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

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    Endolumik Gastric Calibration Tube M Series (EGCT36M); Endolumik Gastric Calibration Tube M Series (EGCT40M)

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    NA

    FDA UDI
    SYNTHES (U.S.A.) LP·10886982164780·SCALLOPED DISTAL TIBIA PLATE 9 HOLES

    LOCKING BONE PLATE STYLE 14, METAFIX LOCKING SCREW 3.8, MERETE CANNULATED PCS 3.0

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DYMEDIX REUSABLE AIRFLOW/SNORE SENSOR

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Widex

    FDA UDI
    Widex A/S·05706069827682·WIDEX EVOKE EBB3D (Summer gold ) 440, Telecoil,...

    Widex

    FDA UDI
    Widex A/S·05706069691245·Widex BEYOND B-F2 (Summer gold ) 440, Telecoil,...

    I-STAT EG7+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 9, 2024

    PCA LL PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE·Product code FRN·November 24, 2008

    ISOFLEX S

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVN·September 9, 2011

    INGENIO

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NKE·July 22, 2013

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE·Product code CHL·April 23, 2024

    ACCOLADE DR SL MRI (Model L311)

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