Data / Medical devices / Replacement Heart-Valve
Replacement Heart-Valve (DYE): 9 FDA-registered makers in 4 countries
9 establishments in 4 countries are registered with the FDA to make Replacement Heart-Valve (product code DYE, Class 3, 21 CFR 870.3925). 4 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- DYE
- Device class
- 3
- Regulation
- 870.3925
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Costa Rica | 2 |
| Singapore | 1 |
| Brazil | 1 |
Makers of Replacement Heart-Valve
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Heart Valves Division | Santa Ana, CA, United States | Manufacturer | 0 | 3 | 1 | 0 | api.fda.gov | |
| EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd | Changi South East, Singapore | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences | Guadalupe Cartago, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Saint Paul, MN, United States | Manufacturer, Manufacturer for export, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Abbott Medical Costa Rica Limitada (Structural Heart) | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| HighLife Medical | Irvine, CA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| St. Jude Medical Brasil Ltda. | Belo Horizonte Minas Gerais, Brazil | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.