BEUDAMED
    16 results · 31ms · Sources: EU EUDAMED, US FDA

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    MODIFIED MODEL 5320 T.E.D. COMPRESSION LIMB

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    SENSTOUCH HIGH RISK BLUE LATEX EXAMINATION GLOVES, POWDERED, NON STERILE

    FDA 510(k)
    FDA Class 1 ·General Hospital

    Navigated ELEVATE Inserter, Navigated Disc Prep Instruments

    FDA 510(k)
    FDA Class 2 ·Neurology

    GREENLIGHT MOXY FIBER OPTIC

    FDA Adverse Event
    Malfunction ·AMERICAN MEDICAL SYSTEMS, INC. (SAN JOSE)·Product code GEX·June 10, 2014

    INSIGNIA

    FDA Adverse Event
    Malfunction ·GUIDANT CRM CLONMEL IRELAND·Product code NVZ·October 11, 2010

    HOMECHOICE PRO

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FKX·December 10, 2012

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 19, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 12, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 20, 2018

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·August 14, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·December 4, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·November 15, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·April 17, 2017

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·October 14, 2019

    ESSURE

    FDA Adverse Event
    Injury ·BAYER PHARMA AG·Product code HHS·April 5, 2018

    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