FDA 510(k) Decisions During April, 2007  

FDA 510(k) Number Decision Date Device Name Applicant Contact
K061479 04/05/2007 ARGOS 3D LINE MEDICAL SYSTEMS S.R.L. MARCO LUZZARA
K063458 04/05/2007 3M TEGADERM CHG DRESSING 3M COMPANY MARIA RUIZ
K061849 04/30/2007 MESODERM AA ADVANCED TECHNOLOGY INC. E.J. SMITH
K070850 04/10/2007 FREESTYLE LITE BLOOD GLUCOSE MONITORING SYSTEM ABBOTT DIABETES CARE INC. DHRUMA SHAH
K063329 04/16/2007 ABBOTT ARCHITECT HAVAB-M ABBOTT LABORATORIES JOSEPH C ORLOWSKI
K063059 04/19/2007 SORBACT WOUND DRESSING ABIGO MEDICAL AB EMALEE G MURPHY
K070943 04/19/2007 B-SCAN PLUS ACCUTOME ULTRASOUND, INC. JEFFREY WRIGHT
K070051 04/06/2007 ACUMEN INSIGHT ENDOCARDIAL VISUALIZATION SYSTEM ACUMEN MEDICAL, INC. MARYBETH GAMBER
K070847 04/11/2007 TRIAL CABLE, 3009 ADVANCED NEUROMODULATION SYSTEMS PENNY HOUSTON
K070168 04/18/2007 N95 RESPIRATOR, MODELS N9504C, N9504CS AND N9514C AEARO COMPANY ANN L PHILLIPS
K070178 04/30/2007 AESCULAP RESORBABLE PIN, MODEL FR735 AESCULAP IMPLANT SYSTEM, INC. MATTHEW M HULL
K063728 04/04/2007 TNN-DU810 NON-INVASIVE SUBDERMAL THERAPY SYSTEM ALFA TECH MEDICAL SYSTEMS, LTD. SUSAN D GOLDSTEIN-FALK
K063306 04/17/2007 ACE HEMOGLOBIN A1C REAGENT, MODEL ACI-21, HEMOGLOBIN A1C CALIBRATORS, MODEL S2-72, HEMOGLOBIN A1C CONTROLS, MODEL C2-72 ALFA WASSERMANN, INC. MURRAY ROSENTHAL, PHD
K070466 04/17/2007 REVOLIX DUO LASER SYSTEM ALLMED SYSTEMS INC. PETER ALLEN
K070004 04/23/2007 ACCENT ALMA LASERS LTD. ANNE WORDEN
K062332 04/25/2007 ALTAIRE MPS#1 MULTIPURPOSE CONTACT LENS SOLUTION ALTAIRE PHARMACEUTICALS, INC. MARTIN DALSING
K061812 04/06/2007 COMBI SCAN 500 URINE TEST STRIP ANALYZER, MODEL A93005 ANALYTICON BIOTECHNOLOGIES AG KLAUS LANGER
K061846 04/06/2007 COMBI SCAN100 ANALYTICON BIOTECHNOLOGIES AG KLAUS LANGER
K070803 04/06/2007 INVIVODENTAL ANATOMAGE, INC ROBERT J CHIN
K063125 04/13/2007 FILTERFLO HEPA; THERMOFLO HEPA (FILTER / HME) ARC MEDICAL, INC. PAUL DRYDEN
K063172 04/27/2007 ARTHROCARE CAVITY SPINEWAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K070374 04/25/2007 ARTHROCARE ENT PLASMA WAND ARTHROCARE CORP. VALERIE DEFIESTA-NG
K070851 04/13/2007 ARTHROCARE SPINEWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K070958 04/23/2007 MODIFICATION TO ARTHROCARE ARTHROWANDS ARTHROCARE CORP. VALERIE DEFIESTA-NG
K070227 04/16/2007 OPUS MAGNUM PI KNOTLESS FIXATION DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K070671 04/06/2007 OPUS SMARTSTITCH SUTURE DEVICE ARTHROCARE CORP. LAURA N KASPEROWICZ
K070866 04/11/2007 ASC-12 PIEZOELECTRIC SCALER ASEPTICO, INC. GRANT RAMALEY
K063779 04/27/2007 OSSEOSPEED 4.0S-6MM, MODEL 24619 ASTRA TECH, INC. FLOYD G LARSON
K070330 04/24/2007 THIRD EYE RETROSCOPE AUXILIARY ENDOSCOPY SYSTEM AVANTIS MEDICAL SYSTEMS, INC. SCOTT RUTHERFORD
K062641 04/30/2007 BODY-STIM, BIOMODULATOR, BEST-RSI, BEST PRO, MODEL BEST-AV1 AVAZZIA, INC. CATHERINE TONE
