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 480 results
Decision Date To: 01/04/2024
 < 
 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]
BioXmark Nanovi A/S DEN220017 12/23/2022
AHIP INTERNAL TRIGGER POINT WAND MODEL: National Center For Pelvic Pain Research DEN100023 K100934 11/20/2012
Natural Cycles Natural Cycles Nordic AB DEN170052 08/10/2018
UROLIFT SYSTEM Neotract, Inc. DEN130023 K130651 09/13/2013
Neurolutions Upper Extremity Rehabilitat Neurolutions, Inc. DEN200046 04/23/2021
Quell-FM Neurometrix, Inc. DEN210046 05/18/2022
Lenire Tinnitus Treatment Device Neuromod Devices Limited DEN210033 03/06/2023
NEUROSTAR TMS SYSTEM Neuronetics DEN070003 K061053 10/07/2008
Monarch eTNS System Neurosigma, Inc. DEN180041 04/19/2019
Modius Lean Neurovalens Limited DEN240076 10/17/2025
-
-