Data / Medical devices / Heart-Valve, Non-Allograft Tissue
Heart-Valve, Non-Allograft Tissue (LWR): 13 FDA-registered makers in 8 countries
13 establishments in 8 countries are registered with the FDA to make Heart-Valve, Non-Allograft Tissue (product code LWR, Class 3). 11 of them have a 510(k) clearance or PMA approval on file and 2 have 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.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- Product code
- LWR
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Costa Rica | 2 |
| Singapore | 1 |
| Italy | 1 |
| Mexico | 1 |
| Brazil | 1 |
| Canada | 1 |
| United Kingdom | 1 |
Makers of Heart-Valve, Non-Allograft Tissue
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 | |
| Abbott Medical | Saint Paul, MN, United States | Manufacturer, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| EDWARDS LIFESCIENCES (SINGAPORE) Pte Ltd | Changi South East, Singapore | Manufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer, Specification developer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Abbott Medical Costa Rica Limitada (Structural Heart) | El Coyol Alajuela, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Corcym S.r.l. | SALUGGIA Vercelli, Italy | Manufacturer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Edwards Lifesciences | Guadalupe Cartago, Costa Rica | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| St. Jude Medical Brasil Ltda. | Belo Horizonte Minas Gerais, Brazil | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Corcym Canada Corp. | Burnaby British Columbia, Canada | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Vascutek Ltd. | Inchinnan Renfrewshire, United Kingdom | Contract manufacturer, Contract sterilizer | 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.