7 results
·
19ms
·
Sources: EU EUDAMED, US FDA
MODEL 533 PHOTOTHERAPY UNIT
FDA 510(k)
FDA Class 2
·General Hospital
CELL-DYN 4000 IMMUNO T-CELL (CD3/4/8) ASSAY
FDA 510(k)
FDA Class 2
·Hematology
VISENSIA, VISENSIA WITH ALERT
FDA 510(k)
FDA Class 2
·Cardiovascular
VASO VIEW HEMPRO
FDA Adverse Event
Malfunction
·BOSTON SCIENTIFIC CORPORATION·Product code GEI·March 23, 2014
CAPSUREFIX NOVUS
FDA Adverse Event
Injury
·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 31, 2012
SURGICAL GUT SUTURE - CHROMIC
FDA Adverse Event
Injury
·ETHICON INC.·Product code GAL·June 2, 2015
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