BEUDAMED
    11 results · 21ms · Sources: EU EUDAMED, US FDA

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    STRATUS N-ACE (NAPA) FLUOROMETRIC ENZYME/IMMUNO.

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PREMIER® Anterior Cervical Plate System

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00681490482226·PLATE 6860140 40 MM ANTERIOR CERVICAL

    ORTHOMED

    FDA UDI
    ORTHO-MED, INC.·B8038601400·INFERO-POSTERIOR ACETABULAR RETRACTOR 10" RIGHT

    CRP-ADVANCE MULTI CALIBRATOR SET, MODEL SE-250

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    DENTRIa series

    FDA 510(k)
    FDA Class 2 ·Radiology

    PREMIER ANTERIOR CERVICAL PLATE SYSTEM

    FDA Adverse Event
    Injury ·WARSAW ORTHOPEDIC, INC.·Product code KWQ·August 12, 2011

    SPRINT QUATTRO SECURE

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

    SOLIA S 53

    FDA Adverse Event
    Injury ·BIOTRONIK SE AND CO. KG·Product code DTB·November 29, 2012

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·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

    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