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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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21 to 30 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)
Number
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Decision
Date
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ensoETM Advanced Cooling Therapy, Inc. d/b/a Att DEN230021 09/13/2023
BioTraceIO Lite TechsoMed Medical Technologies Ltd. DEN230020 12/22/2023
AXIOS Stent and Electrocautery-Enhanced Boston Scientific Corporation DEN230019 08/18/2023
Osteoboost Belt Bone Health Technologies, Inc DEN230015 01/12/2024
Ruthless Spine RJB Ruthless, LLC dba Ruthless Spine DEN230012 07/14/2023
DermaSensor DermaSensor Inc. DEN230008 01/12/2024
LightStrike+ (MXSUV1-SL and MXSUV1-FT) Xenex Disinfection Services, Inc. DEN230007 09/01/2023
esolution S4 Medical Corp DEN230006 09/06/2023
Viz HCM Viz.ai, Inc. DEN230003 08/03/2023
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
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