12 results
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14ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Ongoing
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regard Clinical Packaging Solutions, HT00376I - SPECIAL PROCEDURE, Item Number 800223009
FDA Enforcement
Class II
·Ongoing·ROi CPS LLC·September 25, 2024
INTUA CRT-P, Model Numbers: a) V272 b) V273 c) W273
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
VALITUDE CRT-P, EL (Model Number U125) and EL MRI (Model Number U128)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·January 22, 2025
Altrua 2 pacemaker, Models: a) S701 b) S702 c) S722
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021
Model Number S702, ALTRUA 2 DR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number U128, VALITUDE CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number U125, VALITUDE CRT-P EL
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
Model Number L210 PROPONENT SR SL Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
VITALIO DR EL (pacemaker), Model Numbers: a) J274 b) J277 c) K274 (added 7/15/2021) d) K277 (added 7/15/2021) e) K284 (added 7/15/2021) f) K287 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
INGENIO DR EL (pacemakers), Model Numbers: a) J174 b) J177 c) K174 (added 7/15/2021) d) K184 (added 7/15/2021) e) K187 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
ADVANTIO DR EL (pacemaker), Model Numbers: a) J064 b) J067 c) K064 (added 7/15/2021) d) K084 (added 7/15/2021) e) K087 (added 7/15/2021)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·July 21, 2021
Proponent pacemaker, Models: a) L200 b) L201 c) L209 d) L210 e) L211 f) L221 g) L231
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·July 14, 2021