BEUDAMED
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    MANUAL BONE MARROW BIOPSY DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    artegral life

    FDA UDI
    Merz Dental GmbH·D7091993435·anteriors; shade D2; mould BS

    SILICONE FLOW-DIRECTED THERMODILUTION CATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SHILEY SPECIALIZED TRACHEOSTOMY TUBE

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    TROJAN PLEASURE PACK LUBRICATED CONDOMS

    FDA Adverse Event
    Injury ·CHURCH & DWIGHT CO., INC.·Product code HIS·October 29, 2014

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE SUZHOU·Product code ITI·March 7, 2013

    ZENITH FLEX AAA ENDOVASCULAR GRAFT BIFURCATED MAIN BODY

    FDA Adverse Event
    Injury ·COOK, INC.·Product code MIH·February 8, 2011

    ATTAIN ABILITY

    FDA Adverse Event
    Injury ·MPRI·Product code OJX·August 8, 2014

    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