8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
AeroJet Ventilation Catheter
FDA 510(k)
FDA Class 2
·Anesthesiology
ATRICURE BIPOLAR SYSTEM
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
NuVasive Sterilization Trays
FDA 510(k)
FDA Class 2
·General Hospital
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE FLORIDA OPERATIONS·Product code CAW·November 11, 2014
LIBERTY CYCLER SET, DUAL PATIENT CONNECT
FDA Adverse Event
Malfunction
·REYNOSA MANUFACTURING·Product code FKX·August 19, 2011
ADVANTAGE SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code OTN·July 23, 2013
BD INSYTE AUTOGUARD BC SHIELDED IV CATHETER
FDA Adverse Event
Malfunction
·BECTON DICKINSON INFUSION THERAPY SYSTEMS INC.·Product code FOZ·November 25, 2020
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025