BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    CADWELL FLEX EEG/PSG

    FDA 510(k)
    FDA Class 2 ·Neurology

    AGXO

    FDA UDI
    Oticon A/S·05707131260406·H100, MINIBTE 312 WL 85 SGR AGXO

    GDC 360 DETEACHABLE COIL

    FDA 510(k)
    FDA Class 2 ·Neurology

    LACTOSCREW SCREW ANCHOR

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ASPEN FLEXIBLE LIGHT HANDLE COVER, STERILE

    FDA Adverse Event
    Malfunction ·ASPEN SURGICAL PRODUCTS, CALEDONIA·Product code FTA·February 28, 2018

    DEPTH ELECTRODE

    FDA Adverse Event
    Malfunction ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·December 14, 2021

    SUBDURAL ELECTRODES, DEPTH ELECTRODES, AND ANCHOR BOLTS

    FDA Adverse Event
    Injury ·AD-TECH MEDICAL INSTRUMENT CORP.·Product code GZL·June 14, 2019

    LAMITRODE TRIPOLE 16

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 20, 2013

    ENDURANT ABDOMINAL STENT GRAFT SYSTEM

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·June 14, 2011

    PUMP MMT-712LNAS PRDGM INS SK EN US LN

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·August 22, 2008

    Ultraview SL Command Modules, Model 91496, with the Masimo SpO2 PCBA, PN: 010-1636-02. The Spacelabs Multi-parameter Module is intended for use with the Patient Care Management System (PCMS) to acquire, monitor, and process various clinical parameters from an adult or neonate/infant populations in any type of clinical environment other than home use.

    FDA Enforcement
    Class II ·Terminated·Spacelabs Healthcare Inc·May 13, 2015