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

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    EVEREST Spinal System

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    THE HELENA V8 IMMUNODISPLACEMENT KIT

    FDA 510(k)
    FDA Class 2 ·Immunology

    TANDEM HEART ESCORT (T.H.E.) CONTROLLER, MODEL 5140-8500

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    ZILVER 518 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 21, 2017

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 20, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Malfunction ·COOK IRELAND LTD·Product code FGE·September 7, 2017

    ZILVER 635 SELF-EXPANDING BILIARY STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 28, 2018

    ZILVER 635 BILIARY SELF-EXPANDING STENT

    FDA Adverse Event
    Injury ·COOK IRELAND LTD·Product code FGE·February 12, 2018

    S-ROM*SLEEVE PRX SPA, 16D

    FDA Adverse Event
    Injury ·1818910 DEPUY ORTHOPAEDICS, INC.·Product code MRA·June 11, 2013

    HOMECHOICE

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - LARGO·Product code FKX·July 13, 2011

    PROLIEVE THERMODILITATION KIT

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

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code KRD·April 20, 2026

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code KRD·April 17, 2026

    BD ULTRA-FINE¿ MINI PEN NEEDLE 5MM X 31G

    FDA Adverse Event
    Injury ·BECTON DICKINSON AND CO.·Product code FMI·July 14, 2016

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Injury ·MICROVENTION, INC.·Product code KRD·April 3, 2026

    Jackson-Pratt Silicone Round Drain, 7FR. 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

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code KRD·April 24, 2026

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Injury ·MICROVENTION INC.·Product code KRD·January 14, 2025

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code HCG·May 28, 2026

    AZUR SOFT3D DETACHABLE 10

    FDA Adverse Event
    Malfunction ·MICROVENTION, INC.·Product code KRD·October 16, 2024