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

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    VENA PRO

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    GIARDIA II

    FDA 510(k)
    FDA Class 2 ·Microbiology

    SENTINELLE ENDO COIL ARRAY FOR PELVIC IMAGING

    FDA 510(k)
    FDA Class 2 ·Radiology

    ACTIV.A.C.¿ THERAPY SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·February 12, 2018

    DEXCOM G6 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·June 5, 2024

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES USA·Product code HRS·October 1, 2014

    QUANTUM? MAVERICK?

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code LOX·May 29, 2013

    SM PLUS BTT/ROUND BALLOON DISSECTOR

    FDA Adverse Event
    Malfunction ·USSC PUERTO RICO·Product code GCJ·May 11, 2011

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·June 8, 2021

    ACTIV.A.C. ION PROGRESS REMOTE THERAPY MONITORING SYSTEM

    FDA Adverse Event
    Injury ·KINETIC CONCEPTS, INC.·Product code OMP·July 14, 2021

    PEN NDL 31GA 8MM

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON AND CO.·Product code FMI·September 9, 2021

    Achieva 1.5T

    FDA Enforcement
    Class II ·Ongoing·Philips North America Llc·November 29, 2023

    Stryker T2 Arthrodesis Nailing System. Manufacturer: Stryker Trauma GmbH, Professor-Kuntscher-Str. 1-5, 24232 Schonkirchen Germany. Distributed in the USA by Stryker Orthopaedics, 325 Corporate Drive, Mahwah, NJ 07430. The T2 Arthrodesis Nail is intended for the treatment of Knee Arthrodesis. The design of the T2 Arthrodesis Nail features a unique curvature which incorporates both femur ante curvature and knee valgus bend. Indications: Aseptic failed total knee arthro-plasty with or without bone loss; Failed external fixation, non unions and malunions; Periarticular fractures where repair is not possible; Pathologic fractures and tumor resections; Pseudoarthrosis and correct osteotomy; Ipsilateral femur fractures; and Open and closed femoral fractures.

    FDA Enforcement
    Class II ·Terminated·Stryker Howmedica Osteonics Corp.·July 25, 2012