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
-
1 to 10 of 488 results
Decision Date To: 08/23/2026
 
 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]
CaRi-Heart Caristo Diagnostics , Ltd. DEN250042 07/28/2026
OTTAVA™ Robotic Surgical System Auris Health, Inc., part of Johnson & Jo DEN250068 07/21/2026
SportSuite Vision Software Stryker Endoscopy DEN250040 07/17/2026
TESSA Spatial Surgery System; INTELLIO T Smith & Nephew, Inc. DEN250037 07/06/2026
Claria System Claria Medical, Inc. DEN250034 07/02/2026
Syncron-E Autonomous Healthcare, Inc. DEN250025 06/18/2026
PCWP Analysis Software Cardiosense, Inc. DEN250057 05/22/2026
DeepView AI® System Spectralmd, Inc. DEN250028 05/21/2026
Modius Spero Neurovalens Limited DEN250013 05/08/2026
Prolystica Pass Thru Disinfectant Wipes Steris DEN240075 05/01/2026
-
-