7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
MCGEE FORCEPS
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
V8 TRANSLUMINAL BAV CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
MagnetOs Easypack Putty
FDA 510(k)
FDA Class 2
·Orthopedic
PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)
FDA Adverse Event
Malfunction
·INVACARE SUZHOU·Product code CAW·May 27, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·October 29, 2012
TALENT THORACIC STENT GRAFT SYSTEM
FDA Adverse Event
Injury
·MEDTRONIC CARDIOVASCULAR·Product code MIH·September 8, 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