BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    OSTEOMILL BONE GRINDER

    FDA 510(k)
    FDA Class 1 ·Orthopedic

    ACTIVAPIN

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CareEvent inclusive of the CareEvent Mobile Application accessory

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MALLORY/HEAD - PF ACETABULAR COMPONENT

    FDA Adverse Event
    Injury ·BIOMET UK LTD.·Product code JDI·March 8, 2017

    ADVISA DR MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NVZ·June 10, 2014

    INTERSTIM II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code EZW·October 4, 2010

    SM204 M-SERIES W/BIG WHEEL

    FDA Adverse Event
    Malfunction ·STRYKER MEDICAL·Product code FPO·November 2, 2012

    Daig Livewire Steerable, Product Number 401915; REPROCESSED ELECTROPHYSIOLOGY CATHETER

    FDA Enforcement
    Class II ·Ongoing·Stryker Sustainability Solutions·May 20, 2026

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012