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

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    UNISTIM UNT-1M NEUROSTIMULATOR TRANSMITTER

    FDA 510(k)
    FDA Class 2 ·Neurology

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482400·PLATE 6860185 85 MM ANT CERV

    P.F.C.

    FDA UDI
    DEPUY (IRELAND)·10603295215615·P.F.C. MODULAR PLUS TIBIAL HEMI WEDGE CEMENTED ...

    1688 4K Camera System with Advanced Imaging Modality; 1788 4K Camera System with Advanced Imaging Modality

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Wrist 3

    FDA 510(k)
    FDA Class 2 ·Radiology

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    FDA Adverse Event
    Injury ·MEDTRONIC MILACA, INC.·Product code LWP·June 10, 2014

    THERAPY COOL FLEX, 1304-CF-7-0.5(5)2-M-TE4BE1EB

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, INC. (AF-IRVINE)·Product code OAD·November 21, 2012

    INNOVA 2000

    FDA Adverse Event
    Malfunction ·GE MEDICAL SYSTEMS SCS·Product code MQB·September 21, 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

    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