7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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E600B FOOTSWITCH
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
MCGHAN INTEGRAL VALVE TISSUE EXPANDER
FDA 510(k)
FDA Unclassified
·Unknown
LEPTOS PULSE GENERATOR
FDA 510(k)
FDA Class 3
·Cardiovascular
HOMECHOICE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·June 16, 2014
ADAPTA DR
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code NVZ·October 19, 2010
POWERED WHEELCHAIR
FDA Adverse Event
Malfunction
·INVACARE TAYLOR STREET·Product code ITI·December 16, 2012
CUSTOM SPRYSTEP, custom made device dynamic ankle-foot orthosis (AFO) , Ref #s: 17C1000, 17C2000, 17C1010, 17C2010, 17C1040, 17C2040
FDA Enforcement
Class II
·Completed·Townsend Design·January 17, 2024