7 results
·
33ms
·
Sources: EU EUDAMED, US FDA
MASK, BI FLO NASAL OXYGEN
FDA 510(k)
FDA Class 1
·Anesthesiology
IceSphere 1.5 CX Cryoablation Needle
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NEUROLINK IP, MODEL PK1113
FDA 510(k)
FDA Class 2
·Neurology
CURRENT RF DR
FDA Adverse Event
Death
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·April 30, 2014
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·October 11, 2012
ANIMAS VIBE
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 19, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025