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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: 05/14/2024
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Device Name
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De Novo
Number
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510(k)
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Decision
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Osteoboost Belt Bone Health Technologies, Inc DEN230015 01/12/2024
CERAMENT G BoneSupport AB DEN210044 05/17/2022
Bose Hearing Aid Bose Corporation DEN180026 10/05/2018
WallFlex Biliary RX Fully Covered Stent BOSTON SCIENTIFIC DEN150040 06/03/2016
AXIOS Stent and Electrocautery-Enhanced Boston Scientific Corporation DEN230019 08/18/2023
BrachyGel Vaginal Hydrogel Packing Syste BrachyFoam, Inc. d/b/a Advaray DEN220052 08/22/2023
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test Sy BRAHMS GmbH, Part of Thermo Fisher Scien DEN220027 05/18/2023
BrainTemp Neonate System (BTNeo System) Brain Temp Inc. DEN200042 03/29/2022
The Cooral System BrainCool AB DEN210027 10/14/2022
BrainScope Ahead 100 BRAINSCOPE COMPANY, INC DEN140025 11/17/2014
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