5 results
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12ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Class I
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Vascular Solutions, Inc., Guardian II and Guardian II NC Hemostasis Valve, used in cardiopulmonary bypass. Model numbers: FH101, FH101-T, FH101-25, FH101-50, 8210, 8211, FH102, FH102-T, FH102-25, FH102-50, 8215, 8216, 8241, 8242, 8244, 8272 and 8274. Vascular Solutions Zerusa Limited. Intended to maintain hemostasis during the use of diagnostic/interventional devices during diagnostic/interventional procedures.
FDA Enforcement
Class I
·Terminated·Vascular Solutions, Inc.·March 27, 2013
CAIRE Liberator 45, MODEL 13262253, Liquid Oxygen System Unit
FDA Enforcement
Class I
·Terminated·Caire, Inc.·December 14, 2022
CAIRE Liberator 30, MODEL 13337403, Liquid Oxygen System Unit
FDA Enforcement
Class I
·Terminated·Caire, Inc.·December 14, 2022
CAIRE Liberator 20, MODEL 13256195, Liquid Oxygen System Unit
FDA Enforcement
Class I
·Terminated·Caire, Inc.·December 14, 2022
CAIRE Liberator 45, MODEL 13261699, Liquid Oxygen System Unit
FDA Enforcement
Class I
·Terminated·Caire, Inc.·December 14, 2022