FEI 3014527916
Synchronis Medical Llc
11501 Metro Airport Center drive, Romulus, MI, US
MDR events0All time
Recalls0All time
Registered products19
Establishment typeManufactureManufacture Medical Device
Registered product codes
19 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 3014527916.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Jun 4, 2024
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Jun 4, 2024
Postmarket Assurance: Devices · Citations posted
Inspection citations
2 on file
Top cited requirements
Compare to industry ↗- 21 CFR 820.90(a)Jun 4, 2024
Nonconforming product, Lack of or inadequate procedures
- 21 CFR 830.310(b)Jun 4, 2024
GUDID Information required for unique device identification.
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.