BEUDAMED
    11 results · 20ms · Sources: EU EUDAMED, US FDA

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    INTRINSIC FACTOR BLOCKING ANTIBODY KIT

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ZIMMER M/L TAPER HIP PROSTHESIS, 7711 SERIES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ICEPLEX C. DIFFICILE ASSAY KIT, ICEPLEX SYSTEM

    FDA 510(k)
    FDA Class 2 ·Microbiology

    PLUM XLD 110V L.A.

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·March 26, 2014

    ATTAIN PERFORMA

    FDA Adverse Event
    Malfunction ·MPRI·Product code OJX·June 10, 2015

    COLLEAGUE 3 VOLUMETRIC INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE PTE. LTD.·Product code FRN·September 13, 2010

    DEPTH GAUGE FOR LCKNG SCRS TO 100

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·December 15, 2021

    DEPTH GAUGE FOR LCKNG SCRS TO 100

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·December 15, 2021

    PALINDROME 19/36 KIT W/SLOT

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code MSD·June 5, 2014

    PM3544 QUADRA RELIEVE and PM3562 QUADRA ALLURE MP These low voltage (LV) devices are implantable pacemaker pulse generators, intended to be permanently implanted in the body, that have a power supply and electronic circuits that produce a periodic electrical pulse to stimulate the heart. These devices are used as a substitute for the heart's intrinsic pacing system to correct both intermittent and continuous cardiac rhythm disorders

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·October 25, 2017

    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