| FDA 510(k) Number |
Decision Date |
Device Name |
Applicant |
Contact |
| K071517 |
04/02/2008 |
AP MEDICAL SHARPS CONTAINERS 0,6-12 LT. |
A.B.M. ITALIA S.P.A |
FRANCO GRAVA |
| K080925 |
04/28/2008 |
FOX PLUS PTA CATHETER |
ABBOTT VASCULAR INC. |
Ivalee Cohen |
| K072460 |
04/11/2008 |
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE |
ABBOTT VASCULAR, INC. |
MICHELE WALZ |
| K080408 |
04/25/2008 |
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 |
| K073471 |
04/30/2008 |
VANTAGECATH INTRAVASCULAR CATHETER |
ADVANTAGE MEDICAL DEVICE |
James Smith |
| K080753 |
04/02/2008 |
AESCULAP ENDOSCOPIC CLIP SYTEM |
AESCULAP, INC. |
LISA M BOYLE |
| K073168 |
04/28/2008 |
AESCULAP PRIMELINE CONTAINER LTD. |
AESCULAP, INC. |
KATHY A RACOSKY |
| K080757 |
04/18/2008 |
AMPLATZER TORQVUE LOW PROFILE DELIVERY SYSTEM |
AGA MEDICAL CORP. |
RASHMI BHUSHAN |
| K072720 |
04/11/2008 |
ALIMAXX-B UNCOVERED BILIARY STENT SYSTEM |
ALVEOLUS, INC. |
TONY D ALEXANDER |
| K080838 |
04/24/2008 |
ALVEOLUS ALIMAXX-E ESOPHAGEAL STENT SYSTEM |
ALVEOLUS, INC. |
TONY D ALEXANDER |
| K073716 |
04/11/2008 |
LIFE+CEL OR LIFECEL BATTERY |
AMCO INTERNATIONAL MANUFACTURING & DESIGN, INC. |
ALEX HENDERSON |
| K080185 |
04/10/2008 |
AMS ELEVATE WITH INTEPRO LITE PROLAPSE REPAIR SYSTEM, AMS ELEVATE WITH INTEXEN LP PROLAPSE REPAIR SYSTEM |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K073219 |
04/10/2008 |
WMT COLLAGEN DERMAL MATRIX, 4 CM X 7 CM, MODEL 89XM-4X07, VMT COLLAGEN DERMAL MATRIX, 6 CM X 8 CM, MODEL 89XM-6X08 |
AMERICAN MEDICAL SYSTEMS, INC. |
MONA INMAN |
| K073547 |
04/23/2008 |
ANASEPT ANTIMICROBIAL SKIN AND WOUND CLEANSERS; ANASEPT ANTIMICROBIAL SKIN AND WOUND GEL |
ANACAPA TECHNOLOGIES, INC. |
ILA DOSHI |
| K080151 |
04/25/2008 |
ANGIOSCULPT PTA SCORING BALLOON CATHETER, MODELS 2076 AND 2039 |
ANGIOSCORE, INC. |
KARIN J GASTINEAU |
| K073520 |
04/11/2008 |
ANGIOTECH CVC |
ANGIOTECH PHARMACEUTICALS, INC. |
TRUDY D ESTRIDGE |
| K080736 |
04/16/2008 |
ACTIFUSE SHAPE BONE GRAFT SUBSTITUTE |
APATECH LTD. |
CANDACE F CEDERMAN |
| K073648 |
04/10/2008 |
GLUCOSURE STAR BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90000E1 |
APEX BIOTECHNOLOGY CORP. |
THOMAS Y.S. SHEN |
| K073137 |
04/01/2008 |
GLUCOSURE VOICE BLOOD GLUCOSE MONITORING SYSTEM, MODEL AS90011E1 |
APEX BIOTECHNOLOGY CORP. |
THOMAS Y.S. SHEEN |
| K080396 |
04/30/2008 |
OSSEOSPEED NARROW |
ASTRA TECH AB |
FLOYD G LARSON |
| K080670 |
04/23/2008 |
MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM |
ATCOR MEDICAL |
JOHN ABRAM |
| K080691 |
04/16/2008 |
C-QUR EDGE MESH V-PATCH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K080688 |
04/16/2008 |
C-QUR LITE MESH V-PATCH |
ATRIUM MEDICAL CORP. |
JOSEPH P DE PAOLO |
| K073640 |
04/24/2008 |
ARCHITECT HOMOCYSTEINE REAGENTS, CALIBRATORS AND CONTROLS |
AXIS-SHIELD DIAGNOSTICS, LTD. |
Claire Dora |
| K080557 |
04/02/2008 |
BARRX MODELS HALO360 AND HALO360+ COAGULATION CATHETERS |
BARRX MEDICAL, INCORPORATED |
VIORICA FILIMON |
| K073571 |
04/08/2008 |
TRICOS T RESORBABLE BONE SUBSTITUTE |
BAXTER HEALTHCARE CORPORATION |
BARBARA K BARBEAU |
| K080857 |
04/10/2008 |
CHROMOPHARE E-SERIES |
BERCHTOLD HOLDING GMBH |
SILKE GORAL |
| K072682 |
04/18/2008 |
50W CERALAS D 1950NM DIODE LASER |
BIOLITEC, INC. |
JONATHAN S KAHAN |
| K080201 |
04/30/2008 |
VITEK 2 GRAM POSITIVE INDUCIBLE CLINDAMYCIN RESISTANCE |
BIOMERIEUX, INC. |
JOLYN TENLLADO |
| K080361 |
04/21/2008 |
REGENEREX TIBIAL COMPONENTS |
BIOMET, INC. |
