18 results
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48ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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BOULE MEDICAL AB
FDA registration
BOULE MEDICAL AB·5 products·🇸🇪 Sweden
Swelab Lumi-D Diluent
FDA UDI
Boule Medical AB·07350040796429·The reagents are accessories intended to be use...
Boule EasyCleaner
FDA UDI
Boule Medical AB·07350040791417·Boule EasyCleaner is an accessory intended for ...
Swelab Lumi-L2 Lyse
FDA UDI
Boule Medical AB·07350040796443·The reagents are accessories intended to be use...
Micro pipette, plastic EDTA
FDA UDI
Boule Medical AB·07350040790687·Accessory for the MPA use in Medonic M-series, ...
Swelab Lumi-L1 Lyse
FDA UDI
Boule Medical AB·07350040796436·The reagents are accessories intended to be use...
Medonic M51-L1 Lyse
FDA UDI
Boule Medical AB·07350040796405·The reagents are accessories intended to be use...
Medonic M51-D Diluent
FDA UDI
Boule Medical AB·07350040796399·The reagents are accessories intended to be use...
Medonic M-series
FDA UDI
Boule Medical AB·07350040796344·A fully automatic, 3-part differential, hematol...
Medonic M-series
FDA UDI
Boule Medical AB·07350040796375·A fully automatic, 3-part differential, hematol...
Medonic M-series
FDA UDI
Boule Medical AB·07350040796368·A fully automatic, 3-part differential, hematol...
Medonic M51-L2 Lyse
FDA UDI
Boule Medical AB·07350040796412·The reagents are accessories intended to be use...
Medonic M-series
FDA UDI
Boule Medical AB·07350040796351·A fully automatic, 3-part differential, hematol...
MEDONIC M-SERIES
FDA Adverse Event
Injury
·BOULE MEDICAL AB·Product code GKZ·October 23, 2020
MEDONIC M-SERIES
FDA Adverse Event
Malfunction
·BOULE MEDICAL AB·Product code GKZ·April 7, 2026
MEDONIC M-SERIES
FDA Adverse Event
Malfunction
·BOULE MEDICAL AB·Product code GKZ·October 14, 2019
Medonic M-Series Hematology Analyzer M16S BD ABR US Product code: 1400075; OUS Product code 1400011
FDA Recall
Terminated
·Clinical Diagnostic Solutions, Inc.·Product code GKZ·January 2, 2020
ESSURE
FDA Adverse Event
Injury
·BAYER PHARMA AG·Product code HHS·August 13, 2019