6 results
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29ms
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Sources: EU EUDAMED, US FDA
MYOLYN, INC
FDA registration
MYOLYN, INC·1 product·🇺🇸 United States
MYOCYCLE MC-2
FDA Adverse Event
Injury
·MYOLYN, INC.·Product code GZI·January 19, 2023
MYOCYCLE MC-2
FDA Adverse Event
Injury
·MYOLYN, INC.·Product code GZI·November 17, 2022
MYOCYCLE MC-2
FDA Adverse Event
Malfunction
·MYOLYN INC.·Product code GZI·August 11, 2022
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
FDA Recall
Terminated
·Myolyn Inc.·Product code GZI·July 19, 2022
Power electronic box, Part #AS-0066, subassembly for the MyoCycle MC-2.
FDA Enforcement
Class II
·Terminated·Myolyn Inc.·August 24, 2022