BEUDAMED
    9 results · 27ms · Sources: EU EUDAMED, US FDA

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    M30 IN THE EAR HEARING AID

    FDA 510(k)
    FDA Class 1 ·Ear, Nose, Throat

    INTELLIVUE MULTI MEASUREMENT SERVER X2

    FDA Adverse Event
    Death ·PHILIPS MEDICAL SYSTEMS·Product code MHX·November 12, 2019

    AEI DR. TERAUCHI ULTRASONIC TIPS

    FDA 510(k)
    FDA Class 2 ·Dental

    INSTANT-VIEW MDMA (ECSTASY, XTC) URINE TEST

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    SPRINT QUATTRO SECURE

    FDA Adverse Event
    Malfunction ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·December 13, 2010

    EEA 25MM SINGLE-USE STAPLER

    FDA Adverse Event
    Injury ·COVIDIEN, FORMERLY USSC·Product code GAG·January 14, 2013

    SPECTRUM INFUSION PUMP

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE CORPORATION·Product code FRN·February 5, 2014

    10MM TI CANN TIBIAL NAIL-EX W/PROX BEND 345MM-STERILE

    FDA Adverse Event
    Injury ·WRIGHTS LANE SYNTHES USA PRODUCTS LLC·Product code JDS·January 18, 2019

    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