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

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    MONOSTAR SYSTEM: IM LATEX TEST

    FDA 510(k)
    FDA Class 2 ·Immunology

    MicroPlex Coil System (MCS) - HyperSoft 3D

    FDA 510(k)
    FDA Class 2 ·Neurology

    TF-BP01 BLOOD PRESSURE MEASUREMENT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Injury ·MPRI·Product code DTB·June 10, 2014

    CRYSTALLINE

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code DTB·October 8, 2010

    INFUSE BONE GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC·Product code NEK·December 7, 2012

    Alaris System PC Unit Model 8000, a modular infusion pump and monitoring system

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 12, 2020

    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