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
-
31 to 40 of 416 results
Decision Date To: 06/01/2024
 < 
 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]
DuraGraft Marizyme, Inc. DEN230002 10/04/2023
Invitae Common Hereditary Cancers Panel Invitae Corporation DEN210011 09/29/2023
Procise IFX ProciseDx Inc. DEN210056 09/29/2023
Procise ADL ProciseDx Inc. DEN220023 09/29/2023
VasQ Laminate Medical Technologies Ltd. DEN220026 09/26/2023
Hemanext ONE Hemanext, Inc. BR220665 09/15/2023
ensoETM Advanced Cooling Therapy, Inc. d/b/a Att DEN230021 09/13/2023
esolution S4 Medical Corp DEN230006 09/06/2023
LightStrike+ (MXSUV1-SL and MXSUV1-FT) Xenex Disinfection Services, Inc. DEN230007 09/01/2023
BrachyGel Vaginal Hydrogel Packing Syste BrachyFoam, Inc. d/b/a Advaray DEN220052 08/22/2023
-
-