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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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41 to 50 of 416 results
Decision Date To: 06/01/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
Date
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AXIOS Stent and Electrocautery-Enhanced Boston Scientific Corporation DEN230019 08/18/2023
Revi System BlueWind Medical Ltd. DEN220073 08/16/2023
Viz HCM Viz.ai, Inc. DEN230003 08/03/2023
Galen ES Cooperative Surgical Assistant Galen Robotics DEN220047 07/19/2023
Ruthless Spine RJB Ruthless, LLC dba Ruthless Spine DEN230012 07/14/2023
BT-001 Better Therapeutics DEN220058 07/07/2023
KidneyIntelX.dkd Renalytix AI, Inc. DEN200052 06/29/2023
Neoasis Invictus Medical, Inc. DEN220048 06/16/2023
Eroxon Futura Medical Developments Limited DEN220078 06/09/2023
Cue COVID-19 Molecular Test Cue Health Inc. DEN220028 06/06/2023
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