FEI 3006747129
Ion Medical Inc
4382 Ripken Cir E, Jacksonville, FL, US
MDR events0All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 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 3006747129.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 13, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jun 13, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.22Jun 13, 2025
Quality audits - Lack of or inadequate procedures
- 21 CFR 820.30(i)Jun 13, 2025
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.40(a)Jun 13, 2025
Document review, approval documentation
- 21 CFR 820.50Jun 13, 2025
Purchasing controls, Lack of or inadequate 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.