Data / Medical devices / Ring, Annuloplasty / United States
FDA-registered makers of Ring, Annuloplasty in the United States: 7 establishments
7 establishments in the United States are registered with the FDA to make Ring, Annuloplasty (product code KRH). 7 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Device
- Ring, Annuloplasty
- Product code
- KRH
- Country
- United States
Makers of Ring, Annuloplasty in the United States
| 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 |
| Edwards Lifesciences LLC | Irvine, CA, United States | Manufacturer, Specification developer | 10 | September 23, 2025 | 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 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.