BEUDAMED
    10 results · 17ms · Sources: EU EUDAMED, US FDA

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    LENSOMETER MODEL 11

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Proficient® Posterior Cervical Spine System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BIVONA ADJUSTABLE AND FIXED NECKFLANGE HYPERFLEX TRACHEOSTOMY TUBES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    BRYAN CERVICAL DISC SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDICS·Product code MJO·April 30, 2014

    HEARTMATE II LVAS

    FDA Adverse Event
    Injury ·THORATEC CORPORATION·Product code DSQ·October 10, 2012

    DEPUY ASR XL FEM IMP SIZE 46

    FDA Adverse Event
    Death ·DEPUY INTERNATIONAL LTD. 8010379·Product code JDG·May 19, 2015

    ORTHOPEDIC SALVAGE SYSTEM DIAPHYSEAL SEGMENT

    FDA Adverse Event
    Injury ·ZIMMER BIOMET, INC.·Product code JDI·February 21, 2018

    MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440

    FDA Recall
    Open, Classified ·Philips North America Llc·Product code LNH·May 3, 2024

    MR RT Upgrades- Magnetic Resonance (MR) systems are Medical Electrical Systems indicated for use as a diagnostic device. Model Number (REF): 781440

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·May 29, 2024

    PROPONENT DR SL (Model L201)

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