7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
ECA GEL
FDA 510(k)
FDA Class 2
·Neurology
CO2 Sidestream Module
FDA 510(k)
FDA Class 2
·Anesthesiology
DYNAREX STERILE LUBRICATING JELLY
FDA 510(k)
FDA Class 1
·General Hospital
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 18, 2014
PINNACLE MTL INS NEUT36IDX52OD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KWA·October 16, 2012
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 22, 2015
Unify Quadra, Sterile EO, Model #/ Part #: CD3249-40/100036404, 100038435, CD3249-40Q/100036407, 100038436, CD3251-40/100036405, 100038095, 100038226, 100038437, 100038451, 100072563, CD3251-40Q/100036408, 100038214, 100038230, 100038407, 100038442, 100072564, CD3255-40/100038224, CD3255-40Q/100036514
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018