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

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    BIVONA AIRE-CUF ADJUSTABLE TRACHEOSTOMY TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707065906·EXTRAORAL ELASTICS 1/2" 14 oz

    APEX Knee System

    FDA UDI
    Omni Life Science, Inc.·00841690198062·AK3 PS-C Insert Trial Size 6, 14mm

    WILCOR-XR RP-L MEDICAL FILM

    FDA 510(k)
    FDA Class 1 ·Radiology

    IV START KIT

    FDA 510(k)
    FDA Class 2 ·General Hospital

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·June 25, 2014

    LIFEPAK 20 DEFIBRILLATOR/MONITOR

    FDA Adverse Event
    Malfunction ·PHYSIO-CONTROL, INC.·Product code LDD·November 4, 2010

    RADIOFOCUS GLIDEWIRE

    FDA Adverse Event
    Malfunction ·TERUMO CORPORATION·Product code DQX·December 26, 2012

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Enforcement
    Class II ·Ongoing·Abbott Point Of Care Inc.·September 24, 2025

    i-STAT CG8+ cartridge. List Number: 03P88-25. 510(k) numbers: K894914, K940918, K223710, K230275, K230285, K230300

    FDA Recall
    Open, Classified ·Abbott Point Of Care Inc.·Product code CHL·August 21, 2025