BEUDAMED
    9 results · 26ms · Sources: EU EUDAMED, US FDA

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    AR-1000 AUTOMATIC REFRACTOR

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    SYNERGY HIP SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    SpotLight CT

    FDA 510(k)
    FDA Class 2 ·Radiology

    ECHO TIP PROCORE HIGH DEFINITION ULTRASOUND BIOPSY NEEDLE

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FCG·September 11, 2013

    PLM A+ SPANISH 110V

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·April 14, 2014

    EASYTRAK 2

    FDA Adverse Event
    Injury ·CPI - DEL CARIBE·Product code OJX·October 7, 2010

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·December 3, 2012

    Azurion 7 B20; System Code: (1)722068, (2)722226, (3)722236;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    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