7 results
·
16ms
·
Sources: EU EUDAMED, US FDA
GALLIE CRYONUCLEATOR
FDA 510(k)
FDA Class 2
·Ophthalmic
ENDOCHOICE WATER BOTTLE CAP IRRIGATION SYSTEM
FDA 510(k)
FDA Class 2
·Gastroenterology, Urology
RAMP CK-MB ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GALILEO NEO
FDA Adverse Event
Malfunction
·IMMUCOR, INC.·Product code KSZ·May 27, 2014
RESTORE ULTRA
FDA Adverse Event
Malfunction
·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·November 15, 2012
SPEEDBAND SUPERVIEW SUPER 7, INJECTION SPEEDBAND SUPERVIEW SUPER 7, MODELS 4205
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC - SPENCER·Product code MND·September 14, 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