| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K092141 |
03/10/2010 |
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH |
3M ESPE DENTAL PRODUCTS |
TAMARA L STANCZAK |
| K092740 |
03/05/2010 |
ARCHITECT FOLATE REAGENTS, ARCHITECT FOLATE CALIBRATORS, AND ARCHITECT FOLATE CONTROLS, MODELS 1P74, 1P74, 1P74 |
ABBOTT LABORATORIES |
DARLA ABANO |
| K093594 |
03/03/2010 |
MODIFICATION TO RELIEVA STRATUS MICROFLOW SPACER |
ACCLARENT, INC. |
COURTNEY KALOF |
| K093795 |
03/12/2010 |
ACTHERM INFRARED EAR THERMOMETER ACT 8000R SERIES AND ITS PROBE COVER MED ACCU2010 |
ACTHERM, INC. |
RICHARD HSIEH |
| K092784 |
03/12/2010 |
C. ALBICANS/C. GLABRATA PNA FISH |
ADVANDX, INC. |
HENRIK STENDER |
| K083186 |
03/04/2010 |
AESCULAP HYDROLIFT VBR SYSTEM |
AESCULAP IMPLANT SYSTEM, INC. |
MATHEW M HULL |
| K091688 |
03/02/2010 |
A-GRIX RESORBABLE BONE VOID FILLER |
AG DIGITAL TECHNOLOGY CORP. |
JENNIFER REICH |
| K092427 |
03/16/2010 |
SPINAL GUIDES PACS (PACS MEDICAL IMAGING DISPLAY WORKSTATION) |
ALBERT DAVYDOV DDS PC PROFESSIONAL |
ALBERT DAVYDOV |
| K093210 |
03/04/2010 |
AQUALASE CAPSULE WASH TIP |
ALCON MANUFACTURING, LTD. |
MARTIN A KAUFMAN |
| K092538 |
03/05/2010 |
REFINE SUPPORT SYSTEM, MODEL 100.0100 |
ALURE MEDICAL INC. |
JOSEPH TAMAYO |
| K093571 |
03/12/2010 |
ZR DENTAL BLOCK |
AMS CO., LTD |
CLAUDE YANG |
| K093773 |
03/10/2010 |
AMSINO I.V. ADMINISTRATION SET, AMSAFE3 I.V ADMINISTRATION SET, EXTENSION SETS |
AMSINO INTERNATIONAL, INC. |
JESUS FARINAS |
| K092905 |
03/04/2010 |
AUTOSTART BURETTE |
ANALYTICA PTY LTD |
ELAINE DUNCAN |
| K093406 |
03/25/2010 |
MORPHEUS SMART PICC CT AND PROCEDURE KIT MODEL 12105509, 12105519 |
ANGIODYNAMICS, INC. |
JODI LYNN FRASIER |
| K100303 |
03/22/2010 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER MODEL 2039-XXYY, 2076-XXYY, 2092-XXYY, 2105-XXYY |
ANGIOSCORE, INC. |
KIMBERLEY KLINE |
| K090364 |
03/23/2010 |
EXTRA PTA BALLOON CATHETER WITH EMBOLIC PROTECTION FEATURE |
ANGIOSLIDE, LTD |
ELISA HARVEY |
| K093523 |
03/04/2010 |
MICRO-TOUCH NITRILE |
ANSELL HEALTHCARE PRODUCTS LLC |
CYNTHIA A INGRAM |
| K093894 |
03/03/2010 |
ANTHOGYR IMPULSION IMPLANTOLOGY CONTRA-ANGLE |
ANTHOGYR |
BRAYETTE SABINE |
| K100572 |
03/17/2010 |
VERSACLOSE, MODEL VC-200-01 |
ANULEX TECHNOLOGIES, INC |
RACHEL KENNEDY |
| K100615 |
03/30/2010 |
ARSTASIS ACCESS SYSTEM |
ARSTASIS, INC. |
SU-MIEN CHONG |
| K093912 |
03/18/2010 |
ARTHREX TIBIAL GRAFTBOLT |
ARTHREX, INC. |
DAVID D'ALESSANDRO |
| K100457 |
03/19/2010 |
OPUS SPEEDSCREW SYSTEM |
ARTHROCARE CORP. |
LAURA N KASPEROWICZ |
| K100080 |
03/19/2010 |
REPROCESSED TROCARS, MODEL B5LT AND CB5LT |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON-VARTY |
| K093702 |
03/04/2010 |
REPROCESSED ULTRASONIC COAGULATING SHEARS |
ASCENT HEALTHCARE SOLUTIONS |
MOIRA BARTON VARTY |
| K091631 |
03/18/2010 |
ACCESSNET, ACCESSMED, ACCESSRAD, MEDVIEW |
ASPYRA, INC. |
MARTIN D SARGENT |
| K092089 |
03/10/2010 |
CLARUJUST |
AUDIGENCE, INC. |
CRAIG PAGAN |
| K100016 |
03/04/2010 |
AVITA SCANEO INFRARED EAR THERMOMETER, MODEL TS7 |
AVITA CORPORATION |
JENNIFER REICH |
| K093717 |
03/02/2010 |
C-MOR VISUALIZATION DEVICE |
AXIS SURGICAL TECHNOLOGIES, INC |
JAMES FARNWORTH |
| K100402 |
03/05/2010 |
SITE-RITE VISION ULTRASOUND SYSTEM |
BARD ACCESS SYSTEMS, INC. |
KIMBERLY GEISLER |
| K093930 |
03/12/2010 |
DIDGET WORLD REPORTS |
BAYER HEALTHCARE LLC |
SUSAN BROCCHI |
| K100722 |
03/29/2010 |
TELAVANCIN 30 UG, BBL SENSI-DISC |
Becton, Dickinson and Company |
JANINE SPAFFORD |
| K093872 |
03/31/2010 |
HANDHELD ECG MONITOR, MODEL MD100 |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
YAJING LI |
| K093757 |
03/03/2010 |
MD300C1 FINGERTIP PULSE OXIMETER |
BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. |
YAJING LI |
| K092046 |
03/24/2010 |
BI-OSTETIC FOAM AND PUTTY, GENEROS FOAM AND PUTTY |
