FEI 3003076831
Isomedix Operations Inc.
7685 ST.ANDREWS AVE., SAN DIEGO, CA, US
MDR events12All time
Recalls0All time
Registered products137
Establishment typeSterilizeSterilize Medical Device for Another Party (Contract Sterilizer)
Registered product codes
137 product codes
Recent MDR events
12 on file
- COINTIP SNAREMar 31, 2026MalfunctionMW5186172
- BD SMARTSITE LOW SORBING EXTENSION SETMar 23, 2026MalfunctionMW5185572
- PADLOCK CLIP DEVICEJul 28, 2025InjuryMW5173427
- ENDOSCOPY VALVE KITMay 16, 2023MalfunctionMW5117588
- STERIS LARIATAug 2, 2022MalfunctionMW5111242
- STERIS EXACTO COLD SNAREMay 23, 2022MalfunctionMW5109849
- COOPER SURGICAL - RUMIJul 15, 2021Malfunction12173236
- MASTISOLJul 24, 2017InjuryMW5071189
- AMPLATZER (ASO) SEPTAL OCCLUDERMay 26, 2017InjuryMW5070082
- T-DOC URODYNAMIC CATHETERMar 31, 2017Malfunction6449177
Recalls
0 on file
No recalls on file for this firm name.
Compliance history
Matched by FEI 3003076831.
FDA inspections
2 on file
- No Action Indicated (NAI)Apr 3, 2026
Compliance: Devices
- No Action Indicated (NAI)Apr 3, 2026
Postmarket Assurance: Devices
Inspection citations
0 on file
No citations on file for this FEI number.
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.