fda
6 records
FDA Device Recall: The Better-Bladder (BB), part of extracorporeal membrane oxygenation (ECMO) card
2021-06-23
Class II — The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line...
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FDA Device Recall: **Recall Expanded to add these models: Bigger Better-Bladder cardiopulmonary byp
2018-03-07
Class II — The device is used as part of extracorporeal membrane oxygenation (ECMO) cardiopulmonary bypass circuits and may collapse during use which can increase resistance to flow in the venous line...
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FDA Recall: Circulatory Technology Inc — Class II
20160706
The seal between the balloon and the housing may leak. | Product: Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
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FDA Device Recall: The Better-Bladder With 14" ID tubing, ITEM BB14, STERILE, Measure pressure n
2016-10-19
Class III — Twisted or wrinkled balloon components which are considered a cosmetic defect by the firm.
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FDA Device Recall: The Bigger-Better-Bladder, TM 2 With 3/8"ID tubing, 72" long tubing, ITEM BBB38-
2016-09-21
Class II — The seal between the balloon and the housing may leak.
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FDA Device Recall: Bigger-Better-Bladder With 3/8" ID tubing, ITEM BBB38
2016-07-06
Class II — The seal between the balloon and the housing may leak.
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ny_corps
1 records
NY Corp: CIRCULATORY TECHNOLOGY, INC.
1976-08-17
DOMESTIC BUSINESS CORPORATION | County: Nassau | Jurisdiction: New York
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