BEUDAMED
    11 results · 22ms · Sources: EU EUDAMED, US FDA

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    ATLAS IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    ULTRACONCENTRATOR SYSTEM

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    MEROGEL OTOLOGIC PACK

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

    EDWARDS SAPIEN TRANSCATHETER HEART VALVE

    FDA Adverse Event
    Injury ·EDWARDS LIFESCIENCES·Product code NPT·April 22, 2013

    GE OEC 9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEM INC.·Product code JAA·July 10, 2008

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·April 27, 2011

    FREESTYLE INSULINX

    FDA Adverse Event
    Malfunction ·Product code NBW·April 10, 2013

    EVOLUT FX DCS

    FDA Adverse Event
    Malfunction ·MEDTRONIC IRELAND·Product code NPT·August 7, 2025

    WAVEWRITER ALPHA 16

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·December 27, 2021

    BD TEXIUM¿ NEEDLE-FREE SYRINGE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS, S.A. DE C.V.·Product code FMF·November 29, 2022

    Stryker MA204 Bed Model (FL25E) Beds are intended for medical purposes in both general patient care as well as critical care environments. Each uses built-in electric motors and controls which can be operated by the patient, or caregiver, to adjust the height and/or surface contour of the bed.The devices listed above also include movable and latchable side rails which can be lowered or raised to help prevent patient fall and subsequent injury. The Beds include an optional Scale (Models: FL20E, FL25E, FL28C, FL28EX) as well as an optional Bed Exit (1 Zone) or Chaperone

    FDA Enforcement
    Class II ·Terminated·Stryker Medical Division of Stryker Corporation·July 4, 2012