Data / Medical devices / Mitral Valve Repair Devices / United States
FDA-registered makers of Mitral Valve Repair Devices in the United States: 9 establishments
9 establishments in the United States are registered with the FDA to make Mitral Valve Repair Devices (product code NKM). 6 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 3, 2026.
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- Device
- Mitral Valve Repair Devices
- Product code
- NKM
- Country
- United States
Makers of Mitral Valve Repair Devices in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Vascular | Santa Clara, CA, United States | Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Abbott Medical | Saint Paul, MN, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Medical | Westfield, IN, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Abbott Vascular | Menlo Park, CA, United States | Manufacturer, Manufacturer for export | 0 | 1 | 0 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Irvine, CA, United States | Specification developer | 0 | 1 | 1 | 0 | api.fda.gov | |
| Edwards Lifesciences LLC | Draper, UT, United States | Manufacturer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Cardiac Dimensions, Inc. | Kirkland, WA, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cordica Medical, Inc. | Sunrise, FL, United States | Manufacturer for export | 0 | 0 | 0 | 0 | api.fda.gov | |
| Primo Medical Group, Inc | W Bridgewater, MA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.