K063231 04/16/2007 MICROBLADE SHAVER AND ACCESSORIES BAXANO, INC. SHARON ROCKWELL
K070125 04/16/2007 COLLEAGUE GUARDIAN CONFIGURATION TOOL; COLLEAGUE DL2 EVENT HISTORY DOWNLOAD SOFTWARE APPLICATION BAXTER HEALTHCARE CORP. JEME WALLACE
K070130 04/19/2007 ORBITAL RECONSTRUCTIVE IMPLANT BECKER & ASSOCIATES CONSULTING INC CAMPBELL TUSKEY
K062797 04/11/2007 POWDERED LATEX SURGICAL GLOVE BEIJING REAGENT LATEX PRODUCTS CO., LTD. RYAN BARR
K070546 04/02/2007 LYPHOCHEK DIABETES CONTROL BIO-RAD LABORATORIES ELIZABETH PLATT
K070848 04/25/2007 LIQUICHEK URINALYSIS CONTROL (BI-LEVEL), CONTROL LEVEL1, LEVEL 2,MINIPAK, 435,436,437,435X BIO-RAD, DIAGNOSTICS GRP. ELIZABETH PLATT
K053492 04/12/2007 BIODUCT BIODUCT, LLC HERB SCHWARTZ
K070624 04/06/2007 HYPERQ SYSTEM BIOLOGICAL SIGNAL PROCESSING LTD. GEORGE J HATTUB
K070659 04/04/2007 BIOLUCENT APPLICATOR KIT BIOLUCENT, INC. DAVE CAMPBELL
K070274 04/03/2007 ECHO BI-METRIC PRESS-FIT STEMS BIOMET MANUFACTURING CORP. SUSAN ALEXANDER
K063139 04/04/2007 SPINAL STABILIZING SPHERE SYSTEM BIOMET SPINE PATRICIA SANDBORN BERES
K070710 04/19/2007 ACCUTRANS DISPOSABLE PRESSURE MONITORING SYSTEM BIOSENSORS INTERNATIONAL-USA SARA TOYLOY
K063098 04/11/2007 STATIC CRANIOPLASTY ORTHOSIS BOSTON BRACE INTL., INC. JAMES WYNNE
K071011 04/27/2007 MODIFICATION TO: BRAEMAR ER900 SERIES ENHANCED ALGORITHM ECG EVENT RECORDER BRAEMAR, INC. DARREN DERSHEM
K070106 04/23/2007 VV FLUORO 3D BRAINLAB AG RAINER BIRKENBACH
K070879 04/24/2007 BARD MALECOT AND PEZZER DRAINS C.R. BARD, INC. JOHN KNORPP
K063848 04/04/2007 POWERGROSHONG PICC CATHETER C.R. BARD, INC. LYNN M KIRCHOFF
K070602 04/02/2007 C.T.M. MOBILITY SCOOTER# HS-265 C.T.M. HOMECARE PRODUCT, INC. LINDA J BOVARD
K070718 04/13/2007 MODIFICATION TO: BODYGUARD INFUSION SYSTEM CAESAREA MEDICAL ELECTRONICS LTD. SHLOMI DINES
K070220 04/12/2007 OSTEOFIX BONE VOID FILLER CALCITEC, INC JANICE M HOGAN
K070413 04/26/2007 ASCENT UNIVERSAL ADHESIVE, MODEL 006-00028 CAO GROUP, INC. ROBERT K LARSEN
K070091 04/18/2007 COAXIAL BONE AND VERTEBRAL BODY BIOPSY NEEDLE MODEL# JBC1213, JBC1208 CARDINAL HEALTH, INC. SHARON NICHOLS
K070680 04/05/2007 CARDIOMEMS ENDOSURE S2 14F WIRELESS AAA PRESSURE MEASUREMENT SYSTEM, MODEL# S2-2080 CARDIOMEMS, INC. GRACE POWERS
K070537 04/30/2007 ZIRBLOCK CDL TECHNOLOGIES INC. DANIEL KAMM
K070462 04/17/2007 XPERT MRSA CEPHEID RUSSEL K ENNS
K070512 04/27/2007 MODIFICATION TO AQUADEX FLEXFLOW SYSTEM CHF SOLUTIONS, INC. CHRIS SCAVOTTO
K070796 04/06/2007 CHILI PACS CHILI GMBH UWE ENGELMANN
K063872 04/06/2007 KINESIA CLEVELAND MEDICAL DEVICES, INC. JOSEPH GIUFFRIDA
K070836 04/20/2007 EXICLIP EXCS-M CLEVEX INC. LENA SATTLER
K070521 04/24/2007 MODIFIED MERCY RETRIEVER, MODEL 90070 CONCENTRIC MEDICAL, INC. KIRSTEN VALLEY
K070233 04/02/2007 CONMED LINVATEC SMART GUARD IRRIGATOR CONMED LINVATEC ELIZABETH M PAUL
K063271 04/16/2007 AQUACEL HYDROFIBER DRESSING AND AQUACEL AG WITH HYDROFIBER SILVER IMPREGNATED ANTIMICROBIAL DRESSING CONVATEC, A DIVISION OF E.R. SQUIBB & SONS, LLC. MARILYN KONICKY
