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
-
81 to 90 of 415 results
Decision Date To: 05/23/2024
 < 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 11 
 12 
 13 
 > 
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]
COMPUTERIZED LABOR MONITORING SYSTEM BARNEV, LTD. DEN060006 K060028 01/30/2007
TEPHAFLEX ABSORBABLE SUTURE TEPHA, INC. DEN060003 K052225 02/08/2007
HEALTHCHECK(TM) HOME TEST FOR LOSS OF TH FMG INNOVATIONS, INC. DEN050007 K051653 03/27/2006
INRANGE REMOTE MEDICATION MANAGEMENT SYS INRANGE SYSTEMS, INC. DEN060002 K051338 06/13/2007
CARDIOMEMS ENDOSENSOR WITH DELIVERY SYST CARDIOMEMS INC DEN050006 K050939 10/28/2005
PHICAL TEST GENOVA DIAGNOSTICS DEN060001 K050007 04/26/2006
TAG-IT CYSTIC FIBROSIS KIT TM BIOSCIENCE CORPORATION DEN050004 K043011 05/09/2005
PAXGENE BLOOD RNA SYSTEM PREANALYTIX GMBH DEN050003 K042613 04/18/2005
AFFYMETRIX GENECHIP MICROARRAY INSTRUMEN Affymetrix, Inc. DEN040012 K042279 12/23/2004
AMPLICHIP CYP450 TEST, MODEL 04381866190 ROCHE MOLECULAR SYSTEMS, INC. DEN040011 K042259 12/23/2004
-
-