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

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    QMS TM- PHENYTOIN

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    MOR® RC-2 10 pack

    FDA UDI
    STERNGOLD DENTAL LLC·00841549115721·A female part which is inserted into the acryli...

    Swish™ Healing Collar

    FDA UDI
    IMPLANT DIRECT SYBRON MANUFACTURING LLC·10841307116172·

    MODIFIED STERILIZATION OF INTRA-ART(TM) CORONARY

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    UNICEL® DXI 800 ACCESS® IMMUNOASSAY ANALYZER

    FDA Adverse Event
    Malfunction ·BECKMAN COULTER, INC.·Product code JJE·November 22, 2010

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code LWP·July 1, 2014

    3 X 6 ENDOBAG SPECIMEN RETRIEVAL SYSTEM

    FDA Adverse Event
    Malfunction ·COVIDIEN, FORMERLY USSC·Product code GCJ·December 4, 2012

    Alaris Syringe Pump, Model No. 8110. Delivers fluids. Expansion of Affected Units: BOM Housing Assembly Service, Part No. 49000226, and Lower Housing/Carriage Block Assembly, Part No. 148188-100.

    FDA Enforcement
    Class I ·Terminated·CareFusion 303, Inc.·August 26, 2015