FEI 1000139987
Precision Edge Surgical Products Company
415 W 12th Ave, Sault Sainte Marie, MI, US
MDR events0All time
Recalls0All time
Registered products71
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
71 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 1000139987.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 11, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jul 11, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.25(b)Jul 11, 2025
Training - 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.