2 results
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13ms
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Sources: EU EUDAMED, US FDA
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Status: Completed
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COOLIEF RF Generator is an 80-watt Radio-Frequency (RF) Generator with four independent RF channels, allowing all RF channels to be activated individually or altogether. The system is controlled via a touch screen interface display that includes user controls, alarm messages, and on-screen selection of lesioning modalities.
FDA Enforcement
Class II
·Completed·Avanos Medical, Inc.·September 27, 2023
CardioTek EP-TRACER Software V2.x.
FDA Enforcement
Class II
·Completed·CardioTek BV·June 29, 2022