BERKELEY ADVANCED BIOMATERIALS, INC. |
FRANCOIS GENIN |
| K091616 |
03/29/2010 |
BIOPLEX 2200 MMRV IGG |
Bio-Rad Laboratories |
DAVID BHEND |
| K093577 |
03/12/2010 |
LIQUICHEK OPIATE CONTROL |
Bio-Rad Laboratories |
ELIZABETH PLATT |
| K100162 |
03/24/2010 |
MULTIPLE PRIVATE LABEL |
BIOGREEN YIELDS SDN.BHD |
TIONG CHIONG KIENG |
| K093852 |
03/12/2010 |
EZLASE 3 LASER SYSTEM |
BIOLASE TECHNOLOGY, INC. |
IOANA RIZOIU |
| K093122 |
03/15/2010 |
MBCP+ |
BIOMATLANTE |
JEANNE CHAMOUSSET-ROMAN |
| K091025 |
03/02/2010 |
CHROMID VRE AGAR, MODEL: REF 43 851 |
BIOMERIEUX, INC. |
Nancy Weaver |
| K100048 |
03/09/2010 |
E1 ANTIOXIDANT INFUSED TECHNOLOGY |
BIOMET MANUFACTURING CORP. |
BECKY EARL |
| K093629 |
03/09/2010 |
SOLITAIRE AND SOLITAIRE PEEK ANTERIOR SPINAL SYSTEM |
BIOMET SPINE |
VIVIAN KELLY |
| K093761 |
03/05/2010 |
OPTILOCK VL (VARIABLE ANGLE LOCKING) DISTAL RADIUS PLATING SYSTEM |
BIOMET TRAUMA (AKA EBI, LP) |
MARGARET CROWE |
| K093983 |
03/19/2010 |
SMPLE PLATE AND SCREWS |
BIOMET TRAUMA (AKA EBI, LP) |
MARGARET CROWE |
| K091722 |
03/12/2010 |
COAXIAL APPLICATOR SYSTEM |
BIOMET, INC. |
ELIZABETH WRAY |
| K092786 |
03/10/2010 |
INBODY, MODELS: 270, R20, R20B |
BIOSPACE CORPORATION LIMITED |
DANIEL KAMM |
| K090050 |
03/05/2010 |
STEREOS WORKSTATION |
BIOSPACE MED |
JOHN J SMITH |
| K093764 |
03/02/2010 |
SOLOV2 BLOOD GLUCOSE MONITORING SYSTEM |
Biotest Medical Corp. |
MAGGIE CHU |
| K100712 |
03/30/2010 |
RESOUND ENDOSCOPIC ULTRASOUND ASPIRATION NEEDLE |
Boston Scientific Corporation |
ASHLEY PYLE |
| K092149 |
03/18/2010 |
BOSS COAGULATION DEVICE, MODEL BOSS1215, BOSS COAGULATION DEVICE, ANGLED ACCESS, MODEL BOSA1215 |
BOVIE MEDICAL |
RICHARD KOZLOFF |
| K092383 |
03/10/2010 |
BOVIE ICON VS GENERAL PURPOSE RF GENERATOR, MODEL: VS300 |
BOVIE MEDICAL CORPORATION |
RICHARD KOZLOFF |
| K093965 |
03/17/2010 |
ULTRAVERSE 014 AND 018 BALLOON DILATATION CATHETERS |
C.R. BARD, INC. |
CANDACE WADE |
| K092565 |
03/18/2010 |
DIGITAL RETINAL CAMERA CX-1 |
CANON COMPONENTS, INC. |
SHEILA DRISCOLL |
| K093969 |
03/05/2010 |
ACUITY BREAK-AWAY GUIDE CATHETER |
CARDIAC PACEMAKERS, INC. |
KATHLEEN VITTUM |
| K093124 |
03/10/2010 |
PURESOM NASAL MASK-SMALL, PURESOM NASAL MASK-MEDIUM, PURESOM NASAL MASK-LARGE, MODELS 11924-01, 11924-02, 11924-03 |
CARDINAL HEALTH 207, INC. |
MONTHER ABUSHABAN |
| K100094 |
03/11/2010 |
CARESTREAM IMAGE SUITE |
CARESTREAM HEATLH, INC. |
JOHN PARDO |
| K100035 |
03/17/2010 |
MODEL VISULAS 532S LASER WITH THE VITE OPTION |
CARL ZEISS MEDITEC AG |
JUDITH A BRIMACOMBE |
| K093213 |
03/12/2010 |
GUIDED PROGRESSION ANALYSIS ON THE HUMPHREY FIELD ANALYZER II AND II -I SERIES |
CARL ZEISS MEDITEC INC |
JUDITH A BRIMACOMBE |
| K100468 |
03/03/2010 |
ZEISS INFRARED 800 WITH FLOW 800 OPTION |
CARL ZEISS SURGICAL GMBH |
JUDITH BRIMACOMBE |
| K093787 |
03/11/2010 |
IGUIDE CAPPA |
CAS INNOVATIONS GMBH & CO. KG |
ANGELIKA SCHERP |
| K100386 |
03/01/2010 |
DISPOSABLE CIRCULAR STAPLER, MODELS WHY-25, WHY-29. WHY 32 |
CHANGZHOU WASTON MEDICAL APPLIANCE CO. LTD |
Diana Hong |
| K100490 |
03/16/2010 |
LITEPAC, MODEL 682 |
CLEAR STREAM TECHNOLOGIES, LTD. |
FIONA NI MHULLAIN |
| K092437 |
03/25/2010 |
CODMAN STERILIZATION CONTAINERS |
Codman & Shurtleff, Inc. |
PAUL AMARAL |
| K100351 |
03/16/2010 |
NEUROSCOUT STEERABLE GUIDEWIRE |
Codman & Shurtleff, Inc. |
JOAN BARTLE |
| K092414 |
03/10/2010 |
CONMED DETACHATIP INSTRUMENT TRAY, 33CM AND 43CM |
CONMED CORPORATION |
SANDY COVELESKI |
| K093556 |
03/12/2010 |
VCARE DX |
CONMED CORPORATION |
SARAH RIZK |
| K092847 |
03/11/2010 |
840 VENTILATOR SYSTEM WITH EXPANDED NEOMODE OPTION |
COVIDIEN, FORMERLY NELLCOR PURITAN BENNETT, INC. |
Jean Simon |
| K094028 |
03/18/2010 |
CP-FIBER (ORTHOFIBER) |
CP MEDICAL |
BARBARA K HORTON |
| K093480 |
03/05/2010 |
CUATTRO UNOMD |
CUATTRO, LLC |
MARK SKEELS |
