BEUDAMED
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    FUJI CAP II CAPSULE & APPLIER

    FDA 510(k)
    FDA Class 2 ·Dental

    THERMOSHELL, EXP CASSETTE

    FDA UDI
    Maquet Critical Care AB·17325710002190·

    ALCOHAWK MODEL PT500 DIGITAL ALCOHOL DETECTOR

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    AMBIENT Super MULTIVAC 50 Wand with Integrated Finger Switches

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

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·June 18, 2014

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    PINGHU WEIFENG MATERIAL TECHNOLOGY·Product code IKX·December 20, 2012

    OT PING METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 25, 2010

    Ethos Collar Stem, Cemented, Fluted, 100MM, 1 EACH. Model Numbers: HC-09100-03M, HC-10100-03M, HC-11120-03M, HC-13120-03M, HC-15120-03M, HC-17120-03M. Component of ELEOS SEGMENTAL LIMB SALVAGE SYSTEM

    FDA Enforcement
    Class II ·Ongoing·Onkos Surgical, Inc.·June 4, 2025