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

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    THE INFANT FLOW SYSTEM

    FDA 510(k)
    FDA Class 1 ·Anesthesiology

    BAY AREA HYPERSCIENCES

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LS-1 PORTABLE BLOOD PRESSURE COMPUTER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    OMNIPOD INSULIN PUMP

    FDA Adverse Event
    Malfunction ·INSULET CORPORATION·Product code LZG·June 9, 2020

    MECHANICAL (MANUAL) WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code IOR·January 28, 2013

    PERITONEAL CATHETER WITH BIOGLIDE, STD, 90CM

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROSURGERY·Product code JXG·December 14, 2010

    PARADIGM INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code LZG·July 12, 2014

    Surgical Display, Model No. MDSC-2224 (24 inch), Model No. MDSC-2226 (26 inch) and Model No. MDSC-2242 (42 inch)

    FDA Enforcement
    Class II ·Terminated·Barco Inc.·November 11, 2015

    Covidien Trellis 6 and Trellis 8 Peripheral Infusion Systems, Sterile EO, Rx only. Models BVT608010V01, BVT608030V01, BVT612010V01, BVT612030V01, CVT808015, CVT808025, CVT812015, CVT812025, EVT808015, EVT808025, EVT812015, EVT812025, BVT808015, BVT808030, BVT812015, BVT812030, EUT808015, EUT808030, EUT812015, EUT812030. Product Usage: The Trellis 6 and Trellis 8 peripheral infusion system is intended for controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.

    FDA Enforcement
    Class II ·Terminated·Medtronic Inc. Cardiac Rhythm Disease Management·April 8, 2015