| K093888 |
03/16/2010 |
COOPDECH ENDOBRONCHIAL BLOCKER TUBE |
DAIKEN MEDICAL CO, LTD. |
FUMIAKI KANAI |
| K092944 |
03/18/2010 |
DANA REUSABLE TEST PACK FOR STEAM STERILIZATION |
DANA PRODUCTS, INC. |
HARRY BALA |
| K091732 |
03/04/2010 |
VRLXP, MODEL XP |
DEEP BREEZE LTD. |
JEFF BAETZ |
| K100532 |
03/17/2010 |
VERSALOK PEEK ANCHOR WITH ORTHOCORD SUTURE, MODELS 210818, 210819 |
DEPUY MITEK, A JOHNSON & JOHNSON COMPANY |
KRISTINE CHRISTO |
| K100446 |
03/05/2010 |
CIRCUFLOW 5100 SEQUENTIAL COMPRESSION DEVICE |
DEVON MEDICAL INC. |
RUTH WU |
| K100352 |
03/11/2010 |
DIAGNOSOFT HARP MODEL 2.06 |
DIAGNOSOFT, INC. |
JEFFREY ROBERTS |
| K092244 |
03/01/2010 |
MA61, MA62, MA63 FAMILY OF PORTABLE AUDIOMETERS |
DIAGNOSTIC GROUP LLC |
DANIEL EGGAN |
| K093492 |
03/19/2010 |
MISSION CLINICHECK ASSAYED CHEMISTRY CONTROL, LEVEL 1&2, MISSION CLINICAL CALIBRATOR |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K093384 |
03/10/2010 |
MISSION TRINITY R (LEVEL 1) (LEVEL 2) (LEVEL 3), (LEVEL 1,2,3) |
DIAMOND DIAGNOSTICS, INC. |
KATHY CRUZ |
| K100020 |
03/08/2010 |
DX SERIES FINGER SENSOR |
DIXTAL MEDICAL INC. |
ROBERT SCHIFFMAN |
| K100062 |
03/26/2010 |
INFILTRATION KIT |
DMG USA, INC. |
PAMELA PAPINEAU |
| K100510 |
03/25/2010 |
CERAMIR CROWN & BRIDGE |
DOXA AB |
MARGARETH JORVID |
| K093788 |
03/08/2010 |
INFINITY ACUTE CARE SYSTEM (IACS) MONITORING SOLUTION |
Draeger Medical Systems, Inc. |
CHARLES MORGANSON |
| K093633 |
03/30/2010 |
INFINITY ACUTE CARE SYSTEM WORKSTATION CRITICAL CARE |
Draegerwerk AG & Co. KGaA |
Nataliia Semenova |
| K093779 |
03/09/2010 |
CLEARPATH UGI |
EASYGLIDE LTD. |
PAUL DRYDEN |
| K092428 |
03/18/2010 |
BIO-OSS COLLAGEN |
ED. GEISTLICH SOEHNE AG FUER CHEMISCHE INDUSTRIE |
PETER REICHERTZ |
| K092613 |
03/03/2010 |
COLOR LCD MONITOR, MODEL RADIFORCE RS210 |
EIZO NANAO CORPORATION |
HIROAKI HASHIMOTO |
| K100115 |
03/10/2010 |
XVI R4.5 |
ELEKTA LTD. |
ANDREW HEDGES |
| K093324 |
03/05/2010 |
EMPI CONTINUUM |
EMPI |
JO P CHIU |
| K092331 |
03/03/2010 |
DJO SURGICAL REVISION FEMORAL HIP SYSTEM, MODEL 428-14/24-140/200; 428-00-050/110; |
ENCORE MEDICAL, L.P. |
TEFFANY HUTTO |
| K093003 |
03/24/2010 |
BONASTENT BILIARY |
ENDOCHOICE, INC. |
SHOSHANA FRIEDMAN |
| K092849 |
03/30/2010 |
BLOOD COLLECTION TUBE SAMPLES FOR USE WITH POINT OF CARE BLOOD ANALYZER |
EPOCAL, INC. |
ROY LAYER |
| K093896 |
03/25/2010 |
ETHICON ENDO SURGERY SLOTTED ANOSCOPE |
ETHICON ENDO-SURGERY, INC. |
GLENDA MARSH |
| K100280 |
03/24/2010 |
GYNCARE MORCELLEX TISSUE MORCELLATOR |
ETHICON, INC. |
BRYAN LISA |
| K100485 |
03/16/2010 |
GYNECARE TVT EXACT CONTINENCE SYSTEM |
ETHICON, INC. |
SUSAN LIN |
| K093957 |
03/18/2010 |
ARCHITECT HE4, ARCHITECT HE4 CALIBRATORS AND ARCHITECT HE4 CONTROLS, MODELS 2, 2P54, 2P54-01, 2P54-10 SP54-01, |
FUJIREBIO DIAGNOSTICS, INC |
STACEY DOLAN |
| K093881 |
03/12/2010 |
TRUSIGNAL SPO2 FINGER SENSOR, TRUSIGNAL SPO2 EAR SENSOR, TRUSIGNAL SPO2 WRAP SENSOR |
GE HEALTHCARE FINLAND OY |
TOMMI JOKINIEMI |
| K092061 |
03/26/2010 |
FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 |
GENEXEL MEDICAL INSTRUMENT INC |
JAY MANSOUR |
| K092493 |
03/29/2010 |
GPC BONE PLAES AND BONE SCREW & GPC DHS/DCS PLATE SYSTEM |
GPC MEDICAL LTD |
VIKAS NARANG |
| K093232 |
03/15/2010 |
OPTISEAL ENPATH VALVED PTFE PEELABLE INTRODUCER |
Greatbatch Medical |
SHANNON SPRINGER |
| K100202 |
03/19/2010 |
SLIT LAMP BO 900, BQ 900, BP900 |
HAAG-STREIT AG |
OSCAR BANZ |
| K092148 |
03/04/2010 |
HAMILTON-C2 |
HAMILTON MEDICAL AG |
JOERG SCHNEIDER |
| K092558 |
03/17/2010 |
WRIST TYPE BLOOD PRESSURE MONITOR, HMBPM-005/KINETIK BRANDED BPM2 SERIES |
HARVARD MEDICAL DEVICES LTD. |
MARTIN MA |
| K093831 |
03/25/2010 |
FULLY AUTOMATIC (NIBP) BLOOD PRESSURE MONITOR, MODEL HL868RT |
HEALTH & LIFE CO., LTD. |
SARAH SU |
| K091890 |
03/24/2010 |
EXTENDED USE ALDAHOL HIGH LEVEL DISINFECTANT |
