BEUDAMED
    8 results · 26ms · Sources: EU EUDAMED, US FDA

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    T.B.Q. RTU

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Intracept Intraosseous Nerve Ablation System (component Intracept RF Probe)

    FDA 510(k)
    FDA Class 2 ·Neurology

    MODUMED MUGE

    FDA 510(k)
    FDA Class 2 ·Radiology

    ARCHITECT C4000 SYSTEM

    FDA Adverse Event
    Malfunction ·ABBOTT MANUFACTURING INC·Product code JJE·July 31, 2018

    DIGITAL RETINAL CAMERA CX-1

    FDA Adverse Event
    Malfunction ·CANON INC.·Product code NFJ·January 28, 2013

    UNKNOWN IMPLANTABLE PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code LKK·August 5, 2014

    RESTORE RECHARGABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MDT PUERTO RICO OPERATIONS CO., JUNCOS·Product code LGW·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