BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    ZEUS SCIENTIFIC, INC., ANTI-CARDIOLIPIN IGA ELISA REAGENTS

    FDA 510(k)
    FDA Class 2 ·Immunology

    artegral HD

    FDA UDI
    Merz Dental GmbH·D7091973196·posteriors; shade BL4; size S; upper jaw

    MASTER-VU

    FDA 510(k)
    FDA Class 2 ·Radiology

    SUNTOUCH Dental Dressing

    FDA 510(k)
    FDA Unclassified ·Unknown

    TRIAGE PROFILER SOB PANEL

    FDA Adverse Event
    Malfunction ·QUIDEL CARDIOVASCULAR INC.·Product code MMI·June 27, 2019

    ACCESS® 2 IMMUNOASSAY SYSTEM

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER·Product code MMI·February 21, 2013

    OT PING METER

    FDA Adverse Event
    Malfunction ·Product code NBW·January 28, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 1, 2014

    Exactech Equinoxe REVERSE SHOULDER,38mm Constrained Humeral Liner: a) +0mm, Item Number 320-38-10, b) +2.5mm, Item Number 320-38-13, Shoulder Arthroplasty

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