BEUDAMED
    14 results · 22ms · Sources: EU EUDAMED, US FDA

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    CIRRUS™ HD-OCT Model 6000

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    INJECTION GOLD PROBE BIPOLAR ELECTROHEMOSTASIS CATHETER

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

    POWERLITE 600 EX SYSTEM

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

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 16, 2025

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·January 23, 2025

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·April 22, 2026

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·February 14, 2025

    MODEL NOT SPECIFIED

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code LZG·November 14, 2008

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·September 6, 2011

    AVAULTA PLUS BIOSYNTHETIC SUPPORT SYSTEM - POSTERIOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code OTP·July 16, 2013

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·June 2, 2025

    WALLFLEX ESOPHAGEAL

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC CORPORATION·Product code ESW·May 28, 2025

    ALINITY I TOXO IGM REAGENT KIT

    FDA Adverse Event
    Malfunction ·ABBOTT GMBH·Product code LGD·September 11, 2025

    ACCOLADE DR SL MRI (Model L311)

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