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

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    SAPPHIRE KNIFE BLADE

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    Symmetry Sharp Kerrison Rongeur

    FDA 510(k)
    FDA Class 2 ·Neurology

    COCHLEA-SCAN / COCHLEA-SCAN PLUS

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    CONSULTA CRT-D

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code NIK·June 10, 2014

    EPIX UNIVERSAL CLIP APPLIER

    FDA Adverse Event
    APPLIED MEDICAL·Product code FZP·November 26, 2012

    9800

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS·Product code JAA·June 19, 2015

    PINNACLE MTL INS NEUT40IDX58OD

    FDA Adverse Event
    Death ·DEPUY ORTHOPAEDICS INC US·Product code KWA·November 1, 2011

    12/14 ARTICUL 40MM M SPEC+1.5

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code LPH·November 1, 2011

    2.4MM TI LOCKING SCR SLF-TPNG WITH STARDRIVE RECESS 20MM

    FDA Adverse Event
    Malfunction ·OBERDORF SYNTHES PRODUKTIONS GMBH·Product code HWC·January 5, 2018

    Exactech Equinoxe CAGE GLENOID, CEMENTED, alpha curvature, Mates with: a) 38, 41, 44 head, Small, Item Number 314-13-02, b) 38, 41, 44 head, Medium, Item Number 314-13-03, c) 38, 41, 44 head, Large, Item Number 314-13-04; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024

    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