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    HEMAGEN CHAGAS' KIT (EIA METHOD)

    FDA 510(k)
    FDA Class 1 ·Microbiology

    Grasping forceps

    FDA UDI
    SOPRO-COMEG GmbH·04059082023175·

    Renuvion® APR Handpiece

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

    FLAT PANEL DISPLAY, ME183L

    FDA 510(k)
    FDA Class 2 ·Radiology

    TECNIS

    FDA Adverse Event
    Injury ·ABBOTT MEDICAL OPTICS·Product code HQL·January 25, 2013

    ENDURANT II

    FDA Adverse Event
    Death ·MEDTRONIC IRELAND·Product code MIH·July 11, 2014

    BARD CLOSED WOUND EVACUATOR

    FDA Adverse Event
    Injury ·C.R. BARD, INC.·Product code GCY·September 23, 2010

    Lantis Commander, Model # 4503178 - Product Usage: Lantis Treatstation is to allow the radiation therapist to deliver treatment to the patient using the mevatron and all available accessories. This entails selecting a patient, selecting today s treatment for that patient, setting up and delivering the treatment fields and recording the delivered treatment. Treatstation supports auto sequencing, a process of automatically downloading a group of fields or segments from the verification and record system to the control of the linear accelerator sequentially, without user intervention. In addition, Lantis Treatstation supports intensity modulation, a process of shaping, modifying and moving the beam around a target to maximize the dose at the target and minimize the dose to normal structures.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 14, 2019

    Siemens LANTIS Oncology Information System Servers; allows the radiation therapist to deliver treatment to patient using the MEVATRON and all available accessories

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·March 25, 2015

    Siemens LANTIS System ; LANTIS Commander, 10 Users ; LANTIS 6.1 Commander ; LANTIS 8.3 Commander The intended use of the linear accelerator is to deliver x-ray radiation for therapeutic treatment of cancer.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·July 2, 2014