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
-
271 to 280 of 412 results
Decision Date To: 05/03/2024
 < 
 23 
 24 
 25 
 26 
 27 
 28 
 29 
 30 
 31 
 32 
 > 
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]
AmplideX Fragile X Dx & Carrier Screen K Asuragen, Inc. DEN190023 02/21/2020
iTind System Medi-Tate Ltd. DEN190020 02/25/2020
MyCare Psychiatry Clozapine Assay Kit Saladax Biomedical Inc DEN190028 04/16/2020
CARPEDIEM System Bellco srl (now part of Medtronic, Inc) DEN180055 04/29/2020
iTEAR Neurostimulator Olympic Ophthalmics, Inc. DEN190026 05/01/2020
OGmend Implant System Woven Orthopedic Technologies, LLC DEN180065 05/01/2020
NP Screen Advance Sentry Corporation DEN190031 05/11/2020
NaviCam Capsule Endoscope System with Na AnX Robotica, Inc. DEN190037 05/22/2020
EndeavorRx Akili Interactive Labs Inc. DEN200026 06/15/2020
cobas EBV, cobas EBV/BKV Control Kit, co Roche Molecular Systems, Inc. DEN200015 07/30/2020
-
-