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

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    IRIS Pi Q switched Nd YAG laser

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

    SHANGRING

    FDA 510(k)
    FDA Class 2 ·Obstetrics/Gynecology

    QUICKLAB RSV

    FDA 510(k)
    FDA Class 1 ·Microbiology

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·November 3, 2014

    M SERIES

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code MKJ·August 17, 2011

    CUSTOM PAK

    FDA Adverse Event
    Injury ·ALCON-HOUSTON·Product code KYG·July 9, 2013

    Brand Name: Banner Health Systems Product Name: Cysto Pack Model/Catalog Number: BHCY31E Product Description: Convenience Kit Component: No

    FDA Enforcement
    Class II ·Ongoing·American Contract Systems, Inc.·April 2, 2025