8 results
·
27ms
·
Sources: EU EUDAMED, US FDA
TOILET TRAINER FOR HANDICAPPED CHILD
FDA 510(k)
FDA Class 1
·Physical Medicine
Normandy VBR System
FDA 510(k)
FDA Class 2
·Orthopedic
PROFEMUR HIP SYSTEM MODULAR NECKS
FDA 510(k)
FDA Class 3
·Orthopedic
ANIMAS INSULIN INFUSION PUMP
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·May 5, 2014
INSTRUMENT CABLE
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 15, 2012
CONCERTO CRT-D DR
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code NIK·August 10, 2010
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025