BEUDAMED
    10 results · 19ms · Sources: EU EUDAMED, US FDA

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    Callaly Tampliner

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    Puget Sound Energy - 18 Metal

    FDA UDI
    Certified Safety Manufacturing, Inc.·00766588014692·Puget Sound Energy - 18 Metal

    Mini Spike Plus 6/8R

    FDA 510(k)
    FDA Class 2 ·General Hospital

    STAXXSD SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CARPENTIER-EDWARDS PERIMOUNT MAGNA AORTIC BIOPROSTHESIS

    FDA Adverse Event
    Death ·EDWARDS LIFESCIENCES·Product code LWR·October 23, 2008

    VERIFLEX (TM)

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code MAF·August 15, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 8, 2013

    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