7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
STIMULATOR, TN-3001 SOMATOSENSORY
FDA 510(k)
FDA Class 2
·Neurology
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS
FDA 510(k)
FDA Class 2
·General, Plastic Surgery
Transpara
FDA 510(k)
FDA Class 2
·Radiology
FUSION NAVIGATION SYSTEM
FDA Adverse Event
Malfunction
·MEDTRONIC NAVIGATION, INC.·Product code HAW·April 30, 2014
PRECISION XTRA /OPTIUM
FDA Adverse Event
Malfunction
·ABBOTT DIABETES CARE LIMITED UK·Product code LFR·June 26, 2007
CAPSUREFIX NOVUS
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 11, 2012
PROPONENT DR SL (Model L201)
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025