Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
  • Print
  • Share
  • E-mail
-
281 to 290 of 412 results
Decision Date To: 05/03/2024
 < 
 24 
 25 
 26 
 27 
 28 
 29 
 30 
 31 
 32 
 33 
 > 
results per page
New Search
Download Files | More About De Novo
Device Name
sort by device name [a-z]
sort by device name [z-a]
Requester
sort by requester [a-z]
sort by requester [z-a]
De Novo
Number
sort by DeNovo number [0-9]
sort by DeNovo number [9-0]
510(k)
Number
sort by 510(K) number [0-9]
sort by 510(K) number [9-0]
Decision
Date
sort by decision date [0-9]
sort by decision date [9-0]
Cell-Free DNA BCT Streck, Inc. DEN200001 08/07/2020
Theranova Dialyzers, Theranova 400 Dialy Baxter Healthcare Corporation DEN190042 08/28/2020
ToothWave™ Home Skinovations Ltd. DEN190039 09/17/2020
HemosIL Liquid Anti-Xa Instrumentation Laboratory Co. DEN190032 09/17/2020
Spineology Interbody Fusion System Spineology, Inc. DEN200010 09/18/2020
Tangible Boost Tangible Science, Inc. DEN200002 09/24/2020
NightWare Kit, Apple iPhone, Apple Watch NightWare, Inc DEN200033 11/06/2020
Acumen Assisted Fluid Management (AFM) S Edwards Lifesciences DEN190029 11/13/2020
FilmArray Global Fever Panel BioFire Defense, LLC DEN200043 11/20/2020
CADScor System Acarix A/S DEN190047 11/24/2020
-
-