Data / Medical devices / Mitral Valve Repair Devices
Mitral Valve Repair Devices (NKM): 11 FDA-registered makers in 3 countries
11 establishments in 3 countries are registered with the FDA to make Mitral Valve Repair Devices (product code NKM, Class 3). 8 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 4 recall events (1 Class I). FDA data exported November 2, 2026.
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- Product code
- NKM
- Device class
- 3
- Medical specialty
- Unknown
- Implant
- Yes
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| Singapore | 1 |
| Ireland | 1 |
Makers of Mitral Valve Repair Devices
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 |
|---|---|---|---|---|---|---|---|---|
| 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 (SINGAPORE) Pte Ltd | Changi South East, Singapore | Manufacturer | 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 Ireland Limited | Limerick Munster, Ireland | Manufacturer | 0 | 1 | 0 | 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 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.