4 results
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26ms
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Sources: EU EUDAMED, US FDA
Filters
FDA Enforcement
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Model Number L100, ESSENTIO SR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
FDA Enforcement
Class II
·Ongoing·Remote Diagnostic Technologies Ltd.·January 14, 2026
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