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

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    Skylit Phototherapy System

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

    Avanta CMC

    FDA UDI
    Stryker GmbH·00886385025735·CMC, Instrument Tray

    HEARTWAY POWER TILT SEATING SYSTEM POWER CHAIR, MODEL# P16RT

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    DXH 300 COULTER CELLULAR ANALYSIS SYSTEM, DXH 300C COULTER CELLULAR ANALYSSI SYSTEM MODEL: 71772, 71771

    FDA 510(k)
    FDA Class 2 ·Hematology

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 14, 2014

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 24, 2013

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·July 21, 2011

    GMK-SPHERE FEMORAL COMPONENT SPHERE CEMENTED SIZE 4

    FDA Adverse Event
    Injury ·MEDACTA INTERNATIONAL SA·Product code JWH·December 19, 2018

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·May 5, 2021

    DIDECO EOS ECMO M PHISIO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA·Product code DTZ·May 13, 2021

    SORIN LIFEKIT D905 EOS ECMO

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·October 14, 2021

    EOS PMP, EOS PMP INTEGRATED

    FDA Adverse Event
    Malfunction ·SORIN GROUP ITALIA SRL·Product code DTZ·March 23, 2022

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012