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

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    ROCHE DIAGNOSTICS ELECSYS PRECICONTROL TUMOR

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    INRATIO

    FDA Adverse Event
    Malfunction ·HEMOSENSE, INC.·Product code JPA·September 30, 2005

    TERUMO NEEDLE WITH LOCKING SHEATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    MYALLERGYTEST SYSTEM

    FDA 510(k)
    FDA Class 2 ·Immunology

    SPECTRA WAVEWRITER

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·November 2, 2023

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·March 3, 2025

    COBLATOR II (120V)

    FDA Adverse Event
    Malfunction ·ARTHROCARE CORPORATION·Product code GEI·April 8, 2013

    TELIGEN

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·April 12, 2011

    TENDRIL DX

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code DXY·May 27, 2008

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024