BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    TYRX Absorbable Antibacterial Envelope (medium), TYRX Absorbable Antibacterial Envelope (large)

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

    Aligned Medical Solutions, In House Ocular Pack, AMS12947, STERILEEO

    FDA Enforcement
    Class I ·Ongoing·Windstone Medical Packaging, Inc.·February 28, 2024

    NAVIGATOR APPLICATIONS SUITE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DISPOSAL ECG ELECTRODES, MODEL EASYRODE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UV-FLASH SOLUTION TRANSFER SET (SHORT) - JAPAN

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE·Product code KDJ·October 6, 2008

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·June 18, 2013

    COULTER® LH 780 HEMATOLOGY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code GKZ·August 5, 2011

    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