SUSAN ALEXANDER |
| K080308 |
04/14/2008 |
BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD |
BIOSCAFFOLD INTERNATIONAL PTE LTD |
ROGER GRAY |
| K080425 |
04/23/2008 |
CS REFSTAR CATHETER (D- AND F-CURVES), MODELS D-1285-01 AND D-1285-02 |
BIOSENSE WEBSTER, INC. |
Balaka Das |
| K073434 |
04/01/2008 |
BIPORE ACCUFLEX PERCUTANEOUS SHEATH INTRODUCER |
BIPORE, INC. |
KEITH PALUCH |
| K072041 |
04/10/2008 |
BOVIE IDS-400 ELECTROSURGICAL GENERATOR |
BOVIE MEDICAL |
RICHARD A KOZLOFF |
| K080608 |
04/17/2008 |
DIGITAL LIGHTBOX |
BRAINLAB, AG |
RAINER BIRKENBACH |
| K073458 |
04/04/2008 |
BT-TITE ONE(BTICV1), BT-TITE STANDARD(BTIVSM), BT-TITE CV2(BTICV2) |
BTLOCK SRL |
ESTER BATTILANA |
| K073222 |
04/09/2008 |
MODIFICATION TO:SPECIALTY NEEDLES |
BUSSE HOSPITAL DISPOSABLES, INC. |
MUHAMAD ANSARI |
| K073534 |
04/03/2008 |
CANDELA FAMILY OF Q-SWITCHED ALEXANDRITE LASER (ALEXLAZR) SYSTEMS |
CANDELA CORP. |
LISA LACROIX |
| K080883 |
04/24/2008 |
CR-1 |
CANON, INC. |
SHEILA DRISCOLL |
| K080845 |
04/30/2008 |
ORWELL FLUID COLLECTION AND DISPOSAL SYSTEM |
Cardinal Health |
LAVENIA FORD |
| K080174 |
04/23/2008 |
PHLEBOTOMY BAG WITH VALVE & 17G X 1, MODEL CM-PH17X1B, CM-PH17X1C |
CARDIOMED SUPPLIES, INC. |
CHRISTIAN G DUBE |
| K080770 |
04/09/2008 |
IMAGENMD WITH IMAGENQ |
CARDIOVASCULAR IMAGING TECHNOLOGIES, LLC |
MELANIE HASEK |
| K080624 |
04/11/2008 |
NAVSTATIONIRAD EMT, VERSION 1.1 |
CAS INNOVATIONS AG |
MARKUS NAGEL |
| K080084 |
04/21/2008 |
CELL GEN LASER, MODEL CG-4000 |
CELL GEN THERAPEUTICS, LLC |
DICK RIVERA |
| K080507 |
04/21/2008 |
AOC POROUS POLYETHYLENE, AOC POROUS HDPE, AOC POROUS POLYETHYLENE SURGICAL IMPLANT |
CEREMED, INC. |
TADEUSZ WELLISZ |
| K080565 |
04/04/2008 |
MODIFICATION TO: SAVI APPLICATOR KIT |
CIANNA MEDICAL, INC. |
GARY MOCNIK |
| K080890 |
04/29/2008 |
SMARTSPOT PRIMAX |
CMT MEDICAL TECHNOLOGIES, LTD. |
DAN LAOR |
| K080956 |
04/25/2008 |
MODIFICATION TO VF GEL PLUS |
COAPT SYSTEMS, INC. |
LINDA RUEDY |
| K080363 |
04/10/2008 |
BAHA CORDELLE II |
COCHLEAR BONE ANCHORED SYSTEMS AB |
SEAN BUNDY |
| K072201 |
04/14/2008 |
COMPUMEDICS SOMTE PSG RECORDING SYSTEM |
COMPUMEDICS LIMITED |
GORDON FERGUSON |
| K080444 |
04/02/2008 |
CONMED LINVATEC OSPREY DRILL SYSTEM |
CONMED LINVATEC |
SUE F DAUTERMAN |
| K080525 |
04/17/2008 |
COOK ODYSSEY HOLMIUM LASER SYSTEM, MODEL 30W |
COOK UROLOGICAL, INC. |
CINDY FOOTE |
| K073440 |
04/24/2008 |
FOUNDATION CAGE |
CORELINK LLC |
J.D. WEBB |
| K072032 |
04/04/2008 |
IGG ANTI-ATHEROX TEST KIT |
CORGENIX, INC. |
DANIEL F SIMPSON |
| K071483 |
04/04/2008 |
TETRIX CREAM |
CORIA LABORATORIES, LTD |
AMY CAMPBELL |
| K072814 |
04/16/2008 |
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES |
COVIDIEN |
ROBERT ZOTT |
| K080787 |
04/17/2008 |
BIOMOVE 5000 SYSTEM |
CURATRONIC, LTD. |
AHAVA STEIN |
| K080300 |
04/08/2008 |
CUTERA MULTIMODAL CELLULITE PRODUCT (CMMCD) |
CUTERA, INC. |
KATHY MAYNOR |
| K080373 |
04/14/2008 |
TACAHE PC1350 POWER WHEELCHAIR |
DALTON MEDICAL CORP. |
WILL RIDGWAY |
| K072930 |
04/30/2008 |
DEMETECH ABSORBABLE SURGICAL SUTURE PLAIN & CHROMIC GUT |
DEMETECH CORP. |
A.J. DIMERCURIO |
| K073483 |
04/03/2008 |
SAPPHIRE O/E ORAL EXAMINATION SYSTEM |
DEN-MAT HOLDINGS, LLC |
ALAN MATTHEWS |
| K073486 |
04/04/2008 |
DENTIS DENTAL IMPLANT SYSTEM |
DENTIS CO. LTD. |
CHANG DAE KYU |
| K080246 |
04/11/2008 |
COMPOSITE ALIGNER BUTTON |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K080311 |
04/18/2008 |
MODIFIED TEMPRX ESTHETIC PROVISIONAL SYSTEM |