HEALTHPOINT, LTD. |
AMY CAMPBELL |
| K100327 |
03/22/2010 |
HEARTWAY POWER CHAIR, P23 |
HEARTWAY MEDICAL PRODUCTS CO., LTD. |
Ke-Min Jen |
| K093258 |
03/03/2010 |
BLOM-SINGER INDWELLING TEP OCCLUDER |
HELIX MEDICAL, LLC |
CYNTHIA ANDERSON |
| K093575 |
03/05/2010 |
GLUMA DESENSITIZER POWER GEL |
HERAEUS KULZER, LLC |
CHERYL V ZIMMERMAN |
| K093044 |
03/16/2010 |
OASIS MRI SYSTEM |
HITACHI MEDICAL SYSTEMS AMERICA, INC. |
DOUG THISTLETHWAITE |
| K092448 |
03/30/2010 |
HIVOX ELECTRIC STIMULATOR TENS & EMS, HD2 |
HIVOX BIOTEK, INC. |
Ke-Min Jen |
| K093126 |
03/02/2010 |
ANAPNOGUARD ENDOTRACHEAL TUBE |
HOSPITECH RESPIRATION LTD. |
YORAM LEVY |
| K093946 |
03/22/2010 |
HOVEROUND HOVERGLIDE MODEL HOVERGLIDE MK-2 |
HOVEROUND CORP. |
TONY DIGIOVANNI |
| K100350 |
03/22/2010 |
HOVEROUND TEKNIQUE GT POWER WHEELCHAIR, MODEL# TEKNIQUE GT |
HOVEROUND CORP. |
TONY GIOVANNI |
| K100527 |
03/26/2010 |
HOVEROUND TEKNIQUE, MODEL HD-6 |
HOVEROUND CORP. |
TONY DIGIOVANNI |
| K100401 |
03/30/2010 |
SWERV MAGNETOSTRICTIVE ULTRASONIC SCALER SYSTEM |
HU-FRIEDY MFG. CO., INC |
MARIA VRABIE |
| K091520 |
03/10/2010 |
IMMULISA CELIAC TTG IGA AND IGG ANTIBODY ELISA |
IMMCO DIAGNOSTICS, INC. |
KEVIN LAWSON |
| K093808 |
03/24/2010 |
INCITE INNOVATION STAND ALONE INTERBODY FUSION DEVICE |
INCITE INNOVATION LLC |
JOHN KIRWAN |
| K092842 |
03/01/2010 |
ECHOPLAQUE |
INDEC SYSTEMS, INC. |
CAROL HUBLER |
| K093066 |
03/16/2010 |
I5 DIGITAL X-RAY IMAGING SYSTEM, MODEL I5 |
INFIMED, INC. |
JIGAR SHAH |
| K093669 |
03/18/2010 |
SEC IBF CAGE |
INNVOTEC SURGICAL, INC. |
JUSTIN EGGLETON |
| K092545 |
03/10/2010 |
INOMAX DS (DELIVERY SYSTEM), MODEL 10003 |
INO THERAPEUTICS LLC |
LARRY LEPLEY |
| K092181 |
03/11/2010 |
HEMOSIL ACUSTAR CARDIOLIPIN IGG, IGM AND IGG AND IGM CONTROLS |
INSTRUMENTATION LABORATORY CO. |
CAROL MARBLE |
| K091975 |
03/10/2010 |
INTEGRATED LABORATORY AUTOMATION SOLUTION |
INTEGRATED LABORATORY AUTOMATION SOLUTIONS, INC. |
MARIA F GRIFFIN |
| K100559 |
03/30/2010 |
MYOSURE HYSTEROSCOPIC TISSUE REMOVAL SYSTEM |
INTERLACE MEDICAL INC. |
John Vozella |
| K092409 |
03/10/2010 |
HYDRO-GUARD MINI BREATHING FILTER AND HEAT AND MOISTURE EXCHANGER AND AIR-GUARD CLEAR BREATHING FILTER |
INTERSURGICAL, INC. |
MICHAEL ZALEWSKI |
| K092352 |
03/16/2010 |
SCUBA BILIARY STENT SYSTEM |
INVATEC S.P.A. |
STEVE CAMP |
| K093842 |
03/05/2010 |
1.5T AND 3.0T GENERAL PURPOSE FLEX COILS |
INVIVO CORPORATION |
ELIZABETH WHEELER |
| K093273 |
03/03/2010 |
VIT KIT - FREEZE AND THAW |
IRVINE SCIENTIFIC SALES CO., INC. |
JAYME YAMAGUCHI-OWENS |
| K093744 |
03/10/2010 |
EXCITE F AND EXCITE DSC |
IVOCLAR VIVADENT, INC. |
DONNA MARIE HARTNETT |
| K093708 |
03/10/2010 |
TELIO CAD |
IVOCLAR VIVADENT, INC. |
DONNA MHARTNETT |
| K092326 |
03/05/2010 |
SMOOTHCOOL |
JEISYS MEDICAL, INC. |
Kevin Walls |
| K093576 |
03/04/2010 |
RUBBER-LIKE POWDER FREE VINYL PATIENT EXAMINATION GLOVES, WHITE COLOR |
JIANGSU CUREGUARD GLOVE CO., LTD. |
CHU XIAOAN |
| K092211 |
03/05/2010 |
CHESAPEAKE SPINAL SYSTEM |
K2M, INC. |
RICHARD WOODS |
| K092474 |
03/11/2010 |
PYRENEES CERVICAL PLATE SYSTEM, SEMI-CONSTRAINED SCREWS |
K2M, INC. |
RICHARD W WOODS |
| K093603 |
03/18/2010 |
STORM-BASE 2.0 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
LEIGH SPOTTEN |
| K093526 |
03/10/2010 |
V.A.C. VIA THERAPY SYSTEM, V.A.C. VIA NEGATIVE PRESSURE THERAPY UNIT, V.A.C. VIA DRESSING (CONTAINING V.A.C. GRANUFOAM D |
KCI USA, INC. (KINETIC CONCEPTS, INC.) |
RANDALL WHEELAND |
| K100500 |
03/09/2010 |
PSL CLASSIC SLIT LAMP |
KEELER INSTRUMENTS, INC. |
EUGENE VANARSDALE |
| K100083 |
03/19/2010 |
ESTHETICA |
KERR CORPORATION |
Wendy Garman |
| K093115 |
03/19/2010 |
KIMBERLY-CLARK KC100 SURGICAL GOWN, MODEL KC100 |
KIMBERLY-CLARK CORP. |
MARCIA JOHNSON |
| K100328 |
03/05/2010 |
CLEARFIL MAJETY POSTERIOR |
KURARAY MEDICAL INC. |
