7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Filters
Regulation: Us FDA
×
eVolve PACS
FDA 510(k)
FDA Class 2
·Radiology
VCS-A SERIES CLAMP
FDA 510(k)
FDA Class 2
·Cardiovascular
SIGNATURE PLANNER,SIGNATURE GUIDES
FDA 510(k)
FDA Class 2
·Orthopedic
CONTOUR TEST STRIPS (10)
FDA Adverse Event
Malfunction
·BAYER HEALTHCARE, LLC·Product code NBW·October 20, 2008
TERUMO CDI 500 BLOOD PARAMETER MONITOR
FDA Adverse Event
Malfunction
·TERUMO CARDIOVASCULAR SYSTEM CORP.·Product code DRY·August 10, 2011
ONETOUCHPING GLUCOSEMGMTSYSTEM
FDA Adverse Event
Malfunction
·ANIMAS CORPORATION·Product code LZG·July 8, 2013
Model Number L111, ESSENTIO DR SL MRI Pacemaker
FDA Enforcement
Class I
·Ongoing·Boston Scientific Corporation·October 22, 2025