DENTSPLY INTERNTIONAL |
HELEN LEWIS |
| K080918 |
04/23/2008 |
DOUBLE ARMED MENISCAL NEEDLES WITH SIZE #2-0 ORTHOCORD, MENISCAL NEEDLE WITH WIRE EYELET & 3 FREE STRANDS OF SIZE #2-0 |
Depuy Mitek |
KRISTINE CHRISTO |
| K080191 |
04/02/2008 |
EAGLE PLUS MICRO ANTERIOR CERVICAL PLATE SYSTEM |
DEPUY SPINE, INC. |
FRANK S JURCZAK |
| K073364 |
04/04/2008 |
EXPEDIUM 4.5MM SPINE SYSTEM |
DEPUY SPINE, INC. |
CHRISTOPHER KLACZYK |
| K080315 |
04/23/2008 |
DERMA SCIENCES MEDIHONEY DRESSINGS WITH ACTIVE MANUKA HONEY |
DERMA SCIENCES, INC. |
MARY MCNAMARA-CULLINANE |
| K080351 |
04/22/2008 |
DEXELA DEX TOP MAMMOGRAPHY WORKSTATION, MODEL MAMWKVI |
DEXELA LTD |
BARRY SALL |
| K080005 |
04/24/2008 |
SPARMAX ASPIRATOR, MODELS TC-2000V ND VC-701 |
DING HWA CO., LTD. |
HUI-CHEN KAI |
| K070570 |
04/15/2008 |
DIO IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
KENNY LIM |
| K080126 |
04/11/2008 |
DIO PROTEM IMPLANT SYSTEM |
DIO DEPARTMENT DSI, INC. |
HYUNGICK KIM |
| K080195 |
04/28/2008 |
NACERA Z AND NACERA Z MEDIUM |
DOCERAM MEDICAL CERAMICS GMBH |
HOLGER WAMPERS |
| K081047 |
04/29/2008 |
TRANSPOSAL ULTRA SYSTEMS |
DORNOCH MEDICAL SYSTEMS, INC. |
ANTHONY MARTINI |
| K072885 |
04/07/2008 |
CARINA SYSTEM, MODEL 8419350; CARINA BASIC DEVICE, MODEL 5704110 |
DRAEGER MEDICAL AG & CO. KG |
KATHY ANDERSON |
| K070584 |
04/02/2008 |
SMART-ROD |
DUOJECT MEDICAL SYSTEMS, INC. |
CAROLINE LAVOIE |
| K073166 |
04/22/2008 |
ENDOWAVE INFUSION SYSTEM |
EKOS CORP. |
JOCELYN KERSTEN |
| K080392 |
04/30/2008 |
EndoWave Infusion System |
EKOS CORP. |
JOCELYN KERSTEN |
| K080704 |
04/17/2008 |
LOW FLUID ALARM |
EM-TEC GMBH |
BERNHARD BRAND |
| K080836 |
04/21/2008 |
MODIFICATION TO ENDOFAST RELIANT SYSTEM |
ENDOGUN MEDICAL SYSTEMS |
DORIT WINITZ |
| K080360 |
04/08/2008 |
ENDOLOGIX VISIFLEX DUAL LUMEN CATHETER |
ENDOLOGIX, INC. |
ANNALIZA VICTORIA |
| K072302 |
04/08/2008 |
ENTELLUS MEDICAL RS-SERIES SYSTEM |
Entellus Medical, Inc. |
TOM RESSEMANN |
| K080715 |
04/02/2008 |
ERBE VIO ESU, MODEL VIO 200 S |
ERBE USA, INC. |
JOHN TARTAL |
| K072206 |
04/24/2008 |
ERCHONIA EML LASER |
ERCHONIA MEDICAL, INC. |
Kevin Walls |
| K080968 |
04/29/2008 |
S-SCAN, G-SCAN, DYNAMIC MRI SOFTWARE FOR C-SCAN, E-SCANXQ & E-SCAN OPERA |
ESAOTE S.P.A. |
CARRI GRAHAM |
| K080329 |
04/28/2008 |
CAP PLUS, EQUIVABONE, CAP/DBM |
ETEX CORP. |
PAMELA W ADAMS |
| K080621 |
04/29/2008 |
FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01 |
EUROPEAN CUSTOM MANUFACTURING BV |
WILLIAM GREENROSE |
| K073614 |
04/30/2008 |
WG-SURGICAL SUTURES WITH NEEDLE |
FOOSIN MEDICAL SUPPLIES INC. |
Diana Hong |
| K080270 |
04/16/2008 |
MANUAL RIGID MOBILITY WHEELCHAIR |
FREEDOM DESIGNS, INC. |
BOB GARDNER |
| K080945 |
04/18/2008 |
FCR GO PORTABLE DIGITAL X-RAY SYSTEM |
FUJIFILM MEDICAL SYSTEMS U.S.A., INC. |
DEBBIE PEACOCK |
| K080039 |
04/14/2008 |
PASSIVE WASTE GAS SCAVENGER, MODEL 14600 |
G. DUNDAS CO.,INC. |
MARIO SORCI |
| K073106 |
04/11/2008 |
UNIFAST III |
GC AMERICA, INC. |
MARK HEISS |
| K081028 |
04/25/2008 |
SIGNA 3.0T MR750 SYSTEM |
GE MEDICAL SYSTEMS, LLC |
MARK STAUFFER |
| K080697 |
04/07/2008 |
SKIN CLEAR SRVH LONG-PULSED ND: YAG LASER |
GLOBAL USA DISTRIBUTION, LLC. |
RONALD BERGLUND |
| K072458 |
04/10/2008 |
GBI TSH NEONATAL SCREENING KIT |
GOLDEN BRIDGE INTERNATIONAL, INC. |
XIAOPING ZHANG |
| K080070 |
04/17/2008 |
K-HELIX PISTON AND PORP PARTIAL OSSICULAR REPLACEMENT PROSTHESES |
Grace Medical, Inc. |
JEFF COBB |
| K080235 |
04/24/2008 |
SAFETY INFUSION SET |
