BEUDAMED
    14 results · 21ms · Sources: EU EUDAMED, US FDA

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    FloPatch (FP120)

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    INBONE

    FDA UDI
    WRIGHT MEDICAL TECHNOLOGY, INC.·00840420196316·Poly Removal Screw

    MTP Trial

    FDA UDI
    Treace Medical Concepts, Inc.·00810111224260·TMC MTP Trial, 14MM

    T:FLEX INSULIN DELIVERY SYSTEM

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code LZG·December 11, 2017

    READI-STRAND; MODEL PSSTRAND

    FDA 510(k)
    FDA Class 2 ·Radiology

    MTP DISPOSABLE TROCAR VALVES

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

    T:SLIM X2 INSULIN PUMP WITH CONTROL-IQ TECHNOLOGY

    FDA Adverse Event
    Malfunction ·TANDEM DIABETES CARE·Product code QFG·September 30, 2022

    LINER FOR METAL-BACK (UHMWPE) LINER SMALL

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A·Product code PHX·July 24, 2023

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM.

    FDA Adverse Event
    Malfunction ·COCHLEAR LTD.·Product code MCM·October 24, 2014

    COLLEAGUE PRE P1.7

    FDA Adverse Event
    Malfunction ·BAXTER HEALTHCARE - SINGAPORE·Product code FRN·August 11, 2011

    POWERED WHEELCHAIR

    FDA Adverse Event
    Injury ·INVACARE TAYLOR STREET·Product code ITI·July 1, 2013

    LINER FOR METAL BACK GLENOID STANDARD

    FDA Adverse Event
    Injury ·LIMACORPORATE S.P.A.·Product code KWS·November 23, 2020

    Medrad Continuum MR Infusion system- non-wireless system The MEDRAD Continuum MR Infusion System is designed for patients who require medications and other fluids during an MR procedure. It is intended to provide infusion therapy directly prior to, during and immediately after the MR procedure functioning while either stationary or mobile. It is not intended to provide long-term patient care outside the MR environment. The system is to be used by trained medical staff, primarily critical care, emergency room and radiology nursing staff.

    FDA Enforcement
    Class II ·Terminated·Bayer Corp·June 11, 2014

    Model Number L111, ESSENTIO DR SL MRI Pacemaker

    FDA Enforcement
    Class I ·Ongoing·Boston Scientific Corporation·October 22, 2025