7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AUTODILUTER 2
FDA 510(k)
FDA Class 1
·Clinical Chemistry
StimaWELL 120MTRS
FDA 510(k)
FDA Class 2
·Neurology
AGILIS NXT STEERABLE INTRODUCER, MODEL G408324
FDA 510(k)
FDA Class 2
·Cardiovascular
SCREW, FIXATION, BONE
FDA Adverse Event
Injury
·SYNTHES (USA)·Product code HWC·April 30, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC, USA·Product code LFR·June 21, 2007
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 10, 2012
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025