12/29/2008 |
LUPOTEK CORRECTIN VL, LUPOTEK DETECTIN VL, PLASMACON LA |
R2 DIAGNOSTICS, INC. |
MARC D GOLDFORD |
| K083763 |
12/18/2008 |
ZEUS CT PICC 4 FR AND 5 FR SINGLE AND DUAL LUMEN |
R4 VASCULAR, INC. |
LAURIE LEWANDOWSKI |
| K080307 |
02/05/2008 |
PROCHEM INDICATOR TAPE |
RAVEN LABORATORIES |
WENDY ROYALTY-HANN |
| K080418 |
02/15/2008 |
REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST |
REGENERATION TECHNOLOGIES, INC. |
TRAVIS AROLA |
| K083856 |
12/24/2008 |
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND CURVED INSTRUMENT SET, MODELS: FG0018, FG0026 |
RELIEVANT MEDSYSTEMS, INC. |
Mark Smutka |
| K080516 |
02/25/2008 |
LAMIN AIR |
REMGENIC LLC |
PAUL DRYDEN |
| K083575 |
12/03/2008 |
APNEALINK PLUS, MODEL: 22328 |
RESMED GERMANY INC. |
DAVID D'CRUZ |
| K083816 |
12/22/2008 |
RES TRAXX ONLINE, MODEL: R14 |
RESMED LTD. |
DAVID D'CRUZ |
| K083874 |
12/29/2008 |
GALAXY |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ANDREW P ZELTWANGER |
| K083721 |
12/15/2008 |
MODIFICATION TO ZENIEVA |
RIVER'S EDGE PHARMACEUTICALS, LLC |
SANDRA R KIRCUS |
| K083655 |
12/10/2008 |
ELECSYS TOXO IGG CALCHECK |
Roche Diagnostics |
KELLY FRENCH |
| K083764 |
12/18/2008 |
AMPHETAMINES II |
ROCHE DIAGNOSTICS CORP. |
MICHELLE NEFF |
| K083847 |
12/24/2008 |
MARVEL PEDIATRIC WHEELCHAIR |
ROGUE WHEELCHAIRS INC |
KATHRYN RONALDS |
| K083766 |
12/18/2008 |
PHOGLASS CEM |
S & C POLYMER GMBH |
CHRISTIAN BOETTCHER |
| K083901 |
12/29/2008 |
NAVI ROOT |
S-DENTI CO., LTD. |
Kevin Walls |
| K080375 |
02/12/2008 |
RMX PHYSIOLOGICAL DATA RECORDER |
S.L.P. LTD. |
NOAM HADAS |
| K080380 |
02/13/2008 |
SAS INFLUENZA A & B TEST |
SA SCIENTIFIC, INC. |
ROBBI PERRY |
| K083556 |
12/02/2008 |
MODIFICATION TO AUTO-BAND LIGATOR |
SCANDIMED INTERNATIONAL |
STEPHEN M PAGE |
| K083553 |
12/01/2008 |
NASO-LARYNGO-PHARYNGOSCOPE |
SCHOELLY IMAGING, INC. |
F. DAVID ROTHKOPF |
| K080526 |
02/26/2008 |
SIERRA SYSTEM |
SEASPINE, INC. |
ETHEL BERNAL |
| K080472 |
02/21/2008 |
SEDAT MYSHELL LITE |
SEDAT |
LAETITIA COUSIN |
| K083756 |
12/17/2008 |
GUARDIAN 150 ELECTRODE |
SELECTIVE MED COMPONENTS, INC. |
JAY MANSOUR |
| K080370 |
02/12/2008 |
ABL 80 CO-OX SYSTEM |
SENDX MEDICAL, INC. |
MARK A DZENDZEL |
| K083602 |
12/05/2008 |
KAPPA LIGHT CHAINS |
SENTINEL CH. SpA |
YANGTSE PORTELLES |
| K083601 |
12/05/2008 |
LAMBDA LIGHT CHAINS |
SENTINEL CH. SpA |
YANGTSE PORTELLES |
| K080364 |
02/11/2008 |
FINDRWIRZ GUIDE WIRE SYSTEM |
SENTREHEART INC. |
LINDA GUTHRIE |
