FEI 2246552
Isomedix Operations Inc.
3459 SOUTH CLINTON AVE., S Plainfield, NJ, US
MDR events12All time
Recalls0All time
Registered products192
Establishment typeSterilizeSterilize Medical Device for Another Party (Contract Sterilizer)
Registered product codes
192 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 2246552.
FDA inspections
0 on file
No inspections on file for this FEI number.
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.