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
-
241 to 250 of 412 results
Decision Date To: 04/19/2024
 < 
 20 
 21 
 22 
 23 
 24 
 25 
 26 
 27 
 28 
 29 
 > 
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]
SEM Scanner (Model 200) Bruin Biometrics, LLC DEN170021 12/20/2018
Enlight 1810 Timpel Inc. DEN170072 12/20/2018
MLL (KMT2A) Breakapart FISH Probe Kit; A Cytocell Ltd DEN170070 12/21/2018
Miris Human Milk Analyzer Miris AB DEN180007 12/21/2018
EyeBOX Oculogica, Inc. DEN170091 12/28/2018
Aptima Mycoplasma genitalium Assay Hologic, Inc. DEN180047 01/23/2019
t:slim X2 insulin pump with interoperabl Tandem Diabetes Care, Inc. DEN180058 02/14/2019
Early Bird Bleed Monitoring System Saranas, Inc. DEN180021 03/01/2019
Quantra Hemostasis Analyzer, QPlus Cartr HemoSonics, LLC DEN180017 03/12/2019
ClearMate Thornhill Research, Inc. DEN170044 03/14/2019
-
-