K070738 04/05/2007 SIS FACIAL CYLINDER, SIS FACIAL IMPLANT COOK BIOTECH, INC. MARY A FADERAN
K070410 04/27/2007 COOK MICROWIRE WIRE GUIDE COOK, INC. KAREN BRADBURN
K063791 04/03/2007 CORIN UNIPOLAR MODULAR HEAD CORIN USA KATHY K TRIER
K070583 04/16/2007 NANO COMPOSITE COSMEDENT, INC. JAMES L SANDRIK
K070552 04/30/2007 DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR) DADE BEHRING, INC. LORRAINE H PIESTRAK
K063659 04/30/2007 EASY CURING PEN-STYLE LED CURING LIGHT DENT CORP. RESEARCH & DEVELOPMENT DAVID ALBELDA
K070300 04/10/2007 EXPEDIUM SFX CROSS CONNECTOR SYSTEM DEPUY SPINE, INC. CHRISTOPHER KLACZYK
K062538 04/30/2007 EASY CHECK BLOOD GLUCOSE MONITORING SYSTEM DIACARE CORP. SID MATHUR
K062473 04/12/2007 LIAISON BORRELIA IGG/IGM ASSAY, MODEL 310870; SERUM CONTROLS, MODEL 310871 DIASORIN, INC. CAROL A DEPOUW
K062105 04/23/2007 DIAZYME CREATININE LIQUID REAGENTS ASSAY DIAZYME LABORATORIES ABHIJIT DATTA
K070734 04/09/2007 MODIFICATION TO: DIRECT ENZYMATIC HBA1C ASSAY KIT, MODEL# DZ168A, DZ168A-CAL, DZ168A-CON DIAZYME LABORATORIES ABHIJIT DATTA
K061632 04/30/2007 GLOBUS PREMIUM MUSCLE STIMULATOR DOMINO S.R.L. GIOVANNI CIRIANI
K070658 04/05/2007 DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM E-WOO TECHNOLOGY STEPHEN T MLCOCH
K062449 04/13/2007 EMPOWERMR INJECTOR SYSTEM, MODEL 9730 E-Z-EM, INC. ROBERT WILLIAMS
K063346 04/18/2007 PRO OSTEON 500R EBI, L.P. DEBRA BING
K070221 04/04/2007 FMP METAL/METAL ACETABULAR INSERT, 499-28,449-34, 499-38 ENCORE MEDICAL, L.P. TEFFANY HUTTO
K070367 04/12/2007 ENDIUS TITLE 2 POLYAXIAL SPINAL SYSTEM ENDIUS, INC. CHRISTINE KUNTZ-NASSIF
K062104 04/20/2007 TALKING TRACH ENGINEERED MEDICAL SYSTEMS, INC. PAUL DRYDEN
K070706 04/11/2007 EP-WORKMATE EP MEDSYSTEMS LARRY PICCIANO
K070224 04/17/2007 ULTRAPRO PLUG ETHICON, INC. BRYAN A LISA
K070222 04/24/2007 FRESENIUS RENAL ACUTE CARE (RAC 100) FILTER, MODEL 0500610N FRESENIUS MEDICAL CARE NORTH AMERICA JANET C KAY
K070854 04/12/2007 GC MI PASTE PLUS GC AMERICA, INC. TERRY L JORITZ-LYONS
K070018 04/27/2007 UNIVERSAL SURGICAL MESH, MODEL 100 GENERIC MEDICAL DEVICE, INC. MONICA R MONTANEZ
K062834 04/24/2007 OSTEON, MODELS GBG0305, GBG0510, GBG1020, GBG2030, GBG3040, GBG4050 GENOSS CO., LTD. KLASS BESSELING
K070657 04/05/2007 GETINGE 633HC SERIES VACUUM/GRAVITY STEAM STERILIZER GETINGE SOURCING LLC ANN WHEELER
K070775 04/19/2007 MODIFICATION TO: PROVIDENCE ANTERIOR CERVICAL PLATE SYSTEM GLOBUS MEDICAL INC. KELLY J BAKER
K063766 04/23/2007 TRANSFERRIN TIA , CALIBRATOR SET, CONTROL-L,CONTROL-M,CONTROL-H, MODEL# KT-0105-A,CA-0105-A,B,C GOOD BIOTECH CORP. VICTOR CHIOU
K062130 04/16/2007 MEISINGER BENEX, MODEL BE001 HAGER & MEISINGER GMBH ALEX MILLER
K063636 04/24/2007 ZILOS-TK HAMILTON THORNE BIOSCIENCES DOUGLAS HAMILTON
K063380 04/25/2007 ECHOSTIM FACET TIP HAVEL'S, INC. PATRICK CARROTHERS
