FEI 3017505309
Ksl Biomedical, Inc.
55 Amherst Villa Road, Buffalo, NY, US
MDR events0All time
Recalls0All time
Registered products3
Establishment typeManufactureManufacture Medical Device
Registered product codes
3 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 3017505309.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Oct 24, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Oct 24, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(d)Oct 24, 2025
Design output - Lack of or inadequate procedures
- 21 CFR 820.80(b)Oct 24, 2025
Incoming acceptance records, documentation
- 21 CFR 830.300(a)Oct 24, 2025
Devices subject to device identification GUDID data submission requirements.
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.