• 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
1 to 10 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]
access ck-mb on the access immunoassay analyzer, models 33300, 33305, 33309, 33306 BECKMAN COULTER, INC. k994439 01/14/2000
cynosure m2 dermatology laser for hair removal CYNOSURE, INC. k994427 01/18/2000
cynosure photogenica spir CYNOSURE, INC. k994437 01/18/2000
bilichek non-invasive bilirubin analyzer SPECTRX, INC. k994438 02/04/2000
opc 3g all-ceramic system, core and overlay porcelains JENERIC/PENTRON, INC. k994435 02/10/2000
hwa & silktex powdered latex examination gloves, with protein content labeling claim (140 micrograms or less) HWA TEH INDUSTRIAL SDN. BHD. k994432 02/16/2000
venusa, ltd. extension set with filter VENUSA LTD. k994429 03/03/2000
e7512 premie rem polyhesive ii patient return electrode VALLEYLAB, INC. k994428 03/07/2000
surgi-vision esophageal stylet coil SURGI-VISION, INC. k994436 03/14/2000
shimadzu whole body x-ray computed tomography scanner sct-7800 series SHIMADZU MEDICAL SYSTEMS k994431 03/23/2000

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