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

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    ALLEN UNIVERSAL STIRRUP

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482370·PLATE 6860177 77 5MM ANT CERV

    Gridlock Ankle Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    KLS MARTIN RIGID FIXATION - STERILE

    FDA 510(k)
    FDA Class 2 ·Dental

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·June 10, 2014

    OXIMAX N-595 PULSE OXIMTER

    FDA Adverse Event
    Malfunction ·COVIDIEN·Product code DQA·November 21, 2012

    UNKNOWN NEXGEN LPS-FLEX FEMORAL COMPONENT

    FDA Adverse Event
    Malfunction ·ZIMMER INC.·Product code HSA·September 21, 2010

    Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·July 7, 2021

    KLS Martin Cranial Implants - MR Conditional; K944565: KLS-Martin Micro Osteosynthesis System (1.5MM); K971297: KLS Martin Centre-Drive Drill-Free Screw; K060177: KLS Martin Rigid Fixation - Sterile; K062570: Individual Patient Solutions - Ti (IPS-Ti); K072707: Individual Patient Solutions - PEEK (IPS-PEEK) ; K151382: Individual Patient Solutions - (IPS-PEEK) - STERILE

    FDA 510(k)
    FDA Class 2 ·Neurology

    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