BEUDAMED
    8 results · 29ms · Sources: EU EUDAMED, US FDA

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    Nitrile Examination Gloves

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Pure Vu System

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

    KHEIRON® Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION CLINICAL CHEMISTRY SYSTEM

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS INC.·Product code MMI·October 24, 2008

    SUPER POLIGRIP ORIGINAL DENTURE ADHESIVE CREAM

    FDA Adverse Event
    Other ·GLAXOSMITHKLINE·Product code KOL·August 1, 2011

    ULTRACISION HARMONIC ACE

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC.·Product code LFL·July 9, 2013

    Subcutaneous Implantable Cardioverter Defibrillator (S-ICD) System, labeled as EMBLEM MRI S-ICD Pulse Generator

    FDA Enforcement
    Class II ·Ongoing·Boston Scientific Corporation·September 25, 2019

    Exactech Equinoxe REVERSE SHOULDER,42mm Constrained Humeral Liner, a) +0mm, Item number 320-42-10, b) +2.5mm, Item Number 320-42-13; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024