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

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    Gatekeeper Balloon Catheter

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    AccuQuest

    FDA UDI
    Bernafon AG·05711584088722·AQ CO3 MNR T, 2.4G NFM DPB ANBR ACCUQ

    WELL-LIFE OTC EMS SYSTEM

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INBODY, MODELS: 270, R20, R20B

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    METRX SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code HRX·December 22, 2025

    MONOCRYL (POLIGLECAPRONE 25) SUTURE

    FDA Adverse Event
    Injury ·ETHICON, INC.·Product code GAN·October 8, 2008

    ASR UNI FEMORAL IMPL SIZE 47

    FDA Adverse Event
    Injury ·DEPUY INTERNATIONAL·Product code KWA·June 27, 2013

    MASTERGRAFT PUTTY

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK·Product code MQV·August 5, 2011

    Dragonfly OpStar Imaging Catheter, REF 1014651/1014652, 0.068 in, 0.014 in, 135 cm, STERILE EO

    FDA Enforcement
    Class I ·Ongoing·Abbott Vascular·May 25, 2022

    Boston Scientific Fetch 2 Aspiration Catheter, Catalog No. 109400-001. Product The Fetch 2 Aspiration Catheter is indicated for the removal of fresh, soft emboli and thrombi from vessels in the peripheral and coronary vasculature.

    FDA Enforcement
    Class I ·Terminated·Boston Scientific Corporation·April 27, 2016

    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