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

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    Sovereign Posterior Cervical System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    Darby Dental Supply, LLC

    FDA UDI
    DARBY DENTAL SUPPLY, LLC·00889813036051·C-FILE 21MM #06-15

    SURGISEAL Topical Skin Adhesvie

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

    CENTRION 500 C-ARM SYSTEM

    FDA 510(k)
    FDA Class 2 ·Radiology

    PUMP MMT-515NAS PRDGM INS V2.1 SK EN

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS MED-REL·Product code LZG·November 26, 2008

    AMPLATZER MUSCULAR VSD OCCLUDER

    FDA Adverse Event
    AGA MEDICAL CORP.·Product code MLV·September 6, 2011

    MINICAP TRANSFER SET

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - MOUNTAIN HOME·Product code FKX·July 29, 2013

    TriForce Peripheral Crossing Set, Individual product is packaged in a Tyvek-film sterilizable outer pouch. The TriForce Peripheral Crossing Set is intended to be percutaneously introduced into blood vessels and support a wire guide while performing percutaneous peripheral interventions. This device is also intended for injection of radiopaque contrast media for the purpose of angiography.

    FDA Enforcement
    Class II ·Terminated·Cook Inc.·March 8, 2017

    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