KIYOYUKI ARIKAWA |
| K100575 |
03/31/2010 |
LDR SPINE USA SPINE TUNE TL SPINE SYSTEM |
LDR SPINE USA |
NOAH BARTSCH |
| K093485 |
03/16/2010 |
VESISCAN |
LIFE-TECH, INC. |
JEFF KASOFF |
| K093048 |
03/23/2010 |
D-STORM 810NM, D-STORM 980NM |
LIGHT INSTRUMENTS |
YORAM LEVY |
| K092494 |
03/01/2010 |
GEL FILLED GUM SOOTHER |
LUV N' CARE, LTD. |
JOSEPH H HAKIM |
| K100385 |
03/24/2010 |
NUBY NATURAL TOUCH RHYTHM DUAL ACTION ELECTRIC BREAST PUMP |
LUV N' CARE, LTD. |
JEAN ASQUITH |
| K100053 |
03/10/2010 |
MATTIOLI PULSE TWO/THREE PLUS FAMILY |
MATTIOLI ENGINEERING CORP. |
GIANFRANCO BERNABEI |
| K100314 |
03/31/2010 |
IMNS MEDACTA NAVIGATION SYSTEM,33.221000US |
MEDACTA INTERNATIONAL, SA |
HEATHER NEELY |
| K091967 |
03/02/2010 |
MEDACTA BIPOLAR HEAD |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K092265 |
03/12/2010 |
VESAFITCUP DOUBLE MOBILITY- HIGHCROSS HXUHMWPE LINERS |
MEDACTA INTERNATIONAL, SA |
NATALIE KENNEL |
| K093336 |
03/05/2010 |
INTEGRATED STIMULUS DELIVERY SYSTEM OPTIMUM AND PREMIUM |
MEDICAL NUMERICS, INC. |
DOUGLAS M TUCKER |
| K083803 |
03/10/2010 |
FIXIT HEADREST CLAMP SYSTEM |
MEDICON, E.G. |
JOACHIM SCHMID |
| K100484 |
03/16/2010 |
IMPIX MANTA CERVICAL INTERBODY DEVICE |
MEDICREA |
J.D. WEBB |
| K100297 |
03/04/2010 |
PASS LP SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K100186 |
03/24/2010 |
MYSONO U5 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
MARK JOB |
| K092675 |
03/03/2010 |
GRINDCARE |
MEDOTECH A/S |
Calley Herzog |
| K093535 |
03/22/2010 |
AUTOLOG AUTOTRANSFUSION SYSTEM |
MEDTRONIC INC. |
CARALEE WALTON |
| K092308 |
03/16/2010 |
POLESTAR, MODEL N-30 |
MEDTRONIC NAVIGATION ISRAEL, LTD. |
YAIR PENIAS |
| K082855 |
03/09/2010 |
MENICON PROGENT PROTEIN REMOVER FOR RIGID GAS PERMEABLE CONTACT LENSES |
MENICON CO. LTD. |
BEVERLEY D VENUTI |
| K092584 |
03/22/2010 |
LAPORT |
MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) |
PATRICK GAENSICKE |
| K093194 |
03/03/2010 |
MGB DISPOSABLE RETRIEVAL BAG LAPBAG |
MGB ENDOSKOPISCHE GERATE GMBH (BERLIN) |
PATRICK GAENSICKE |
| K093815 |
03/12/2010 |
LIGHT DIAGNOSTICS HUMAN METAPNEUMOVIRUS DFA KIT, MODEL CATALOG NUMBER 3124 |
MILLIPORE CORPORATION |
CATHERINE KARAMAN |
| K094047 |
03/22/2010 |
18 STANDARD WHEELCHAIR, MODEL MS005-4, 18 RECLINING WHEELCHAIR , MODEL MS008-1, 14 PEDIATRIC WHEELCHAIR |
MODERN REHABILITATION SOLUTIONS CO., LTD |
Kevin Walls |
| K093380 |
03/05/2010 |
MIZZY EXPRESS |
MYCONE DENTAL SUPPLY CO., INC. |
NICK PALMER |
| K091634 |
03/01/2010 |
NMI FC |
NAVILYST MEDICAL, INC. |
SHILPA PREM |
| K092908 |
03/10/2010 |
NEOMED STERILE SYRINGE, MODELS SD-S1EO, SD-S3EO, SD-S630, SD-S12EO, SD-S20EO, SD-S35EO, SD-S60EO |
NEOMED, INC. |
PENNY NORTHCUTT |
| K092699 |
03/18/2010 |
NOMAD SLEEP SYSTEM RECORDER, MODEL PMU800 |
NEUROTRONICS, INC. |
JAMES SCHUBERT |
| K092930 |
03/10/2010 |
NEXUS INTRAVASCULAR TUBING SETS-PRE-PIERCED |
NEXUS MEDICAL, LLC |
HEATHER TURNER |
| K091978 |
03/25/2010 |
DBB-06 HEMODIALYSIS DELIVERY SYSTEM |
NIKKISO CO. LTD. |
FUMIAKI KANAI |
| K100520 |
03/17/2010 |
NIPRO BIOHOLE NEEDLE WITH CAPICK SCAB REMOVER |
NIPRO MEDICAL CORPORATION |
JESSICA OSWALD |
| K093306 |
03/04/2010 |
SINGLE-PATIENT USE DISPOSABLE SENSOR |
NONIN MEDICAL, INC. |
LORI ROTH |
| K100671 |
03/30/2010 |
NOVABONE DENTAL PUTTY-BIOACTIVE SYNTHETIC BONE GRAFT |
NovaBone Products, LLC |
DAVID M GAISSER |
| K093585 |
03/08/2010 |
MICROCYN SKIN AND WOUND HYDROGEL |
OCULUS INNOVATIVE SCIENCES, INC. |
ANTOINETTE DOUGLAS |
| K093507 |
03/10/2010 |
OLYMPUS CHF TYPE Y0003 |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY ABBATIELLO KLUESNER |
| K100345 |
03/22/2010 |
SYSTEMS INTEGRATION MODEL: ENDOALPHA |
OLYMPUS MEDICAL SYSTEMS CORPORATION |
STACY KLUESNER |
| K100555 |
03/29/2010 |
APEX-LNK ACETABULAR INSERT, E, APEX-LNK ACETABULAR INSERT, F, APEX-LNK |
