7 results
·
17ms
·
Sources: EU EUDAMED, US FDA
LEONARD PERIPHERAL VENOUS PRESSURE CATH
FDA 510(k)
FDA Class 2
·Cardiovascular
BE PLUS LTM AMPLIFIER GWI AMPLIFIER
FDA 510(k)
FDA Class 2
·Neurology
BOLTON PTA CATHETER
FDA 510(k)
FDA Class 2
·Cardiovascular
COREVALVE
FDA Adverse Event
Injury
·MEDTRONIC HEART VALVES DIVISION·Product code NPT·May 20, 2014
QUPID HCG URINE PREGNANCY CASSETTE
FDA Adverse Event
Malfunction
·ALERE SAN DIEGO, INC.·Product code JHI·October 1, 2012
OT PING METER
FDA Adverse Event
Malfunction
·LIFESCAN, INC.·Product code MDS·September 1, 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