BEUDAMED
    9 results · 22ms · Sources: EU EUDAMED, US FDA

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    Aptima Neisseria gonorrhoeae Assay

    FDA 510(k)
    FDA Class 2 ·Microbiology

    1.9FR DUAL LUMEN POLYURETHANE PIC CATHETER

    FDA Adverse Event
    Malfunction ·FOOTPRINT MEDICAL, INC.·Product code LJS·November 18, 2024

    VECTOR PTA BALLOON DILATATION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    DYNATRON SOLARIS SERIES, MODELS 705, 706, 708, 709 D880 INFRARED PROBE (OPTIONAL ACCESSORY)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    QUARTET

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code OJX·November 6, 2014

    LIGASURE V SEALER/DIVIDER

    FDA Adverse Event
    Malfunction ·COVIDIEN LP (VALLEYLAB)·Product code GEI·July 25, 2011

    GYNECARE PROLIFT TOTAL PELVIC FLOOR REPAIR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTP·July 17, 2013

    Azurion 5 M12; System Code: (1)722227, (2)722231;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Revogene, Catalog no. 610210. IVD test instrument

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