BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    CORTISOL REAGENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    RANGER IRRIGATION FLUID WARMING SYSTEM

    FDA 510(k)
    FDA Class 2 ·General Hospital

    VALVE, I.M.V. (U-MID ONE WAY)

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TELIGEN

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·April 21, 2014

    ACCU-CHEK COMFORT CURVE TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 17, 2007

    PROSTAR XL SUTURE-MEDIATED CLOSURE

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code MGB·September 26, 2012

    STERRAD 100NX Sterilization System, P/N 10104 Product Usage: The STERRAD 100NX Sterilization System is a general purpose, low temperature sterilizer which uses the STERRAD 100NX process to inactivate microorganisms on a board range of medical devices and surgical instruments.

    FDA Enforcement
    Class II ·Terminated·Advanced Sterilization Products·April 10, 2013

    PROPONENT DR SL (Model L201)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025