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

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    GELMAN GLYCO-PHORE BUFFER

    FDA 510(k)
    FDA Class 2 ·Hematology

    NA

    FDA UDI
    Richard Wolf GmbH·04055207038864·NORM-CONNECTOR FOR BRONCH. reusable

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113331·PS Insert, Size 5 x 18mm

    LEONE SPA

    FDA UDI
    LEONE SPA·08033707027997·WEB 1ST MOLAR BANDS n.UR 18

    MEDELA SYMPHONY BREAST PUMP, MODEL 024

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    END TIDAL CO2 NASAL CANNULA

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    MED-EL COMBI 40+ COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE GMBH·Product code MCM·April 11, 2014

    PROXIMATE** LINEAR STAPLER

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code GDW·November 6, 2012

    ENDEAVOR RESOLUTE RX

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NIQ·June 5, 2015

    EQUINOXE REVERSE 38MM GLENOSPHERE

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code PHX·October 29, 2025

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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