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
-
471 to 480 of 480 results
Decision Date To: 03/05/2026
 < 
 43 
 44 
 45 
 46 
 47 
 48 
 
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]
Sana Device Sana Health DEN250005 01/16/2026
Amferia Wound Dressing Amferia AB DEN250006 02/06/2026
Delivery Date AI Ultrasound AI DEN250007 02/11/2026
LifeVac Lifevac, LLC DEN250012 03/04/2026
Tyto Insights for Eardrum Bulging Detect Tyto Care , Ltd. DEN250014 03/17/2026
neuropacs Automated Imaging Diagnostics, LLC DEN240071 04/03/2026
XplantR Explant Tool Hjarta Care, LLC DEN250033 04/17/2026
Aurie System Cathbuddy, Inc. DEN250023 04/30/2026
Prolystica Pass Thru Disinfectant Wipes Steris DEN240075 05/01/2026
Modius Spero Neurovalens Limited DEN250013 05/08/2026
-
-