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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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61 to 70 of 412 results
Decision Date To: 05/01/2024
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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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Symani Surgical System MMI North America, Inc. DEN230032 04/05/2024
Surfacer Inside-Out Access Catheter Syst Bluegrass Vascular Technologies, Inc. DEN190038 02/10/2020
SureTune4 Software Medtronic Neuromodulation DEN210003 08/23/2021
Sunrise Sleep Disorder Diagnostic Aid Sunrise DEN210015 01/07/2022
STUDIO ON THE CLOUD DATA MANAGEMENT SOFT DEXCOM, INC. DEN140016 08/19/2014
STRATIFY JCV(TM) ANTIBODY FOCUS DIAGNOSTICS, INC. DEN120008 K112394 01/20/2012
Stanza Swing Therapeutics, Inc. DEN220083 05/09/2023
Spineology Interbody Fusion System Spineology, Inc. DEN200010 09/18/2020
SpaceOAR System AUGMENIX , INC. DEN140030 04/01/2015
Sonu Sound Health Systems, Inc. DEN230045 12/04/2023
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