BEUDAMED
    9 results · 30ms · Sources: EU EUDAMED, US FDA

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    ZIMMER TRABECULAR METAL REVERSE SHOULDER SYSTEM, BASE PLATES & HUMERAL STEMS

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    VIRTUOSO (TM) SYSTEM FOR IHC HER2 (4B5)

    FDA 510(k)
    FDA Class 2 ·Hematology

    TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND AC200

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    THORATEC® HEARTMATE 3¿ SYSTEM CONTROLLER

    FDA Adverse Event
    Malfunction ·THORATEC CORPORATION·Product code DSQ·September 16, 2024

    HUMAPEN ERGO TEAL/CLEAR

    FDA Adverse Event
    Malfunction ·ELI LILLY AND COMPANY·Product code NSC·May 21, 2013

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·September 26, 2014

    1/4" DRILL WITH JACOBS CHUCK

    FDA Adverse Event
    Malfunction ·STRYKER INSTRUMENTS KALAMAZOO·Product code KIJ·May 6, 2011

    WALLFLEX? BILIARY TRANSHEPATIC

    FDA Adverse Event
    Injury ·BOSTON SCIENTIFIC - GALWAY·Product code FGE·August 21, 2012

    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