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

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    Interson USB Ultrasound System

    FDA 510(k)
    FDA Class 2 ·Radiology

    BIO-CLAD ALL POLY CUP SYSTEM

    FDA UDI
    Biomet Orthopedics, LLC·00880304255739·

    DRAEGER ALCOTEST 6510

    FDA 510(k)
    FDA Class 1 ·Clinical Toxicology

    21.3 INCH (54 CM) MONOCHROME LCD MONITOR MS23I2 (ML21023)

    FDA 510(k)
    FDA Class 2 ·Radiology

    VITALITY 2

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code LWS·July 15, 2011

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·June 11, 2013

    ACCU-CHEK SPIRIT

    FDA Adverse Event
    Malfunction ·DISETRONIC MEDICAL SYSTEMS·Product code LZG·September 10, 2008

    ASAHI CONQUEST PRO 9-40

    FDA Adverse Event
    Malfunction ·ASAHI INTECC CO., LTD.·Product code DQX·April 27, 2016

    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