41 results
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22ms
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Sources: EU EUDAMED, US FDA
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·October 2, 2024
CARDIOSAVE HYBRID INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·October 2, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·October 2, 2024
CARDIOSAVE RESCUE INTRA-AORTIC BALLOON PUMP (IABP). Electromechanical system used to inflate and deflate intra-aortic balloons.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·October 2, 2024
Cardiosave Rescue Model Nos. 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Containing Coiled Cord cable (part number 0012-00-1801, Model Numbers 0998-00-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-00-0800-53, 0998-00-0800-55, 0998-00-0800-65, 0998-UC-0800-31, 0998-UC-0800-33, 0998-UC-0800-52, 0998-UC-0800-53, 0998-00-0800-55
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Hybrid Model Nos. 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* * -- not distributed in US
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·March 15, 2023
Cardiosave Rescue IABP, 0998-00-0800-83 Intra-Aortic Balloon Pump For cardiovascular use.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 24, 2019
CS300 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3023-53 For cardiovascular use.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 24, 2019
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), 0998-00-0800-53 For cardiovascular use.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 24, 2019
CS100 Intra-Aortic Balloon Pump, English, 110V; 0998-00-3013-53 For cardiovascular use.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 24, 2019
CS300 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3023-55 For cardiovascular use.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 24, 2019
CS100 Intra-Aortic Balloon Pump, English, 220V; 0998-00-3013-55 For cardiovascular use.
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 24, 2019
Cardiosave Hybrid Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-31 0998-00-0800-32 0998-00-0800-33 0998-00-0800-34 0998-00-0800-35 0998-00-0800-45 0998-00-0800-52 0998-00-0800-53 0998-00-0800-55 0998-00-0800-65 0998-UC-0800-31* 0998-UC-0800-33* 0998-UC-0800-52* 0998-UC-0800-53* 0998-00-0800-55* *Not US distribution
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 26, 2023
Cardiosave Hybrid Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-31, 0998-UC-0800-31, 0998-00-0800-32, 0998-00-0800-33, 0998-UC-0800-33, 0998-00-0800-34, 0998-00-0800-35, 0998-00-0800-45, 0998-00-0800-52, 0998-UC-0800-52, 0998-00-0800-53, 0998-UC-0800-53, 0998-00-0800-55, 0998-UC-0800-55, 0998-00-0800-65
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pumps (IABP), Part Numbers 0998-00-0800-75, 0998-00-0800-83, 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·September 6, 2023
Cardiosave Rescue Intra-Aortic Balloon Pump (IABP), Model numbers 0998-00-0800-75 0998-00-0800-83 0998-00-0800-85
FDA Enforcement
Class I
·Ongoing·Datascope Corp.·July 26, 2023