| K080442 |
02/19/2008 |
SERISCAFFOLD SURGICAL MESH |
SERICA TECHNOLOGIES, INC. |
CONNIE H GARRISON |
| K080412 |
02/15/2008 |
ABSORBABLE SYNTHETIC SUTURE WITH NEEDLE ATTACHMENT (PGA BRAIDED) |
SHANGHAI PUDONG JINHUAN MEDICAL PRODUCTS CO., LTD. |
BRANDON CHOI |
| K080517 |
02/25/2008 |
RESICEM |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K080398 |
02/13/2008 |
SI JOINT FUSION SYSTEM |
SI-BONE, INC. |
JEFFERY DUNN |
| K080520 |
02/25/2008 |
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K083755 |
12/17/2008 |
NON-STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, LAVENDER BLUE COLOR, POLYMER COATED, TEXTED WITH CHEMOTHERAPY DRUGS |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K083844 |
12/24/2008 |
ADVIA CENTAUR TSH3-ULTRA METHOD |
SIEMENS HEALTHCARE DIAGNOSTICS |
Ernest Joseph |
| K083906 |
12/30/2008 |
ADVIA CHEMISTRY CYSTATIN C REAGENT, ADVIA CHEMISTRY CYSTATIN C CALIBRATOR, MODELS P/N 04851534, P/N 10376487 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K083579 |
12/04/2008 |
DIMENSION VISTA SYSTEM ENZYME 6 CALIBRATOR, MODEL KC360 |
SIEMENS HEALTHCARE DIAGNOSTICS |
VICTOR M CARRIO |
| K083853 |
12/24/2008 |
IMMULITE 2000 3GALLERGY SPECIFIC IGE ASSAY KIT |
SIEMENS HEALTHCARE DIAGNOSTICS |
CLARE SANTULLI |
| K083852 |
12/24/2008 |
BIOGRAPH 16 TRUE POINT SYSTEMS |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
ALAINE MEDIO |
| K080349 |
02/11/2008 |
KIMBA MINI |
SIGNUS MEDIZINTECHNIK GMBH |
ALAN ALEXANDER |
| K083569 |
12/03/2008 |
SURGYBONE |
SILFRADENT S.R.L. |
CLAUDE D BERTHOIN |
| K083886 |
12/29/2008 |
SIMPLER MINI IMPLANT, MODELS SM 5002, SM 5003, SM 5004 |
SIMPLER ONE STOP |
HAROLD BERGMAN |
| K083635 |
12/08/2008 |
SMITH & NEPHEW BIOSURE PK INTERFERENCE SCREW |
SMITH & NEPHEW ENDOSCOPY, INC. |
CHRISTINA FLORES |
| K080358 |
02/11/2008 |
PLLA, HA SCREW |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
DEANA BOUSHELL |
| K083762 |
12/18/2008 |
BIOLOX DELTA CERAMIC FEMORAL HEADS |
SMITH & NEPHEW, INC. |
MANDY COE |
| K080434 |
02/19/2008 |
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW |
SMITH & NEPHEW, INC. |
ELIZABETH MILLER |
| K083565 |
12/03/2008 |
PIGALILEO TOTAL HIP REPLACEMENT (THR) SOFTWARE APPLICATION V3.0 |
SMITH & NEPHEW, INC. |
GINO ROUSS |
| K083566 |
12/03/2008 |
R3 CONSTRAINED LINER, CONSTRAINED LINER |
SMITH & NEPHEW, INC. |
JASON SELLS |
| K083641 |
12/09/2008 |
BIVONA TRACHEOSTOMY TUBES |
SMITHS MEDICAL ASD, INC. |
DANIEL COATES |
| K083787 |
