BEUDAMED
    13 results · 21ms · Sources: EU EUDAMED, US FDA

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    MYAH

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    ENTERAL EXPRES PUMP UNIT, ENTERAL EXPRES GIVING SETS

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STERILE POLYISOPRENE POWDER-FREE BLUE SURGICAL GLOVES WITH NEU-THERA EMOLLIENT COATING

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TOTALCARE

    FDA Adverse Event
    Malfunction ·HILL-ROM RITTER·Product code FNL·October 22, 2008

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·August 10, 2011

    MONOPOLAR CURVED SCISSORS INSTRUMENT

    FDA Adverse Event
    Malfunction ·INTUITIVE SURGICAL,INC.·Product code NAY·July 8, 2013

    WALLACH ULTRA FREEZE

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·January 25, 2022

    MENTOR SILTEX ROUND MODERATE PROFILE

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FWM·March 13, 2018

    WALLACH ULTRA FREEZE

    FDA Adverse Event
    Malfunction ·COOPERSURGICAL, INC.·Product code GEH·August 12, 2019

    Veradius Unity with Software Release 2.1- Amobile, diagnostic X-ray imaging and viewing system. . Model Number: 718132

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

    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

    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