BEUDAMED
    7 results · 17ms · 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.

    SPYROFLEX WOUND DRESSING

    FDA 510(k)
    FDA Unclassified ·Unknown

    Capillus202

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    INSPECTRA TISSUE SPECTROMETER SYSTEM, MODEL 325

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    VIRTUOSO II VR

    FDA Adverse Event
    Injury ·IPG MFG SWITZERLAND·Product code LWS·February 9, 2013

    COGNIS

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NIK·January 10, 2011

    ACCU-CHEK ® AVIVA COMBO

    FDA Adverse Event
    Malfunction ·ROCHE DIAGNOSTICS·Product code NBW·July 23, 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