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

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    SGOT (AST) REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    Revolution Spinal Fixation System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    ENERGIST ULTRA VPL INTENSE PULSE LIGHT SYSTEM

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    REVEAL XT

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code DSI·June 10, 2014

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·October 7, 2010

    SYMBIQ SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 21, 2012

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    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