FEI 3018126402
Archform, Inc.
2255 Martin Ave Ste H, Santa Clara, CA, US
MDR events0All time
Recalls0All time
Registered products4
Establishment typeManufactureManufacture Medical Device
Registered product codes
4 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 3018126402.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jul 28, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Jul 28, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.90(a)Jul 28, 2025
Nonconforming product control
- 21 CFR 820.100(a)Jul 28, 2025
Lack of or inadequate procedures
- 21 CFR 820.198(a)Jul 28, 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.