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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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51 to 60 of 413 results
Decision Date To: 05/16/2024
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Download Files | More About De Novo
Device Name
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De Novo
Number
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510(k)
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Decision
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CEFALY STX-MED SPRL DEN120019 K122566 03/11/2014
Cell-Free DNA BCT Streck, Inc. DEN200001 08/07/2020
Hem-Avert Perianal Stabilizer STETRIX, INC. DEN160005 12/19/2016
SYSTEM 1E PROCESS BIOLOGICAL MONITORING STERIS Corporation DEN110002 K100049 03/30/2012
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL STERIS Corporation DEN110006 K102469 07/12/2013
EasySep™ Human Bone Marrow CD138 Positiv STEMCELL Technologies Canada Inc. DEN220090 11/06/2023
SNAP WOUND CARE DEVICE SPIRACUR, INC. DEN080011 K081406 08/07/2009
Spineology Interbody Fusion System Spineology, Inc. DEN200010 09/18/2020
CavaClear Laser Sheath Spectranetics, Inc. DEN210024 12/21/2021
ENDOTOXIN ACTIVITY ASSAY (EAA) DEVICE SPECTRAL DIAGNOSTICS, INC. DEN030002 K021885 06/16/2003
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