BEUDAMED
    9 results · 20ms · Sources: EU EUDAMED, US FDA

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    Relizorb

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

    CRANIAL REMOLDING ORTHOSIS

    FDA 510(k)
    FDA Class 2 ·Neurology

    DIASORIN LIAISON TREPONEMA ASSAY

    FDA 510(k)
    FDA Class 2 ·Microbiology

    CARELINK

    FDA Adverse Event
    Malfunction ·MEDTRONIC, INC.·Product code KRG·October 10, 2014

    OT VERIO IQ METER

    FDA Adverse Event
    Malfunction ·LIFESCAN EUROPE, A DIVISION OF CILAG GMBH INTL·Product code NBW·June 11, 2013

    FREESTYLE FLASH

    FDA Adverse Event
    Injury ·ABBOTT DIABETES CARE INC, USA·Product code LFR·September 11, 2008

    Jackson-Pratt Silicone Flat Drain, 10mm, Full Ducts. Sterile, Rx Only. For Single Use Only. Jackson-Pratt Wound Drainage Systems are sterile single use devices. The wound drainage system consist of a wound drain and a fluid collection reservoir. The wound drain is a radio-opaque section of tubing which has perforations or ducts. The wound drain is surgically placed in a surgical wound site using a trocar. Blood and fluids are collected through a wound drain into a fluid collection reservoir. Wound drains are used to remove exudates from wound sites. Trocars, drains and reservoirs are for a single patient use only and should be discarded after use

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·May 31, 2017

    AlignRT is a video-based three-dimensional (3D) surface imaging system which is used to image the skin surface of a patient in 3D before and during radiotherapy treatment.

    FDA Enforcement
    Class II ·Terminated·Vision Rt Inc·January 14, 2015

    Azurion 3 M15; Catalog numbers: (1) 722064, (2) 722222 (3) 722280(OUS ONLY).

    FDA Enforcement
    Class I ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 26, 2025