BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    ETHICON LINX® Esophagus Sizing Tool

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    TRIAGE CARDIAC CONTROLS; TRIAGE CARDIO PROFILER CONTROLS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    CROSSTREES PVA POD

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 20, 2025

    MINICAP EXTEND LIFE PD TRANSFER SET - JAPAN

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code KDJ·November 17, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 31, 2011

    PINNACLE MTL INS NEUT36IDX52OD

    FDA Adverse Event
    Malfunction ·DEPUY ORTHOPAEDICS INC US·Product code KWA·July 16, 2013

    Dimension Vista Thyroid Stimulating Hormone (TSH) Flex reagent cartridge

    FDA Enforcement
    Class II ·Terminated·Siemens Healthcare Diagnostics, Inc.·June 28, 2017

    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