BEUDAMED
    12 results · 22ms · Sources: EU EUDAMED, US FDA

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    DEEPVESSEL FFR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    RIGIDFIX

    FDA UDI
    DEPUY MITEK, LLC·10886705002887·RIGIDFIX Tibial Locking Ring 7.5mm

    Search-Cyte I+II 0.8%

    FDA UDI
    Medion Grifols Diagnostics AG·07640137340360·Reagent Red Blood Cells for use in the detectio...

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180124684·5MM DIA., 36CM, INSULATED "L" HOOK ELECTRODE, T...

    BINAXNOW COVID-19 AG SELF TEST 2CT

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·December 22, 2022

    MODIFICATION TO: BIOMET HUMERAL CABLE PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    INTELLIVUE PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 16, 2011

    ACUSON

    FDA Adverse Event
    Malfunction ·SIEMENS MEDICAL SOLUTIONS USA INC.·Product code IYN·September 26, 2014

    INCEPTA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 9, 2013

    DEKA SMARTPERIO

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code NVK·December 11, 2024

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019