BEUDAMED
    9 results · 24ms · Sources: EU EUDAMED, US FDA

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    Access Thyroglobulin

    FDA 510(k)
    FDA Class 2 ·Immunology

    VIABIL BILIARY ENDOPROSTHESIS

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

    NASOPORE-FD

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    ARCHITECT I2000 ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING, INC.·Product code DHA·November 25, 2008

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code FRN·August 9, 2011

    M2A-MAGNUM MODULAR HEAD SIZE 54MM

    FDA Adverse Event
    Injury ·BIOMET ORTHOPEDICS·Product code KWA·July 22, 2013

    BD NEXIVA¿ DIFFUSICS¿ CLOSED IV CATHETER SYSTEM

    FDA Adverse Event
    Malfunction ·BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.·Product code FOZ·May 3, 2023

    PKG, NEEDLE HOLDER, CURVED LEFT, P/N 0250080341. Laparoscopic Manual Instruments are intended for cutting, holding, grasping and manipulating of tissue, organs, organ areas and surgical auxiliaries such as suturing material. Some instruments have radio frequency (RF) ports which allow them to be used for electrosurgery. Laparoscopic surgical manual instruments are designed to be used endoscopically through cannulae to perform cutting, grasping, dissecting, retracting, and manipulating functions. This device does not sustain or support life.

    FDA Enforcement
    Class II ·Terminated·Stryker Endoscopy·December 24, 2014

    ACCOLADE DR SL MRI (Model L311)

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