8 results
·
19ms
·
Sources: EU EUDAMED, US FDA
KNIFE, TROUTMAN CORNEAL SMALL
FDA 510(k)
FDA Class 1
·Ophthalmic
Ceramill® ZI
FDA UDI
Amann Girrbach AG·E4947601871·
TOPSLANE DMLC
FDA 510(k)
FDA Class 2
·Radiology
Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0
FDA 510(k)
FDA Class 2
·Cardiovascular
RESERVOIR 3ML
FDA Adverse Event
Malfunction
·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·April 18, 2014
BACT/ALERT SA
FDA Adverse Event
Malfunction
·BIOMERIEUX, INC.·Product code LIO·April 18, 2007
1.7MM CABLE WITH CRIMP 750MM-STERILE
FDA Adverse Event
Injury
·SYNTHES USA·Product code JDQ·May 8, 2015
Model Number U228, VISIONIST CRT-P EL MRI
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025