OMNI LIFE SCIENCE, INC. |
RADHIKA PONDICHERRY |
| K094017 |
03/05/2010 |
TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158 |
OMNI LIFE SCIENCE, INC. |
Robert Zoletti |
| K093624 |
03/05/2010 |
OPTISCAN MODEL OPTISCAN CEIS |
OPTISCAN PTY LTD. |
PETER PAVLICEK |
| K091656 |
03/11/2010 |
SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L |
ORGAN RECOVERY SYSTEMS, INC. |
PJ PARDO |
| K093388 |
03/04/2010 |
SMART CAPNOLINE GUARDIAN |
ORIDION MEDICAL 1987 LTD. |
RACHEL WEISSBROD |
| K091564 |
03/19/2010 |
NBM-200MP PULSE OXIMETRY DEVICE |
ORSENSE LTD |
AHAVA STEIN |
| K093998 |
03/22/2010 |
KNEEALIGN SYSTEM WITH REFERENCE SENSOR |
ORTHALIGN, INC |
AMY WALTERS |
| K094037 |
03/10/2010 |
TC PLATING SYSTEM |
ORTHO-PRO LLC |
J.D. WEBB |
| K091208 |
03/03/2010 |
GS III SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MINJOO KIM |
| K093719 |
03/01/2010 |
PRO-FIX PRECISION FIXATION SYSTEM MODEL PFM#, PFB#, PFT# |
OSTEOGENICS BIOMEDICAL, INC. |
DUSTYN WEBB |
| K092817 |
03/09/2010 |
POC-AS10 AUTO SAMPLER |
OTSUKA PHARMACEUTICAL CO., LTD. |
CYNTHIA A SINCLAIR |
| K092424 |
03/05/2010 |
P-ART, MODEL 001 |
P-CURE LTD |
MICHAEL MARASH |
| K100270 |
03/29/2010 |
ARTISAN AESTHETIC SYSTEM |
PALOMAR MEDICAL TECHNOLOGIES, INC. |
SHARON TIMBERLAKE, MSHS, RAC, CC |
| K092980 |
03/11/2010 |
PANPAC UTERINE MANIPULATOR INJECTOR, MODEL UMI 4.5 |
Panpac Medical Corporation |
Yen-Ming Pan |
| K093494 |
03/30/2010 |
LINASYS IMAGE-GUIDED LIVER SURGERY SYSTEM |
PATHFINDER THERAPEUTICS, INC. |
CRAIG HENDERSON |
| K083842 |
03/23/2010 |
ROTEM DELTA THROMBOELASTOMETRY SYSTEM |
PENTAPHARM GMBH |
VOLKER JOACHIM FRIEMERT |
| K090123 |
03/05/2010 |
NEONATAL BIOTINIDASE KIT, MODEL 3018 |
PERKINELMER, INC. |
KAY A TAYLOR |
| K091120 |
03/19/2010 |
MEDPOR CONTAIN IMPLANT |
POREX SURGICAL, INC. |
JERRI L MANN |
| K093976 |
03/25/2010 |
RAISIN PERSONAL MONITOR |
PROTEUS BIOMEDICAL, INC. |
GREGORY MOON |
| K092460 |
03/05/2010 |
STAR-LITE -LM, MODEL SL8809 |
PS ADVANCED ENGINEERING |
WEN YANG |
| K093620 |
03/10/2010 |
PULPDENT FLUORIDE VARNISH |
PULPDENT CORPORATION |
KENNETH J BERK |
| K093155 |
03/01/2010 |
VASHE WOUND CLEANSING SYSTEM |
PURICORE INC. |
DENNIS MAHONEY |
| K100474 |
03/16/2010 |
QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W |
QUICKLASE LIMITED |
CALVIN OSTLER |
| K100552 |
03/12/2010 |
RAYSTATION VERSION 1.0 |
RAYSEARCH LABORATORIES AB |
ANDERS MURMAN |
| K100641 |
03/30/2010 |
INTRACEPT FLEXIBLE BI-POLAR RF PROBE AND EASY ACCESS INSTRUMENT SET, MODEL FG0018 (PROBE), FG0036 (INSTRUMENT SET) |
RELIEVANT MEDSYSTEMS |
ADAM SAVAKUS |
| K093731 |
03/22/2010 |
VPAP III ST-A |
RESMED LTD. |
DAVID D'CURZ |
| K100226 |
03/18/2010 |
WIRELESS BODY TEMPERATURE MONITOR MODEL BTM-DIX SERIES (BTM-DIC,D,E,F,G & H) |
RIO FLEXON TECHNOLOGY CO., LTD. |
CHI-HUNG LIAO |
| K092363 |
03/18/2010 |
SOFTVIEW, MODEL 2.01 |
RIVERAIN MEDICAL GROUP |
JENNIFER VETTER |
| K093460 |
03/18/2010 |
COAGUCHEK XS PRO SYSTEM |
Roche Diagnostics |
JENNIFER TRIBBETT |
| K093582 |
03/29/2010 |
ELECSYS CK-MB CALCHECK 5 |
Roche Diagnostics |
JACK ROGERS |
| K092322 |
03/12/2010 |
ELECSYS RUBELLA IGM IMMUNOASSAY |
Roche Diagnostics |
THERESA A BUSH |
| K091741 |
03/18/2010 |
TINA-QUANT CERULOPLASMIN |
Roche Diagnostics |
KATHIE J GOODWIN |
| K092940 |
03/05/2010 |
COAGUCHEK XS PLUS PST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
JENNIFER TRIBBETT |
| K093700 |
03/04/2010 |
ELECSYS HCG STAT CALCHECK 5 |
ROCHE DIAGNOSTICS CORP. |
KELLY C O'MAINE ADAMS |
| K092848 |
03/19/2010 |
ELECSYS TROPONIN T CALCHECK 5 |
ROCHE DIAGNOSTICS CORP. |
Sarah Baumann |
| K092907 |
03/05/2010 |
DIGITAL ULTRASOUND IMAGING SYSTEM, CONVEX ARRAY TRANSDUCER, LINEAR ARRAY TRANSDUCER, CONVEX ARRAY TRANSDUCER, PHASED ARR |
SHANTOU INSTITUTE OF ULTRASONIC INSTUMENTS |
BOB LEIKER |
| K093016 |
03/30/2010 |