K071007 04/19/2007 HEARTWAY LIGHTWEIGHT POWER MOBILITY SCOOTER, S33 HEARTWAY MEDICAL PRODUCTS CO., LTD. KE-MIN JEN
K070211 04/05/2007 TRAUMARREST AND BLEEDARREST HEMOSTATIC PARTICLES AND FOAM HEMOSTASIS, LLC KEITH ROBERTS
K070249 04/26/2007 ABX PENTRA 400, CALCIUM CP, CREATININE CP, PHOSPHORUS CP, AMYLASE CP, URINE CONTROL L/H HORIBA ABX PASCAL MACZIOLA
K070398 04/24/2007 HOSPIRA PLUM A+ INFUSION PUMP, MODEL 12391 HOSPIRA, INC. NICOHL R WILDING
K070454 04/12/2007 OMEGA 3 SUPRACONDYLAR PLATE HOWMEDICA OSTEONICS CORP FRANCISCO HARO
K070948 04/25/2007 HSINER NEBULIZER BOTTLE HSINER TOM SHANKS
K063784 04/16/2007 DYE MANAGEMENT SYSTEM ICU MEDICAL, INC MARTIN MAIER
K063328 04/27/2007 IMC HEARTWAY, LLC ELECTRIC POWERED WHEELCHAIR, MODEL ALLURE (HP6) IMC-HEARTWAY, LLC MICHAEL CHEN
K063341 04/30/2007 3I OSSEOTITE CERTAIN DENTAL IMPLANTS IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K063286 04/24/2007 OSSEOTITE; OSSEOTITE NT; XP; TG OSSEOTITE IMPLANT INNOVATIONS, INC. JACQUELYN A HUGHES
K070904 04/13/2007 ANTLIA II SUCTION PUMP SYSTEM INNOVATIVE THERAPIES, INC. JUDITH HARBOUR
K070867 04/27/2007 INOMAX DS (DELIVERY SYSTEM), MODEL 10003 INO THERAPEUTICS LLC RICHARD K BOURNE
K070066 04/11/2007 QUANTA LITE RNA POL III ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K063565 04/04/2007 QUANTA LITE SS-A 52 ELISA INOVA DIAGNOSTICS, INC. BRYS C MYERS
K070136 04/13/2007 AUDICOR 200 SYSTEM, MODELS 200D AND 200S INOVISE MEDICAL, INC. STEVE HESLER
K062261 04/09/2007 FOAM RING PORT PROTECTOR INSPIRED IDEAS, INCORPORATED ALLISON SCOTT
K070321 04/30/2007 TWILIGHT FULL FACE MASK INVACARE CORP. CARROLL MARTIN
K070203 04/23/2007 INVIROSNAP SAFETY SYRINGE, MODELS 120006, 120007, 120008, 100080, 130022, 130023 AND 130024 INVIRO MEDICAL DEVICES, INC. JIM BARLEY
K070574 04/13/2007 FLEXITRON ISODOSE CONTROL B.V. HUB VAN DE BERGH
K063359 04/16/2007 INQU ISTO TECHNOLOGIES, INC. GARY GAGE
K070143 04/10/2007 JMS PLANECTA STOPCOCK JMS NORTH AMERICA CORP. CHONG SWEE CHEAU
K070606 04/24/2007 VISIO+CD VIEWER# KPSCDVE01 KEOSYS S.A.S. ANTHONY MOTTIER
K062453 04/17/2007 KINGLY STAR POWERED MUSCLE STIMULATOR, MODEL KS-138 KINGLY STAR INTL. TECHNOLOGY CO., LTD. JEN KE-MIN
K060915 04/17/2007 KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS KIRWAN SURGICAL PRODUCTS, INC. KEVIN P PRARIO
K063071 04/13/2007 DISCYPHOR CATHETER SYSTEM, MODEL D01A; DISCYPHOR INTRODUCER NEEDLE, MODEL D01B KYPHON, INC. CINDY DOMECUS
K062682 04/04/2007 CVS PERSONAL LUBRICANT AND MOISTURIZER LAKE CONSUMER PRODUCTS, INC. MARY L WUNDROCK
K063745 04/23/2007 MEDILASER, MODEL 1000 LASER THERA, LLC SHELLY HENRY
K070523 04/05/2007 MODIFICATION TO: VELSCOPE LED DENTAL INC. DAVID C MORGAN, PHD
K070483 04/19/2007 LEONE MONOIMPLANT FOR O-RING OVERDENTURE LEONE SPA ELIA LADANI
K070817 04/13/2007 LERADOTECH SCOOTER, MODEL SB LERADO CHINA LIMITED KE-MIN JEN
