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

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    PL EXAM LIGHT

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

    MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS - AMPICILLIN

    FDA 510(k)
    FDA Class 2 ·Microbiology

    Cydar EV

    FDA 510(k)
    FDA Class 2 ·Radiology

    CAPSUREFIX NOVUS

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

    E360 VENTILATOR

    FDA Adverse Event
    Malfunction ·NEWPORT MEDICAL INSTRUMENTS, INC.·Product code CBK·November 21, 2012

    COOL PATH 7F, 1304-CP-7-25-L1-AB

    FDA Adverse Event
    Malfunction ·ST JUDE MEDICAL, IRVINE·Product code OAD·September 20, 2010

    Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·October 1, 2025

    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