BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

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    PPG BIOMEDICAL FLEXIBLE MICRO TRANSDUCER CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BI-PLANE DIGITAL FLUOROGRAPHY DFX7000

    FDA 510(k)
    FDA Class 2 ·Radiology

    FLASH GUARD PLASTIC VERSION

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·June 25, 2014

    NAVILYST MEDICAL

    FDA Adverse Event
    Malfunction ·NAVILYST MEDICAL·Product code DQX·November 4, 2010

    HEARTMATE II LVAD

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·December 27, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020