FEI 3011170410
Surgtech, Inc.
24600 Center Ridge Road, Suite 195, Westlake, OH, US
MDR events0All time
Recalls0All time
Registered products10
Establishment typeDevelopDevelop Specifications But Do Not Manufacture At This Facility
Registered product codes
10 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 3011170410.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)May 7, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)May 7, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(c)May 7, 2025
Design input - documentation
- 21 CFR 820.30(g)May 7, 2025
Design validation- Lack of or inadequate procedures
- 21 CFR 820.30(h)May 7, 2025
Design transfer - Lack of or inadequate procedures
- 21 CFR 820.50(a)(2)May 7, 2025
Supplier oversight
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.