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

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    DURALASTIC I

    FDA 510(k)
    FDA Class 2 ·Ear, Nose, Throat

    STC DIAGNOSTIC 8000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SERENA WHEELCHAIR CUSHIONS

    FDA 510(k)
    FDA Class 1 ·Physical Medicine

    SPRINT QUATTRO

    FDA Adverse Event
    Malfunction ·MPRI·Product code LWS·February 11, 2013

    MEDISENSE OPTIUM

    FDA Adverse Event
    Malfunction ·Product code NBW·January 10, 2011

    DAILY ACTIVITY ASSIST DEVICES

    FDA Adverse Event
    JIANGSU YUYUE MEDICAL EQUIP.·Product code IKX·July 24, 2014

    ENDURITY Pulse Generator REF PM**** SN ********* St. Jude Medical Cardiac Rhythm Assurity and Endurity pacemakers are intended to provide single-chamber or dual-chamber bradycardia pacing.

    FDA Enforcement
    Class I ·Ongoing·St. Jude Medical, Cardian Rhythm Management Division·May 19, 2021

    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