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

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    DigiGuide System

    FDA 510(k)
    FDA Class 2 ·Dental

    EarQ

    FDA UDI
    Oticon A/S·05707131343802·G10, MINIRITE 312 2.4G C091 EARQ

    A SCOPE

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HAIRMAX LASERCOMB

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    MIRU 1DAY UPSIDE (MIDAFILCON A)

    FDA Adverse Event
    Injury ·MENICON CO., LTD.·Product code LPL·January 22, 2025

    THERMACHOICE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code MKN·October 8, 2008

    BIOMEDICS 55 -5.50

    FDA Adverse Event
    Malfunction ·COOPERVISION·Product code LPL·June 20, 2013

    ENTRAK 2500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code LLZ·July 21, 2011

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Injury ·CONMED UTICA·Product code GEI·May 18, 2023

    AES-50SP PARADIGM EDGE HIP PROBE, 50 DEGREE

    FDA Adverse Event
    Malfunction ·CONMED UTICA·Product code GEI·May 25, 2023

    Thoratec HeartMate 3 Coring Tool, Sterile EO, Rx Only, REF 10005872, an optional accessory of Thoratec HeartMate 3 Left Ventricular Assist System - Product Usage: The HeartMate 3 Coring Tool is intended for use with the HeartMate 3 Left Ventricular Assist System (LVAS). The Coring Tool provides a means to resect a plug of myocardium from the left ventricle, which allows for HeartMate 3 inflow cannula insertion.

    FDA Enforcement
    Class II ·Terminated·Thoratec Corp.·May 1, 2019