BEUDAMED
    29 results · 69ms · Sources: EU EUDAMED, US FDA

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    NICOLET VEEG SYSTEM

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY, INCORPORATED·Product code GWQ·September 10, 2015

    LUMBAR DRAINAGE CATH II KIT LAWSON

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY INC.·Product code CAZ·February 7, 2019

    NATUS DISPOSABLE DISC ELECTRODES

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY, INCORPORTAED·Product code GXY·July 21, 2015

    NICOLET CORTICAL STIMULATOR

    FDA Adverse Event
    Malfunction ·NATUS NEUROLOGY, INCORPORATED·Product code GYC·September 10, 2015

    NATUS DISPOSABLE DISC ELECTRODES

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY, INCORPORTAED·Product code GXY·July 30, 2015

    NATUS DISPOSABLE DISC ELECTRODES

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY, INCORPORATED·Product code GXY·August 11, 2015

    NATUS DISPOSABLE DISC ELECTRODES

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY, INCORPORTAED·Product code GXY·August 12, 2015

    NATUS DISPOSABLE DISC ELECTRODES

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY, INCORPORTAED·Product code GXY·August 12, 2015

    NATUS DISPOSABLE DISC ELECTRODES

    FDA Adverse Event
    Injury ·NATUS NEUROLOGY, INCORPORTAED·Product code GXY·August 12, 2015

    natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252

    FDA Enforcement
    Class II ·Ongoing·Natus Neurology Inc·March 27, 2024

    Natus Manufacturing Ltd

    Authorized representative
    🇮🇪 Ireland·4 Manufacturers

    natus neurology, Sleep Supplies Start Kit with Single Use Supplies for Embla EX Series Amplifiers, REF 024252

    FDA Recall
    Open, Classified ·Natus Neurology Inc·Product code GYB·February 7, 2024

    EPWorks software used in the Protektor 32 Product Usage: Uses electroencephalography (EEG), evoked potentials (EP), electromyography (EMG) and transcranial motor evoked potentials (TcMEP) stimulation techniques to provide healthcare professionals with information to help assess patients neurological status during surgery.

    FDA Recall
    Terminated ·Natus Medical Incorporated 2568 Bristol Circle Oakville Canada Ontario·Product code GWE·January 2, 2015

    Nicolet Elite 3 MHz OB Probe, Model #: X1L001, Catalog Code: N300. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

    NicoletOne Software v5.94, Catalog/Part Number: 482-649600. The NicoletOne data acquisition and review system, either with or without synchronous digital video. The system is intended for medical purposes to record, measure, store and display full band (FbEEG) cerebral EEG and extracerebral activity for Clinical EEG, Electrocorticography (EcOG), Long Term Monitoring (LTM), Intensive Care Unit (ICU) monitoring and Polysomnography (PSG) Sleep studies. While the Nicolet Neurodiagnostic systems are capable of displaying signals, such as Sp02 and EKG, the system is NOT intended for monitoring such signals for the preservation of life, The Nicolet Neurodiagnostic systems are intended to acquire, analyze, and display data

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code GWQ·September 11, 2015

    TENSIVE Conductive Adhesive Gel, REF 016-401600

    FDA Recall
    Open, Classified ·Natus Neurology Inc·Product code GYB·February 7, 2024

    Nicolet Ambulatory EEG

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code OLV·February 1, 2018

    Nicolet Elite 2 MHz OB Water Proof Probe, Model #: X1L008, Catalog Code: NW20. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

    Nicolet Elite 2 MHz OB Probe, Non-Fetal Monitor, Model #: X1L007, Catalog Code: N200. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017

    Nicolet Elite 5 MHz Vascular Probe, Model #: X1L004, Catalog Code: N500. Intended for non-invasive support, i.e. early detection of fetal life, monitor blood flow before and after surgery, etc.

    FDA Recall
    Terminated ·Natus Neurology Inc·Product code JAF·June 9, 2017