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
-
91 to 100 of 415 results
Decision Date To: 05/23/2024
 < 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 14 
 > 
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]
RIDASCREEN NOROVIRUS 3RD GENERATION EIA R-Biopharm AG DEN110001 K093295 02/23/2011
Rho 16 Bit Inc DEN230023 04/09/2024
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPH SOMNA THERAPEUTICS, LLC DEN130046 03/06/2015
REWALK ARGO MEDICAL TECHNOLOGIES, INC. DEN130034 K131798 06/26/2014
Revi System BlueWind Medical Ltd. DEN220073 08/16/2023
RETROX AURIC HEARING SYSTEMS, INC. DEN020003 K013298 08/20/2002
Retrograde Intubation Set Cook Incorporated DEN170055 12/12/2018
RESTLESS LEG DEVICE MARY M. SORG (AN INDIVIDUAL) DBA PJ SLEE DEN110009 K102707 12/18/2013
reSet PEAR THERAPEUTICS, INC. DEN160018 09/14/2017
remOVE System OVESCO ENDOSCOPY AG DEN160014 12/22/2017
-
-