8 results
·
26ms
·
Sources: EU EUDAMED, US FDA
HYPOTHERMIC MYCARDIAL PROTECTION DEV
FDA 510(k)
FDA Class 2
·Cardiovascular
Ophthalmic Spatula
FDA UDI
KATENA PRODUCTS, INC.·00841668102923·GRAYSON NUCLEUS MANIPULATOR
HEPARIN LOCK FLUSH SYRINGE
FDA 510(k)
FDA Class 2
·General Hospital
MR Q; MR Q SUPINE; MR Q SLT
FDA 510(k)
FDA Class 2
·Ophthalmic
2008K HEMODIALYSIS SYS OLC/DIASAFE PLUS
FDA Adverse Event
Malfunction
·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·March 27, 2014
TOTAL ASR FEM IMP SIZE 57
FDA Adverse Event
Injury
·DEPUY INTERNATIONAL·Product code KXA·November 14, 2012
SYNCHRON LX® I 725 CLINICAL SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER, INC.·Product code MMI·September 13, 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