7 results
·
26ms
·
Sources: EU EUDAMED, US FDA
THERAPEUTIC DRUG CONTROL
FDA 510(k)
FDA Class 2
·Clinical Toxicology
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
FDA 510(k)
FDA Class 2
·Neurology
APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0
FDA 510(k)
FDA Class 2
·Radiology
NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM
FDA Adverse Event
Injury
·COCHLEAR LTD .·Product code MCM·May 27, 2014
OT ULTRALINK METER
FDA Adverse Event
Malfunction
·LIFESCAN INC.·Product code NBW·November 15, 2012
DXTEND STAND PE CUP D42 +9MM
FDA Adverse Event
Injury
·DEPUY FRANCE S.A.·Product code KWS·September 8, 2010
Fortify, Sterile EO, Model #/ Part #: CD1231-40/100029238,100030095, 100041981; CD1231-40Q/100029229, 100030087, 100041982; CD1233-40/100029230, 100029250, 100029259,100031058, 100059778, 100070017; CD1233-40Q/100029260, 100029271, 100029277, 100031104, 100070089; CD1235-40/100029272, 100029282, 100029311, 100031039, 100059779; CD1235-40Q/100029273, 100029295, 100029312, 100030840; CD1241-40/100046351; CD1241-40Q/100046167; CD2231-40/100029274, 100030110, 100041922; CD2231-40Q/100029275, 100030089, 100041923; CD2233-40/100029147, 100029276, 100029313, 100031066, 100037043, 100048759, 100070007; CD2233-40Q/100029148, 100029263, 100029314, 100031067, 100037044, 100059770, 100070068; CD2235-40/100029149, 100029265, 100029283, 100031029, 100059837; CD2235-40Q/100029239, 100029258, 100029284, 100031030, 100066504; CD2241-40/100046148; CD2241-40Q/100046149; CD2299-40/100056952
FDA Enforcement
Class II
·Terminated·St Jude Medical Inc.·July 4, 2018