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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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11 to 20 of 413 results
Decision Date To: 05/18/2024
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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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CADScor System Acarix A/S DEN190047 11/24/2020
Accelerate Pheno system, Accelerate Phen ACCELERATE DIAGNOTICS DEN160032 02/23/2017
Acclarent Aera Eustachian Tube Balloon D ACCLARENT, INC. DEN150056 09/16/2016
OsteoProbe Active Life Scientific, Inc. DEN210013 08/19/2021
Adaptive Biotechnologies clonoSEQ Assay Adaptive Biotechnologies Corporation DEN170080 09/28/2018
NP Screen Advance Sentry Corporation DEN190031 05/11/2020
ensoETM Advanced Cooling Therapy, Inc. d/b/a Att DEN230021 09/13/2023
ESOPHAGEAL COOLING DEVICE ADVANCED COOLING THERAPY, LLC DEN140018 06/23/2015
CELLSEARCH EPITHELIAL CELL ENRICHMENT KI ADVANCED DIAGNOSTIC SYSTEMS DEN040001 K031588 01/21/2004
PneumoLiner ADVANCED SURGICAL CONCEPTS LTD. DEN150028 04/07/2016
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