FEI 1038833
Eyekon Medical, Inc.
2451 Enterprise Rd, CLEARWATER, FL, US
MDR events0All time
Recalls0All time
Registered products6
Establishment typeRepackRepack or Relabel Medical Device
Registered product codes
6 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 1038833.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 10, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jun 10, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.50(a)(2)Jun 10, 2025
Supplier oversight
- 21 CFR 820.72(a)Jun 10, 2025
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 820.100(a)Jun 10, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jun 10, 2025
Lack of or inadequate complaint procedures
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.