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 |