7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
AO FLEXIBLE FIBER OPTIC S/COLONOSCOPE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
EMIT ANTIEPILEPTIC DRUG ASSAYS
FDA 510(k)
FDA Class 2
·Clinical Toxicology
APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A VERSION 4.0R001
FDA 510(k)
FDA Class 2
·Radiology
UNKNOWN_RECONSTRUCTIVE_PRODUCT
FDA Adverse Event
Injury
·STRYKER ORTHOPAEDICS-MAHWAH·Product code JWH·May 6, 2014
SPEEDLOCK IMPLANT
FDA Adverse Event
Injury
·ARTHROCARE CORPORATION·Product code MBI·October 11, 2012
FREESTYLE FREEDOM LITE
FDA Adverse Event
Malfunction
·Product code NBW·August 10, 2010
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025