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

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    CREATINE KINASE-MB REAGENT SET

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    N/A

    FDA UDI
    MEDTRONIC SOFAMOR DANEK, INC.·00613994122728·INSTRUMENT 6971566 TRL CUT GUID 6MMX16MM

    ENDOCAR. PACING LEAD-STD. LENGTH PL202

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    Atellica IM High-Sensitivity Troponin I (TNIH)

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    ATTUNE PS RP INSRT SZ5 5MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code NJL·March 15, 2024

    PINNACLE SECTOR II CUP 54MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code KWA·February 21, 2013

    PRECISION

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC NEUROMODULATION·Product code LGW·January 25, 2011

    ABBOTT CLINICAL CHEMISTRY ICT CALIBRATOR

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JGS·July 31, 2014

    ATELLICA IM HIGH-SENSITIVITY TROPONIN I (TNIH)

    FDA Adverse Event
    Malfunction ·SIEMENS HEALTHCARE DIAGNOSTICS, INC.·Product code MMI·December 10, 2020

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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