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

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    BARRON MICROKERATOME SYSTEM, MODEL B2000

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    CLEARVIEW HCG DEV(URINE)20T

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 22, 2024

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5902

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AdvantageRib System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CLEARVIEW HCG DEV(URINE)20T

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·June 6, 2025

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ZOLL LIFECOR CORPORATION·Product code MVK·February 4, 2013

    LIFEPAK 12 DEFIBRILLATOR/MONITOR SERIES

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC·Product code MKJ·February 4, 2011

    ESSURE

    FDA Adverse Event
    Injury ·BAYER·Product code HHS·August 6, 2014

    ALERE HCG CASSETTE

    FDA Adverse Event
    Malfunction ·ABON BIOPHARM (HANGZHOU) CO., LTD.·Product code JHI·May 25, 2023

    CADD Medication Cassette Reservoir, 100mL, FS, Product Code 21-7302-24

    FDA Enforcement
    Class II ·Ongoing·Smiths Medical ASD Inc.·October 30, 2024