BEUDAMED
    7 results · 34ms · Sources: EU EUDAMED, US FDA

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    EMIT CONVENIENCE PACK: PHENYTOIN ASSAY

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    THERMORITE MODEL HC-83 HYPO/HYPERTHERMIA UNIT

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ME20 TRACERITE CLEAR VENT TAPE, ME30 TRACERITE NON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    NOVATION CROWN ACETABULAR CUP

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code KWA·June 9, 2014

    VITALITY 2

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·October 19, 2010

    VENTED AUTOFEED CHAMBER

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE LTD·Product code BTT·December 16, 2012

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. NOVATION CONSTRAINED LINER 28MM ID GROUP 1, REF 134-28-41 b. NOVATION CONSTRAINED LINER 32MM ID GROUP 2, REF 134-32-42 c. NOVATION CONSTRAINED LINER 36MM ID GROUP 3, REF 134-36-43 d. NOVATION CONSTRAINED LINER 36MM ID GROUP 4, REF 134-36-44 e. NOVATION CONSTRAINED LINER 36MM ID GROUP 5, REF 134-36-45

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022