BEUDAMED
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    TES-20

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Armada

    FDA UDI
    Nuvasive, Inc.·00887517458148·Armada Ti Spoon Retractor, 25mm

    IOLs, APHAKIC, MONOFOCAL, TORIC, HYDROPHOBIC ACRYLIC

    Device
    EU MDD · Eu Md Class 2b ·AST VisionCare Inc.·On the market·10 countries

    REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    Hair Boom 69, Hair Boom Air, Ulike Hair UpUp

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    UNKNOWN DEPUY PINNACLE METAL LINER

    FDA Adverse Event
    Injury ·DEPUY ORTHOPAEDIC INC, 1818910·Product code KWA·March 7, 2013

    REVEAL DX

    FDA Adverse Event
    Injury ·MEDTRONIC S.A.·Product code DSI·February 15, 2011

    ENTRUST

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code LWS·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

    Zeiss brand IOLMaster, Version 1-5, Biomicroscope, Slit-Lamp, AC-Powered, Product is manufactured by Carl Zeiss Meditec AG (Jena), Carl Zeiss Promenade 10, Jena, Germany 07745; and distributed by Carl Zeiss Meditec, Inc., Dublin, CA This device is intended for use primarily by physicians and health care workers and may be only used under the supervision of a physician. This device will not be sold to the general public. The IOLMaster is intended for the biometric determination of ocular measurements of axial length, anterior chamber depth, corneal radius, white-to white (WTW), and for the measurement of pupil size and deviation of the visual axis from the center of the pupil. For patients who are candidates for intraocular lens (IOL) implantation, the device also performs calculations to assist physicians in determining the appropriate IOL power and type for implantation

    FDA Enforcement
    Class II ·Terminated·Carl Zeiss Meditec, Inc.·November 27, 2013