12/19/2008 |
BCI WW1000 PULSE OXIMETER, MODEL WW1000 |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
| K083705 |
12/15/2008 |
BCI WW1020 PULSE OXIMETER, MODEL WW1020 |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
| K083557 |
12/02/2008 |
BCI WW1030 PULSE OXIMETER |
SMITHS MEDICAL PM, INC. |
DONALD ALEXANDER |
| K080321 |
02/06/2008 |
SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM |
SNAP LABORATORIES, L.L.C. |
GIL RAVIV |
| K083597 |
12/05/2008 |
SONOWAND INVITE |
SONOWAND AS |
CONSTANCE G BUNDY |
| K080314 |
02/06/2008 |
SPINAL USA INTERBODY FUSION DEVICE |
SPINAL USA |
JEFFREY JOHNSON |
| K083743 |
12/16/2008 |
CAPSURE PS SYSTEM |
SPINE WAVE, INC. |
ROAIDA RIZKALLAH |
| K083835 |
12/23/2008 |
ATTUNE ADJUSTABLE FLEXIBLE ANNULOPLASTY RING MODEL AFR |
ST. JUDE MEDICAL |
WILLIAM MCKELVEY |
| K080292 |
02/04/2008 |
EPICOR ABLATION SYSTEM |
ST. JUDE MEDICAL |
KAREN J MCKELVEY |
| K083577 |
12/03/2008 |
HARMONIE SYSTEM |
STELLATE SYSTEMS |
GOLDY SINGH |
| K083636 |
12/09/2008 |
REPROCESSED EXTERNAL FIXATION DEVICE |
STERILMED, INC. |
GARRETT AHLBORG |
| K080420 |
02/15/2008 |
RESERT XL HLD HIGH LEVEL DISINFECTANT |
STERIS Corporation |
JOHN R SCOVILLE JR. |
| K083643 |
12/09/2008 |
VERIFY 275F GRAVITY INDICATORS |
STERIS Corporation |
JOHN ROBERT SCOVILLE, JR. |
| K083665 |
12/10/2008 |
VERIFY SCBI 275F 3-10 |
STERIS Corporation |
JOHN ROBERT SCOVILLE, JR. |
| K083650 |
12/09/2008 |
EMU-GRAPH 4 EMULATOR, MODEL CI 144 |
STERITEC PRODUCTS, INC. |
LINDA NELSON |
| K080430 |
02/19/2008 |
STOMA BONE BLOCK SCREW |
STORZ AM MARK GMBH |
FRANZ MENEAN |
| K080286 |
02/04/2008 |
CEMENTABLE ABUNTMENTS; TEMPORARY COPINGS; PROTECTIVE CAPS |
STRAUMANN USA |
ELAINE ALAN |
| K083550 |
12/01/2008 |
STRAUMANN DENTAL IMPLANT SYSTEM |
STRAUMANN USA |
ELAINE ALAN |
| K083926 |
12/31/2008 |
CD4 COUNT |
Streck |
KERRIE OETTER |
| K080552 |
02/28/2008 |
CYTO-CHEX BCT |
Streck |
CARL THOMPSON |
| K083661 |
12/10/2008 |
AVS TL PEEK SPACERS |
STRYKER CORP. |
KIMBERLY LANE |
| K080450 |
02/19/2008 |
STRYKER POWER TOOL NAVIGATOR ATTACHMENT |
STRYKER CORP. |
BECKY DITTY |
| K083562 |
12/02/2008 |
STRYKER SPINE NULOCK ANTERIOR CERVICAL PLATING SYSTEM |
STRYKER CORP. |
KIMBERLY LANE |
| K083917 |
12/30/2008 |
X-RAY, TOMOGRAPHY, COMPUTED, DENTAL |
SUNI MEDICAL IMAGING, INC. |
AL BETTENCOURT |
| K080271 |
02/01/2008 |
INREACH SYSTEM |
SUPERDIMENSION, LTD. |
JONATHAN KOVACH |
| K083781 |
12/19/2008 |
EEA HEMORRHOID STAPLER & ACCESSORIES |
