7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
DERMACARE TIE HOLDER
FDA 510(k)
FDA Class 1
·General, Plastic Surgery
MINI OX II
FDA 510(k)
FDA Class 2
·Anesthesiology
IG 4 IMAGE GUIDED SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
LIGASURE V SEALER/DIVIDER
FDA Adverse Event
Injury
·COVIDIEN LP·Product code GEI·June 16, 2014
AED PLUS
FDA Adverse Event
Malfunction
·ZOLL MEDICAL CORPORATION·Product code MKJ·November 3, 2010
AVALON FM50 FETAL MONITOR
FDA Adverse Event
Injury
·PHILIPS MEDICAL SYSTEMS·Product code HGM·December 21, 2012
Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system
FDA Enforcement
Class I
·Terminated·CareFusion 303, Inc.·August 12, 2020