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

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    The Red Head Collection Device, The Jordy Connection System

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DUOCOOL PAIN MANAGEMENT PROBE, MODEL OSP-17-180-20

    FDA 510(k)
    FDA Class 2 ·Neurology

    CENTRICITY AW SUITE OPTION

    FDA 510(k)
    FDA Class 2 ·Radiology

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·March 17, 2020

    FLOGARD

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·July 13, 2011

    XMAX MOTOR

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code ERL·June 11, 2013

    PROLIEVE THERMODILITATION KIT

    FDA Adverse Event
    Malfunction ·BOSTON SCIENTIFIC CORPORATION·Product code MEQ·September 12, 2008

    IKAZUCHI ZERO

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·June 13, 2019

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·August 19, 2019

    IKAZUCHI ZERO

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·August 20, 2019

    Jackson-Pratt Silicone Round Drain, 10FR. 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

    KANEKA PTCA CATHETER CO-R7(IKAZUCHI ZERO)

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·August 21, 2019

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code LOX·April 14, 2022

    KANEKA PTCA CATHETER CO-R8 (TASUKI)

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·December 13, 2020

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code LOX·December 21, 2020

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    FDA Adverse Event
    Malfunction ·KANEKA CORPORATION·Product code LOX·April 13, 2022

    KANEKA PTCA CATHETER CO-R6 (RAIDEN3)

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·June 6, 2025

    KANEKA PTCA CATHETER ZINRAI

    FDA Adverse Event
    Death ·KANEKA CORPORATION·Product code LOX·February 3, 2025

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    FDA Adverse Event
    Injury ·KANEKA CORPORATION·Product code LOX·December 21, 2017

    KANEKA PTCA CATHETER CO-R7 (IKAZUCHI ZERO)

    FDA Adverse Event
    Death ·KANEKA CORPORATION·Product code LOX·April 14, 2021