BEUDAMED
    7 results · 17ms · Sources: EU EUDAMED, US FDA

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    MEDICAL IMAGE MANAGEMENT SYSTEM/X-RAY TERMINAL

    FDA 510(k)
    FDA Class 1 ·Radiology

    OSTEOGEN SBRG

    FDA 510(k)
    FDA Class 2 ·Dental

    SENYINT PACS

    FDA 510(k)
    FDA Class 2 ·Radiology

    COROX OTW-S 75-BP

    FDA Adverse Event
    Injury ·BIOTRONIK SE & CO. KG.·Product code NKE·January 23, 2013

    WANDA PTA BALLOON DILATATION CATHETER

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC - GALWAY·Product code LIT·December 20, 2010

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code OYC·July 14, 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