16 results
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45ms
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Sources: EU EUDAMED, US FDA
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Regulation: Us FDA
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Best Theratronics Ltd.
FDA registration
Best Theratronics Ltd.·4 products·🇨🇦 Canada
Gammacell
FDA UDI
Best Theratronics Ltd·07540146000012·Blood Irradiator
GammaBeam
FDA UDI
Best Theratronics Ltd·07540146000067·A Cobalt Teletherapydevice by which gamma radia...
GammaBeam
FDA UDI
Best Theratronics Ltd·07540146000074·A Cobalt Teletherapy device by which gamma radi...
Raycell
FDA UDI
Best Theratronics Ltd·07540146000104·Blood Irradiator
Raycell
FDA UDI
Best Theratronics Ltd·07540146000043·Blood Irradiator
Avanza
FDA UDI
Best Theratronics Ltd·07540146000050·Patient positioning table
Theratron
FDA UDI
Best Theratronics Ltd·07540146000036·A Cobalt Teletherapydevice by which gamma radia...
Gammacell
FDA UDI
Best Theratronics Ltd·07540146000029·Blood Irradiator
GAMMABEAM 100
FDA Adverse Event
Malfunction
·BEST THERATRONICS LTD.·Product code IWB·July 21, 2015
THERATRON
FDA Adverse Event
Malfunction
·BEST THERATRONICS LTD.·Product code IWD·March 9, 2009
THERATRON
FDA Adverse Event
Malfunction
·BEST THERATRONICS LTD.·Product code IWB·May 13, 2014
THERATRON
FDA Adverse Event
Malfunction
·BEST THERATRONICS LTD·Product code IWB·December 24, 2012
THERATRON
FDA Adverse Event
Malfunction
·BEST THERATRONICS LTD·Product code IWB·January 15, 2014
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
FDA Enforcement
Class II
·Terminated·BEST THERATRONICS LTD.·August 3, 2016
Best Theratronics cabinet x-ray systems intended for use in the irradiation of blood and blood products (packaged in transfusion bags) to inactivate T-lymphocytes for the prevention of Graft Versus Host Disease.
FDA Recall
Terminated
·BEST THERATRONICS LTD.·Product code MOT·May 6, 2016