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

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    XEN Glaucoma Treatment System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EASYPLUS MINI R9N SELF MONITORING BLOOD GLUCOSE SYSTEM MODEL EPS10031

    FDA 510(k)
    FDA Class 2 ·Clinical Chemistry

    UCP RAPID DRUG SCREENING TRICYCLIC ANTIDEPRESSANT, PROPOXYPHENE TESTS

    FDA 510(k)
    FDA Class 2 ·Clinical Toxicology

    QUATTRODE

    FDA Adverse Event
    Injury ·ST. JUDE MEDCIAL - NEUROMODULATION·Product code GZB·June 5, 2013

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 14, 2011

    OUTBACK RE-ENTRY CATHETER

    FDA Adverse Event
    Malfunction ·CORDIS DE MEXICO·Product code DQY·September 12, 2008

    Jackson-Pratt Hemaduct Silicone Round Drain, 19FR. 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

    Presource Procedure Packs containing AAMI Level 3 surgical gowns, Multiple Catalog Numbers Produced Between September 1, 2018 and January 15, 2020. Additional kits produced through February 19, 2020 were included.

    FDA Enforcement
    Class II ·Terminated·Cardinal Health 200, LLC·February 26, 2020