7 results
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19ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
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ENA PROFILE-6 ELISA TEST SYSTEM
FDA 510(k)
FDA Class 2
·Immunology
BUSH NECK W/PLUG
FDA 510(k)
FDA Class 2
·General Hospital
MICRO-RECORDING AND STIMULATION ELECTRODES-MICRO MACROELECTRODE MODEL NO. 230700-230799
FDA 510(k)
FDA Class 2
·Neurology
SPEEDBAND SUPERVIEW SUPER 7
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC·Product code MND·January 29, 2013
MEDISENSE OPTIUM
FDA Adverse Event
Malfunction
·Product code NBW·December 29, 2010
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·July 17, 2014
ev3 Pipeline Flex Embolization Device with Shield Technology. Sold OUS. For neurological endovascular use.
FDA Enforcement
Class I
·Terminated·Micro Therapeutics Inc, Dba Ev3 Neurovascular·April 1, 2020