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
-
21 to 30 of 415 results
Decision Date To: 05/24/2024
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
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]
XSTAT REVMEDX, INC. DEN130016 K130218 04/03/2014
PIXEL 3 SYSTEM GAUSS SURGICAL, INC. DEN130015 K130190 05/09/2014
VITEK MS BIOMERIEUX, INC. DEN130013 K124067 08/21/2013
FERRISCAN R2-MRI ANALYSIS SYSTEM RESONANCE HEALTH ANALYSIS SERVICES PTY L DEN130012 K124065 01/23/2013
ILLUMINA MISEQDX PLATFORM ILLUMINA, INC. DEN130011 K123989 11/19/2013
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN ABBOTT MOLECULAR, INC. DEN130010 K123951 07/29/2013
GIVEN PILLCAM COLON 2 CAPSULE ENDOSCOPY GIVEN IMAGING LTD. DEN120023 K123666 01/29/2014
X-RAY ATTENUATING CREAM BLOXR CORPORATION DEN120022 K123422 05/09/2013
AXIOS STENT AND DELIVERY SYSTEM XLUMENA, INC DEN130007 K123250 12/18/2013
CEFALY STX-MED SPRL DEN120019 K122566 03/11/2014
-
-