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 413 results
Decision Date To: 05/14/2024
 < 
 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]
Adaptive Biotechnologies clonoSEQ Assay Adaptive Biotechnologies Corporation DEN170080 09/28/2018
NP Screen Advance Sentry Corporation DEN190031 05/11/2020
ensoETM Advanced Cooling Therapy, Inc. d/b/a Att DEN230021 09/13/2023
ESOPHAGEAL COOLING DEVICE ADVANCED COOLING THERAPY, LLC DEN140018 06/23/2015
PneumoLiner ADVANCED SURGICAL CONCEPTS LTD. DEN150028 04/07/2016
ContainOR Advanced Surgical Concepts Ltd. DEN170075 12/19/2017
Parathyroid Detection (Model PTeye) Syst AiBiomed, Corp. DEN170056 11/02/2018
AeroForm Tissue Expander System AIRXPANDERS, INC DEN150055 12/21/2016
EndeavorRx Akili Interactive Labs Inc. DEN200026 06/15/2020
Kerasave AL.CHI.MI.A. S.r.l DEN200063 05/02/2022
-
-