BEUDAMED
    11 results · 27ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    SagiNova

    FDA 510(k)
    FDA Class 2 ·Radiology

    LATERAL FUSION DEVICE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MODIFICATION TO SYNTHES (USA) (SYNTHES) LOW PROFILE NEURO SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC·Product code LIT·November 18, 2015

    TRILOGY SR

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

    ACRYSOF RESTOR

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code MFK·May 30, 2013

    INRATIO2

    FDA Adverse Event
    Other ·ALERE SAN DIEGO, INC.·Product code GJS·June 21, 2011

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Injury ·ANGIOSCORE, INC·Product code LIT·March 29, 2016

    ANGIOSCULPT PTA SCORING BALLOON CATHETER (OTW)

    FDA Adverse Event
    Malfunction ·ANGIOSCORE, INC·Product code LIT·November 26, 2015

    ProScreen 12 Drug Cup w/Adulteration, Item No. PSCupA-12TBU

    FDA Enforcement
    Class III ·Terminated·Ameditech Inc·December 30, 2015

    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