FDA 510(k) Applications for Medical Device: Ring, Annuloplasty

FDA 510(k) Applications for Medical Device:
Ring, Annuloplasty

FDA 510(k) Number	Applicant	Address	City / Country	State / Province	Postal Code
K980487	BAXTER EDWARDS	17221 RED HILL AVE.	IRVINE	CA	92614-5627
K970375	CARBOMEDICS, INC.	1300 EAST ANDERSON LN.	AUSTIN	TX	78752-1793
K230318	Corcym S.r.l.	Via Crescentino Sn	Saluggia		13040
K192762	Edwards Lifesciences LLC	One Edwards Way	Irvine	CA	92614
K083470	EDWARDS LIFESCIENCES, LLC.	ONE EDWARDS WAY	IRVINE	CA	92614
K103520	EDWARDS LIFESCIENCES, LLC.	ONE EDWARDS WAY	IRVINE	CA	92614
K083623	EDWARDS LIFESCIENCES, LLC.	ONE EDWARDS WAY	IRVINE	CA	92614
K083191	EDWARDS LIFESCIENCES, LLC.	ONE EDWARDS WAY	IRVINE	CA	92614
K020864	EDWARDS LIFESCIENCES, LLC.	ONE EDWARDS WAY	IRVINE	CA	92614
K032250	EDWARDS LIFESCIENCES, LLC.	ONE EDWARDS WAY	IRVINE	CA	92614
K230679	Genesee Biomedical Inc	700 W. Mississippi Ave	Denver	CO	80223
K190506	Genesee BioMedical, Inc	700 W Mississippi Ave, Unit D5	Denver	CO	80223-4509
K202253	Genesee BioMedical, Inc	700 W Mississippi Ave, Unit D5	Denver	CO	80223-4509
K071214	Genesee BioMedical, Inc.	1308 SOUTH JASON ST.	DENVER	CO	80223
K090428	Genesee BioMedical, Inc.	1308 SOUTH JASON ST.	DENVER	CO	80223
K052899	Genesee BioMedical, Inc.	1308 SOUTH JASON ST.	DENVER	CO	80223
K052565	Genesee BioMedical, Inc.	1308 SOUTH JASON ST.	DENVER	CO	80223
K083683	Genesee BioMedical, Inc.	1308 SOUTH JASON ST.	DENVER	CO	80223
K072655	Genesee BioMedical, Inc.	1308 SOUTH JASON ST.	DENVER	CO	80223
K093903	Genesee BioMedical, Inc.	1308 SOUTH JASON ST.	DENVER	CO	80223
K161815	Genesee BioMedical, Inc.	700 W. Mississippi Ave	Denver	CO	80223-4509
K033685	MEDICALCV, INC.	9725 SOUTH ROBERT TRAIL	INVER GROVE HEIGHTS	MN	55077
K181132	Medtronic	1851 East Deere Ave	Santa Ana	CA	92705
K052860	MEDTRONIC HEART VALVES	8299 CENTRAL AVE., N.E.	MINNEAPOLIS	MN	55432-3576
K032810	MEDTRONIC HEART VALVES	8299 CENTRAL AVE., N.E.	MINNEAPOLIS	MN	55432-3576
K052970	MEDTRONIC HEART VALVES	8299 CENTRAL AVE., N.E.	SPRING LAKE PARK	MN	55432-3576
K101212	MEDTRONIC INC.	8200 Coral Sea Street NE	Mounds View	MN	55112
K073324	MEDTRONIC INC.	8299 CENTRAL AVENUE NE	MINNEAPOLIS	MN	55432
K061127	MEDTRONIC VASCULAR	8299 CENTRAL AVENUE N.E.	MINNEAPOLIS	MN	55432
K011395	MEDTRONIC VASCULAR	8299 CENTRAL AVE., N.E.	MINNEAPOLIS	MN	55432
K984435	MEDTRONIC VASCULAR	7000 CENTRAL AVE. NE	MINNEAPOLIS	MN	55432-3576
K201449	Medtronic, Inc.	1851 E. Deere Ave.	Santa Ana	CA	92705
K070488	MICARDIA CORPORATION	30 HUGHES SUITE 206	IRVINE	CA	92618
K071281	PETERS SURGICAL	Z.I. LES VIGNES	BOBIGNY		93013
K103812	SCIENCITY CO., LTD	325 N. PUENTE ST.	BREA	CA	92821
K023940	SHELHIGH, INC.	650 LIBERTY AVE.	UNION	NJ	07083
K071327	SORIN BIOMEDICA CARDIO S.R.L.	1300 EAST ANDERSON LANE	AUSTIN	TX	78752-1793
K142221	SORIN GROUP ITALIA S.R.L	VIA CRESCENTINO SN	SALUGGIA		13040
K180411	Sorin Group Italia S.r.l.	Via Crescentino sn	Saluggia		13040
K083835	ST. JUDE MEDICAL	177 EAST COUNTY ROAD B	ST. PAUL	MN	55117
K092310	ST. JUDE MEDICAL	177 EAST COUNTY ROAD B	ST. PAUL	MN	55117
K092876	ST. JUDE MEDICAL	177 EAST COUNTY ROAD B	ST. PAUL	MN	55117
K042734	ST. JUDE MEDICAL, INC.	ONE LILLEHEI PLAZA	ST. PAUL	MN	55117
K014037	ST. JUDE MEDICAL, INC.	ONE LILLEHEI PLAZA	ST. PAUL	MN	55117
K961246	ST. JUDE MEDICAL, INC.	ONE LILLEHEI PLAZA	ST. PAUL	MN	55117
K022363	ST. JUDE MEDICAL, INC.	ONE LILLEHEI PLAZA	ST. PAUL	MN	55117
K014161	ST. JUDE MEDICAL, INC.	ONE LILLEHEI PLAZA	ST. PAUL	MN	55117
K000119	ST. JUDE MEDICAL, INC.	ONE LILLEHEI PLAZA	ST. PAUL	MN	55117
K992056	SULZER CARBOMEDICS, INC.	1300 EAST ANDERSON LN.	AUSTIN	TX	78752
K023185	SULZER CARBOMEDICS, INC.	1300 EAST ANDERSON LN.	AUSTIN	TX	78752
K021051	SULZER CARBOMEDICS, INC.	1300 EAST ANDERSON LN.	AUSTIN	TX	78752
K980534	THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG	18011 SOUTH MITCHELL	IRVINE	CA	92714
K960356	THE HEART VALVE DIV. MEDTRONIC CARDIOVASCULAR SURG	18011 SOUTH MITCHELL	IRVINE	CA	92714