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

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    Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Anterolateral Tibia Plate

    FDA UDI
    I.T.S. GmbH·09120047299784·Anterolateral Tibia Plate, 9-Hole, Right

    Stryker Performance Series

    FDA UDI
    STRYKER CORPORATION·04546540605634·Stryker Performance Series Sagittal Blade

    VALIDATE CHEM 6 CALIBRATION VERIFICATION TEST SET MODEL # 10006

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ENDOGATOR ADVANTAGE IRRIGATION PUMP

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

    BASIX COMPAK INFLATION SYRINGE

    FDA Adverse Event
    Malfunction ·MERIT MEDICAL SYSTEMS, INC.·Product code DXT·June 27, 2011

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·October 23, 2008

    ANIMAS INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·August 16, 2011

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·July 9, 2013

    EVOLUT R TRANSCATHETER AORTIC VALVE

    FDA Adverse Event
    Injury ·MEDTRONIC HEART VALVES DIVISION·Product code NPT·February 9, 2024

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    DRX Revolution Mobile X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Carestream Health, Inc.·December 13, 2023