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

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    Luminelle DTx Hysteroscopy System, Luminelle Dx 360 Rotatable Disposable Sheath (Diagnostic)

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

    QUADRA BLOC TENS PLUS

    FDA 510(k)
    FDA Class 2 ·Neurology

    GYRUS ACMI INVISIO DIGITAL HYSTEROSCOPE, MODEL IDH-4

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

    MERGE CARDIO

    FDA Adverse Event
    Malfunction ·MERGE HEALTHCARE SOLUTIONS INC.·Product code LLZ·October 20, 2023

    ACCENT SR RF OUS

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. CRMD·Product code DXY·January 13, 2014

    MULTI-LINK RX ZETA CORONARY STENT SYSTEM

    FDA Adverse Event
    Malfunction ·AV-TEMECULA-CT·Product code MAF·August 4, 2011

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORP·Product code LZG·May 23, 2013

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020