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

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    FAQ™ (302)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    JOURNEY TIBIA BASE NP RT SZ 3

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JWH·April 16, 2019

    Da Vinci SP Surgical System

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

    Klarity Bolus

    FDA 510(k)
    FDA Class 2 ·Radiology

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 11, 2014

    RIATA ST ACTIVE FIXATION

    FDA Adverse Event
    Injury ·ST JUDE MEDICAL CARDIAC RHYTHM MANAGEMENT DIVISION·Product code NVY·September 10, 2011

    GYNECARE TVT OBURATOR SYSTEM

    FDA Adverse Event
    Injury ·ETHICON INC.·Product code OTN·July 23, 2013

    ACCOLADE DR SL MRI (Model L311)

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025