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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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71 to 80 of 413 results
Decision Date To: 05/17/2024
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Device Name
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De Novo
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510(k)
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Decision
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VITROS Immunodiagnostic Products Anti-SA Ortho-Clinical Diagnostics, Inc. DEN210038 05/05/2023
“Genius™ Digital Diagnostics System with Hologic Inc. DEN210035 01/31/2024
ONE Male Condom Global Protection Corp. DEN210034 02/23/2022
Lenire Tinnitus Treatment Device Neuromod Devices Limited DEN210033 03/06/2023
AccuMeasure System RQMIS Inc. DEN210032 07/26/2022
The Cooral System BrainCool AB DEN210027 10/14/2022
CavaClear Laser Sheath Spectranetics, Inc. DEN210024 12/21/2021
PMD-200 Medasense Biometrics Ltd. DEN210022 02/17/2023
Sunrise Sleep Disorder Diagnostic Aid Sunrise DEN210015 01/07/2022
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
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