Allied Medical Llc
13622 Lakefront Dr, Earth City, MO, US
Registered product codes
61 product codes
Recent MDR events
164 on file
- GOMCOJul 1, 2026MalfunctionMW5190159
- GOMCOJun 12, 2026Malfunction1924066-2026-00008
- GOMCOJun 12, 2026Malfunction1924066-2026-00009
- GOMCOMay 8, 2026Malfunction1924066-2026-00007
- GOMCOMay 8, 2026Malfunction1924066-2026-00006
- GOMCOApr 9, 2026Malfunction1924066-2026-00005
- LITHOLYMEMar 26, 2026Malfunction1924066-2026-00004
- GOMCOJan 30, 2026Malfunction1924066-2026-00001
- GOMCOJan 30, 2026Malfunction1924066-2026-00002
- GOMCOJan 15, 2026Malfunction24078670
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 1924066.
FDA inspections
3 on file
- Voluntary Action Indicated (VAI)Oct 30, 2024
Compliance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Oct 30, 2024
Postmarket Assurance: Devices · Citations posted
- Voluntary Action Indicated (VAI)Nov 8, 2023
Compliance: Devices · Citations posted
Inspection citations
12 on file
Top cited requirements
Compare to industry ↗21 CFR 820.50Purchasing controls, Lack of or inadequate procedures
221 CFR 820.70(e)Contamination control, Lack of or inadequate procedures
221 CFR 820.100(a)Lack of or inadequate procedures
221 CFR 803.50(a)(1)Report of Death or Serious Injury
121 CFR 820.75(a)Lack of or inadequate process validation
121 CFR 803.50(a)(2)Individual Report of Malfunction
1
- 21 CFR 803.50(a)(1)Oct 30, 2024
Report of Death or Serious Injury
- 21 CFR 820.50Oct 30, 2024
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(e)Oct 30, 2024
Contamination control, Lack of or inadequate procedures
- 21 CFR 820.75(a)Oct 30, 2024
Lack of or inadequate process validation
- 21 CFR 820.100(a)Oct 30, 2024
Lack of or inadequate procedures
- 21 CFR 803.50(a)(2)Nov 8, 2023
Individual Report of Malfunction
- 21 CFR 820.25(b)Nov 8, 2023
Training - Lack of or inadequate procedures
- 21 CFR 820.50Nov 8, 2023
Purchasing controls, Lack of or inadequate procedures
- 21 CFR 820.70(e)Nov 8, 2023
Contamination control, Lack of or inadequate procedures
- 21 CFR 820.100(a)Nov 8, 2023
Lack of or inadequate procedures
- 21 CFR 820.198(a)Nov 8, 2023
Lack of or inadequate complaint procedures
- 21 CFR 820.200(d)Nov 8, 2023
Service reports
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.