7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
CIRCAPAK
FDA 510(k)
FDA Class 1
·Anesthesiology
Europa Pedicle Screw System
FDA 510(k)
FDA Class 2
·Orthopedic
RANDOX BARITURATES ASSAY
FDA 510(k)
FDA Class 2
·Clinical Toxicology
9800
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·January 13, 2014
EZ-28 DELIVERY SYSTEM
FDA Adverse Event
Injury
·BAUSCH + LOMB·Product code MSS·October 12, 2012
CARPENTIER-EDWARDS PERIMOUNT MAGNA PERICARDIAL BIOPROSTHESIS
FDA Adverse Event
Injury
·EDWARDS LIFESCIENCES·Product code DYE·August 10, 2010
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