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
-
11 to 20 of 469 results
Decision Date To: 06/23/2025
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
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]
KMT2A Breakapart FISH Probe Kit PDx (CDA Cytocell Limited DEN240067 09/19/2025
Delphi-MD System Quantalx Neuroscience, Ltd. DEN250002 08/20/2025
ArteraAI Prostate Artera, Inc. DEN240068 07/31/2025
Oxiplex® Fziomed, Inc. DEN240038 06/17/2025
COAPTIUM Connect with TISSIUM LIGHT Tissium SA DEN240066 06/17/2025
APO-Easy Genotyping kit Firalis SA DEN240032 06/12/2025
Allix5 Clairity, Inc. DEN240047 05/30/2025
Spur Peripheral Retrievable Stent System Reflow Medical, Inc. DEN240048 05/29/2025
ConcizuTrace™ ELISA Randox Laboratories, Ltd. DEN240035 05/22/2025
Teal Wand Teal Health, Inc. DEN240045 05/09/2025
-
-