K070802 04/13/2007 LERADOTECH, MODEL SC LERADO CHINA LIMITED JUNNATA CHANG
K063354 04/17/2007 LINDE INTEGRATED VALVE (LIV) LINDE GAS THERAPEUTICS JAMES J ROGERS
K061505 04/09/2007 POWERED NITRILE BLUE EXAMINATION GLOVES LIWE TRADING K M LEE
K070022 04/20/2007 MISTRAL - ONE STAGE SCREW-TYPE DENTAL IMPLANT, MODEL MF9 M.I.S. IMPLANTS TECHNOLOGIES LTD. MOTTI WEISMAN
K063501 04/06/2007 KNIGHTCONTROL REMOTE CONTROL, MODEL M-114700-US MALLINCKRODT DEVELOPPEMENT FRANCE JAMES BONDS
K063503 04/27/2007 OPTIVANTAGE DH INJECTOR SYSTEM WITH ENHANCED COMMUNICATION MALLINCKRODT INC., LIEBEL-FLARSHEIM BUSINESS DALE MOORE
K061896 04/12/2007 MEDIAID DISPOSABLE NON-ADHESIVE SENSORS, MODEL CST050-2101N; REUSABLE FINGER CLIP SP02 SENSORS, MODEL CST060-2101N MEDIAID INC. MAHESH PATEL
K070858 04/16/2007 EXPRESS SERIES MEDICAL GRAPHICS CORP. MARY E DONLIN
K070506 04/18/2007 SMS MULTI GLUCOSE CONTROL, MODEL 2120049 MEDICAL SPECIALTIES SUPPLY CO., INC. JOHN C GORMLEY
K070714 04/30/2007 MEDISIZE GOLD HEATER AND BOOSTER MEDISIZE BV SOPHIA LAM
K070813 04/10/2007 ACCUVIX V10 DIAGNOSTIC ULTRASOUND SYSTEM MEDISON CO., LTD. KYUNG-AM SHIM
K063468 04/18/2007 THE FUGO BLADE FOR DENTISTRY MEDISURG LTD. RICHARD J FUGO
K070886 04/26/2007 MEROGEL INJECTABLE BIORESORBABLE STENT MEDTRONIC INC. JAYME WILSON
K070311 04/24/2007 CARDIOBLATE GEMINI SURGICAL ABLATION DEVICE, MODELS 49260 AND 49261 MEDTRONIC VASCULAR DEBBIE KIDDER
K063216 04/02/2007 RESCUE INTERNAL IMPLANT SYSTEM MEGAGEN CO., LTD. SUN HAHM
K070254 04/19/2007 HORIZON SE MENNEN MEDICAL LTD. MICHA OESTEREICH
K070016 04/02/2007 BLUE SHARK MERIDAN MEDICAL GRACE HOLLAND
K071019 04/27/2007 DIGITAL CLINICAL THERMOMETER/MODELS ST8C SERIES MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K063542 04/10/2007 WIRELESS TEMPERATURE MONITOR / MODELS ST323C AND ST323F. MESURE TECHNOLOGY CO.,LTD. JOHN CHEN
K060747 04/24/2007 FX DETACHABLE COIL SYSTEM MICRO THERAPEUTICS, INC. FLORIN TRUUVERT
K070707 04/06/2007 MICRUS MICROCOIL SYSTEM MICRUS ENDOVASCULAR CORPORATION PATRICK LEE
K070686 04/05/2007 MINI LAP INSTRUMENTS MINI LAP TECHNOLOGIES INC. JOSEPH AZARY
K070352 04/05/2007 MINI LAP PEDIATRIC INSTRUMENTS WITH MEDUSA CLAMPING SYSTEM MINI LAP TECHNOLOGIES INC. JOSEPH AZARY
K062526 04/13/2007 BLUE POWDERED LATEX EXAMINATION GLOVES, NON-STERILE MULTISAFE SDN BHD ABD HADI BIN HUSIN
K062631 04/12/2007 MYOMO E100 MYOMO, INC. KATE ZEBROSE
K070778 04/11/2007 NEOCOIL 3.0T 6-CHANNEL CAROTID ARRAY COIL NEOCOIL BRIAN BROWN
K062284 04/05/2007 CES ULTRA NEURO-FITNESS LLC MICHAEL STEVENS
K070474 04/25/2007 NEWLIFE SCIENCES LLC, MODEL TMR NEWLIFE SCIENCES, LLC RONALD WEINSTOCK
K070231 04/24/2007 ORION NIDEK TECHNOLOGIES SRL ALDO COCCHIGLIA
K070182 04/04/2007 ZYGOMA IMPLANT (IMMEDIATE FUNCTION) NOBEL BIOCARE AB HERBERT CRANE
K070273 04/03/2007 MODIFICATION TO NUVASIVE LATERAL PLATE SYSTEM NUVASIVE, INC. LAETITIA COUSIN
K070618 04/25/2007 DICOMPACS, MODEL 5 OEHM UND REHBEIN GMBH FRANZISKA GUNTHER
