BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    LINICAL URIC ACID CALIBRATION VERIFIERS LEVELS A - E FOR OLYMPUS AU SYSTEMS

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    Leksell Stereotactic System

    FDA UDI
    Elekta Solutions AB·07340201503263·Leksell Coordinate Frame G - POSTERIOR MEMBER

    RMO

    FDA UDI
    Rmo, Inc.·00885797099884·IMPRES TRAY KIT MX/MN ASST 30

    C & B FORMULA

    FDA UDI
    AMERICAN TOOTH INDUSTRIES·D772ATI400404550·C & B FORMULA 4 OZ SHADE 55

    GETTIG GUARD

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN

    FDA 510(k)
    FDA Class 2 ·Hematology

    STELLARIS 23GA POSTERIOR PACK

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQC·April 3, 2013

    MEDISENSE OPTIUM

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

    LCS COMPLETE FEM CEM L STD

    FDA Adverse Event
    Injury ·DEPUY - CORK, A DIV OF DEPUY ORTHOPAEDICS INC·Product code NJL·May 8, 2008

    ULTRA 2 CUTTING BALLOON

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code LOX·August 4, 2010

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524INT, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    Thoratec HeartMate 3, LVAS Implant Kit, REF:106524US, Sterile EO, RxOnly

    FDA Enforcement
    Class I ·Ongoing·Thoratec Corp.·May 8, 2024

    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