SURGICAL DEVICES, A GLOBAL BUSINESS UNIT COVIDIEN |
FRANK GIANELLI |
| K083582 |
12/04/2008 |
SIGN HIP CONSTRUCT (SHC), MODEL: 701 |
SURGICAL IMPLANT GENERATION NETWORK (SIGN) |
DOUGLAS J DONNELLY |
| K080447 |
02/19/2008 |
SURGICRAFT SCREW FIXATION SYSTEM |
SURGICRAFT LTD. |
DONALD W GUTHNER |
| K083817 |
12/22/2008 |
M. DIOR BRAND |
SUZHOU COLOUR-WAY ENTERPRISE DEVELOPMENT CO., LTD. |
CHU XIAOAN |
| K083921 |
12/31/2008 |
SYNERGEYES SIG (PETRAFOCON A HEM-LARAFILCON A) HYBRID CONTACT LENS |
Synergeyes, Inc. |
RICHARD E LIPPMAN |
| K080317 |
02/06/2008 |
ENOLOK-FOR ENDOSCOPED WITH 12.8>DIA.<13.3MM SHAFT DIAMETER, MODEL AEL; ENDOSCOPES WITH 11.3>DIA. 11.5MM SHAFT ,MODEL PEL |
SYNTHEON LLC |
AL WEISENBORN |
| K083694 |
12/12/2008 |
SYNTHES (USA) 2.4 MM VA-LCP TWO COLUMN VOLAR DISTAL RADIUS PLATES |
SYNTHES (USA) |
SHERI L MUSGUNG |
| K083573 |
12/03/2008 |
SYNTHES (USA) 3.5MM LOCKING ATTACHMENT PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K080522 |
02/26/2008 |
SYNTHES 3.5 MM LCP DISTAL TIBIA T PLATES |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K080331 |
02/06/2008 |
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K083664 |
12/10/2008 |
FORA TD-4245 BLOOD GLUCOSE MONITORING SYSTEM, TD-4245 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K080283 |
02/04/2008 |
IDEAL LIFE GLUCO-MANAGER GMM 0001 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
Yuhua Chen |
| K080501 |
02/25/2008 |
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K083570 |
12/03/2008 |
U-RIGHT TD-4249/U-RIGHT TD-4250 BLOOD GLUCOSE MONITORING SYSTEM |
TaiDoc Technology Corporation |
SOPHIE LIN |
| K080347 |
02/08/2008 |
UNISCAN -DOA SYSTEM |
TAIWAN UNISON BIOTECH, INC. |
KUANG-PIN HSIUNG |
| K083614 |
12/08/2008 |
SONOLITH I-SYS LITHOTRIPER |
TECHNOMED MEDICAL SYSTEMS, SA |
LYNETTE L HOWARD |
| K083898 |
12/29/2008 |
SURGIMEND |
TEI BIOSCIENCES INC. |
KENNETH JAMES |
| K083630 |
12/08/2008 |
CLUE MEDICAL AND CLUE MEDICAL BASIC |
TELOVITAL GMBH TELEMEDIZIN |
CHERITA JAMES |
| K083747 |
12/17/2008 |
TERUMO PALL AL3X ARTERIAL FILTER |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K083834 |
12/23/2008 |
TERUMO PALL AL6X ARTERIAL FILTER |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
EILEEN DORSEY |
| K080415 |
02/14/2008 |
DEVICE MODIFICATION TO PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K080563 |
02/28/2008 |
RUNTHROUGH NS EXTENSION WIRE |
TERUMO MEDICAL CORP. |
MARK UNTERREINER |
| K080384 |
02/13/2008 |