K070210 04/20/2007 GIRAFFE AND PANDA T- PIECE RESUSCITATION SYSTEM OHMEDA MEDICAL AGATA SMIEJA
K070247 04/20/2007 GIRAFFE AND PANDA BAG AND MASK RESUSCITATION SYSTEM OHMEDA MEDICAL AGATA SMIEJA
K062862 04/06/2007 OLYMPUS URIC ACID REAGENT, MODEL OSR6X98 OLYMPUS AMERICA, INC. BEV HARDING
K063842 04/17/2007 CYRTINA SYSTEM ORATIO B.V. JEF M VAN DER ZEL
K063720 04/09/2007 VITROS IMMUNODIAGNOSTIC PRODUCTS TOTAL B-HCG II REAGENT PACK, CALIBRATORS, RANGE VERIFIERS ORTHO-CLINICAL DIAGNOSTICS SARAH CV PARSONS
K070505 04/05/2007 KRYSTAL-X WIFI OWANDY CLAUDE BERTHOIN
K063233 04/30/2007 DELTACUT (APPARATUS AND CANNULA) PAJUNK GMBH MEDIZINTECHNOLOGIE CHRISTIAN QUASS
K070498 04/26/2007 HYPER SAL PARI INNOVATIVE MANUFACTURERS, INC. PAUL DRYDEN
K063783 04/27/2007 PHILIPS REUSABLE SPO2 SENSORS M1191T, M1192T AND M1193T, CLIP SENSOR M1196T AND DISPOSABLE SPO2 SENSORS M1131A, M1132A PHILIPS MEDICAL SYSTEMS, INC. TAPAN D SHAH
K070792 04/06/2007 QLAB QUANTIFICATION PHILIPS ULTRASOUND, INC. LYNN HARMER
K070335 04/16/2007 SIMPLEX CERVICAL FIXATION SYSTEM PISHARODI SURGICALS, INC. J.D. WEBB
K070745 04/13/2007 MODIFICATION TO: PLAYTEX GENTLE GLIDE PLASTIC, PLAYTEX GENTLE PLASTIC MULTIPACK TAMPONS PLAYTEX PRODUCTS, INC. KEITH EDGETT
K070278 04/16/2007 POLARCUP DUAL MOBILITY SYSTEM PLUS ORTHOPEDICS AG PAMELA J WEAGRAFF
K070504 04/11/2007 AMMONIA/ALCOHOL CONTROL SET POINTE SCIENTIFIC, INC. RON JAMISON
K070251 04/30/2007 CARBON DIOXIDE LIQUID STABLE REAGENT POINTE SCIENTIFIC, INC. WILLIAM F WALTERS, JR
K070207 04/13/2007 MULTI-ANALYTE CHEMISTRY CALIBRATOR POINTE SCIENTIFIC, INC. RON JAMISON
K070467 04/17/2007 HEALTH MASK POLAR WRAP LLC PAUL DRYDEN
K070950 04/16/2007 LIFT CHAIR, MODEL C5 PRIDE MOBILITY PRODUCTS CORP. THOMAS J SCHAPPERT
K070664 04/26/2007 PROGENY IMAGING SOFTWARE, MODEL# 500-405 (6,7,8). PROGENY, INC. ALAN KREMA
K063159 04/02/2007 STERILOX LIQUID CHEMICAL STERILANT SYSTEM PURICORE, INC. HOWARD MANN
K062957 04/02/2007 FASTPACK TOTAL PSA METHOD VERIFICATION KIT QUALIGEN, INC. MELISSA SAAM
K070776 04/24/2007 SUPRA OPHTHALMIC LASER PHOTOCOAGULATOR QUANTEL MEDICAL GEORGE MYERS
K070747 04/23/2007 QUICK VUE RSV TEST, MODELS 20193, 20199 QUIDEL CORP. JENNIFER HANKARD
K062963 04/03/2007 PHAROS EXCIMER LASER SYSTEM, MODEL EX-308 RA MEDICAL SYSTEMS, INC. DEAN IRWIN
K070976 04/20/2007 RII INFRARED EAR THERMOMETER, MODEL TH01BN RADIANT INNOVATION INC. FRANK LIN
K070954 04/20/2007 PATIENTGALLERY IMAGING SOFTWARE RASTER BUILDERS, INC. DAVID L STARK
K070907 04/17/2007 INTERSON USB ULTRASOUND PROBE SYSTEM REGULATORY MANAGEMENT SERVICES GARY J ALLSEBROOK
K063038 04/27/2007 FRAXEL III SR LASER SYSTEM AND ACCESSORIES RELIANT TECHNOLOGIES, INC. HEATHER TANNER MACFALLS
K063808 04/27/2007 FRAXEL IV SR LASER SYSTEM RELIANT TECHNOLOGIES, INC. HEATHER TANNER MACFALLS
K062545 04/09/2007 RMI LCD ALCOHOL DETECTOR RESOURCE MANAGEMENT INTERNATIONAL, LLC DANIEL KAMM
