BEUDAMED
    8 results · 23ms · Sources: EU EUDAMED, US FDA

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    Portable Dental X-ray System Model PDX nova

    FDA 510(k)
    FDA Class 2 ·Dental

    Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

    FDA 510(k)
    FDA Class 2 ·Dental

    TENOLIG

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

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·November 18, 2014

    VERSACARE BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·August 18, 2011

    IVT DISPOSABLE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - AIBONITO·Product code KPE·August 1, 2013

    BioGX SARS-CoV-2 Reagents for BD MAX System-IVD PCR test intended for the qualitative detection of nucleic acid from the SARS-CoV-2 in nasopharyngeal specimens Catalog Number: 444213

    FDA Enforcement
    Class II ·Terminated·Becton Dickinson & Co.·April 21, 2021

    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