9 results
·
35ms
·
Sources: EU EUDAMED, US FDA
HELENA SICKLE-THAL QUIK COLUMN METHOD
FDA 510(k)
FDA Class 2
·Hematology
Bioplate®
FDA UDI
Bioplate, Inc.·M3848120771·Self-Drilling Screw - Ø1.9 mm x 5 mm [5 PK]
Bioplate®
FDA UDI
Bioplate, Inc.·M384812077US1·Self-Drilling Screw - Ø1.9 mm x 5 mm [5 PK]
HBIDB - HUMAN BRIAN INDEX SOFTWARE
FDA 510(k)
FDA Class 2
·Neurology
IMMULITE RUBELLA IGM,LKRM1, LKRM2, IMMULITE 2000 RUBELLA IGM, MODEL L2KRM2, L2KRM6
FDA 510(k)
FDA Class 2
·Microbiology
INFUSOR
FDA Adverse Event
Malfunction
·BAXTER HEALTHCARE - IRVINE·Product code MEB·May 15, 2014
REVEAL XT
FDA Adverse Event
Injury
·MEDTRONIC MED REL, INC.·Product code DSI·October 31, 2012
C-ARM
FDA Adverse Event
Malfunction
·GE MEDICAL SYSTEMS (INDIA) PRIVATE LTD (GE PRIVATE)·Product code JAA·August 17, 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