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
-
111 to 120 of 413 results
Decision Date To: 05/17/2024
 < 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 14 
 15 
 16 
 > 
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]
Sepsis ImmunoScore Prenosis, Inc. DEN230036 04/02/2024
PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH DEN050003 K042613 04/18/2005
HEM-AVERT PERIANAL STABILIZER PLEXUS BIOMEDICAL INC. DEN090011 K083692 01/13/2011
Philips IntelliSite Pathology Solution Philips Medical Systems Nederland B.V. DEN160056 04/12/2017
Phagenyx System Phagenesis Limited DEN220025 09/16/2022
IMMUNOCAP TRYPTASE, CALIBRATORS, CURVE C PHADIA US INC. DEN120001 K103039 02/15/2012
NEOGRAM AMINO ACIDS AND ACYLCARNITINES T PERKINELMER LIFE SCIENCES, INC. DEN040002 K031878 08/24/2004
GSP Neonatal Creatine Kinase - MM kit PerkinElmer Inc. DEN180056 12/12/2019
Eonis SCID-SMA Kit PerkinElmer Inc. DEN200044 11/09/2022
ECLIPSE SYSTEM PELVALON DEN140020 02/12/2015
-
-