K070711 04/24/2007 INCIRCLE BI-POLAR RF ABLATION SYSTEM RFA MEDICAL, INC. NANCY LINCE
K070174 04/16/2007 AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS; ROCHE SCRIPTS FOR CT/NG TEST ACCESSORY ROCHE DIAGNOSTICS CORPORATION THERESA AMBROSE BUSH
K070172 04/17/2007 AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE ROCHE DIAGNOSTICS CORPORATION THERESA AMBROSE BUSH
K062325 04/13/2007 RS-4I MUSCLE STIMULATOR FAMILY RS MEDICAL STEVEN CHERNOFF
K070316 04/19/2007 INTERPLATE VBR SYSTEM RSB SPINE LLC. KAREN E WARDEN
K063391 04/26/2007 SAPHENEIA CLARITY SAPHENEIA COMMERCIAL PRODUCTS AB RICK MANCILLA
K062362 04/13/2007 SINGLE USE ESOPHAGEAL MANOMETEY CATHETERS AND SINGLE USE ANO-RECTAL MANOMETRY CATHETERS SARMED SRL ANTONIO ROSSETTI
K070397 04/13/2007 DGSCOPE, RELEASE 1.0 SEGAMI CORPORATION PHILIPPE BRIANDET
K070683 04/12/2007 MIRAGE CEDARS OPTION SEGAMI CORPORATION PHILIPPE BRIANDET
K061756 04/19/2007 TEXTURED POWDER FREE NITRILE EXAM GLOVES WITH SAP SHEN WEI (USA), INC. CYNTHIA LIU
K062194 04/11/2007 HYPERVISOR VI CENTRAL MONITORING SYSTEM SHENZHEN MINDRAY BIO-MEDICAL ELECTRONICS CO., LTD SUSAN D GOLDSTEIN-FALK
K070181 04/18/2007 SINTEA BIOTECH DSC/ALF SPINAL SYSTEM, DSC.XX.T5.XX, ALF.XX.T5.XX SINTEA BIOTECH, INC. GUSTAVO A RIOS
K070167 04/12/2007 ENDOBUTTON DIRECT SMITH & NEPHEW INC., ENDOSCOPY DIVISION DEANA BOUSHELL
K070649 04/12/2007 SMS GLUCOSE CONTROL, MODEL 2120061 SPECTRUM MEDICAL SUPPLY, INC. JOHN C GORMLEY
K070245 04/05/2007 CAPSURE PEDICLE SCREW SYSTEM SPINE WAVE, INC. RONALD K SMITH
K063606 04/13/2007 MODIFICATION TO STAXX FX SYSTEM SPINE WAVE, INC. RONALD K SMITH
K070676 04/18/2007 KOREBALANCE (KINESTHETIC ABILITY TRAINER) SPORTKAT, LLC DAMON R LAWSON
K070166 04/06/2007 STRADA CAROTID GUIDING SHEATH ST. JUDE MEDICAL JEFF STURM
K070884 04/11/2007 POD B-SCAN STARFISH PRODUCT ENGINEERING INC. DAYRL WISDAHL
K070871 04/13/2007 STARION UNIVERSAL POWER SUPPLY STARION INSTRUMENTS BRIAN GRIGSBY
K061277 04/12/2007 STRAUMANN COMPUTER AIDED RESTORATION SERVICE (C.A.R.E.S.) CERAMIC COPING STRAUMANN USA ELAINE ALAN
K070876 04/27/2007 STRYKER TWIST DRILLS STRYKER CRANIOMAXILLOFACIAL TENNILLE FOLK
K070896 04/24/2007 ENSEAL PTC TISSUE SEALING DEVICE SURGRX, INC. LINDA OLESON
K070782 04/11/2007 WILLSON ONE-FIT FLAT-FOLD HEALTHCARE PARTICULATE RESPIRATOR AND SURGICAL MASK, MODELS HC-NB095F AND HC-NB295F SURVIVAIR RESPIRATORS, LLC RICHARD O WOOD
K063790 04/16/2007 THE SYNTHES MATRIXMANDIBLE PLATE AND SCREW SYSTEM SYNTHES (USA) DEBORAH L JACKSON
K062083 04/03/2007 SYNFIX -LR SYNTHES SPINE CO.LP BONNIE J SMITH
K070108 04/04/2007 ELIBRA DYNAMIC KNEE BALANCER SYNVASIVE TECHNOLOGY, INC. DANIEL KAMM
K063708 04/24/2007 4S SPINAL SYSTEM TAE YEON MEDICAL CO., LTD GIL WOON CHOI
K070641 04/09/2007 ADVOCATE DUO BLOOD GLUCOSE PLUS BLOOD PRESSURE MONITORING SYSTEM, MODEL TD-3223 TAIDOC TECHNOLOGY CORPORATION ERICA LI
