7 results
·
20ms
·
Sources: EU EUDAMED, US FDA
VA 1000
FDA 510(k)
FDA Class 2
·Cardiovascular
Quantum® Total Ankle Prosthesis
FDA 510(k)
FDA Class 2
·Orthopedic
CORDCAP
FDA 510(k)
FDA Unclassified
·Unknown
G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM INC·Product code MDS·May 5, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
VIRTUOSO DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code LWS·August 10, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025