BEUDAMED
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    geko W-3

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    ELMED

    FDA UDI
    ELMED INCORPORATED·00842180135413·3 MM DIA., 33 CM INSULATED BUTTON ELECTRODE, SI...

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·August 1, 2022

    ALARIS SMARTSITE

    FDA Adverse Event
    Malfunction ·SISTEMAS MEDICOS ALARIS S.A DE C.V.·Product code FPA·January 26, 2026

    SURGIC IV IMPLANT CONTROL UNIT

    FDA 510(k)
    FDA Class 1 ·Dental

    VERTESSA

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    SYNCHROMED II

    FDA Adverse Event
    Death ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LKK·November 4, 2008

    OPTIVANTAGE DH

    FDA Adverse Event
    Injury ·LIEBEL-FLARSHEIM CO.·Product code IZQ·August 16, 2011

    DURATA STS OPTIM ACTIVE FIXATION, DF4 CONNECTOR

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·July 11, 2013

    BD MICROLANCE¿ 3 NEEDLES

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMI·March 10, 2023

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025