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
-
171 to 180 of 412 results
Decision Date To: 05/05/2024
 < 
 13 
 14 
 15 
 16 
 17 
 18 
 19 
 20 
 21 
 22 
 > 
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]
Hemospray Endoscopic Hemostat Wilson-Cook Medical, Inc DEN170015 05/07/2018
Hominis Surgical System Memic Innovative Surgery Ltd. DEN190022 02/26/2021
IB-Stim Innovative Health Solutions (IHS), Inc. DEN180057 06/07/2019
ID-FISH Plasmodium Genus Test Kit, ID-FI ID-FISH TECHNOLOGY, INC DEN160025 08/18/2017
ID-TAG RESPIRATORY VIRAL PANEL LUMINEX MOLECULAR DIAGNOSTICS, INC. DEN070013 K063765 01/03/2008
IDx-DR IDx, LLC DEN180001 04/11/2018
ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. DEN130011 K123989 11/19/2013
IlluminOss Bone Stabilization System IllminOss Medical, Inc. DEN160062 12/19/2017
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE C PHADIA US INC. DEN120001 K103039 02/15/2012
ImPACT Computerized Neurocognitive Concu IMPACT APPLICATIONS, INC. DEN150037 08/22/2016
-
-