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 413 results
Decision Date To: 05/15/2024
 < 
 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]
Irregular Rhythm Notification Feature Apple Inc DEN180042 09/11/2018
ECG App Apple Inc DEN180044 09/11/2018
EaseVRx AppliedVR, Inc. DEN210014 11/16/2021
ARK Voriconazole II Assay Test System ARK DIAGNOSTICS, INC DEN160033 05/05/2017
NEPHROCHECK TEST SYSTEM ASTUTE MEDICAL, INC DEN130031 09/05/2014
Quantidex qPCR BCR-ABL IS Kit ASURAGEN, INC. DEN160003 07/22/2016
AmplideX Fragile X Dx & Carrier Screen K Asuragen, Inc. DEN190023 02/21/2020
SpaceOAR System AUGMENIX , INC. DEN140030 04/01/2015
Ellipsys Vascular Access System Avenu Medical, Inc DEN170004 06/22/2018
B.R.A.H.M.S PCT sensitive KRYPTOR B.R.A.H.M.S GMBH DEN150009 02/20/2016
-
-