63 results
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22ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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Intra-Aortic Balloon Catheter Mega 8FR 50cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·April 25, 2018
Intra-Aortic Balloon Catheter Mega 7.5FR 40cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·April 25, 2018
Small Patient ECC Pack, REF BEQ-TOP 24100, Product Usage: The HLM Tubing Sets with Bioline Coating are for single use only. They may be sold sterile, non-sterile and bulk packed. Custom tubing sets that are sold sterile are not to be re-sterilized by the user. In open heart surgery the HLM Tubing Sets with Bioline Coating are used in combination with the heart-lung machine for the oxygenation of blood and removal of carbon dioxide. The main purpose of the HLM Tubing Sets with Bioline Coating is to connect the patient to the hear-lung machine and its components. The HLM Tubing Sets with Bioline Coating are therefore a component in the extracorporeal perfusion circulation system. The utilization period of the use of the tubing sets is restricted to six hours
FDA Enforcement
Class II
·Terminated·Datascope Corporation·June 22, 2016
Intra-Aortic Balloon Catheter Mega 7.5FR 30cc Product Usage: The intra-aortic balloon catheter and accessories are used to provide counter pulsation therapy in the aorta, whereby balloon inflation during diastole and deflation during systole increases blood supply to the heart muscle and decreases the work of the left ventricle.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·April 25, 2018
SENSATION PLUS¿ 8Fr. 50cc Intra-Aortic Balloon Catheter with Insertion Kit & STATLOCK¿ Product Code/Part Number: 0684-00-0576-01U is a cardiac assist device which support the heart's left ventricle by increasing coronary perfusion and reducing the work of the left ventricle.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 31, 2017
Small Patient ECC Pack BEQ-TOP 22301, Catalog No. 701049513
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
Adult ECC Pack BEQ-TOP 22300, Catalog No. 701049504
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 49101 Childrens Large ECC Pack, Custom Tubing Kit, Catalog No. 701067069R01
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 22702 ECC W/HMOD 30000, Catalog No. 701051179
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 5210 ECC Set - Respiratory, Custom Tubing Kit, Catalog No. 701055604R01
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 33500 3/8" ECC PACK, Catalog No. 701053752
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 24500 ADULT ECC, Custom Tubing Kit, Catalog No. 701050253
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 50900 Custom ECC Pack-Neonatal 1/4, Custom Tubing Kit, Catalog No. 709000069R02
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 27610 ECC PACK 3/8, Custom Tubing Kit, Catalog No. 701065622
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
ECC Small - Respiratory BEQ-TOP 5210, Custom Tubing Kit, Catalog No. 701055604
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BO-TOP 20700 SMALL PATIENT 3/8, Custom Tubing Kit, Catalog No. 701050966
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·June 20, 2018
BEQ-T 9410 Lurie Chldns Small 1/4, Custom Tubing Kit, Catalog No. 709000430
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
BEQ-TOP 25500 ECC 3/8 w/QiD, Custom Tubing Kit, Catalog No. 701052461
FDA Enforcement
Class II
·Terminated·Datascope Corporation·May 16, 2018
Maquet Cardiopulmonary Bypass Custom Tubing kit BO-TOP 38600 ADULT CPB, Part Number 701056035R01 Product Usage: The Maquet Cardiopulmonary Bypass Custom Tubing kit is a sterile, non-pyrogenic device for single use only and is not to be re-sterilized by the user. The product consists of tubing and connectors with connected oxygenators, reservoirs, filters and other cardiopulmonary bypass components assembled into user specified circuits for procedures requiring extracorporeal support for up to six hours. See Attachment 6 for a copy of MCP Instructions for Use.
FDA Enforcement
Class II
·Terminated·Datascope Corporation·June 20, 2018