7 results
·
25ms
·
Sources: EU EUDAMED, US FDA
QUICK-COUNT HEMATOLOGY REAGENT KIT
FDA 510(k)
FDA Class 1
·Hematology
SCORPIO TOTAL KNEE SYSTEM
FDA 510(k)
FDA Class 2
·Orthopedic
ASPIRE CRISTALLE
FDA 510(k)
FDA Class 2
·Radiology
TOTAL ASR FEM IMP SIZE 53
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL LTD. 8010379·Product code KXA·May 27, 2014
9900
FDA Adverse Event
Malfunction
·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·November 9, 2012
HEART START XL
FDA Adverse Event
Malfunction
·PHILIPS HEALTHCARE·Product code MKJ·August 31, 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