BEUDAMED
    11 results · 23ms · Sources: EU EUDAMED, US FDA

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    REUSABLE CUTANEOUS ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Neurology

    JOBST UltraSheer

    FDA UDI
    BSN MEDICAL, INC.·00035664214838·ULTRA SHEER 30-40 MM HG WAIST HIGH CLOSED TOE S...

    RICH-MAR THERASOUND 6.5 THERAPEUTIC ULTRASOUND

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JOULE CLEARSENSE LASER SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYNCHROMED II

    FDA Adverse Event
    Malfunction ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·May 21, 2013

    INRATIO

    FDA Adverse Event
    Malfunction ·ALERE SAN DIEGO, INC.·Product code GJS·May 6, 2011

    ORTHO SUMMIT SAMPLE HANDLING SYSTEM

    FDA Adverse Event
    Malfunction ·HAMILTON BONADUZ AG·Product code JTC·May 19, 2008

    BD PHOENIX¿ NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·July 23, 2025

    PANEL PHOENIX NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·March 21, 2025

    PANEL PHOENIX NMIC/ID-307

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON & CO. (SPARKS)·Product code LON·January 21, 2025

    LUX-Dx II Plus, Arrythmia detector and alarm, Model M312, with SERVER SW LATITUDE DRAGON EU (Europe), Model 6446, Version 7.5, or SERVER SW LATITUDE DRAGON AU (Australia/New Zealand), Model 6448, Version 7.5

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·May 13, 2026