7 results
·
28ms
·
Sources: EU EUDAMED, US FDA
CURITY PERINEAL COLD PACK
FDA 510(k)
FDA Class 1
·Physical Medicine
VIGIL DNASE B CONTROL
FDA 510(k)
FDA Class 1
·Clinical Chemistry
PACEART OPTIMA SYSTEM SOFTWARE
FDA 510(k)
FDA Class 2
·Cardiovascular
QUICK-COUPLING GAUTHIER 103800
FDA Adverse Event
Malfunction
·NEWDEAL S.A.S.·Product code LXH·March 21, 2014
ATTAIN OTW
FDA Adverse Event
Malfunction
·MEDTRONIC, INC.·Product code DTB·October 31, 2012
1644487-2008-00545
FDA Adverse Event
Malfunction
·CYBERONICS, INC.·Product code LYJ·February 29, 2008
TFN-ADVANCED Proximal Femoral Nailing System (TFNA); for treatment of fractures in orthopedics and trauma.
FDA Enforcement
Class II
·Terminated·Synthes, Inc.·May 20, 2015