7 results
·
34ms
·
Sources: EU EUDAMED, US FDA
MICRO SURGICAL HANDLE
FDA 510(k)
FDA Class 1
·Ophthalmic
S-SCAN
FDA 510(k)
FDA Class 2
·Radiology
EXTENTRAC ELITE
FDA 510(k)
FDA Class 2
·Physical Medicine
ACCUTORR V MONITOR
FDA Adverse Event
Malfunction
·MINDRAY DS USA, INC.·Product code MHX·March 7, 2014
UNKNOWN DEPUY ASR HEAD
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·November 14, 2012
MINI-CAP, DISCONNECT W/PVP-1SOLUTION
FDA Adverse Event
Injury
·BAXTER HEALTHCARE - CLEVELAND·Product code KDI·September 13, 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