BEUDAMED
    17 results · 23ms · Sources: EU EUDAMED, US FDA

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    Neurovision Nerve Locator Monitor (Nerveana), EMGView Software

    FDA 510(k)
    FDA Class 2 ·Neurology

    CD HORIZON® SOLERA® VOYAGER¿ SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·February 15, 2021

    COLORISE

    FDA 510(k)
    FDA Class 2 ·Dental

    LYMPHA PRESS 201MAX, MODEL 201MAX

    FDA 510(k)
    FDA Class 2 ·Cardiovascular

    CD HORIZON SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MEDTRONIC SOFAMOR DANEK USA, INC.·Product code KWP·July 28, 2019

    TARGET DEVICE GAMMA3 300X160MM

    FDA Adverse Event
    Malfunction ·STRYKER OSTEOSYNTHESIS KIEL·Product code LXH·November 13, 2012

    SYRINGE S2 NS 20ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·July 30, 2020

    CD HORIZON SOLERA VOYAGER SPINAL SYSTEM

    FDA Adverse Event
    Injury ·MDT SOFAMOR DANEK PUERTO RICO MFG·Product code NKB·May 27, 2024

    BD SYRINGE S2 NS 20ML

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·February 4, 2020

    ASAHI PROWATER PTCA GUIDE WIRE

    FDA Adverse Event
    Malfunction ·AV-ASAHI·Product code DQX·July 21, 2011

    SYSTEM CONSOLE

    FDA Adverse Event
    Malfunction ·DEPUY SYNTHES POWER TOOLS·Product code HBC·June 14, 2013

    ADULT BREATHING CIRCUIT

    FDA Adverse Event
    Malfunction ·FISHER & PAYKEL HEALTHCARE, LTD.·Product code BTT·September 16, 2008

    BD DISCARDIT II SYRINGE

    FDA Adverse Event
    Malfunction ·BECTON DICKINSON, S.A.·Product code FMF·November 6, 2019

    CD HORIZON® SOLERA® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·December 30, 2025

    CD HORIZON® SOLERA® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code KWP·June 10, 2025

    TSRH® SPINAL SYSTEM

    FDA Adverse Event
    Malfunction ·MEDTRONIC MEDICAL COSTA RICA S.R.L.·Product code NKB·January 22, 2026

    OPTETRAK Comprehensive Knee System including OPTETRAK All-polyethylene UNI Tibial Components, Product Lines, 252-12-XX, 252-13-XX, 252-22-XX, 252-23-XX. NOTE: Information reflects Exactech recall expansion initiated on 02/07/2022.

    FDA Enforcement
    Class II ·Ongoing·Exactech, Inc.·October 13, 2021