7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
ACTH RIA SYSTEM-DSI 2300
FDA 510(k)
FDA Class 2
·Clinical Chemistry
XPERCT REL. 3
FDA 510(k)
FDA Class 2
·Radiology
LEVO COMBI
FDA 510(k)
FDA Class 2
·Physical Medicine
TREK CORONARY DILATATION CATHETER
FDA Adverse Event
Malfunction
·AV-TEMECULA-CT·Product code LOX·May 23, 2014
MYNXGRIP VASCULAR CLOSURE DEVICE 6F/7F
FDA Adverse Event
Malfunction
·ACCESSCLOSURE, INC.·Product code MGB·November 13, 2012
INQUIRY FIXED CATHETER 6F, 1010-6-28-SC1-L(60)
FDA Adverse Event
Injury
·ST. JUDE MEDICAL, IRVINE·Product code DRF·September 7, 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