BEUDAMED
    9 results · 17ms · Sources: EU EUDAMED, US FDA

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    MAGNETIC PORT SILICONE TISSUE EXPANDER

    FDA 510(k)
    FDA Unclassified ·Unknown

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091982067·posteriors; shade B4; size L; lower jaw

    ACCU-CHEK ® FASTCLIX

    FDA Adverse Event
    Malfunction ·ROCHE DIABETES CARE, INC.·Product code QRL·March 16, 2026

    PleuraFlow System with FlowGlide Extra Drainage Length

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

    MSC LIPID CONTROL

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    OCTRODE

    FDA Adverse Event
    Malfunction ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·February 8, 2013

    ACCU-CHECK SPIRIT

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·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