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

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    ET/RT PAPILLOTOME

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

    PORTABLE CARDIAC MONITOR, ABBY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Indy OTW Vascular Retriever

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INSYNC III PROTECT

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NIK·June 10, 2014

    OT ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 7, 2010

    MED-EL MAESTRO COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Malfunction ·MED-EL ELEKTROMEDIZINISCHE GERAETE, GMBH·Product code MCM·December 5, 2012

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·December 23, 2016

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·March 23, 2017

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·October 24, 2016

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·February 20, 2019

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Malfunction ·COOK INC·Product code MMX·October 29, 2018

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·August 3, 2018

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·September 7, 2016

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·April 30, 2018

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·April 14, 2017

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·June 14, 2018

    INDY OTW VASCULAR RETRIEVER

    FDA Adverse Event
    Injury ·COOK INC·Product code MMX·April 20, 2017

    OEC 6800 Miniview, Image-intensified fluoroscopic x-ray system used during diagnostic, surgical and interventional procedures. Designed to provide the physician with general fluoroscopic visualization of the patient including but not limited to surgical orthopedic and extremity imagine. The device is not intended for whole-body pediatric imaging.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012