BEUDAMED
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    GENZYME DIAGNOSTICS CONTRAST MONO

    FDA 510(k)
    FDA Class 2 ·Immunology

    NMUC Brand Small And Large Fragment Osteosynthesis Plating System, NMUC Brand of DHS/DCS Plating System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONTROL MEDIUM, AND PROTEIN 1 CONTROL HIGH

    FDA 510(k)
    FDA Class 2 ·Immunology

    UNKNOWN ZIMMER KNEE

    FDA Adverse Event
    Injury ·ZIMMER, INC.·Product code JWH·February 13, 2013

    LEAD MODEL 302

    FDA Adverse Event
    Malfunction ·CYBERONICS INC·Product code LYJ·December 20, 2010

    SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FKX·July 29, 2014

    SCREW, FIXATION, BONE

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code HWC·February 6, 2017

    ARTISTE, ONCOR Avantgarde, ONCOR Impression Plus, ONCOR Expression, PRIMUS, PRIMUS Plus, Syngo RT Therapist; therapeutic treatment of cancer Product Usage: The intended use of the SIEMENS branded ARTISTE and ONCOR family of linear accelerator systems is to deliver X-Ray photon and electron radiation for the therapeutic treatment of cancer. PRIMUSTM family of linear accelerator systems is to deliver x-ray radiation for therapeutic treatment of cancer. Syngo RT Therapist is a software application whose indication for use includes the viewing, processing, filming, and archiving of medical images. It also permits patient data management, patient selection/setup, patient positioning verification, treatment planning, treatment delivery/verification, and treatment recording.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 30, 2015