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

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    PINPOINT Endoscopic Fluorescence Imaging System

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    Oticon

    FDA UDI
    Oticon A/S·05707131334664·OPN 2, KIT 312 NFM 85 PB L C001

    AVS ANCHOR-C CERVICAL CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    COMMISSIONING DATA MANAGEMENT SYSTEM (CDMS)

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·October 17, 2014

    RELION PRIME BLOOD GLUCOSE SYSTEM

    FDA Adverse Event
    Injury ·ARKRAY, INC.·Product code NBW·June 21, 2013

    UNICEL® DXC 800 SYNCHRON® SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·July 28, 2011

    Olympus Sterile Optical Laser Fiber, single use and reusable

    FDA Enforcement
    Class II ·Terminated·Quanta System, S.p.A.·June 16, 2021