BEUDAMED
    9 results · 19ms · 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 ×

    ELEFIX ELECTRODE CREAM

    FDA 510(k)
    FDA Class 2 ·Neurology

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482462·PLATE 6860210 110 MM ANT CERV

    Shoreline ACS

    FDA UDI
    Seaspine Orthopedics Corporation·10889981127268·16x14x10mm, 7 Degree Trial

    EnSite Precision Cardiac Mapping System v2.0

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    MEDIPORT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ENRHYTHM MRI

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code NVZ·June 10, 2014

    GEMSTAR 7 THERAPY

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·November 21, 2012

    UNK NEXGEN LPS-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER, INC.·Product code HSA·September 21, 2010

    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