BEUDAMED
    8 results · 27ms · Sources: EU EUDAMED, US FDA

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    VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 AND 19096

    FDA 510(k)
    FDA Class 2 ·Immunology

    SCREENERS METHAMPHETAMINE TEST, DRUGSCREEN DIP METHAMPHETAMINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    BI-DIRECTIONAL DOPPLER VOLUME FLOWMETER, MODEL DVM-4300 & 4300T

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HIP IMPLANT

    FDA Adverse Event
    Injury ·SMITH & NEPHEW, INC.·Product code JDH·April 8, 2013

    OT VERIO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN INC.·Product code NBW·April 5, 2011

    ATN LAG SCREW 110MM STERILE

    FDA Adverse Event
    Injury ·DEPUY ACE S.A. R.L.·Product code HSB·May 8, 2008

    Exactech Equinoxe REVERSE SHOULDER, 38mm Humeral Liner: a) +0mm, Item Number 320-38-00, b) +2.5mm, Item Number 320-38-03; Shoulder Arthroplasty

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

    Unify Assura, Sterile EO, Model #/ Part #: CD3257-40/100042333, 100059944; CD3257-40Q/100042334, 100059936; CD3261-40/100048460, 100048546, 100059897, 100059954, 100059996, 100078828; CD3261-40Q/100048568, 100048581, 100059898, 100059955, 100059997, 100078853; CD3357-40C/100080408, 100080424, 100083511; CD3357-40Q/100080419, 100080463, 100083504; CD3361-40/100078842, 100079211, 100083506, 100096893; CD3361-40C/100078604, 100079159, 100079160, 100079338, 100083429, 100083514, 100117625; CD3361-40Q/100078805, 100079222, 100079456, 100083523, 100098067; CD3361-40QC/100078654, 100079202, 100079221, 100083475, 100083515, 100117558; CD3389-40C/100080778; CD3389-40QC/100080780, 100105489

    FDA Enforcement
    Class II ·Terminated·St Jude Medical Inc.·July 4, 2018