Biofusion Medical
4020 S Industrial Drive, Austin, TX, US
Registered product codes
1 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 3015422154.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Feb 26, 2025
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Feb 26, 2025
Postmarket Assurance: Devices · Citations posted
Inspection citations
6 on file
Top cited requirements
Compare to industry ↗21 CFR 801.20(a)Label to bear a unique device identifier
121 CFR 820.20(c)Management review dates
121 CFR 820.22Quality Audit/Reaudit - conducted
121 CFR 820.25(b)Training records
121 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
121 CFR 830.300(a)Devices subject to device identification GUDID data submission requirements.
1
- 21 CFR 801.20(a)Feb 26, 2025
Label to bear a unique device identifier
- 21 CFR 820.20(c)Feb 26, 2025
Management review dates
- 21 CFR 820.22Feb 26, 2025
Quality Audit/Reaudit - conducted
- 21 CFR 820.25(b)Feb 26, 2025
Training records
- 21 CFR 820.72(a)Feb 26, 2025
Calibration, Inspection, etc. Procedures Lack of or Inadequ
- 21 CFR 830.300(a)Feb 26, 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.