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

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    Synthes Patient Specific Implants

    FDA 510(k)
    FDA Class 2 ·Neurology

    Cascadia™ Interbody System

    FDA UDI
    VB Spine LLC·10888857369542·Trial, Size 12x14x8 mm, 7°

    Revolution Apex, Revolution Apex Elite, Revolution Apex Plus, Revolution Apex Select,Revolution CT; Revolution CT ES; Revolution CT with Apex edition; Revolution CT ES with Apex edition

    FDA 510(k)
    FDA Class 2 ·Radiology

    Powder Free Vinyl Patient Examination Gloves, Clear (non-colored)

    FDA 510(k)
    FDA Class 1 ·General Hospital

    I-STAT EC8+ CARTRIDGE

    FDA Adverse Event
    Malfunction ·ABBOTT POINT OF CARE INC.·Product code CHL·March 4, 2025

    530G INSULIN PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OZO·November 11, 2014

    RESTORE ULTRA

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LGW·November 25, 2008

    HEARTSTART XL

    FDA Adverse Event
    Malfunction ·AGILENT TECHNOLOGIES, INC.·Product code MKJ·July 28, 2011

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025

    Alcon Custom Pak

    FDA Enforcement
    Class II ·Ongoing·Alcon Research, LTD.·August 23, 2023