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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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1 to 10 of 494 results
Decision Date To: 04/02/2026
 
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Device Name
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De Novo
Number
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510(k)
Number
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Decision
Date
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STEMI AI ECG Model Powerful Medical, Inc. DEN250044 09/03/2026
Libre Duo 10 Day Continuous Dual Glucose Abbott Diabetes Care DEN250049 08/25/2026
ReneuRx™ (Neural Ice) Brixton Biosciences DEN250067 08/21/2026
Avulux Matap Ii, LLC DEN250026 08/21/2026
Qoramatic Automated Stool Management Cm Technologies, Inc. DEN250043 08/20/2026
Aletta® Autonomous Robotic Phlebotomy De Vitestro DEN250046 08/19/2026
CaRi-Heart Caristo Diagnostics , Ltd. DEN250042 07/28/2026
OTTAVA™ Robotic Surgical System Auris Health, Inc., part of Johnson & Jo DEN250068 07/21/2026
SportSuite Vision Software Stryker Endoscopy DEN250040 07/17/2026
TESSA Spatial Surgery System; INTELLIO T Smith & Nephew, Inc. DEN250037 07/06/2026
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