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

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    myTAP2

    FDA 510(k)
    FDA Class 2 ·Dental

    Eye Shield

    FDA UDI
    KATENA PRODUCTS, INC.·00841668101018·SCLERAL SHIELD LARGE (PAIR)

    CSBP-001A BODY ORGAN PERFUSION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    EM-9000

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

    530G INSULIN PUMP

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

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·June 21, 2013

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER INC.·Product code JJE·July 27, 2011

    EPIQ 7C ULTRASOUND CHINA LOCAL

    FDA Adverse Event
    Malfunction ·PHILIPS ULTRASOUND (SHANGHAI) CO., LTD·Product code IYN·June 2, 2023

    DEKA MOTUS AY

    FDA Adverse Event
    Injury ·EL.EN. ELECTRONIC ENGINEERING S.P.A.·Product code GEX·February 18, 2019

    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