8 results
·
17ms
·
Sources: EU EUDAMED, US FDA
VISUALAX
FDA 510(k)
FDA Class 2
·Neurology
VEST RESTRAINT
FDA 510(k)
FDA Class 1
·General Hospital
CONMED GOLDVAC INTEGRATED SMOKE EVACUATION PENCIL
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
HFN RH 130 DEG 11MM X 360MM
FDA Adverse Event
Injury
·BIOMET ORTHOPEDICS·Product code HSB·April 30, 2014
PULSE GEN MODEL 103
FDA Adverse Event
Injury
·CYBERONICS, INC.·Product code LYJ·October 10, 2012
MAKO IMPLANT
FDA Adverse Event
Malfunction
·AMENDIA·Product code MQP·July 22, 2010
PIPELINE FLEX W/SHIELD TECHNOLOGY
FDA Adverse Event
Malfunction
·MICRO THERAPEUTICS, INC. DBA EV3·Product code OUT·December 10, 2024
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025