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

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    TK Insulin Syringe with/without Saftey Retractable Device

    FDA 510(k)
    FDA Class 2 ·General Hospital

    FRESENIUS 2008T HEMODIALYSIS MACHINE

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

    CG-6108 ACT-IL CONTINUOUS ECG MONITOR AND ARRYTHMIA DETECTOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    STYLE 68 SALINE FILLED BREAST IMPLANT

    FDA Adverse Event
    Injury ·ALLERGAN (COSTA RICA)·Product code FWM·August 15, 2017

    GORE® TAG® THORACIC ENDOPROSTHESIS

    FDA Adverse Event
    Malfunction ·W.L. GORE & ASSOCIATES·Product code MIH·October 22, 2014

    STERRAD 200 STERILIZER

    FDA Adverse Event
    Malfunction ·ADVANCED STERILIZATION PRODUCTS·Product code MLR·June 26, 2013

    INSTATRAK 3500

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 27, 2011

    RX HERCULINK 14 STENT SYSTEM

    FDA Adverse Event
    Injury ·ABBOTT VASCULAR-VASCULAR SOLUTIONS·Product code FGE·March 16, 2009

    TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.

    FDA Enforcement
    Class II ·Terminated·Varian Medical Systems·October 10, 2018