BEUDAMED
    8 results · 34ms · Sources: EU EUDAMED, US FDA

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    MODEL 450 INFRARED IMAGING SYSTEM

    FDA 510(k)
    FDA Class 1 ·Obstetrics/Gynecology

    EasyOne Pro Respiratory Analysis System

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS

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

    CAPSURE SP NOVUS

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

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS INC·Product code LZG·November 28, 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