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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 416 results
Decision Date To: 06/01/2024
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Device Name
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Requester
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De Novo
Number
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510(k)
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Decision
Date
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NTX100 Tonic Motor Activation (NTX100 To Noctrix Health, Inc. DEN220059 04/17/2023
BT-001 Better Therapeutics DEN220058 07/07/2023
BrachyGel Vaginal Hydrogel Packing Syste BrachyFoam, Inc. d/b/a Advaray DEN220052 08/22/2023
Neoasis Invictus Medical, Inc. DEN220048 06/16/2023
Galen ES Cooperative Surgical Assistant Galen Robotics DEN220047 07/19/2023
Active Anthrax DetectTM Plus Rapid Test InBios International, Inc. DEN220044 02/03/2023
Tristel Duo ULT Tristel Solutions Limited DEN220041 06/02/2023
Fibresolve Imvaria, Inc DEN220040 01/12/2024
Sofia 2 SARS Antigen+ FIA, Sofia 2 SARS Quidel Corporation DEN220039 03/08/2023
MISHA Knee System Moximed, Inc. DEN220033 04/10/2023
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