FEI 1935627
Surgical Instrument Manufacturers, Llc
2076 Fenton Logistics Park, FENTON, MO, US
MDR events0All time
Recalls0All time
Registered products87
Establishment typeManufactureManufacture Medical Device for Another Party (Contract Manufacturer)
Registered product codes
87 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 1935627.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 22, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 22, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(a)Feb 22, 2024
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.