BEUDAMED
    7 results · 28ms · Sources: EU EUDAMED, US FDA

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    ORGENTEC ANTI-CARDIOLIPIN ELISA ASSAY

    FDA 510(k)
    FDA Class 2 ·Immunology

    REPLACEMENT RECHARGEABLE BATTERY PACK'S

    FDA 510(k)
    FDA Class 2 ·General Hospital

    ELECTROSONOGRAM ESG-1

    FDA 510(k)
    FDA Class 1 ·Dental

    PLUM XLD 110V L.A.

    FDA Adverse Event
    Malfunction ·HOSPIRA COSTA RICA LTD.·Product code FRN·June 12, 2014

    VIRTUOSO VR

    FDA Adverse Event
    Malfunction ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·February 11, 2013

    PRECISION XTRA

    FDA Adverse Event
    Malfunction ·Product code NBW·January 10, 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