BEUDAMED
    12 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 ×

    Cam Lock Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CoRoent

    FDA UDI
    Nuvasive, Inc.·00887517637963·CoRoent Ant TLIF PEEK, 15x12x28mm 12°

    HairCheck-DT (Cocaine)

    FDA UDI
    Quest Diagnostics·00868586000216·HairCheck-DT (Cocaine) is an ELISA test kit use...

    KMEDIC

    FDA UDI
    TELEFLEX INCORPORATED·24026704284027·

    THE VARIA FIBULA LOCKED PLATING SYSTEM LINE EXTENSION ADDITION OF STRAIGHT PLATES

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VENAFLO II VASCULAR GRAFT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 7, 2013

    IDENTITY XL DR

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL, CARDIAC RHYTHM MANAGEMENT DIVISI·Product code DXY·January 13, 2014

    OT VITA METER

    FDA Adverse Event
    Injury ·LIFESCAN INC.·Product code NBW·July 7, 2011

    LIGASURE

    FDA Adverse Event
    Malfunction ·COVIDIEN MFG DC BOULDER·Product code GEI·March 21, 2022

    ELEKTA LIMITED Elekta Synergy, REF MRT 8501, MRT 8511; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

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

    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