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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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31 to 40 of 415 results
Decision Date To: 05/23/2024
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Device Name
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De Novo
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510(k)
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Decision
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AQUABEAM System PROCEPT BioRobotics Corporation DEN170024 12/21/2017
ARK Voriconazole II Assay Test System ARK DIAGNOSTICS, INC DEN160033 05/05/2017
AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC DEN130007 K123250 12/18/2013
AXIOS Stent and Electrocautery-Enhanced Boston Scientific Corporation DEN230019 08/18/2023
B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GMBH DEN150009 02/20/2016
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test Sy BRAHMS GmbH, Part of Thermo Fisher Scien DEN220027 05/18/2023
Banyan BTI Banyan Biomarkers, Inc. DEN170045 02/14/2018
BD MAX Vaginal Panel, BD MAX Instrument GENEOHM SCIENCES CANADA , INC (BD DIAGNO DEN160001 10/28/2016
BEAR (Bridge-Enhanced ACL Repair) Implan Miach Orthopaedics, Inc. DEN200035 12/16/2020
BINAX NOW MALARIA TEST; MODEL 660-000, 6 INVERNESS MEDICAL PROFESSIONAL DIAGNOSTI DEN070006 K061542 06/13/2007
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