K063701 04/11/2007 TECO HOMOCYSTEINE ENZYMATIC ASSAY TECO DIAGNOSTICS JIAN VAECHES
K062102 04/16/2007 ODONCER TEKNIMED SA J.D. WEBB
K063758 04/23/2007 CHONCHA THERM NEPTUNE HEATED HUMIFIER, CHONCHA THERM NEPTUNE HEATED HUMIFIER (REMANUFACTURER), MODEL# 425-00,425-00R TELEFLEX MEDICAL LORI HAYS
K070673 04/02/2007 FORCE FIBER BLACK CO-BRAID POLYETHYLENE NON-ABSORBABLE SURGICAL SUTURE TELEFLEX MEDICAL, INC. ELIZABETH LANDON
K070894 04/13/2007 TEPHAFLEX SURGICAL MESH TEPHA, INC. MARY P LEGRAW
K070839 04/24/2007 MODIFICATION TO CAPIOX FLEXIBLE VENOUS RESERVOIR TERUMO CARDIOVASCULAR SYSTEMS CORP. GARRY COURTNEY
K063695 04/27/2007 RUNTHROUGH NS TERUMO MEDICAL CORP. MARK UNTERREINER
K070381 04/25/2007 THEKEN VU MESH VBR SYSTEM THEKEN SPINE LLC DALE DAVISON
K070290 04/17/2007 SPI VECTODRILL CERAMIC DRILLS THOMMEN MEDICAL, AG FLOYD LARSON
K070818 04/06/2007 MEDILOGAR4, MEDILOGAR12 TOM MEDICAL ENTWICKLUNGS GMBH THOMAS HASIBA
K070589 04/24/2007 C! TRANSPHOTON CORPORATION BRANT WIGGER
K070674 04/11/2007 AEROCHAMBER PLUS ANTI-STATIC VALVED HOLDING CHAMBER WITH FLOW-VU INSPIRATORY FLOW INDICATOR TRUDELL MEDICAL INTL. JOHN STRAATMAN
K070430 04/04/2007 PARADIGM QUICK-SET II AND QUICK-SET II SUBCUTANEOUS INFUSION SETS UNOMEDICAL A/S JOHN M LINDSKOG
K070056 04/13/2007 VAPOTHERM MODEL# 2000I AND 2000H VAPOTHERM, INC. JOHNATHAN KAHAN
K070082 04/20/2007 XY COR SPINAL IMPLANT FOR MINIMAL INVASIVE SPINAL SURGERY VERTEBRATION,INC BARBARA S FANT, PHARM.D.
K070218 04/06/2007 VERTIFLEX OCTANE PEEK VERTEBRAL BODY REPLACEMENT (PEEK VBR) VERTIFLEX (TM), INCORPORATED STEVE REITZLER
K063061 04/02/2007 CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 VIASYS MEDSYSTEMS STEPHANIE WASIELEWSKI
K070535 04/24/2007 RETROPAN CCD-TWAIN-USB VIDEO DENTAL CONCEPTS, INC. CLAUDE BERTHOIN
K070390 04/05/2007 FLUOROPRO RF DIGITAL IMAGING SYSTEM VIRTUAL IMAGING, INC. DANIEL KAMM
K070243 04/17/2007 SUTRALENE POLYPROPYLENE SUTURES VISIONARY MEDICAL SUPPLIES, INC. GARY SYRING
K070644 04/02/2007 GORE SEAMGUARD STAPLE LINE REINFORCEMENT MATERIAL FOR CIRCULAR STAPLERS W. L. GORE & ASSOCIATES, INC. BARBARA L SMITH
K070772 04/30/2007 PRESSX ZR WIELAND DENTAL + TECHNIK GMBH & CO. KG GERHARD POLZER
K061815 04/20/2007 COOK CELECT VENA CAVA FILTER WILLIAM COOK EUROPE APS THALIA BRINE
K070655 04/02/2007 WU'S POWERED WHEELCHAIR, MAMBO 36 WU'S TECH CO., LTD. JEN KE-MIN
K070519 04/10/2007 PRIME PROTECTION POWDERED VINYL EXAMINATION GLOVES ZHANGJIAGANG HUAYUAN PLASTIC CO., LTD. Y. T YEO
K070700 04/25/2007 FREEALGIN ZHERMACK S.P.A. GERALD W SHIPPS
K070292 04/26/2007 DUROM HIP RESURFACING SYSTEM, FEMORAL COMPONENTS ZIMMER GMBH ANTHONY FRANCALANCIA
K063582 04/26/2007 ZIMMER CUT RESISTANT GLOVE LINER, XSMALL, SMALL, MEDIUM, LARGE, XLARGE ZIMMER, INC. CINDY J DICKEY
K070455 04/26/2007 ZOLL E SERIES WITH SEE-THRU CPR ZOLL MEDICAL CORPORATION, WORLD WIDE HEADQUARTERS EILEEN M BOYLE


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