BEUDAMED
    8 results · 20ms · Sources: EU EUDAMED, US FDA

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    G-Cem LinkForce, Dual Cure Activator, Try-In Paste, Multi Primer

    FDA 510(k)
    FDA Class 2 ·Dental

    WARP10,WARP75

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    KYPHON INFLATION SYRINGE

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CAPSUREFIX NOVUS

    FDA Adverse Event
    Malfunction ·MPRI·Product code DTB·June 8, 2013

    TALENT THORACIC STENT GRAFT

    FDA Adverse Event
    Injury ·MEDTRONIC CARDIOVASCULAR·Product code MIH·June 23, 2011

    ZYDERM 2 COLLAGEN IMPLANT (1.0ML)

    FDA Adverse Event
    Injury ·INAMED CORP. (FREMONT)·Product code LMH·September 8, 2008

    ELEKTA LIMITED Precise Digital Accelerator, REF MRT 6001, MRT 6011; Medical Charged-Particle Radiation Therapy System Accelerator, Linear

    FDA Enforcement
    Class II ·Ongoing·Elekta, Inc.·December 13, 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