HUMAN CYSTATIN C KIT FOR USE ON MODULAR P ANALYSER |
THE BINDING SITE, LTD. |
JAY H GELLER |
| K083758 |
12/17/2008 |
SENSORY NERVE ELECTRODES-TWO FINGER RINGS, STIMULATOR PROBE ELECTRODES-FACIAL, MONO, BI- & TRIPOLAR NERVE STIMULATORS |
THE ELECTRODE STORE, INC. |
CARL YOUNGMANN |
| K080499 |
02/25/2008 |
MAGSTIM DOUBLE 70MM AIR FILM COIL, MODEL 3910-00 |
THE MAGSTIM COMPANY LTD. |
ANWEN EVANS |
| K083620 |
12/08/2008 |
SOMNOLYZER 24X7 |
THE SIESTA GROUP NORTH AMERICA |
ZVI LADIN |
| K083863 |
12/29/2008 |
THEKEN ATOLL OCT SPINAL SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K083710 |
12/15/2008 |
RETRACTOR LITE |
THOMAS SURGICAL INSTRUMENTS, INC. |
STEPHANIE A ZALUCHA |
| K080274 |
02/01/2008 |
AMBULO 2400 |
TIBA MEDICAL, INC. |
MERAT BAGHA |
| K083714 |
12/15/2008 |
ENDOSKELETON TT INTERBODY FUSION DEVICE (IBD) |
TITAN SPINE, LLC |
RICHARD JANSEN |
| K080335 |
02/07/2008 |
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
TORNIER, INC. |
Howard Schrayer |
| K083828 |
12/23/2008 |
SLEUTH AT IMPLANTABLE CARDIAC MONITORING SYSTEM -6 CM AND 8CM ANTENNA, PERSONAL DIAGNOSTICS MANAGER (PDM) ACCESSORY KIT |
TRANSOMA |
LISA STONE |
| K080527 |
02/26/2008 |
TWINGUARD WITH CAPNOGRAPH ACCESSORY |
TRAWAX PTY LIMITED |
CINDY MARTIN |
| K083606 |
12/05/2008 |
SENSITITRE 18-24 HOUR SUSECEPTIBILITY PLATES |
TREK DIAGNOSTIC SYSTEMS, INC. |
CYNTHIA C KNAPP |
| K083912 |
12/30/2008 |
TREU; BONE SCREWS, SCHANZ SCREWS, KIRSCHNER WIRES, STEINMANN PINS, LARSEN PINS |
TREU-INSTRUMENTE GMBH |
FRANZ MENEAN |
| K080448 |
02/19/2008 |
CENTURION PROTECTIVE RESTRAINT, SCR SERIES |
TRI-STATE HOSPITAL SUPPLY CORP. |
MATTHEW K PRICE |
| K080524 |
02/26/2008 |
CENTURION SORBAVIEW OTC |
TRI-STATE HOSPITAL SUPPLY CORP. |
MATTHEW K PRICE |
| K083896 |
12/29/2008 |
DESTINY MAX COAGULATION ANALYZER |
TRINITY BIOTECH |
Bonnie B DeJoy |
| K083647 |
12/09/2008 |
VALO, MODEL 5919 |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K080532 |
02/26/2008 |
BENACEL, MODELS C-001, C-002 AND C-005 |
UNICARE BIOMEDICAL, INC. |
STAN YANG |
| K080551 |
02/28/2008 |
UNIVERSITY HEALTH CARE PROCESSED ALTERNATING LEG PRESSURE (UHC APL) SLEEVE DEVICE |
UNIVERSITY OF UTAH HOSPITALS AND CLINICS |
BRENT ALM |
| K083679 |
12/11/2008 |
UROVAL BRS SYSTEM, MODEL BRS01; TELESIS, MODEL PROMO1 |
UROVAL |
SHARON IVERSON |
| K083784 |
12/19/2008 |
PRONTO V3 EXTRACTION CENTER, MODEL 5003, PRONTO LP EXTRACTION CATHETER, MODEL 5010, SKYWAY RX SUPPORT CATHETER, |
VASCULAR SOLUTIONS, INC. |
