BEUDAMED
    8 results · 17ms · Sources: EU EUDAMED, US FDA

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    AMYLASE PROCEDURE

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SERALYZER GLUCOSE TEST MODULE

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FORMCORE DC, MODEL 28-700100

    FDA 510(k)
    FDA Class 2 ·Dental

    MENTOR MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·January 28, 2021

    CAPSUREFIX MRI SURESCAN

    FDA Adverse Event
    Malfunction ·MPRI·Product code NVN·June 10, 2014

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO·Product code LKK·December 7, 2012

    ENVISTA INTRAOCULAR LENS

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB·Product code HQL·June 19, 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