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

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    Electrocardiograph

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHIKANI SPEAKING VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ARX-LINK CROSS CONNECTOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LOGIC CR TIB INSERT SLOPE+, SZ 3, 11MM

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JWH·October 11, 2024

    I-STAT CHEM8+ CARTRIDGE (SEE H10 FOR EC8+)

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code JGS·October 7, 2017

    ARCHITECT ANTI-HBS

    FDA Adverse Event
    Malfunction ·ABBOTT IRELAND·Product code LOM·June 14, 2013

    HEARTSTREAM FR2

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 14, 2014

    2800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·June 30, 2011

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·August 31, 2021

    CARTO VIZIGO 8.5F BI-DIRECTIONAL GUIDING SHEATH - MEDIUM

    FDA Adverse Event
    Injury ·BIOSENSE WEBSTER INC·Product code DYB·June 8, 2021

    Ingenia 1.5T- a Magnetic Resonance Medical Electrical Systems indicated for use as a diagnostic device. The system can produce cross-sectional images, spectroscopic images and/or spectra in any orientation of the internal structure of the head, body, or extremities Models: 781341 781396

    FDA Enforcement
    Class II ·Completed·Philips North America Llc·September 15, 2021