• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(K) Premarket Notification

  • Print
  • Share
  • E-mail
61 to 70 of 500 Results *
results per page
New Searchexport reports to excelExport to Excel | HelpHelp
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Sort by PMA Number [0-9]
Sort by PMA Number [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
advia centaur vitamin b12 master curve material, total hcg master curve material, and testosterone master curve material Siemens Healthcare Diagnostics Inc. k140505 03/31/2014
celesteion, pca-9000a/2 TOSHIBA MEDICAL SYSTEMS CORPORATION k140651 06/11/2014
super sheath TOGO MEDIKIT CO., LTD. k141070 01/15/2015
fingertip pulse oximeter BEIJING CHOICE ELECTRONIC TECHNOLOLGY CO., LTD. k141128 08/13/2014
echo-screen iii pro hearing screener with barcode scanner, echo-screen iii pro hearing screener without barcode scanner, NATUS MEDICAL INCORPORATED k141446 08/22/2014
t-8000 therozone unit THEROZONE USA, INC. k141504 02/24/2015
range/mesa/denali spinal system K2M, INC. k141873 09/08/2014
eli 380 electrocardiograph MORTARA INSTRUMENT, INC k142105 09/05/2014
rapidfret oral fluid assay for cocaine, rapidfret oral fluid cocaine calibrator set, rapidfret oral fluid cocaine control set BIOPHOR DIAGNOSTICS, INC. k142129 07/24/2015
amedica valeo ii interbody fusion device Amedica Corp k142347 11/18/2014

*   The maximum 500 records meeting your search criteria returned. Please narrow your search.