GREINER BIO-ONE VACUETTE NORTH AMERICA |
JUDITH SMITH |
| K072444 |
04/04/2008 |
WELLGRAFT PE I |
GWOWEI TECHNOLOGY CO., LTD. |
JENNIFER REICH |
| K072170 |
04/04/2008 |
WELLGRAFT PE II |
GWOWEI TECHNOLOGY CO., LTD. |
JENNIFER REICH |
| K080827 |
04/04/2008 |
HANDAN N95 PARTICULATE RESPIRATORS AND SURGICAL MASK, MODELS HY8510 AND HY9810 |
HANDAN HENGYONG PROTECTIVE & CLEAN PRODUCTS CO., L |
MAGGIE ZHONG |
| K073358 |
04/25/2008 |
LUMIMED SERIES 5MP DIGITAL FLAT PANEL DISPLAY SYSTEM, MODEL MM50/MM50A |
HEEYOUNG CO., LTD. |
CARL THOMAS |
| K080338 |
04/21/2008 |
CUTTERSIL ACTIVATOR UNIVERSAL PLUS |
HERAEUS KULZER GMBH |
CHERYL V ZIMMERMAN |
| K080226 |
04/09/2008 |
NAVICARE -WATCHCHILD OBSTETRICAL DATA MANAGEMENT SYSTEM (NAVICARE -WATCHCHILD), MODEL P2912 |
HILL-ROM MANUFACTURING, INC. |
DAWN M REILLY |
| K073269 |
04/18/2008 |
HC1000P SLEEP DIAGNOSIS SOFTWARE SYSTEM |
HYPNOCORE, LTD. |
GEORGE J HATTUB |
| K080325 |
04/08/2008 |
IGROK |
IGROK, LLC |
ROBERT J RIKER |
| K072932 |
04/25/2008 |
INFRAREDIX NIR IMAGING SYSTEM, GEN. 1.0, MODEL MC-5 |
Infraredx, Inc. |
STEVEN J CHARTIER |
| K072379 |
04/29/2008 |
MPS OXIPORT AND MPS OXIPORT PLUS |
INNERSPACE, INC. |
DON BOBO |
| K080917 |
04/09/2008 |
IROOT SP |
INNOVATIVE BIOCERAMIX INC. |
QUANZU YANG |
| K073690 |
04/17/2008 |
INTERLACE MEDICAL HYSTEROSCOPIC MORCELLATION SYSTEM |
INTERLACE MEDICAL, INC. |
RON ADAMS |
| K072598 |
04/14/2008 |
IRSG I-MOVER FOR BEDS |
INTERNATIONAL RETAIL SERVICES GROUP, LLC |
KAREN M RUSSELL |
| K073710 |
04/11/2008 |
INTOUCH REMOTE PRESENCE ROBOTIC SYSTEM, MODEL RP-7 |
INTOUCH TECHNOLOGIES |
BILL STOUT |
| K073404 |
04/25/2008 |
IFS LASER SYSTEM |
INTRALASE CORP. |
MAUREEN WEINER |
| K073695 |
04/09/2008 |
3D ACCU-I-TOMO XYZ SLICE VIEW TOMOGRAPH, MODEL MCT-1F8/F17 |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K073696 |
04/08/2008 |
VERAVIEWEPOCS |
J. MORITA USA, INC. |
KEITH A BARRITT |
| K070587 |
04/10/2008 |
ELEGANCE WOMAN'S LUBRICANT |
JULIE WILLIAMS, PA-C |
JULIE WILLIAMS |
| K080792 |
04/08/2008 |
K2M COCR ROD |
K2M, INC. |
RICHARD W WOODS |
| K080410 |
04/09/2008 |
KARL STORZ SCB/CONMED ESU INTERFACE MODULE, MODEL 20091522 |
KARL STORZ ENDOSCOPY-AMERICA, INC. |
SUSIE CHEN |
| K080821 |
04/22/2008 |
MICROCUFF PEDIATRIC ENDOTRACHEAL TUBE |
KIMBERLY-CLARK CORP. |
SHERRI SAURINI |
| K072811 |
04/21/2008 |
MARIONETTE SA, MODEL 001 001 & 001 002 |
KINETIC SURGICAL LLC |
JIM CAPUTO |
| K080681 |
04/04/2008 |
KOWA GENESIS-D |
KOWA CO. LTD. |
SATOHIKO TAKANASHI |
| K073590 |
04/10/2008 |
KRONUS IA-2 AUTOANTIBODY RIA ASSAY KIT |
KRONUS MARKET DEVELOPMENT ASSOCIATES, INC. |
HEATHER VIELE |
| K080572 |
04/07/2008 |
LDR SPINE ROI-A IMPLANT |
LDR SPINE USA |
NOAH BARTSCH |
| K080502 |
04/08/2008 |
MODIFICATION TO:PILOT SPINAL SYSTEM |
LIFE SPINE |
REBECCA M BROOKS |
| K073187 |
04/22/2008 |
PERIPHERAL NERVE BLOCK SUPPORT TRAY |
LIFE-TECH, INC. |
JEFF KASOFF |
| K080353 |
04/03/2008 |
LTM-T SURGICAL MESH |
LIFECELL CORP. |
LORRAINE T MONTEMURRO |
| K073231 |
04/18/2008 |
ONETOUCH ULTRALINK BLOOD GLUCOSE MONITORING SYSTEM |
LIFESCAN, INC. |
KIM FONDA |
| K072414 |
04/07/2008 |
CRYOSTAT |
LIL DRUG STORE PRODUCTS, INC. |
PATRICIA L MILLER |
| K080248 |
04/23/2008 |
SPECTRA VRMIII Q-SWITCHED ND: YAG LASER SYSTEM AND DYE HANDPIECES |
LUTRONIC CORPORATION |
MAUREEN O'CONNELL |
| K080162 |
04/22/2008 |
UNO - ONE PIECE SCREW-TYPE DENTAL IMPLANT |
M.I.S. IMPLANTS TECHNOLOGIES LTD. |
IMAN KHORSHID |
| K072583 |
04/04/2008 |
