FEI 3005977121
Bihlermed, Llc
85 INDUSTRIAL DRIVE, Phillipsburg, NJ, US
MDR events1All time
Recalls0All time
Registered products6
Establishment typeManufactureManufacture Medical Device
Registered product codes
6 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 3005977121.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Nov 30, 2023
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Nov 30, 2023
Postmarket Assurance: Devices · Citations posted
Inspection citations
3 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.30(c)Nov 30, 2023
Design input - Lack of or inadequate procedures
- 21 CFR 820.30(i)Nov 30, 2023
Design changes - Lack of or Inadequate Procedures
- 21 CFR 820.90(a)Nov 30, 2023
Nonconforming product, 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.