BEUDAMED
    24 results · 23ms · Sources: EU EUDAMED, US FDA

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    Electronic Stethoscope

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    XTAG RESPIRATORY VIRAL PANEL, MODELS I019A0110, I019C011, I019D0112, I019E0113, S019-0116

    FDA 510(k)
    FDA Class 2 ·Microbiology

    ENSITE VELOCITY SYSTEM REFERRED TO ENSITE VELOCITY SYSTEM WITH POSITIONAL REFERENCE TOOL (PRT)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·December 23, 2024

    UNKNOWN SAPPHIRE PUMP

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·August 6, 2025

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·April 6, 2026

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Injury ·EITAN MEDICAL LTD.·Product code FRN·March 17, 2026

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 25, 2025

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·May 26, 2026

    UNKNOWN SAPPHIRE PUMP

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·February 2, 2026

    SAPPHIRE M.T INFUSION PUMP - GERMAN

    FDA Adverse Event
    Death ·EITAN MEDICAL LTD.·Product code FRN·April 28, 2025

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·November 14, 2025

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·July 15, 2025

    SAPPHIRE M.T INFUSION PUMP - FRENCH

    FDA Adverse Event
    Malfunction ·EITAN MEDICAL LTD.·Product code FRN·March 24, 2025

    3002 SECURE II

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FNL·July 1, 2011

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 26, 2013

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE REHABILITATION EQUIP·Product code ITI·October 22, 2014

    NC QUANTUM APEX

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 14, 2025

    NC QUANTUM APEX?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code LOX·March 4, 2026

    Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)

    FDA Recall
    Open, Classified ·TELEFLEX LLC·Product code CAH·August 29, 2022