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

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    JLK-SDH

    FDA 510(k)
    FDA Class 2 ·Radiology

    Fenom Pro

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Calibrate LTX Interbody System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    IMP,TSV,4.1,10,MTX,MG

    FDA Adverse Event
    Injury ·ZIMMER DENTAL·Product code DZE·November 17, 2021

    HAKIM PROGRAMMABLE VALVE, RT ANGLE

    FDA Adverse Event
    Injury ·CODMAN & SHURTLEFF, INC·Product code JXG·November 11, 2014

    HIRES 90K

    FDA Adverse Event
    Malfunction ·ADVANCED BIONICS, LLC·Product code MCM·July 27, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·July 23, 2013

    Richard Wolf Bronchoscope Tubes, Model Texas. Device is reusable and should be sterilized prior to each use. Product Usage: Bronchoscopes are intended for investigation, diagnosis and therapy of pathological changes and removal of foreign bodies in the area of the tracheobronchial respiratory pathways, in conjunction with endoscopic accessories. The bronchoscopes can also be used endoscopically to visualize the tracheobionchial respiratory tract via the natural passage (oral). Tracheoscope tubes are used as follows: 1. The tube is used as a passage to the area to be examined or treated and allows the insertion of auxiliary instruments such as forceps, resector, remover , suction device and stents; 2. The internal diameter allows the conveying of gases for artificial respiration of the patient and via the ventilation connector in conjunction with the telescope element, the tube can be connected to all known respiration and anasthetic systems; 3. Sampling channel for respiratory gas analysis when gas for analysis is gained from the patient s central respiratory tract by means of the bypass method via the tracheoscope tube. M = identification on Luer connector; 4.Tracheoscopes are used in the trachea up to the tracheal bifurcation.

    FDA Enforcement
    Class II ·Ongoing·Richard Wolf GmbH·February 13, 2019

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

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