3 results
·
14ms
·
Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
×
ACCOLADE DR SL (Model L301)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ESSENTIO DR Pacemaker, SL (Model Number L101, SL MRI (Model Number L111), EL (Model Number L121), and EL MRI (Model Number L131)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025
Impella CP Smart Assist Set, EU; Product Code: 0048-0014;
FDA Enforcement
Class II
·Ongoing·Abiomed, Inc.·September 11, 2024