BEUDAMED
    12 results · 25ms · Sources: EU EUDAMED, US FDA

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    Alliance Augmented Glenoid

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    n/a

    FDA UDI
    Hager & Meisinger Gesellschaft mit beschränkter Haftung·E0HM46001932061801·Rotary instrument for endodontic application

    ERBE ESU MODEL VIO DV WITH ACCESSORIES

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    FALCON SPACER

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    EVIS EXERA III DUODENOVIDEOSCOPE

    FDA Adverse Event
    Injury ·OLYMPUS MEDICAL SYSTEMS CORP.·Product code FDT·February 18, 2022

    NV GXL LINER LIPPED 36MM ID GROUP 2

    FDA Adverse Event
    Injury ·EXACTECH, INC.·Product code JDI·December 15, 2023

    TRUE METRIX AIR

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH INC·Product code NBW·August 22, 2022

    SILICONE ADVANCED OPTIC-VIOLET SHIELD

    FDA Adverse Event
    Malfunction ·BAUSCH & LOMB, INC.·Product code HQL·October 7, 2008

    CIRRUS HD OCT

    FDA Adverse Event
    Malfunction ·CARL ZEISS MEDITEC, INC.·Product code HLI·June 25, 2013

    9900

    FDA Adverse Event
    Malfunction ·GE OEC MEDICAL SYSTEMS (SLC)·Product code JAA·July 22, 2011

    INTELLIVUE MX800 PATIENT MONITOR

    FDA Adverse Event
    Malfunction ·PHILIPS MEDIZIN SYSTEME BÖBLINGEN GMBH·Product code DSI·August 17, 2022

    GXL acetabular liners, orthopedic hip implant component. Product Line Numbers: a. GXL NEUTRAL LINER, G0 28MM ID, 130-28-50; b. GXL NEUTRAL LINER, G00 22MM ID, 130-22-70; c. NOVATION GXL LIPPED LINER, G0 28MM ID, 132-28-50; d. NOVATION GXL LIPPED LINER, G00 22MM ID, 132-22-70;

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·September 21, 2022