BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    PENTO Nd:YAG and Alexandrite laser system

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IFA 40: HEP-20-10

    FDA 510(k)
    FDA Class 2 ·Immunology

    Ez3D-i/E3

    FDA 510(k)
    FDA Class 2 ·Radiology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

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

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 23, 2019

    BIOMET MICROFIXATION MANDIBULAR FRACTURE/RECONSTRUCTION DEVICES AND PREBENT PLAT

    FDA Adverse Event
    Injury ·BIOMET MICROFIXATION·Product code HWC·November 6, 2014

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·September 1, 2011

    20X10MM 40CM HEMA MDV BIF

    FDA Adverse Event
    Malfunction ·MAQUET CARDIOVASCULAR, LLC·Product code MAL·July 15, 2013

    Revogene, Catalog no. 610210. IVD test instrument

    FDA Enforcement
    Class II ·Ongoing·Meridian Bioscience Inc·August 3, 2022