7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
Lynx Aspiration Catheter System
FDA 510(k)
FDA Class 2
·Cardiovascular
Nitinol Enhanced Device (NED)
FDA 510(k)
FDA Class 2
·Cardiovascular
Swoop® Portable MR Imaging® System
FDA 510(k)
FDA Class 2
·Radiology
COBAS® WNV (192T)
FDA Adverse Event
Malfunction
·ROCHE MOLECULAR SYSTEMS, INC. - BRANCHBURG·Product code QHO·September 22, 2025
COGNIS HE IS-1/DF-1/IS-1
FDA Adverse Event
Injury
·CARDIAC PACEMAKERS, INC·Product code NIK·November 11, 2008
HOMECHOICE AUTOMATED PD SET WITH CASSETTE
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·September 19, 2011
SOLYX SIS SYSTEM
FDA Adverse Event
Injury
·BOSTON SCIENTIFIC - MARLBOROUGH·Product code FTL·July 30, 2013