4 results
·
9ms
·
Sources: EU EUDAMED, US FDA
Model Number U125, VALITUDE CRT-P EL
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
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