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

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    Target Detachable Coils

    FDA 510(k)
    FDA Class 2 ·Neurology

    BINAXNOW¿ COVID-19 ANTIGEN SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·October 12, 2021

    FLEXTIP PLUS CLOSED TIP EPIDURAL CATHERTER

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AMPLATZER VASCULAR PLUG 4

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BINAX NOW COVID-19 SELF TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·July 24, 2021

    CLEARLINK PACLITAXEL SETS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·February 2, 2024

    ASKU

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 6, 2026

    SEE H10

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 17, 2020

    ASKU

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

    ASKU

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·January 3, 2026

    DUO-VENT CLEARLINK LUER ACTIVATED VALVE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·July 12, 2023

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    DRUG ELUTING PERMANENT LEFT VENTRICULAR (LV) PACEMAKER ELECTRODE

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·June 8, 2013

    INSIGNIA

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·July 7, 2011

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS INC.·Product code JAA·September 11, 2008

    NI

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FPA·May 23, 2017

    Stryker Sustainability Solutions (SSS) reprocessed Arthroscopic Shavers Arthroscopic shavers can be used to abrade, cut and excise tissue and bone; remove loose fragments; and, shave away debris in arthroscopic surgeries, as well as surgeries of the jaw and sinuses. Intended for use in orthopedic surgical procedures of the joints, jaw or sinuses where the cutting and removal of soft and hard tissue or bone is needed in patients requiring orthopedic surgery.

    FDA Enforcement
    Class II ·Terminated·Stryker Sustainability Solutions·March 13, 2019

    ELEKTA LIMITED Versa HD, REF XRT 2121, 2131; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 2023