BEUDAMED
    7 results · 19ms · Sources: EU EUDAMED, US FDA

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    TriMed® Compression Screws

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SmartSurgN Visualization System

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

    AUTOMATED PD SET W/CASSETTE4 PRONG

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE CORPORATION·Product code FKX·November 25, 2008

    BOSTON SCIENTIFIC GREENFIELD FILTER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC·Product code DTK·September 6, 2011

    AFX SYSTEM

    FDA Adverse Event
    Death ·ENDOLOGIX, INC.·Product code MIH·July 23, 2013

    Access 2 Reaction Vessels, individual, disposable, plastic tubes used to process patient, quality control and calibration samples on the Access 2 Immunoassay system, Catalog Number 81901

    FDA Enforcement
    Class II ·Ongoing·Beckman Coulter, Inc.·December 17, 2025