VITAL SIGNS MONITOR |
SHENZHEN CREATIVE INDUSTRY CO., LTD |
CHARLIE MACK |
| K100079 |
03/01/2010 |
DIGITAL ULTRASOUND SCANNER |
SHENZHEN WELL.D MEDICAL ELECTRONICS CO., LTD |
Diana Hong |
| K093559 |
03/03/2010 |
VINTAGE MP |
SHOFU DENTAL CORP. |
DAVID P MORAIS |
| K093612 |
03/04/2010 |
SYNGO.PLAZA |
SIEMENS AG, MEDICAL SOLUTIONS |
|
| K093732 |
03/22/2010 |
ADVIA CHEMISTRY DRUG CALIBRATOR I MODEL 10376770 |
SIEMENS HEALTHCARE DIAGNOSTICS |
KIRA GORDON |
| K093645 |
03/05/2010 |
EXL ANEM CAL, MODEL RC640 |
SIEMENS HEALTHCARE DIAGNOSTICS |
ANNA M KATHLEEN ENNIS |
| K100293 |
03/19/2010 |
ADVIA CENTAUR CALIBRATOR 30, MODELS 10379811/10379810 |
SIEMENS HEATLHCARE DIAGNOSTICS INC |
Ernest Joseph |
| K093812 |
03/03/2010 |
ACUSON S2000 DIAGNOSTIC ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC. |
SHELLY PEARCE |
| K093943 |
03/05/2010 |
BIOSURE SYNC TIBIAL FIXATION DEVICE, 6MM, 8MM,10MM,12MM |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
JULIE ACKER |
| K093897 |
03/04/2010 |
SMITH & NEPHEW FOOTPRINT ULTRA PK SUTURE ANCHOR |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
CHRISTINA FLORES |
| K093414 |
03/01/2010 |
PORT-A-CATH POWER P.A.C. IMPLANTABLE VENOUS ACCESS SYSTEMS |
SMITHS MEDICAL ASD, INC. |
RACHELLE PARSONS |
| K092950 |
03/12/2010 |
SOLARIS MODELS NT1 AND NT1A HANDHELD PULSE OXIMETERS WITH SENSOR ACCESSORIES |
SOLARIS MEDICAL TECHNOLOGY, INC. |
SUSAN D GOLDSTEIN-FALK |
| K092922 |
03/12/2010 |
SSI-8000/S8/S6 DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, 2P1 PHASED ARRAY DIAGNOSTIC ULTRASOUND TRANSDUCER |
SONOSCAPE COMPANY LIMITED |
BOB LEIKER |
| K100507 |
03/24/2010 |
XRES BLOOD COLLECTION RESERVOIR |
SORIN GROUP ITALIA S.R.L |
BARRY SALL |
| K093257 |
03/26/2010 |
TORQMAX SHEATH GRIP ACCESSORY |
SPECTRANETICS CORP. |
BRANDON HANSEN |
| K100413 |
03/03/2010 |
TEMP IT |
SPIDENT CO., LTD. |
I.S. WHANG |
| K093936 |
03/11/2010 |
ROMEO POSTERIOR OSTEOSYNTHESIS SYSTEM |
SPINEART |
FRANCK PENNESI |
| K092825 |
03/16/2010 |
APEX SPINE SYSTEM 5.50 MM TITANIUM ROD & POLYAXIAL SCREW WASHER |
SPINECRAFT, INC. |
AMI AKALLAL-ASAAD |
| K093776 |
03/26/2010 |
INDUS ANTERIOR CERVICAL PLATE SYSTEM |
SPINEFRONTIER, INC. |
JOHN SULLIVAN |
| K092852 |
03/11/2010 |
SAVIEW 58 UV; TORIC & MULTIFOCAL (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR |
ST. SHINE OPTICAL CO., LTD. |
BRIAN LAI |
| K100236 |
03/29/2010 |
STAIR SYSTEMS PACS & DICOM VIEWER |
STAIR SYSTEMS, INC. |
JAMES W MONROE |
| K100395 |
03/17/2010 |
HARMONY VLED SURGICAL LIGHTNING SYSTEM |
STERIS Corporation |
ROBERT SULLIVAN |
| K093864 |
03/11/2010 |
AVS ALIGN PEEK SPACERS MODEL 48328XXX, 48326XXX |
STRYKER CORP. |
KIMBERLY S LANE |
| K093677 |
03/05/2010 |
STRYKER ARTHROSCOPE |
Stryker Endoscopy |
SHIBIR DESAI |
| K093419 |
03/18/2010 |
IVAS 2-10MM (10 GAUGE) BALLOON CATHETER, IVAS 2-15 MM(10 GAUGE)0705-115-500, IVAS 3-10MM(8 GAUGE)BALLOON CATHETER, IVAS |
STRYKER INSTRUMENTS, INSTRUMENTS DIV. |
BECKY E DITTY |
| K093670 |
03/18/2010 |
MODIFICATION TO: OASYS SYSTEM |
STRYKER SPINE |
PAULINE SHAND |
| K093792 |
03/18/2010 |
LED LIGHT SOURCE |
SUNOPTIC TECHNOLOGIES, LLC |
JANICE G LEE |
| K092726 |
03/15/2010 |
MESH GPS - LARGE, SMALL, SM, SM SMALL |
SURGICAL STRUCTURES LTD. |
SHOSH FRIEDMAN |
| K093772 |
03/29/2010 |
SYNTHES STERNAL FIXATION SYSTEM |
SYNTHES |
ANDREA M TASKER |
| K093928 |
03/29/2010 |
SYNTHES 3.5MM QUADRILATERAL SURFACE PLATES |
SYNTHES (USA) |
KARL J NITTINGER |
| K090658 |
03/03/2010 |
SYNTHES EXTERNAL FIXATION DEVICES, MR CONDITIONAL |
SYNTHES (USA) |
JILL R YELTON |
| K093668 |
03/09/2010 |
SYNTHES MATRIX MIS RODS |
SYNTHES (USA) |
HEATHER GUERIN |
| K091313 |
03/30/2010 |
SYSMEX MODEL XT-4000I |
SYSMEX AMERICA, INC. |
SHARITA BROOKS |
| K093941 |
03/26/2010 |
CLEVER CHOICE MINI BLOOD GLUCOSE MONITORING SYSTEM MODEL TD-4265 |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K091555 |
