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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 415 results
Decision Date To: 05/24/2024
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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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BioFire Joint Infection (JI) Panel BioFire Diagnostics, LLC DEN200066 04/29/2022
BioFire Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics, LLC DEN200031 03/17/2021
BIO-SEAL LUNG BIOPSY TRACT SYSTEM ANGIOTECH DEN090007 K082438 12/19/2012
BioTraceIO Lite TechsoMed Medical Technologies Ltd. DEN230020 12/22/2023
BioXmark Nanovi A/S DEN220017 12/23/2022
Body Temperature Software (BTS) Fitbit LLC DEN230050 12/15/2023
Bonebridge MED-EL Elektromedizinische Geraete GmbH DEN170009 07/20/2018
Bose Hearing Aid Bose Corporation DEN180026 10/05/2018
BrachyGel Vaginal Hydrogel Packing Syste BrachyFoam, Inc. d/b/a Advaray DEN220052 08/22/2023
BraidE Embolization Assist Device Rapid Medical Ltd. DEN230064 02/21/2024
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