Data / Medical devices / Ring, Annuloplasty
Ring, Annuloplasty (KRH): 10 FDA-registered makers in 4 countries
10 establishments in 4 countries are registered with the FDA to make Ring, Annuloplasty (product code KRH, Class 2, 21 CFR 870.3800). 10 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 75 510(k) clearances under this code, the latest on June 18, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- KRH
- Device class
- 2
- Regulation
- 870.3800
- Medical specialty
- Cardiovascular
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 7 |
| Mexico | 1 |
| Costa Rica | 1 |
| Italy | 1 |
Makers of Ring, Annuloplasty
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 | Specification developer | 16 | July 1, 2020 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Mexico S. de R.L. de CV | Tijuana Baja California, Mexico | Manufacturer | 16 | July 1, 2020 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer, Specification developer | 10 | September 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences | Guadalupe Cartago, Costa Rica | Manufacturer | 9 | September 23, 2025 | 0 | 0 | 0 | api.fda.gov |
| Corcym S.r.l. | SALUGGIA Vercelli, Italy | Manufacturer | 7 | June 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Saint Paul, MN, United States | Manufacturer | 5 | October 16, 2009 | 0 | 0 | 0 | api.fda.gov |
| Genesee Biomedical, Inc. | Denver, CO, United States | Manufacturer | 5 | April 9, 2024 | 0 | 0 | 0 | api.fda.gov |
| Abbott Medical | Caguas, PR, United States | Manufacturer | 4 | August 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| St. Jude Medical | Roseville, MN, United States | Manufacturer | 4 | August 27, 2009 | 0 | 0 | 0 | api.fda.gov |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 2 | December 16, 2019 | 0 | 0 | 0 | api.fda.gov |
Updated June 18, 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.