FEI 2528981
Lynx Medical Pennsylvania
2205 E 33rd St, ERIE, PA, US
MDR events0All time
Recalls0All time
Registered products109
Establishment typeSterilizeSterilize Medical Device for Another Party (Contract Sterilizer)
Registered product codes
109 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 2528981.
FDA inspections
2 on file
- Voluntary Action Indicated (VAI)Mar 11, 2026
Compliance: Devices · Citations posted
- No Action Indicated (NAI)Mar 11, 2026
Postmarket Assurance: Devices · Citations posted
Inspection citations
1 on file
Top cited requirements
Compare to industry ↗- ISO 13485:2016 Clause 7.1Mar 11, 2026
Product realization risk management processes not documented
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.