BEUDAMED
    9 results · 35ms · Sources: EU EUDAMED, US FDA

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    Drug Relief v1

    FDA 510(k)
    FDA Class 2 ·Neurology

    SYNDE-LOCK SYNDESMOSIS REPAIR KIT

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NAVIGUS TRAJECTORY GUIDE BIOPSY KIT, MODELS BK-7000 AND 8000

    FDA 510(k)
    FDA Class 2 ·Neurology

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·August 15, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 8, 2013

    OLM INTRACRANIAL PRESSURE MONITORING KIT

    FDA Adverse Event
    Injury ·INTEGRA NEUROSCIENCES CA/USA·Product code GWM·November 9, 2015

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    Model Number L211 PROPONENT DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    PROPONENT DR Pacemaker, SL (Model Number L201), (VDD) SL (Model Number L209), SL MRI (Model Number L211), EL (Model Number L221), and EL MRI (Model Number L231).

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·January 22, 2025