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

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    Tokuyama Rebase III

    FDA 510(k)
    FDA Class 2 ·Dental

    SPOTCHECK BLOOD SPOT CONTROL, ASSAYED

    FDA 510(k)
    FDA Class 1 ·Clinical Chemistry

    FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    G4 PLATINUM CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code MDS·October 21, 2014

    3.5MM HEXAGONAL SCREWDRIVER SHAFT-6MM HXC

    FDA Adverse Event
    Malfunction ·SYNTHES GMBH·Product code HXX·June 26, 2013

    MANTIS ROD INSERTER INNER SHAFT

    FDA Adverse Event
    Malfunction ·STRYKER SPINE BORDEAUX·Product code LXH·July 19, 2011

    Allura Exper FD Series. System codes 722003 722010 722022 722005 722011 722019 722001 722002 722006 722012 722008 722013 722020 722025 722015 722023 722038 889006 889016 889009 722005 The device is an X-Ray Generator.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·March 25, 2020

    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