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

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    Filters Regulation: Us FDA ×

    Essenz HLM, Essenz ILBM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NAMSA CHEMICAL PROCESS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    TOSCA PCO2, SPO2 AND PULSE RATE MONITORING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 21, 2025

    PERIMOUNT MAGNA EASE AORTIC SIZER

    FDA Adverse Event
    Malfunction ·EDWARDS LIFESCIENCES·Product code DTI·November 5, 2008

    BIOMET METAL-ON-METAL PROSTHETIC HIP JOINT

    FDA Adverse Event
    Malfunction ·BIOMET·Product code KWA·August 26, 2011

    ECLIPSE FILTER SYSTEM

    FDA Adverse Event
    Injury ·BARD PERIPHERAL VASCULAR, INC.·Product code DTK·July 10, 2013

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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