BEUDAMED
    11 results · 28ms · Sources: EU EUDAMED, US FDA

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    CMV BRITE TURBO KIT

    FDA 510(k)
    FDA Class 2 ·Microbiology

    INVISION-PLUS

    FDA Adverse Event
    Malfunction ·RYMED TECHNOLOGIES, LLC·Product code FPA·July 7, 2022

    MaXcess

    FDA UDI
    Nuvasive, Inc.·00887517200723·MaXcess-C Blade, 50mm Lateral Serrated

    CD 3700 SL

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION/CELLDYN·Product code GKZ·May 23, 2007

    LEGION System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    AXS-590 SERIES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    CELL-DYN 3700 SL ANALYZER

    FDA Adverse Event
    Malfunction ·ABBOTT DIAGNOSTICS DIVISION·Product code GKZ·February 22, 2019

    JOURNEY I BCS/RENASY

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·March 6, 2013

    ATTAIN ABILITY

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code OJX·February 15, 2011

    ADAPTA DR

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code NVZ·August 8, 2014

    Flexor Radial Access Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The Flexor¿ Radial Hydrophilic Introducer Access Set is intended to introduce diagnostic and interventional devices In radial artery access procedures

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017