BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    Visualase Thermal Therapy System

    FDA 510(k)
    FDA Class 2 ·Radiology

    MODIFICATION TO ONEDOSE PATIENT DOSIMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    REL-K ARTIFICAL LIMB PROSTHESIS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    BINAXNOW COVID-19 ANTIGEN SELF-TEST

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS SCARBOROUGH, INC.·Product code QKP·September 6, 2022

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 28, 2011

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    DANYANG MAXTHAI MEDICAL EQUIPMENT·Product code IOR·June 21, 2013

    CPR STAT PADZ

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MLN·September 25, 2008

    Aespire View. This anesthesia gas machine is intended to provide general inhalation anesthesia and ventilatory support to patients and are to be used only by medical professionals trained and qualified in the administration of general anesthesia.

    FDA Enforcement
    Class I ·Ongoing·Datex-Ohmeda, Inc.·October 30, 2024