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U.S. Department of Health and Human Services

Medical Device Recalls
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11 to 20 of 25 Results
510(K) Number: K112372
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Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers Model Numbers 0998-00-0800-75, 099... 2 03/22/2023 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, ... 2 03/22/2023 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-31, 0998-00-0800-32, ... 2 03/06/2023 FEI # 3001418283
Datascope Corp.
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model Numbers 0998-00-0800-75, 0998-00-0800-83, ... 2 03/06/2023 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 099... 2 10/07/2021 FEI # 3001418283
Datascope Corp.
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model Nos. 0998-00-0800-31, 0998-00-0800-32, 099... 2 09/30/2021 FEI # 3001418283
Datascope Corp.
CARDIOSAVE Hybrid IABP and CARDIOSAVE Rescue IABP affected part number is 0998-:XX-0800-XX Li-Ion ... 2 03/02/2017 FEI # 3001418283
Maquet Datascope Corp - Cardiac Assist Division
Cardiosave Hybrid and rescue IABP 2 03/25/2016 FEI # 3001418283
Maquet Datascope Corp - Cardiac Assist Division
Maquet CARDIOSAVE Hybrid Intra-Aortic Balloon Pump (IABP) 2 02/23/2015 FEI # 3001418283
Maquet Datascope Corp - Cardiac Assist Division
CARDIOSAVE Intra-Aortic Balloon Pump and CS300 Intra-Aortic Balloon Pump; and, non-sterile, not for ... 2 02/07/2015 FEI # 3001418283
Maquet Datascope Corp - Cardiac Assist Division
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