BEUDAMED
    10 results · 25ms · Sources: EU EUDAMED, US FDA

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    DTRAX Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DVX SPINE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    AESCULAP MONOMAX ABSORBABLE SUTURE

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    ARTERIAL PRESSURE MONITORING TRAY

    FDA Adverse Event
    Malfunction ·COOK INC·Product code DQO·December 3, 2024

    COMPACT SPEEDREDUCER, BLACK MAX

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBE·October 17, 2014

    HEARTSTREAM FR2

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS (HTST)·Product code MKJ·July 21, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·June 20, 2013

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019

    MONOMAX VIOLET 1(4)150CM HRT48 LOOP(M

    FDA Adverse Event
    Malfunction ·B.BRAUN SURGICAL SA·Product code NWJ·June 4, 2019

    SenTec Membrane Changer (reloadable) [9 pcs] - Product Usage: Is indicated for continuous, non-invasive monitoring of carbon dioxide tension and oxygen tension as well as oxygen saturation and pulse rate in adult and pediatric patients. In neonatal patients the SDMS is indicated for carbon dioxide and oxygen tension monitoring only. Oxygen tension monitoring is contraindicated for patients under gas anesthesia.

    FDA Enforcement
    Class II ·Terminated·SenTec AG·August 14, 2019