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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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Decision Date To: 06/15/2024
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Download Files | More About De Novo
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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CEFALY STX-MED SPRL DEN120019 K122566 03/11/2014
CELLERATION MIST THERAPY SYSTEM CELLERATION DEN040004 K032378 06/25/2004
Cell-Free DNA BCT Streck, Inc. DEN200001 08/07/2020
CELLSEARCH EPITHELIAL CELL ENRICHMENT KI ADVANCED DIAGNOSTIC SYSTEMS DEN040001 K031588 01/21/2004
CERAMENT G BoneSupport AB DEN210044 05/17/2022
Cereve Sleep System CEREVE, INC. DEN140032 05/13/2016
CINtec Histology (50 tests), CINtec Hist VENTANA MEDICAL SYSTEMS, INC DEN160019 03/04/2017
CipherOx CRI Tablet Flashback Technologies, Inc. DEN160020 12/21/2016
CleanCisionTM Wound Retraction and Prote Prescient Surgical DEN150038 12/16/2016
ClearLLab T1, ClearLLab T2, ClearLLab B1 Beckman Coulter DEN160047 06/29/2017
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