FEI 1627497
Immy, Inc.
2701 Corporate Centre Dr, NORMAN, OK, US
MDR events0All time
Recalls0All time
Registered products25
Establishment typeManufactureManufacture Device in the United States for Export Only
Registered product codes
25 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 1627497.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Mar 5, 2026
Compliance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- ISO 13485:2016 Clause 7.1Mar 5, 2026
Records of risk management activities in product realization not maintained
- ISO 13485:2016 Clause 7.3.9Mar 5, 2026
Requirements for design and development changes not met before implementation
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.