FEI 3003857817
Dane Technologies
10400 Fountains Drive, Maple Grove, MN, US
MDR events1All time
Recalls0All time
Registered products1
Establishment typeManufactureManufacture Medical Device
Registered product codes
1 product codes
Recent MDR events
1 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3003857817.
FDA inspections
1 on file
- Voluntary Action Indicated (VAI)Aug 25, 2025
Compliance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.20(c)Aug 25, 2025
Management review - defined interval, sufficient frequency
- 21 CFR 820.22Aug 25, 2025
Quality Audits - defined intervals
- 21 CFR 820.100(a)Aug 25, 2025
Lack of or inadequate procedures
- 21 CFR 820.200(a)Aug 25, 2025
Servicing - 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.