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

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    SAFE-EDGE EYESHIELD

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE

    FDA 510(k)
    FDA Class 1 ·Hematology

    FETAL TELEMETRY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    JAGWIRE?

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - COSTA RICA (COYOL)·Product code EZB·June 25, 2014

    1/4" CHUCK W/KEY

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·November 5, 2010

    HEARTMATE II VENTRICULAR ASSIST DEVICE

    FDA Adverse Event
    Injury ·THORATEC CORP.·Product code DSQ·November 19, 2012

    PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS TRACHEOSTOMY TUBE 7.0MM TIGHT TO SHAFT CUFF, Product Code/List Number/Item Code 670170; b) TTS TRACHEOSTOMY TUBE 8.0MM TIGHT TO SHAFT CUFF 1/EA, Product Code/List Number/Item Code 670180

    FDA Enforcement
    Class I ·Ongoing·Smiths Medical ASD Inc.·September 4, 2024