BEUDAMED
    8 results · 18ms · Sources: EU EUDAMED, US FDA

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    MEDI-LET

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

    CELL CULTURE LINES

    FDA 510(k)
    FDA Class 1 ·Hematology

    ACCESS TOXO IGG, ACCESS TOXO IGG CALIBRATORS AND ACCESS TOXO IGG QC

    FDA 510(k)
    FDA Class 2 ·Microbiology

    GREENLIGHT HPS BPH FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·June 18, 2014

    VISISTAT SKIN STAPLER 35W

    FDA Adverse Event
    Malfunction ·TELEFLEX MEDICAL·Product code GDT·October 1, 2010

    UTS

    FDA Adverse Event
    Malfunction ·COOK MEDICAL·Product code FDR·December 14, 2012

    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

    Exactech Equinoxe REVERSE SHOULDER,46mm Humeral Liner, a) +0mm, Item number 320-46-00, b) +2.5mm, Item Number 320-46-03; Shoulder Arthroplasty

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·April 10, 2024