BEUDAMED
    10 results · 33ms · Sources: EU EUDAMED, US FDA

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    2-Way 100% Silicone Cleartract Catheter

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

    APEX PS Knee

    FDA UDI
    Omni Life Science, Inc.·00841690113478·PS-C Insert, Size 1 x 18mm

    IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    HAKIM PROGRAMMABLE AND PRECISION VALVE SHUNT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·August 13, 2025

    TIBIAL BASEPLATE AUGMENT MODEL KC-22118, KC-22128, KC-22138, KC-22148, KC-22158

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    NXSTAGE SYSTEM ONE

    FDA Adverse Event
    Injury ·NXSTAGE MEDICAL, INC·Product code KDI·November 5, 2008

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 24, 2011

    HEARTSTART MRX

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·July 2, 2013

    Oasis Dry Suction Water Seal Chest Drain, DRY SINGLE W/AC P/N: 3600-100

    FDA Enforcement
    Class II ·Terminated·Atrium Medical Corporation·July 8, 2015