11 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ABBOTT TOXO-M EIA DIAGNOSTIC KIT
FDA 510(k)
FDA Class 2
·Microbiology
MEDTRONIC BIO-MEDICUS CANNULA INSERTION KIT
FDA 510(k)
FDA Class 2
·Cardiovascular
HEALTH BUDDY APPLIANCE
FDA 510(k)
FDA Class 2
·Cardiovascular
COBAS 6000 C (501) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·August 12, 2025
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·May 19, 2025
COBAS 6000 C (501) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·September 30, 2025
CHARGING SYSTEM
FDA Adverse Event
Injury
·ST. JUDE MEDICAL - NEUROMODULATION·Product code GZB·May 29, 2014
STENOSCOP
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 27, 2012
HEARTMATE II LVAD
FDA Adverse Event
Injury
·THORATEC CORP.·Product code DSQ·July 20, 2010
COBAS 6000 C501 MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·June 23, 2025
COBAS 6000 C (501) MODULE
FDA Adverse Event
Malfunction
·ROCHE DIAGNOSTICS·Product code JJE·July 21, 2025