PLEGIOX CARDIOPLEGIA HEAT EXCHANGER, WITH SAFELINE COATING, MODEL(S) CHX30, BSQ-CHX 30 |
MAQUET CARDIOPULMONARY AG |
KATRIN SCHWENKGLENKS |
| K072614 |
04/15/2008 |
MATANG BLACK, POWDER FREE AND POLYMER COATED LATEX EXAMINATION GLOVE |
MATANG MFG. SDN. BHD. |
LESLIE LEONG |
| K073468 |
04/02/2008 |
MIMICS |
MATERIALISE N.V. |
MIEKE JANSSEN |
| K073449 |
04/16/2008 |
SURGICASE |
MATERIALISE N.V. |
MIEKE JANSSEN |
| K080885 |
04/28/2008 |
MEDACTA TOTAL HIP PROSTHESIS SYSTEM - LINE EXTENSION |
MEDACTA INTERNATIONAL, SA |
NATALIE J KENNEL |
| K072722 |
04/24/2008 |
MEDDORNA WIRELESS PRN SPIROMETER 100 |
MEDDORNA LLC |
J. HARVEY KNAUSS |
| K073497 |
04/14/2008 |
HDL CHOLESTEROL REAGENT, MODEL 10211 |
MEDICA CORP. |
Photios Makris |
| K080099 |
04/09/2008 |
PASS SPINAL SYSTEM |
MEDICREA TECHNOLOGIES |
J.D. WEBB |
| K080095 |
04/11/2008 |
CORAMATE/SPIROTOME SYSTEM |
MEDINVENTS |
JAAK JANSSENS |
| K080800 |
04/07/2008 |
ACCUVIX V20 DIAGNOSTIC ULTRASOUND SYSTEM |
MEDISON CO., LTD. |
SHIM KYUNG-AM |
| K072551 |
04/02/2008 |
LD-I 75 AND LD-I 200 |
MEDITECH INTERNATIONAL, INC. |
RICHARD KEEN |
| K071552 |
04/25/2008 |
PURACOL PLUS AG COLLAGEN MICROSCAFFOLD WOUND DRESSING |
MEDLINE INDUSTRIES, INC. |
MATT CLAUSEN |
| K080884 |
04/11/2008 |
QHRV 1 - HEALTH ASSESSMENT SYSTEM |
MEDTECHS, LLC |
MEGHAN ATH |
| K073356 |
04/25/2008 |
PARADIGM INSULIN INFUSION PUMP, MODELS MMT-512, MMT-712, MMT-515 AND MMT-715 |
MEDTRONIC MINIMED |
MARK J FAILLACE |
| K080083 |
04/10/2008 |
INTREPID SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK |
LEE GRANT |
| K080805 |
04/18/2008 |
MODIFICATION TO VERTEX RECONSTRUCTION SYSTEM |
MEDTRONIC SOFAMOR DANEK |
CHRISTINE SCIFERT |
| K073291 |
04/24/2008 |
CAPSTONE SPINAL SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LEE GRANT |
| K080429 |
04/30/2008 |
MODIFICATON TO: PYRAMID +4 ANTERIOR LUMBAR PLATE SYSTEM |
MEDTRONIC SOFAMOR DANEK USA, INC. |
LILA JOE |
| K073058 |
04/11/2008 |
RESCUE INTERNAL IMPLANT SYSTEM |
MEGAGEN CO., LTD. |
STEVE CHANG |
| K080305 |
04/07/2008 |
NEXCOMP AND META ETCHANT |
META BIOMED CO., LTD. |
TAE-HOON KIM |
| K073447 |
04/24/2008 |
SURGI GLOVES |
METACURE SURGICAL GLOVES SDN BHD |
JEFRI SHARAAI |
| K072613 |
04/21/2008 |
DIRECTVIEW, LIGHTGUIDE, MODEL(S) 10RLL-320 LAPAROSCOPE, 10DLG-320 DISPOSABLE LIGHT GUIDE FOR ABOVE |
MICRO INVASIVE TECHNOLOGY INC. |
JOHN BALA |
| K080863 |
04/17/2008 |
TRAXCESS 0.014 HYDROPHILIC GUIDEWIRE |
MICROVENTION, INC. |
KEVIN E DALY |
| K063437 |
04/04/2008 |
ACCUBIND NEO-TSH MICROWELL ELISA, MODEL 3425-300 |
MONOBIND, INC. |
JAY SINGH |
| K080820 |
04/02/2008 |
TEM 3002G- HN DUAL TUNE HEAD COIL |
MR INSTRUMENTS, INC. |
MARK WATSON |
| K071447 |
04/18/2008 |
VARIOS 75 |
NAKANISHI, INC. |
TOMOKO HIRABAYASHI |
| K072905 |
04/18/2008 |
3TEST SUPREME GLUCOSE MONITORING SYSTEM |
NEUERO ENGINEERING INC. |
Ke-Min Jen |
| K070217 |
04/04/2008 |
INTERX 1000/DERMA 200 STIMULATOR FOR COSMETIC USE |
NEURO RESOURCE GROUP, INC. |
KRISTA OAKES |
| K080261 |
04/11/2008 |
IMPULSE IQ ADJUSTING INSTRUMENT |
NEUROMECHANICAL INNOVATIONS, LLC |
CHRISTOPHER J COLLOCA |
| K070109 |
04/25/2008 |
NEUROMETRIX ADVANCE |
NEUROMETRIX, INC. |
RAINER N MAAS |
| K080163 |
04/10/2008 |
COOLTOUCH MODELS LC215 AND COOLLIPO |
NEW STAR LASERS, INC. |
NATALIE R VOLLRATH |
| K080880 |
04/09/2008 |
RTM AND OVAL |
NEXT MOBILITY, LLC |
JOSEPH AZARY |
| K080141 |
04/25/2008 |
PC ECG 1200W SYSTEM |
NORAV MEDICAL LTD. |
BENNY ARAZY |
| K073132 |
04/03/2008 |
MODEL D DISC FORCE |
