BEUDAMED
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    VISUALINE II (ALSO KNOWN AS SUNLINE) METHADONE

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    Polystar Selection EDITION

    FDA UDI
    Merz Dental GmbH·D7091981314·anteriors; shade C3; mould IM2

    THERAPY UNIT & ELECTRODIAG.

    FDA 510(k)
    FDA Class 2 ·Neurology

    IntelliVue Patient Monitor MX100, IntelliVue Multi-Measurement Module X3, IntelliVue Microstream Extension

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·February 27, 2013

    HILL-ROM 100 LOW BED

    FDA Adverse Event
    Malfunction ·HILL-ROM, INC.·Product code FNL·February 2, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Malfunction ·INVACARE TAYLOR STREET·Product code ITI·August 5, 2014

    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