FEI 1043653
Onyx Medical Llc
1800 North Shelby Oaks Drive, MEMPHIS, TN, US
MDR events0All time
Recalls0All time
Registered products68
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
68 product codes
Recent MDR events
0 on file
No MDR events on file for this firm name.
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1043653.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Feb 13, 2026
Compliance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- ISO 13485:2016 Clause 4.1.2Feb 13, 2026
Risk-based approach not applied to QMS processes
Compliance actions
0 on file
No warning letters or injunctions on file for this FEI number.
Import refusals
0 on file
No import refusals on file for this FEI number.