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 |
| K232599 | Genesee Biomedical Inc |
700 W. Mississippi Ave Unit D-5 | Denver | CO | 80223 |
| K250859 | Genesee Biomedical Inc |
700 W. Mississippi Ave Unit D-5 | Denver | CO | 80223 |
| 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 |
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