BEUDAMED
    8 results · 21ms · Sources: EU EUDAMED, US FDA

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    SPINE-TECH CERVICAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DATEX-OHMEDA HMEF 750

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    LZI ORAL FLUID AMPHETAMINE ENZYME IMMUNOASSAY, CALIBRATORS, CONTROLS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    INVISION-PLUS

    FDA Adverse Event
    Malfunction ·RYMED TECHNOLOGIES, LLC·Product code FPA·July 7, 2022

    RESTORE SENSOR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LGW·January 28, 2013

    ACCU-CHEK ® AVIVA TEST STRIPS

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code LFR·December 17, 2010

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Death ·MEDTRONIC SINGAPORE OPERATIONS·Product code DTB·July 14, 2014

    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