2 results
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49ms
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Sources: EU EUDAMED, US FDA
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Status: Terminated
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Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.
FDA Recall
Terminated
·Thermo Finnigan LLC·Product code DOP·July 19, 2016
Endura MD Mass Spectrometer u using software versions Endura MD Software 1.0 and 1.0 SP1. In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body. Chemistry: In vitro diagnostic medical device used to identify and quantify inorganic and organic compounds in the human body.
FDA Enforcement
Class II
·Terminated·Thermo Finnigan LLC·September 21, 2016