BEUDAMED
    9 results · 18ms · Sources: EU EUDAMED, US FDA

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    SHIKANI-FRENCH SPEAKING VALVE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    Modulus

    FDA UDI
    Nuvasive, Inc.·00195377049384·Modulus ALIF Trial, 12x34x28mm 15°Sm

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982128·posteriors; shade BL1; size XL; upper jaw

    THERA CHEM

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    DEPUY SPINE LATERAL CAGE SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    STENOSCOP

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·February 8, 2013

    ACCU-CHEK D-TRONPLUS

    FDA Adverse Event
    Malfunction ·ROCHE INSULIN DELIVERY SYSTEMS, INC.·Product code LZG·January 14, 2011

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·August 5, 2014

    OPTETRAK Comprehensive Knee System including OPTETRAK Logic RBK PS Tibial Components (Product Line: 02-012-38-XXXX). NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021