BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    FFX Facet Fixation System

    FDA 510(k)
    FDA Unclassified ·Unknown

    EndoVive Initial Placement Standard PEG Kit with ENFit Connector, EndoVive Initial Placement Safety PEG Kit with ENFit Connector

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    CUTERA SOLERA OPUS AESTHETIC PRODUCT

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

    PD1400 DEFIBRILLATOR/PACEMAKER

    FDA Adverse Event
    Malfunction ·ZOLL MEDICAL CORPORATION·Product code LDD·November 26, 2008

    KINETRA

    FDA Adverse Event
    Injury ·MEDTRONIC EUROPE SARL·Product code MHY·September 12, 2011

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 14, 2014

    Exactech Equinoxe CAGE GLENOID,POSTERIOR AUGMENT, CEMENTED, Left, Mates with: a) 38, 41, 44, 47 head, Small, Item Number 314-13-22, b) 41, 44, 47, 50, head, Medium, Item Number 314-13-23, c) 44, 47, 50, 53 head, Large, Item Number 314-13-24, d) 44, 47, 50, 53 head, Extra Large, Item Number 314-13-25; Shoulder Arthroplasty

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