BEUDAMED
    10 results · 20ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    Advantage Lumbar System - ALIF, PLIF, DLIF, TLIF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    SURGICASE CONNECT, SURGICASE GUIDE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    LINEAR 3-4

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·April 28, 2023

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 15, 2011

    THERMACHOICE

    FDA Adverse Event
    Malfunction ·ETHICON, INC.·Product code MNB·June 26, 2013

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 30, 2014

    Sheep Blood, Defibrinated - Catalog Number 212389, Unit 30 ml.

    FDA Recall
    Terminated ·Becton Dickinson & Co.·Product code JSO·July 2, 2004

    OEC 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023