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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 413 results
Decision Date To: 05/17/2024
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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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Lenire Tinnitus Treatment Device Neuromod Devices Limited DEN210033 03/06/2023
Caption Interpretation Automated Ejectio Caption Health, Inc DEN220063 02/24/2023
Pill Sense System EnteraSense Ltd. DEN220065 02/24/2023
PMD-200 Medasense Biometrics Ltd. DEN210022 02/17/2023
Active Anthrax DetectTM Plus Rapid Test InBios International, Inc. DEN220044 02/03/2023
RefleXion Medical Radiotherapy System (R RefleXion Medical Inc DEN220014 02/01/2023
BioXmark Nanovi A/S DEN220017 12/23/2022
Tornier Pyrocarbon Humeral Head Tornier SAS DEN220012 12/16/2022
SeCore CDx HLA Sequencing System One Lambda, Inc. BR220737 11/28/2022
Eonis SCID-SMA Kit PerkinElmer Inc. DEN200044 11/09/2022
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