4 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Ongoing
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Boston Scientific Guider Softip XF, 40 XF, 8F, Guide Catheter, REF H965100440
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·August 31, 2022
SHIP KIT, PROCEDURE KIT, PROTEKDUO LS - DL31 for temporary Cardiopulmonary bypass. Including the following components: a) 31 Fr ProtekDuo Veno-Venous Cannula Set b) LifeSPARC Pump c) 14Fr to 26 Fr Dilator Set d) TandemHeart Wrap. Kit Number: 5820-3118 Intended use is applicable to the intended use of specific devices included in the kit.
FDA Enforcement
Class III
·Ongoing·Cardiac Assist, Inc·December 8, 2021
Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;
FDA Enforcement
Class II
·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026
EMBLEM MRI S-ICD pulse generators, as part of Boston Scientific S-ICD System; Model A219
FDA Enforcement
Class II
·Ongoing·Boston Scientific Corporation·February 3, 2021