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

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    MySpine S2-SI Pedicle and Sacro-Iliac Screw Placement Guides

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    FUNDUS AUTOIMAGER

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    PSG-1100 SLEEP DIAGNOSTIC SYSTEM

    FDA 510(k)
    FDA Class 2 ·Neurology

    ONE TOUCH ULTRALINK METER

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code NBW·October 29, 2008

    COLLEAGUE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 23, 2011

    DUAL CHAMBER TEMPORARY PACEMAKER

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·July 8, 2013

    Alinity m Resp-4-Plex AMP Kit (Emergency Use Authorization, US Assay) and Alinity m Resp-4-Plex Application Specification File. in vitro diagnostic

    FDA Enforcement
    Class I ·Terminated·Abbott Molecular, Inc.·October 20, 2021

    Syngo.via and Syngo.x ; a software solution intended to be used for viewing, manipulation, communication, and storage of medical images.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·June 10, 2015

    cobas 6000 Modular Series system; Part Numbers: 1. 04745914001 cobas c 501 module; 2. 05036453001 cobas 6000 UL c 501 + Core Fix configuration; 3. 05036453692 - cobas 6000 UL + CORE CU; and 4. 05860636001 cobas 6000 c 501 (UL) V

    FDA Enforcement
    Class II ·Terminated·Roche Diagnostics Corporation·March 14, 2018