BEUDAMED
    8 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.

    SERUM IRON & IRON BINDING REAGENT SET

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ARTHREX BIO-COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    REAGENT, BUN (UREA NITROGEN) DETERM.

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·June 10, 2014

    ALTRUA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 7, 2010

    DUROM ACETABULAR COMPONENT 56/50 CODE P

    FDA Adverse Event
    Injury ·ZIMMER GMBH·Product code KWA·December 5, 2012

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    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