CHARMAINE SUTTON |
| K083820 |
12/22/2008 |
VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C |
VASOMEDICAL, INC. |
MELISSA PURPURA |
| K083920 |
12/31/2008 |
FLOWPICC CATHETER |
VASONOVA INC. |
KIM TOMPKINS |
| K080265 |
02/01/2008 |
DENFIL ETCHANT-37 |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| K080266 |
02/01/2008 |
WELL-PEX |
VERICOM CO., LTD. |
MYUNG-HWAN OH |
| K083704 |
12/15/2008 |
NUTRAC PELVATOR, MODEL PEL 200 |
VERITY SCIENTIFIC LTD. |
BRENT REIDER |
| K080510 |
02/25/2008 |
VIP PULMONARY FUNCTION SYSTEM |
VIASYS HEALTHCARE GMBH |
THOMAS RUST |
| K083910 |
12/30/2008 |
VIDISTAR PACS & DICOM VIEWER SOFTWARE SERVER SOFTWARE SYSTEM, HEART VIEW, STANDALONE VIEWER |
VIDISTAR, LLC |
CRAIG WALKER |
| K080553 |
02/28/2008 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 |
VIEWORKS CO., LTD. |
CHARLIE MACK |
| K083725 |
12/15/2008 |
RADPRO ION |
VIRTUAL IMAGING, INC. |
DANIEL KAMM |
| K080446 |
02/19/2008 |
RAPIDVIT AND RAPIDWARM CLEAVE |
VITROLIFE SWEDEN AB |
KJELL KJORK |
| K080341 |
02/08/2008 |
ENDODRAPE(TM) |
VORTEK SURGICAL, LLC |
THOMAS SZYMCZAK |
| K083811 |
12/22/2008 |
W&H HANDPIECE ANESTO, MODEL: RA-5 |
W & H DENTALWERK BUERMOOS GMBH |
JOHANN G SCHARL |
| K080304 |
02/05/2008 |
PRO TENS, MODEL WL-240 RX |
WELL-LIFE HEALTHCARE LIMITED |
JENNY HSIEH |
| K083724 |
12/15/2008 |
WIENER LAB. URINE STRIP 10 AND 11 |
WIENER LABORATORIOS S.A.I.C. |
VIVINA CETOLA |
| K080533 |
02/26/2008 |
WINCO MODEL POWER SERIES LIFT CHAIR |
WINCO, INC. |
JIM ANKOVIAK |
| K080295 |
02/04/2008 |
CHARLOTTE CLAW 3.5 |
WRIGHT MEDICAL TECHNOLOGY, INC. |
SARAH HOLTGREWE |
| K080465 |
02/21/2008 |
WS FAR INFRARED THERAPY UNIT, MODEL # TY-101 SERIES |
WS FAR IR MEDICAL TECHNOLOGY CO., LTD. |
JENNIFER REICH |
| K083637 |
12/09/2008 |
CALIX SPINAL IMPLANT SYSTEM |
X-SPINE SYSTEMS, INC. |
DAVID KIRSCHMAN |
| K083734 |
12/16/2008 |
AXXENT SURFACE APPLICATOR, MODEL 710257 |
XOFT, INC. |
STEVE LIN |
| K083823 |
12/22/2008 |
SECURIAN TISSUE REINFORCEMENT MATRIX |
XYLOS CORPORATION |
JOYCE ELKINS |
| K080366 |
02/12/2008 |
DURACHECK BLOOD PRESSURE CUFF, MODEL ZDC4000 SERIES |
ZEFON INTL. |
SCOTT RYAN |
| K083739 |
12/16/2008 |
HYDRORISE AND HYDROSYSTEM |
ZHERMACK S.P.A. |
GERALD W SHIPPS |
| K080367 |
02/12/2008 |
ZIMMER MIS LIGHT |
ZIMMER SPINE, INC. |
ELSA A LINKE |
| K083654 |
12/10/2008 |
ZIMMER UNIVERSAL LOCKING SYSTEM 2.7 MM LOCKING PLATES AND SCREWS ( TIVANIUM TI-6A1-4V ALLOY, CP GRADE TITANIUM) |
ZIMMER, INC. |
ANTHONY FRANCALANCIA |
