BEUDAMED
    8 results · 19ms · Sources: EU EUDAMED, US FDA

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    SELF-CENTERING HIP

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    HEADLESS COMPRESSION SCREW

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    BOSS-2000-2 VACUUM ERECTION DEVICE

    FDA 510(k)
    FDA Class 2 ·Gastroenterology, Urology

    UMBILICAL CORD CLAMP

    FDA Adverse Event
    Injury ·UNOMEDICAL LTD.·Product code HFW·May 1, 2014

    RESERVOIR 3ML

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO OPERATIONS CO.·Product code FRN·October 31, 2012

    MEDFUSION 3500 SYRINGE INFUSION PUMP

    FDA Adverse Event
    Malfunction ·SMITHS MEDICAL MD·Product code FRN·August 18, 2010

    ENTERPRISE2 4MMX23MM

    FDA Adverse Event
    Malfunction ·MEDOS INTERNATIONAL SARL·Product code NJE·July 19, 2022

    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