NORTH AMERICAN MEDICAL CORP (NAM) |
CHELLO GRACE |
| K080438 |
04/04/2008 |
DENTAL UNIT WITH CHAIR |
NORTH WEST MEDICAL INSTRUMENT (GROUP) CO., LTD. |
DIANA HONG |
| K080929 |
04/16/2008 |
ONCENTRA GYN |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K080871 |
04/29/2008 |
TROCAR POINT TITANIUM NEEDLE SETS, ROUND POINT TITANIUM NEEDLE SETS |
NUCLETRON CORPORATION |
LISA DIMMICK |
| K080376 |
04/02/2008 |
ONCOBIONIC SYSTEM |
ONCOBIONIC INCORPORATED |
PAUL MIKUS |
| K080622 |
04/02/2008 |
ENTITY NASOVIEW LED NASOPHARYNGOSCOPE, MODEL 006105 |
OPTIM, INC. |
ROBERT KRUPA |
| K073465 |
04/07/2008 |
US/GS ULTRA WIDE SYSTEM |
OSSTEM IMPLANT CO.,LTD |
MIN JOO KIM |
| K080511 |
04/21/2008 |
PLEXUR-P |
OSTEOTECH, INC. |
CHRIS TALBOT |
| K073617 |
04/09/2008 |
PHARAON LIPO |
OSYRIS |
JAOUAD ZEMMOURI |
| K080082 |
04/16/2008 |
OXLIFE INDEPENDENCE OXYGEN CONCENTRATORS |
OXLIFE LLC |
MARGARET K POTEAT |
| K080567 |
04/16/2008 |
PALOMAR ASPIRE LASER PLATFORM |
PALOMAR MEDICAL PRODUCTS, INC. |
Sharon Timberlake |
| K071867 |
04/28/2008 |
RAPID GENOTYPING ASSAY -CYP2C9 & VKORC1, MODEL CATALOG NO. 006+0203 GACTGA |
PARAGONDX, LLC |
DEBORAH N KLOOS |
| K073376 |
04/11/2008 |
PHILIPS ECG ALGORITHM |
PHILIPS MEDICAL SYSTEMS |
PAUL SCHRADER |
| K080927 |
04/11/2008 |
BRIGHTVIEW VCT IMAGING SYSTEM |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
COLEEN A COLEMAN |
| K081135 |
04/29/2008 |
GEMINI CONDOR |
PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. |
MELINDA NOVATNY |
| K080961 |
04/18/2008 |
NM APPLICATION SUITE |
PHILIPS NUCLEAR MEDICINE, INC |
LORI R PETERSON |
| K080806 |
04/04/2008 |
ANGIOJET ULTRA SPIROFLEX VG THROMBECTOMY SET, MODEL 106608 |
POSSIS MEDICAL, INC. |
MIKE BURNSIDE |
| K080627 |
04/24/2008 |
PROMEDICAL SURGICAL GOWNS, MODELS: 1002494A, 100770A |
PROMEDICAL PRODUCTS CO., LTD. |
LEO WEI |
| K080865 |
04/24/2008 |
FAST1 INTRAOSSEOUS INFUSION SYSTEM |
PYNG MEDICAL CORP. |
MAYA BUTTERFIELD |
| K080418 |
04/30/2008 |
REGENAFIL, REGENAFORM, ALRIVA DBM PASTE, SLTIVA DM WITH CORTICAL CANCELLOUS SHIPS, BIOSET, SIOSET IC, RTI ALLOGRAFT PAST |
REGENERATION TECHNOLOGIES, INC. |
TRAVIS AROLA |
| K080079 |
04/08/2008 |
S8 ESCAPE II |
RESMED LTD. |
DAVID D'CRUZ |
| K080131 |
04/01/2008 |
VPAP ST |
RESMED LTD. |
DAVID D'CRUZ |
| K073600 |
04/25/2008 |
COMFORTGEL FULL FACE MASK |
RESPIRONICS INC., SLEEP & HOME RESPIRATORY GROUP |
ZITA T YURKOS |
| K071591 |
04/16/2008 |
RAMP INFLUENZA A/B ASSAY |
RESPONSE BIOMEDICAL CORP. |
KEN PILGRIM |
| K072714 |
04/18/2008 |
TINA-QUANT HEMOGLOBIN A1C GEN.2 TEST SYSTEM |
ROCHE DIAGNOSTICS CORP. |
THERESA A BUSH |
| K071261 |
04/17/2008 |
ISOBAR SEMI-RIGID DUAL DAMPENER |
SCIENT'X |
JOHN SANDERS |
| K072729 |
04/17/2008 |
SIERRA |
SEASPINE, INC. |
ETHEL BERNAL |
| K080526 |
04/16/2008 |
SIERRA SYSTEM |
SEASPINE, INC. |
ETHEL BERNAL |
| K080472 |
04/23/2008 |
SEDAT MYSHELL LITE |
SEDAT |
LAETITIA COUSIN |
| K080789 |
04/03/2008 |
BLOOD PRESSURE MONITOR, MODELS BP-102, BP-103, BP-201 AND BP-202 |
SEJOY ELECTRONICS & INSTRUMENTS CO., LTD. |
JIANYAO WU |
| K080791 |
04/30/2008 |
CONTURA MULTI-LUMEN BALLOON SOURCE APPLICATOR FOR BRACHYTHERAPY, MODELS B001-45 AND B011-45 |
SENORX, INC. |
EBEN GORDON |
| K080192 |
04/03/2008 |
HYPERVISOR VI CENTRAL MONITORING SYSTEM (INCLUDING TMS) |
SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD |
SUSAN D GOLDSTEIN |
| K080520 |
04/30/2008 |
NON STERILE, POWDER FREE NITRILE EXAMINATION GLOVE, BLUE, POLYMER COATING WITH CHEMOTHERAPY CLAIM |
