BEUDAMED
    11 results · 17ms · Sources: EU EUDAMED, US FDA

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    KALLESTAD FLORESCENT ANA/AMA/ASMA TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198819·AK3 Ultra Insert Trial Size 6, 10mm

    Lacrimal Probe

    FDA UDI
    KATENA PRODUCTS, INC.·00841668108826·JACKSON LACRIMAL INTUBATION SET

    MODIFICATION TO BEACON STABILIZATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SIGMOIDOSCOPE TIPLESS

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    BD NEXIVA

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON INFUSION THERAPY SYSTEMS, INC.·Product code FOZ·March 25, 2014

    UNKNOWN DEPUY ASR FEMORAL HEAD

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KXA·October 16, 2012

    LIFEVEST WCD 4000 SYSTEM

    FDA Adverse Event
    Injury ·ZOLL MANUFACTURING CORPORATION·Product code MVK·May 20, 2015

    M2A-MAGNUM PF CUP 52ODX46ID

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 29, 2016

    M2A MAGNUM MODULAR HEAD 46MM HEAD DIAMETER

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·June 29, 2016

    ACCOLADE SR SL MRI (Model L310)

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