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

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.
    Filters Regulation: Us FDA ×

    LARIAT PALATE EXPANDER

    FDA 510(k)
    FDA Class 1 ·Dental

    SUMMIT NUCLEAR VISION 1024RZ GAMMA CAMERA SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PERCOR STAT DL 9.5 FR 40CC INTRA-AORTIC BALLOON

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ACCESS

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code FPA·July 20, 2015

    INVASIVE CIRCUIT ASSEMBLY

    FDA Adverse Event
    Malfunction ·RESPIRONICS INC·Product code CBK·January 15, 2013

    PULSE GEN MODEL 103

    FDA Adverse Event
    Injury ·CYBERONICS INC·Product code LYJ·July 10, 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