10 results
·
36ms
·
Sources: EU EUDAMED, US FDA
CARDIO CK-B RIA KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Cartesion Prime
FDA 510(k)
FDA Class 2
·Radiology
GTX GUIDEWIRE, MODELS TBD-GTX 1, 3,6,9,12, 15
FDA 510(k)
FDA Class 2
·Cardiovascular
UNICEL® DXC 600 PRO SYNCHRON® SYSTEM
FDA Adverse Event
Malfunction
·BECKMAN COULTER·Product code JJE·May 6, 2014
SPRINT QUATTRO SECURE
FDA Adverse Event
Death
·MEDTRONIC PUERTO RICO, INC.·Product code LWS·October 15, 2012
LAUREATE WORLD PHACO SYSTEM
FDA Adverse Event
Malfunction
·ALCON - IRVINE TECHNOLOGY CENTER·Product code HQC·August 6, 2010
UNSPECIFIED BD ALARIS INFUSION SET
FDA Adverse Event
Malfunction
·BECTON DICKINSON·Product code FPA·May 28, 2021
BD ALARIS¿ SECONDARY SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·March 24, 2023
UNSPECIFIED BD ALARIS¿ INFUSION SET
FDA Adverse Event
Malfunction
·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FPA·December 29, 2022
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