BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    TIPSEP-TBG ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    De Soutter Medical

    FDA UDI
    DE SOUTTER MEDICAL LIMITED·05051471156692·SAGITTAL BLADE - DE SOUTTER STANDARD 9 x 35 x 0...

    INFIBRA, MODEL 1200

    FDA 510(k)
    FDA Class 2 ·Dental

    Non-contact Forehead Thermometer

    FDA 510(k)
    FDA Class 2 ·General Hospital

    DEFIBRILLATOR, AUTOMATIC IMPLANTABLE CARDIOVERTER, WITH CARDIAC RESYNCHRONIZATIO

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO·Product code NIK·June 10, 2014

    PROMUS EVEROLIMUS ELUTING CORONARY STENT SYSTEM

    FDA Adverse Event
    Injury ·AV-TEMECULA-CT·Product code NIQ·December 7, 2012

    PARAGON LABORATORY MANAGEMENT

    FDA Adverse Event
    Malfunction ·MCKESSON TECHNOLOGIES INC.·Product code JQP·June 18, 2015

    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