BEUDAMED
    7 results · 25ms · Sources: EU EUDAMED, US FDA

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    PSI-TEC ASPIRATOR

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

    EndoWave Infusion System

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ORTHOLUX VISIBLE LIGHT CURING UNIT

    FDA 510(k)
    FDA Class 2 ·Dental

    FRESENIUS 2008K

    FDA Adverse Event
    Death ·FRESENIUS MEDICAL CARE NORTH AMERICA·Product code KDI·June 25, 2014

    2520274-2013-10525

    FDA Adverse Event
    Injury ·SYNTHES (USA)·Product code MNI·February 22, 2013

    HEMASHIELD PLATINUM VASCULAR GRAFT

    FDA Adverse Event
    Injury ·MAQUET CARDIOVASCULAR, LLC·Product code DSY·February 3, 2011

    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