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

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    VEX-S 100W INTRAORAL X-RAY SYSTEM

    FDA 510(k)
    FDA Class 2 ·Dental

    BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GMQ·August 26, 2021

    HEAD FIATION DEVICE (HFD 100)

    FDA 510(k)
    FDA Class 2 ·Neurology

    PK ZIP WING CUTTING DISSECTOR

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

    HAHN TAPERED IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·August 29, 2024

    HAHN TAPERED IMPLANT Ø4.3 X 10 MM

    FDA Adverse Event
    Injury ·PRISMATIK DENTALCRAFT, INC.·Product code DZE·May 10, 2024

    PEN NEEDLE 32GX4MM 7 PACK

    FDA Adverse Event
    Malfunction ·EMBECTA MEDICAL DEVICES (SUZHOU) CO., LTD., CHINA·Product code FMI·May 20, 2024

    SINGLE EXTENSION

    FDA Adverse Event
    Injury ·ST. JUDE MEDICAL - NEUROMODULATION·Product code LGW·May 17, 2013

    530G INSULIN PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC MINIMED·Product code OZO·September 26, 2014

    INSYNC MAXIMO

    FDA Adverse Event
    Injury ·MEDTRONIC MED REL, INC.·Product code NIK·June 14, 2011

    BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GMQ·March 15, 2022

    BD MACRO-VUE¿ RPR CARD ANTIGEN SUSPENSION

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON CARIBE LTD.·Product code GMQ·March 12, 2022

    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