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

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    C-BOX PEEK CERVICAL IBF

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    M5 DIAGNOSTIC ULTRASOUND SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    LIGHT AGE EPICARE ALEXANDRITE LASER, MODELS 501-1H, 501-SP, 501-LP AND 501-LPX

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

    DEXCOM G7 CONTINUOUS GLUCOSE MONITORING SYSTEM

    FDA Adverse Event
    Malfunction ·DEXCOM, INC.·Product code QBJ·May 29, 2025

    SYNCHROMED II

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·May 29, 2013

    ESPRIT VENTILATOR

    FDA Adverse Event
    Malfunction ·RESPIRONICS CALIFORNIA, INC.·Product code CBK·June 17, 2011

    PORTABLE OXYGEN GENERATOR (CONCENTRATOR, HOMEFILL)

    FDA Adverse Event
    Malfunction ·INVACARE FLORIDA OPERATIONS·Product code CAW·October 1, 2014

    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