BEUDAMED
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    GuardianTM Burr Hole Cover System

    FDA 510(k)
    FDA Class 2 ·Neurology

    ELEFANT SUCTION-IRRIGATION DEVICE

    FDA Adverse Event
    Injury ·COLOPLAST A/S·Product code FQH·January 18, 2024

    DUCKWORTH & KENT, LTD., IMPLANTATION SYSTEM, MODEL DK7786

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    DPL NUVE

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

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·December 27, 2018

    OSSURE LOEP KIT

    FDA Adverse Event
    Death ·AGNOVOS HEALTHCARE USA, LLC·Product code MQV·January 18, 2020

    HOMECHOICE AUTOMATED PD SET WITH CASSETTE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·June 21, 2013

    NDEHP LS TWN 2CLVE

    FDA Adverse Event
    Malfunction ·HOSPIRA, LTD·Product code FPA·July 7, 2011

    FRESENIUS LIBERTY CYCLER

    FDA Adverse Event
    Injury ·FRESENIUS MEDICAL NORTH AMERICA·Product code FKX·September 10, 2014

    PENUMA IMPLANT

    FDA Adverse Event
    Injury ·INTERNATIONAL MEDICAL DEVICES, INC.·Product code MIB·October 7, 2019

    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 9800; OEC FluoroTrak 9800 Plus; OEC 9800 Plus; OEC 9800 MD Motorized C-arm System, 892.1650 Image-intensified fluoroscopic x-ray system. The OEC 9800 is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. The system includes features specifically designed for use in diagnostic and interventional cardiac imaging procedures and is also intended for cholangiography, endoscopic, urologic orthopedic, neurologic, vascular, critical care and emergency room procedures. It may be used for other imaging applications at the physician's discretion.

    FDA Enforcement
    Class I ·Terminated·GE OEC Medical Systems, Inc·August 1, 2012