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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 413 results
Decision Date To: 05/15/2024
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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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SEEKER System Baebies, Inc. DEN150035 02/03/2017
Banyan BTI Banyan Biomarkers, Inc. DEN170045 02/14/2018
Theranova Dialyzers, Theranova 400 Dialy Baxter Healthcare Corporation DEN190042 08/28/2020
Caption Guidance Bay Labs, Inc. DEN190040 02/07/2020
ClearLLab T1, ClearLLab T2, ClearLLab B1 Beckman Coulter DEN160047 06/29/2017
CARPEDIEM System Bellco srl (now part of Medtronic, Inc) DEN180055 04/29/2020
SkinPen Precision System BELLUS MEDICAL, LLC. DEN160029 03/01/2018
BT-001 Better Therapeutics DEN220058 07/07/2023
Innovo Bio-Medical Research Ltd. DEN170049 11/06/2018
Amplichek II, Negative and Amplichek II, Bio-Rad Laboratories DEN150058 03/28/2016
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