4 results
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13ms
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Sources: EU EUDAMED, US FDA
Filters
Status: Open, Classified
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Monarch Platform (Urology), REF: MON-000007, MON-000007-RFB
FDA Recall
Open, Classified
·AURIS HEALTH INC·Product code FGB·August 2, 2024
Verigene Processor SP, Model Numbers: 10-0000-07 and 10-0000-07-R
FDA Recall
Open, Classified
·Luminex Corporation·Product code NSU·April 22, 2019
Verigene Processor SP, Models 10-0000-07/10-0000-07R a component of the Verigene system
FDA Recall
Open, Classified
·Luminex Corporation·Product code OOI·April 5, 2022
VERIGENE Processor SP Model No. 10-0000-07. An in vitro diagnostic device intended for processing and identifying nucleic acids
FDA Recall
Open, Classified
·Luminex Corporation·Product code OCC·December 10, 2018