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

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    HEMOGLOBIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    S.C.A

    Device
    EU MDR · Eu Md Class 1 ·SAMSUN CERRAHİ ALETLER SANAYİ VE TİCARET LİMİTED ŞİRKETİ·On the market·32 countries

    DigiX FDX

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACCULASER PRO4

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTJ·December 3, 2015

    GRANUFLO

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL GROUP·Product code KPO·October 26, 2012

    ESTYLUS 1:5 CONTRA ANGLE ATTACHMENT

    FDA Adverse Event
    Malfunction ·DENTSPLY PROFESSIONAL·Product code EKX·January 17, 2014

    6461500 INFUSOR PUMP (1 LABEL)

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2010

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code HTJ·March 4, 2020

    DEPTH GAUGE FOR 2.0MM AND 2.4MM SCREWS

    FDA Adverse Event
    Malfunction ·SYNTHES MONUMENT·Product code HTJ·December 3, 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