FDA 510(k) Decisions During April, 2008  

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 MODIFICATION TO 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
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