BEUDAMED
    9 results · 19ms · Sources: EU EUDAMED, US FDA

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    PRIMUS

    FDA 510(k)
    FDA Class 2 ·Radiology

    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

    artegral life

    FDA UDI
    Merz Dental GmbH·D7091993425·anteriors; shade C4; mould IXL

    MAKO SURGICAL CORP ROBOTIC ARM INTERACTIVE ORTHOPEDIC SYSTEM-THA

    FDA 510(k)
    FDA Class 2 ·Neurology

    Pre-Milled Blank

    FDA 510(k)
    FDA Class 2 ·Dental

    MEMORYGEL BREAST IMPLANT

    FDA Adverse Event
    Injury ·MENTOR TEXAS·Product code FTR·June 24, 2019

    OT VERIO PRO METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·March 7, 2013

    SUBQ

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code LWS·August 8, 2014

    STERLING BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - MAPLE GROVE·Product code DQY·February 16, 2011