8 results
·
18ms
·
Sources: EU EUDAMED, US FDA
EMIT-ST PHOTOMETER & DILUTER VERIFICA
FDA 510(k)
FDA Class 1
·Clinical Toxicology
LEONE SPA
FDA UDI
LEONE SPA·08033707028963·WEB 1ST MOLAR BANDS n.UL 18
MINI-MIDLINE EXTENDED DWELL SAFETY CATHETER
FDA 510(k)
FDA Class 2
·General Hospital
AMERITEK SURE-POINT TRACKER SYSTEM
FDA 510(k)
FDA Class 2
·Radiology
INFUSE BONE GRAFT
FDA Adverse Event
Injury
·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·May 23, 2014
TENSION FREE VAGINAL TAPE
FDA Adverse Event
Injury
·ETHICON, INC.·Product code FTL·November 13, 2012
ACCU-CHEK SPIRIT
FDA Adverse Event
Malfunction
·ROCHE INSULIN DELIVERY SYSTEMS INC.·Product code LZG·September 2, 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