BEUDAMED
    17 results · 32ms · Sources: EU EUDAMED, US FDA

    Get notified when this changes

    We'll email you when new records match this search — new devices, new clearances, certificate changes, or withdrawals.

    CARDIOTEK BV

    FDA registration
    CARDIOTEK BV·1 product·🇳🇱 Netherlands

    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

    FDA Enforcement
    Class II ·Completed·CardioTek BV·July 12, 2017

    CardioTek EP-TRACER Software V2.x.

    FDA Enforcement
    Class II ·Completed·CardioTek BV·June 29, 2022

    CardioTek EP-TRACER Software V1.x and V2.0 The EP-TRACER System is an electrophysiology measurement system used to acquire, filter, digitize, amplify, display, and record signals obtained during electrophysiological studies and related procedures. The system allows the user to monitor, display and record the signals. The system incorporates a stimulator intended to be used for diagnostic cardiac stimulation during electrophysiological testing of the heart.

    FDA Recall
    Completed ·CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands·Product code DQK·April 13, 2017

    CardioTek EP-TRACER Software V2.x.

    FDA Recall
    Completed ·CardioTek BV Amerikalaan 70 Maastricht-Airport Netherlands·Product code DQK·April 25, 2022

    CardioTek B.V

    Manufacturer
    🇳🇱 Netherlands

    CardioTek B.V

    Manufacturer
    🇳🇱 Netherlands

    EP-TRACER

    FDA UDI
    CardioTek B.V.·04260441455326·EP-TRACER 70 included in the stationary system ...

    EP-TRACER

    FDA UDI
    CardioTek B.V.·04260441455425·EP-TRACER 70 included in the portable system se...

    EP-TRACER

    FDA UDI
    CardioTek B.V.·04260441452622·EP-TRACER 70 included in the cart system setup....

    EP-TRACER

    FDA UDI
    CardioTek B.V.·04260441452639·EP-TRACER 102 included in the cart system setup...

    Aluminium carrying case

    FDA UDI
    CardioTek B.V.·04260441450574·

    Adapter cables unipolar/ bipolar (set of 10)

    FDA UDI
    CardioTek B.V.·04260441450482·

    EP-TRACER

    FDA UDI
    CardioTek B.V.·04260441452615·EP-TRACER 38 included in the cart system setup....

    EP-TRACER

    FDA UDI
    CardioTek B.V.·04260441455418·EP-TRACER 38 included in the portable system se...

    CardioTek B.V

    Importer
    🇳🇱 Netherlands

    CardioTek B.V

    System producer
    🇳🇱 Netherlands