BEUDAMED
    19 results · 22ms · Sources: EU EUDAMED, US FDA

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    Low-frequency Multi-function physiotherapy instrument

    FDA 510(k)
    FDA Class 2 ·Neurology

    DEBAKEY FORCEPS

    FDA UDI
    SONTEC INSTRUMENTS, INC.·00192896060401·DEBAKEY FORCEPS MICROSCOPICWIDE TIPS ROUND HAND...

    Drill Guide

    FDA UDI
    Treace Medical Concepts, Inc.·00810111222617·Drill Guide

    Ophthalmic Cannula

    FDA UDI
    KATENA PRODUCTS, INC.·00841668114070·MCINTYRE-BINKHORST CAN 25GA ANG LT PK/10

    Merit Medical®

    FDA UDI
    Merit Medical Systems, Inc.·00884450155134·

    RENEGADE HI-FLO MICROCATHETER

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    BioMin Restore Plus

    FDA 510(k)
    FDA Class 2 ·Dental

    AFX

    FDA Adverse Event
    Death ·ENDOLOGIX, INC.·Product code MIH·January 13, 2016

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·March 5, 2016

    INFINITI VISION SYSTEM OZIL

    FDA Adverse Event
    Malfunction ·ALCON-IRVINE TECHNOLOGY CTR·Product code HQC·October 21, 2014

    SPRINT FIDELIS

    FDA Adverse Event
    Injury ·MEDTRONIC PUERTO RICO, INC.·Product code LWS·August 10, 2011

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    FDA Adverse Event
    Injury ·COCHLEAR LTD.·Product code MCM·July 1, 2013

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·March 5, 2016

    TRUEMETRIX

    FDA Adverse Event
    Malfunction ·TRIVIDIA HEALTH, INC.·Product code NBW·December 5, 2017

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·March 5, 2016

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·March 5, 2016

    UNKNOWN IMPLANTABLE NEUROSTIMULATOR

    FDA Adverse Event
    Injury ·MEDTRONIC NEUROMODULATION·Product code MHY·March 5, 2016

    MAKO Integrated Cutting System (MICS) HANDPIECE, Catalog Number 209063

    FDA Enforcement
    Class II ·Ongoing·Howmedica Osteonics Corp.·October 16, 2024

    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