03/15/2010 |
MODEL TD-3252 BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM |
TaiDoc Technology Corporation |
ERICA LI |
| K092902 |
03/02/2010 |
U-RIGHT TD-4238 AND TD-4246 BLOOD GLUCOSE MONITORING SYSTEM FORA G31 BLOOD GLUCOSE MONITORING SYSTEM, TD-4256 BLOOD GLUC |
TaiDoc Technology Corporation |
DEBRA LIANG |
| K093240 |
03/22/2010 |
BELRAY II |
TAKARA BELMONT CORP. |
KUNIHIKO SOUE |
| K100339 |
03/22/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN CHANGRONG GLOVE CO., LTD. |
CHU XIAOAN |
| K100324 |
03/29/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HENGTONG PLASTIC PRODUCTS CO. |
CHU XIAOAN |
| K100326 |
03/24/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN HONGDA PLASTCI PRODUCTS CO LTD |
CHU XIAOAN |
| K100337 |
03/29/2010 |
POWDER-FREE VINYL PATIENT EXAMINATION GLOVES |
TANGSHAN QIXIN GLOVE CO., LTD. |
CHU XIAOAN |
| K100058 |
03/05/2010 |
POWDER FREE VINYL PATIENT EXAMINATION GLOVES, COLORED (YELLOW) |
TANGSHAN ZHONGPU PLASTIC PRODUCTS CO., LTD |
CHU XIAOAN |
| K094044 |
03/23/2010 |
SPIRAL LAMINAR FLOW VASCULAR ARTERIOVENOUS GRAFT |
TAYSIDE FLOW TECHNOLOGIES LIMITED |
RUDY MOUNIA |
| K100506 |
03/10/2010 |
FORCE FIBER GREEN ULTRA HIGH MOLECULAR WEIGHT POLYETHYLENE NON ABSORBABLE SUTURES MODEL:X-5000FFK, X-5001FFK, X-5002FFK |
TELEFLEX MEDICAL |
VALERIE FOLLOWELL |
| K092435 |
03/09/2010 |
VERSEO AIR PRESSURE MASSAGER |
THE AMERICAN EXPORT GROUP & INTERNATIONAL SERVICES |
ROBERT WAGNER |
| K082823 |
03/01/2010 |
HEVYLITE HUMAN IGA KAPPA AND IGA LAMBDA BN KITS |
THE BINDING SITE GROUP LTD |
JAY H GELLER |
| K090753 |
03/05/2010 |
THERATEST EL-ANTI-CCP/2 |
THERATEST LABORATORIES, INC. |
MARIUS TEODORESCU |
| K092366 |
03/04/2010 |
TTS100 PORTABLE HYPERTHERMIC PERFUSION DEVICE |
THERMAL THERAPEUTIC SYSTEMS, INC |
JAMES J ROGERS |
| K093615 |
03/04/2010 |
SPI DENTAL IMPLANT, ELEMENT |
THOMMEN MEDICAL, AG |
LINDA K SCHULZ |
| K093261 |
03/26/2010 |
MOVES |
THORNHILL RESEARCH INC |
CLIFF ANSEL |
| K093984 |
03/24/2010 |
PICA WHOLE BODY MRI SYSTEM MODEL TMS-MRI-3500WB-01 |
TIME MEDICAL LIMITED |
Diana Hong |
| K091940 |
03/26/2010 |
MAGPRO, MODELS R30 WITH MAGOPTION, X100, X100 WITH MAGOPTION |
TONICA ELEKTRONIK A/S |
LISE TERKELSEN |
| K093676 |
03/17/2010 |
OMNITECH LARGE, TRIMED COMPRESSION SCREW |
TRIMED, INC. |
KELLI ANDERSON |
| K093524 |
03/26/2010 |
PIVIT A/B ST AND PIVIT A/B ST-R |
TYRX ,INC |
MARK CITRON |
| K094006 |
03/23/2010 |
OPAL BOND MV |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K100317 |
03/24/2010 |
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO |
VATECH CO., LTD. |
DAVE KIM |
| K100346 |
03/10/2010 |
ENDOCLEAR SYSTEM |
VIRTUAL PORTS LTD |
YORAM LEVY |
| K093934 |
03/17/2010 |
GORE HYBRID VASCULAR GRAFT |
W.L. GORE & ASSOCIATES |
Michael Ivey |
| K093791 |
03/22/2010 |
GORE DRYSEAL SHEATH |
W.L. GORE & ASSOCIATES,INC |
ALICIA HEMPHILL |
| K092886 |
03/11/2010 |
WELL LEAD ENDOBRONCHIAL TUBES |
WELL LEAD INSTRUMENTS |
ARTHUR WARD |
| K091538 |
03/25/2010 |
PRESSURE RELEASE VALVE W/AUDIBLE, MODEL PRV 20/40/60; WITH T6 ADAPTER, MODEL PRV 120/140/160; T6 ADAPTER, MODEL T6-100 |
WET NOSE TECHNOLOGIES, LLC |
JIM BARLEY |
| K092857 |
03/04/2010 |
VERICORE ABUTMENT IN TITANIUM FOR IMPLANT SYSTEMS |
WHIP-MIX CORP. |
STUART STEINBOCK |
| K093508 |
03/04/2010 |
RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) |
WOMANCARE GLOBAL |
Susanne Parks |
| K093552 |
03/04/2010 |
EVOLUTION MP TOTAL KNEE SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN ROSS |
| K100579 |
03/26/2010 |
G-FORCE TI SUTURE ANCHOR SYSTEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
KELLEN HILLS |
| K093127 |
03/04/2010 |
TRABECULAR METAL (TM) VERTEBRAL BODY REPLACEMENT (VBR) SYSTEM INSTRUMENT SET |
ZIMMER TRABECULAR METAL TECHNOLOGY |
KATHLEEN RUTHERFORD |
