BEUDAMED
    9 results · 24ms · 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 ×

    Operating Room Light Handle Adapter

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    EXAIR ANTERIOR AND POSTERIOR PROLAPSE REPAIR SYSTEM

    FDA 510(k)
    FDA Class 3 ·Obstetrics/Gynecology

    DIRECT DIGITIZER, REGIUS MODEL 190

    FDA 510(k)
    FDA Class 2 ·Radiology

    NOBLUS ULTRASOUND SCANNER

    FDA Adverse Event
    Malfunction ·Product code IYO·March 30, 2017

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 5, 2014

    ARCHITECT STAT TROPONIN-I

    FDA Adverse Event
    Malfunction ·ABBOTT LABORATORIES·Product code MMI·June 3, 2013

    PARADIGM REAL-TIME INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·June 21, 2011

    XIA TITANIUM 4.5 BLOCKER

    FDA Adverse Event
    Malfunction ·STRYKER SPINE-US·Product code NKB·September 3, 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