BEUDAMED
    7 results · 26ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    GDS ENZYMATIC ACETAMINOPHEN REAGENT

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    PROLENE Polypropylene Mesh Non-Absorbable Synthetic Surgical Mesh, PROLENE (Polypropylene) Hernia System, Non-absorbable Synthetic Surgical Mesh

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

    SYSING AND HEMOGLOBIN REAGENT

    FDA 510(k)
    FDA Class 2 ·Hematology

    HEARTSTART MRX -EMS DEFIBRILLATOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDICAL SYSTEMS·Product code MKJ·May 29, 2014

    SYMBIQ DUAL CHANNEL

    FDA Adverse Event
    Malfunction ·HOSPIRA, INC.·Product code FRN·October 1, 2010

    6.0MM/45 DEG TI S-ROD 400MM- LEFT

    FDA Adverse Event
    Death ·SYNTHES BRANDYWINE·Product code NKB·December 20, 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