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

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    EPIQ Series Diagnostic Ultrasound System, Affiniti Series Diagnostic Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    SMARTMONITOR 2, MODEL 4000

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    DISPOSABLE STIMULATING ELECTRODE

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 29, 2014

    ENDOTAK RELIANCE

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code NVY·July 8, 2013

    DEXCOM G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM DEXCOM SHARE SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 9, 2015

    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

    BV Pulsera with Software Release 2.3-A mobile, diagnostic X-ray image acquisition and viewing system. Model Number: 718095

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·December 15, 2021