BEUDAMED
    37 results · 24ms · Sources: EU EUDAMED, US FDA

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    Xpert TV, Xpert Urine Specimen Collection Kit, GeneXpert Dx Systems (GX-I, GX-II, GX-IV, GX-XVI), GeneXpert Infinity-48, Genxpert Infinity-48s and GeneXpert Infinity-80 Systems

    FDA 510(k)
    FDA Class 2 ·Immunology

    INSPECTRA STO2 TISSUE OXYGENATION MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    WELCH ALLYN 1500 PATIENT MONITOR

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·November 8, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·November 8, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·November 8, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·November 8, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·November 7, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·November 8, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·February 15, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·November 10, 2022

    CONTAK RENEWAL TR

    FDA Adverse Event
    Injury ·GUIDANT CRM CLONMEL IRELAND·Product code NKE·July 14, 2011

    PROTECTA XT VR

    FDA Adverse Event
    Death ·MEDTRONIC MED REL MEDTRONIC PUERTO RICO·Product code LWS·June 11, 2013

    CAPSUREFIX

    FDA Adverse Event
    Injury ·MPRI·Product code LWS·October 10, 2014

    EASYDRILL PERFORATOR

    FDA Adverse Event
    Injury ·MICROMAR INDUSTRIA E COMERCIO LTDA·Product code HBF·August 4, 2020

    Jackson-Pratt Silicone Flat Drain, 10mm, 3/4 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

    MARCON COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·November 29, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·March 9, 2022

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FEG·February 27, 2024

    COLON DECOMPRESSION SET

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FEG·September 15, 2023