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

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    MODIFIED CARDIOCAP MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ADVIA® Chemistry MYO Myoglobin Reagents

    FDA UDI
    Siemens Healthcare Diagnostics Inc.·00630414000190·Myoglobin - ADVIA Chem. - RGT - 2x100 tests

    Humelock Reversed Shoulder

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    PHILIPS ADULT REUSABLE SP02 SENSOR, MODEL M1191B, M1191BL, M1191BNL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CONCERTO CRT-D DR

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·October 8, 2010

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 23, 2014

    MINICAP TRANSFER SET

    FDA Adverse Event
    Injury ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code KDJ·December 10, 2012

    OPTETRAK Comprehensive Knee System including OPTETRAK RBK PS Tibial Components. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

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