8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MIRROR WARMER
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SITZMARKS
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RF CHOKE CABLE
FDA 510(k)
FDA Class 2
·Cardiovascular
FORTIFY DR, DF-4 CONNECTOR
FDA Adverse Event
Malfunction
·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·April 30, 2014
PRECISION XTRA/OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code NBW·June 19, 2007
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012
STERNALOCK BLU SYSTEM PLATE, 8 HOLE STRAIGHT
FDA Adverse Event
Injury
·BIOMET MICROFIXATION·Product code HRS·July 6, 2015
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025