SIAM SEMPERMED CORP. LTD. |
WILLIAM E HARRIS |
| K072728 |
04/22/2008 |
SYNGO MULTIMODALITY WORKPLACE |
SIEMENS AG, MEDICAL SOLUTIONS |
SABINE SCHROEDEL |
| K081018 |
04/25/2008 |
SYNGO DYNAMICS VERSION 7.0 |
SIEMENS MEDICAL SOLUTIONS |
|
| K072658 |
04/01/2008 |
ADVIA CHEMISTRY C-REACTIVE PROTEIN_2, (CRP_2) AND CALIBRATORS |
SIEMENS MEDICAL SOLUTIONS DIAGNOSTICS |
PHILIP LIU |
| K080760 |
04/25/2008 |
ACUSON X300 ULTRASOUND SYSTEM |
SIEMENS MEDICAL SOLUTIONS USA, INC., ULTRASOUND DI |
MARTINA VOGT |
| K080815 |
04/23/2008 |
TOSCA II ANTERIOR CERVICAL PLATE SYSTEM |
SIGNUS MEDIZINTECHNIK GMBH |
KAREN E WARDEN |
| K080882 |
04/11/2008 |
CEREC OPTI SPRAY |
SIRONA DENTAL SYSTEMS GMBH |
|
| K080358 |
04/23/2008 |
PLLA, HA SCREW |
SMITH & NEPHEW INC., ENDOSCOPY DIV. |
DEANA BOUSHELL |
| K080434 |
04/10/2008 |
INTERTAN CHS LOCKING PLATE SYSTEM PROX FEM PLATES/SCREW |
SMITH & NEPHEW, INC. |
ELIZABETH MILLER |
| K080743 |
04/25/2008 |
LOCKBOX FOR USE WITH CADD SOLIS INFUSION PUMP |
SMITHS MEDICAL MD, INC. |
DAVID H SHORT |
| K080058 |
04/16/2008 |
TURBO PRIME IBD SYSTEM |
SPINE SELECT, LLC |
RICHARD JANSEN |
| K080042 |
04/03/2008 |
SPIRUS MEDICAL SURGICAL INSTRUMENT |
SPIRUS MEDICAL, INC. |
PAMELA PAPINEAU |
| K071626 |
04/01/2008 |
DUREX PLAY SOFT & SENSUAL LUBRICANT |
SSL AMERICAS |
CHRIS ROBINSON |
| K080924 |
04/30/2008 |
MOND RVOT STYLET MODELS 4140, 4141, 4150, 4151 |
ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI |
COLLEEN CANAN |
| K072408 |
04/30/2008 |
EMU-GRAPH EMULATOR, MODEL CI 131 |
STERITEC PRODUCTS MFG. CO., INC. |
LINDA NELSON |
| K080239 |
04/30/2008 |
P.004 ABUTMENTS, P.004 TEMPORARY COPINGS, P.004 PROTECTIVE CAPS, P.004 PERMANENT COPINGS |
STRAUMANN MANUFACTURING, INC. |
ELAINE ALAN |
| K080928 |
04/30/2008 |
XIA SPINAL SYSTEM, STAINLESS STEEL UNI-PLANAR SCREWS |
STRYKER SPINE |
CURTIS TRUESDALE |
| K080985 |
04/23/2008 |
QUILL SELF-RETAINING SYSTEM (SRS) COMPRISED OF POLYDIOXANONE (PDO) |
SURGICAL SPECIALTIES CORP. |
TRUDY D ESTRIDGE |
| K073610 |
04/23/2008 |
ELTA ADVANCED WOUND WASH |
SWISS AMERICAN PRODUCTS, INC. |
ERIC LUO |
| K073715 |
04/23/2008 |
ELIPO |
SYNERON MEDICAL LTD. |
YONI IGER |
| K080317 |
04/29/2008 |
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 |
| K080943 |
04/23/2008 |
SYNTHES 4.5 MM AND 6.5 MM HEADLESS COMPRESSION SCREWS |
SYNTHES (USA) |
SHERI L MUSGNUNG |
| K080331 |
04/30/2008 |
SYNTHES CRANIOFACIAL PLATE AND SCREW SYSTEM |
SYNTHES (USA) |
AMNON TALMOR |
| K073494 |
04/02/2008 |
CLEVER CHEK BLOOD GLUCOSE MONITORING SYSTEM, MODELS TD-4209, -4222, -4225 AND -4226 AND ACHTUNG BLOOD GLUCOSE MONITORING |
TaiDoc Technology Corporation |
Yuhua Chen |
| K073445 |
04/02/2008 |
CLEVER TD-3026 DIGITAL WRIST BLOOD PRESSURE MONITOR, MODEL TD-3026 |
TaiDoc Technology Corporation |
ERICA LI |
| K080593 |
04/02/2008 |
FORA COMFORT 4 IN 1 EAR THERMOMETER, MODEL TD-1116 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K080501 |
04/21/2008 |
SURECHEK EDGE BLOOD GLUCOSE MONITORING SYSTEM, MODEL SMS-4240 |
TaiDoc Technology Corporation |
Yuhua Chen |
| K062691 |
04/15/2008 |
COMPORUS |
TAKIRON CO., LTD |
KENSHI OKAZAKI |
| K071524 |
04/10/2008 |
TCMNATURELMED, HEALTHCARE, BLOODCARE, BO'S ABDOMINAL |
TCM WORLD INC. |
YUWADEE IMTANAVANICH |
| K072548 |
04/18/2008 |
CREATINE KINASE LIQUID REAGENT, MODEL C519-440 |
TECO DIAGNOSTICS |
KELLY CHEN |
| K080774 |
04/17/2008 |
CAPIOX SP PUMP (WITH OR WITHOUT X-COATING) |
TERUMO CARDIOVASCULAR SYSTEMS CORP. |
GARRY A COURTNEY |
| K080132 |
