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Maquet Datascope Corp - Cardiac Assist Division

9 FDA 510(k) clearances · Recalling firm

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RecordFirmDate
Cardiosave Hybrid IABP, Part Number 0998-00-0800-53 recall (Z-0099-2019)Maquet Datascope Corp - Cardiac Assist Division2018-10-27
Cardiosave Rescue IABP, Part Number 0998-UC-0800-83 recall (Z-0100-2019)Maquet Datascope Corp - Cardiac Assist Division2018-10-27
CS 100i Intra-Aortic Balloon Pump recall (Z-2736-2017)Maquet Datascope Corp - Cardiac Assist Division2017-06-23
CS 100 Intra-Aortic Balloon Pump recall (Z-2737-2017)Maquet Datascope Corp - Cardiac Assist Division2017-06-23
CS 300 Intra-Aortic Balloon Pump recall (Z-2738-2017)Maquet Datascope Corp - Cardiac Assist Division2017-06-23
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) recall (Z-1140-2015)Maquet Datascope Corp - Cardiac Assist Division2015-02-23
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile recall (Z-1062-2015)Maquet Datascope Corp - Cardiac Assist Division2015-02-07
Datascope System 98/98xt, CS 100/CS100i and CS 300 Intra-Aortic Balloon Pump. The Intra-Ao recall (Z-1523-2014)Maquet Datascope Corp - Cardiac Assist Division2014-05-21
Datascope/ Maquet IABPs. System 98/98XT Intra-Aortic Balloon Pump; CS100/CS100i Intra-Aort recall (Z-2414-2011)Maquet Datascope Corp - Cardiac Assist Division2011-06-13

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Every clearance here is in the API, with alerts when new ones post.