BEUDAMED
    8 results · 28ms · Sources: EU EUDAMED, US FDA

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    SILCATH

    FDA 510(k)
    FDA Class 2 ·General Hospital

    Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    LITH A TEST TM

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    COBAS 8000 COBAS C 502 MODULE

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code JJE·February 25, 2025

    ONETOUCHPING GLUCOSEMGMTSYSTEM

    FDA Adverse Event
    Malfunction ·ANIMAS CORPORATION·Product code LZG·May 27, 2014

    PROGRAMMING SOFTWARE

    FDA Adverse Event
    Malfunction ·CYBERONICS, INC.·Product code LYJ·November 15, 2012

    PRECISION

    FDA Adverse Event
    BOSTON SCIENTIFIC NEUROMODULATION CORPORATION·Product code LGW·September 7, 2010

    Zimmer, Cuff Tourniquet Dual Hose Single Bladder Maroon Reprocessed by Sterilmed, Sterile EO, Rx only.

    FDA Enforcement
    Class II ·Terminated·STERILMED, INC.·December 16, 2015