7 results
·
18ms
·
Sources: EU EUDAMED, US FDA
HEATING BLOCK MICROELISA SYSTEM
FDA 510(k)
FDA Class 1
·Microbiology
RSH BILIARY STONE REMOVAL DEVICE
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
Veuron-Brain-pAb3
FDA 510(k)
FDA Class 2
·Radiology
COMPACT AIR DRIVE II
FDA Adverse Event
Malfunction
·DEPUY SYNTHES POWER TOOLS·Product code HWE·May 26, 2014
PERCLOSE PROGLIDE 6F SUTURE MEDIATED CLOSURE (SMC) SYSTEM
FDA Adverse Event
Injury
·AV-TEMECULA-CT·Product code MGB·November 14, 2012
CAPSURE SENSE
FDA Adverse Event
Injury
·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·June 10, 2015
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