BEUDAMED
    7 results · 18ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    HEAD & CHIN RESTS

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    VersaPAP Positive Airway Pressure (PAP) Device

    FDA 510(k)
    FDA Class 2 ·Anesthesiology

    AUSTIN MODIFIED PARTIAL OSSICULAR RE-

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·January 21, 2014

    LINEAGE® TRANSCEND® CERAMIC FEMORAL HEAD

    FDA Adverse Event
    Injury ·WRIGHT MEDICAL TECHNOLOGY, INC.·Product code MRA·December 14, 2012

    PATIENT BED

    FDA Adverse Event
    Malfunction ·HILL-ROM·Product code FNL·September 22, 2010

    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