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
-
301 to 310 of 416 results
Decision Date To: 06/07/2024
 < 
 26 
 27 
 28 
 29 
 30 
 31 
 32 
 33 
 34 
 35 
 > 
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]
BioFire Respiratory Panel 2.1 (RP2.1) Biofire Diagnostics, LLC DEN200031 03/17/2021
Portable Neuromodulation Stimulator (PoN Helius Medical, Inc. DEN200050 03/26/2021
Oxehealth Vital Signs Oxehealth Limited DEN200019 03/26/2021
Gili Pro BioSensor (also known as “Gili ContinUse Biometrics Ltd. DEN200038 04/01/2021
GI Genius Cosmo Artificial Intelligence - AI, LTD DEN200055 04/09/2021
Neurolutions Upper Extremity Rehabilitat Neurolutions, Inc. DEN200046 04/23/2021
SafeBreak Vascular Site Saver, Inc. d/b/a Lineus Medical DEN190043 05/27/2021
Cognoa ASD Diagnosis Aid Cognoa, Inc. DEN200069 06/02/2021
InSpace Subacromial Tissue Spacer System Ortho-Space Ltd. DEN200039 07/12/2021
OsteoProbe Active Life Scientific, Inc. DEN210013 08/19/2021
-
-