8 results
·
22ms
·
Sources: EU EUDAMED, US FDA
Ureteral Stents (AF-D series)
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
SYNTHES (USA) EXTERNAL FIXATION COMPONENT LINE EXTENSION - MR SAFE
FDA 510(k)
FDA Class 2
·Orthopedic
CrossRoads Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM
FDA Adverse Event
Malfunction
·DEXCOM, INC.·Product code QBJ·September 22, 2024
SETROX S 60
FDA Adverse Event
Malfunction
·BIOTRONIK GMBH AND CO.·Product code DTB·November 20, 2008
DURATA STS OPTIM ACTIVE FIXATION, DF-4 CONNECTOR
FDA Adverse Event
Injury
·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 11, 2011
GYNECARE TVT OBURATOR SYSTEM
FDA Adverse Event
Injury
·ETHICON INC.·Product code OTN·July 23, 2013
ACCOLADE DR SL MRI (Model L311)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025