7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
NERVE APPROXIMATER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
1500 PRO
FDA 510(k)
FDA Class 2
·Cardiovascular
3D Bolus Software
FDA 510(k)
FDA Class 2
·Radiology
EON MINI
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·October 5, 2012
SPECTRUM INFUSION PUMP
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 3, 2014
FREESTYLE FLASH
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE INC., USA·Product code NBW·July 12, 2007
ACCOLADE SR SL MRI (Model L310)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025