BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Nano-Check™ COVID-19 Antigen Test

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SURESTEP

    FDA Adverse Event
    Malfunction ·LIFESCAN, INC.·Product code CGA·July 28, 1999

    LESSER METATARSAL HEAD IMPLANT SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEARTSTART MRX, MODEL M3535A

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    PROX ACCESS 55MM ART STAP THIC

    FDA Adverse Event
    Malfunction ·ETHICON ENDO-SURGERY, LLC·Product code GDW·November 10, 2008

    UNK -- IOL

    FDA Adverse Event
    Injury ·ALCON RESEARCH, LTD. / HUNTINGTON·Product code HQL·August 26, 2011

    TITANIUM ROOF PILE SCREW 45MM

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDICS INC US·Product code JDJ·July 17, 2013

    TRUBALANCE

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·August 15, 2016

    RECLAIM DISTAL TAPERED, Angled Distal Stem, various sizes. Taper Protector Sleeve. RECLAIM Revision Hip System Orthopedic Manual Surgical Instrument, used to ensure the locking taper surface of the Distal Stem is protected during proximal preparation.

    FDA Enforcement
    Class II ·Terminated·DePuy Orthopaedics, Inc.·July 30, 2014