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

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    REAGENT, HDL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    ZELTIQ CoolSculpting System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    HEMOBAND, MODELS HB-NS AND HB-NSXL

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

    ATLAS II PLUS DR

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL, INC., CRMD·Product code LWS·April 30, 2014

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 11, 2012

    LASIK

    FDA Adverse Event
    Injury ·UNK·Product code LZS·July 24, 2010

    PROPONENT DR SL (Model L201)

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