FEI 3014680735
Sonavex, Inc.
2835 ODONNELL ST STE 200, Baltimore, MD, US
MDR events4All time
Recalls0All time
Registered products5
Establishment typeManufactureManufacture Medical Device
Registered product codes
5 product codes
Recent MDR events
4 on file
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3014680735.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 6, 2025
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Feb 6, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
4 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.100(b)Feb 6, 2025
Documentation
- 21 CFR 803.50(a)(1)Feb 6, 2025
Report of Death or Serious Injury
- 21 CFR 820.70(g)Feb 6, 2025
Equipment Installation, Placement, Specified Requirements
- 21 CFR 820.198(a)Feb 6, 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.