04/09/2008 |
THD DISPOSABLE ANOSCOPE/PROCTOSCOPE |
THD SPA |
GUIDO BONAPACE |
| K080802 |
04/30/2008 |
EMAX 2 PLUS SYSTEM, MODEL EMAX 2 PLUS MOTOR, EMAX 2 CONSOLE>FIRMWARE UPGRADE, EMAX 2 FP FOOT PEDAL |
THE ANSPACH EFFORT, INC. |
JIM BANIC |
| K080690 |
04/25/2008 |
MANTA RAY ANTERIOR CERVICAL PLATE SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K080790 |
04/29/2008 |
MODIFICATION TO THEKEN ATOLL CERVICO-THORACIC SYSTEM |
THEKEN SPINE LLC |
DALE DAVISON |
| K072064 |
04/21/2008 |
GRAVILAX TRACTION SYSTEM |
THERAPEUTIC CLINICAL TECHNOLOGIES, INC. |
DANIEL J MANELLI |
| K080085 |
04/30/2008 |
MAS TOX CONTROL |
Thermo Fisher Scientific |
JACK ROGERS |
| K080274 |
04/23/2008 |
AMBULO 2400 |
TIBA MEDICAL, INC. |
MERAT BAGHA |
| K080335 |
04/23/2008 |
TORNIER CINCH KNOTLESS FIXATION IMPLANT SYSTEM |
TORNIER, INC. |
Howard Schrayer |
| K073643 |
04/28/2008 |
TRANS1 AXIALIF 2-LEVEL OR II SYSTEM |
TRANS1 INCORPORATED |
ROBERT SHERIDAN |
| K080524 |
04/23/2008 |
CENTURION SORBAVIEW OTC |
TRI-STATE HOSPITAL SUPPLY CORP. |
MATTHEW K PRICE |
| K080889 |
04/29/2008 |
KODAK 9000C EXTRAORAL IMAGING SYSTEM |
TROPHY |
MARIE-PIERRE LABAT-CAMY |
| K073492 |
04/08/2008 |
DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-INFINITY BLOOD GLUCOSE MONITORING SYSTEM |
TYSON BIORESEARCH, INC. |
WEN-HAI TSAI |
| K080768 |
04/11/2008 |
ULTRATEMP FIRM, FAST AND REGULAR SET |
ULTRADENT PRODUCTS, INC. |
DIANE ROGERS |
| K080784 |
04/02/2008 |
WBR XPRESS.CARDIAC, WBR XPRESS.BONE; WBR XACT.CARDIAC, WBR XACT.BONE |
ULTRASPECT LTD. |
DAN LAOR |
| K073585 |
04/17/2008 |
INNERCHANGE MICRO-INTRODUCER CATHETER, MODELS 7900, 7901, 7902, 7903, 7904 AND 7905 |
VASCULAR SOLUTIONS, INC. |
ALYSSA MALINSKI |
| K060387 |
04/10/2008 |
PHYSIOFLOW SYSTEM |
VASOCOM, INC. |
STEPHEN STAATS |
| K073365 |
04/08/2008 |
DENTAL DIGITAL X-RAY IMAGING SYSTEM |
VATECH CO., LTD. |
STEPHEN T MLCOCH |
| K073143 |
04/07/2008 |
MODIFIED VERTIFLEX SPINAL SCREW SYSTEM |
VERTIFLEX, INC. |
STEVE REITZLER |
| K072061 |
04/22/2008 |
MASTERSCREEN PFT, MASTERSCREEN PFT CT, MASTERSCREEN PFT BODY |
VIASYS HEALTHCARE GMBH |
Yvette Lloyd |
| K080553 |
04/16/2008 |
DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16 |
VIEWORKS CO., LTD. |
CHARLIE MACK |
| K072799 |
04/24/2008 |
TARGET STERILE ELECTRODE |
VISION QUEST INDUSTRIES, INC. |
JAIME X PULLEY |
| K080060 |
04/04/2008 |
VIVOSONIC NEUROSCREEN |
VIVOSONIC, INC. |
AMJAD RANA |
| K070889 |
04/14/2008 |
AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112 |
WALLAC OY |
GUNNEL LAAKSONEN |
| K080686 |
04/22/2008 |
WESTCON HORIZON 49% (HIOXIFILCON B) |
WESTCON CONTACT LENS CO. |
KEVIN RANDALL |
| K080182 |
04/08/2008 |
ZENO PMMA DISC |
WIELAND DENTAL + TECHNIK GMBH & CO. KG |
GERHARD POLZER |
| K080850 |
04/10/2008 |
DARCO HEADLESS COMPRESSION SCREW |
WRIGHT MEDICAL TECHNOLOGY, INC. |
THERESA LEISTER |
| K080663 |
04/08/2008 |
PROFEMUR LX REVISION 5/8 COATED HIP STEM |
WRIGHT MEDICAL TECHNOLOGY, INC. |
RYAN ROSS |
| K063810 |
04/18/2008 |
YULEX LATEX POWDER-FREE EXAM GLOVES |
YULEX CORPORATION |
KATRINA CORNISH |
| K080043 |
04/04/2008 |
VIZILITE EYEWEAR |
ZILA, INC. |
MARK BRIDE |
| K080735 |
04/04/2008 |
CRYOMINI |
ZIMMER ELEKTROMEDIZIN GMBH |
ARMIN PETRASCHKA |
| K080232 |
04/23/2008 |
ZOLL E SERIES 12SL, ANALYSIS OPTION |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
EILEEN M BOYLE |
| K072923 |
04/24/2008 |
ZOLL E SERIES DEFIBRILLATOR |
ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS |
SEAN REYNOLDS |
