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

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    AMPLAID EMG15

    FDA 510(k)
    FDA Class 2 ·Neurology

    LYMPHANGIOGRAPHY SET SPECIAL 30G

    FDA 510(k)
    FDA Class 2 ·General Hospital

    POLYFLEX 493-07 ENDOCARDIAL IMPLANTABLE PAC-LEAD

    FDA 510(k)
    FDA Class 3 ·Cardiovascular

    LENSX LASER SYSTEM

    FDA Adverse Event
    Injury ·ALCON - LENSX LASERS, INC.·Product code OOE·June 9, 2014

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·October 27, 2010

    CAPSURE EPI

    FDA Adverse Event
    Injury ·RICE CREEK MFG·Product code DTB·December 21, 2012

    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