3 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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Model Number U125, VALITUDE CRT-P EL
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE DR Pacemaker, SL (Model Number L301), SL MRI (Model Number L311), EL (Model Number L321), and EL MRI (Model Number L331)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025
Impella CP Smart Assist Set, JP; Product Code: 0048-0024-JP;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024