• 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]
yooeehouse breast pump Nantong Poly Technology Co., Ltd. k163183 10/02/2017
iba proton therapy system- proteus 235 (proteus one, proteus plus, proteus tk2, proteus class) Ion Beam Applications S.A. k163500 08/17/2017
everyway otc ems, model ev-805 EVERYWAY MEDICAL INSTRUMENT CO., LTD. k162744 08/03/2017
rt300 fes cycle ergometer Restorative Therapies, Inc. k162470 07/11/2017
assuretech panel dip test, assuretech quick cup test ASSURE TECH (HANGZHOU) CO., LTD. k170049 05/02/2017
multipulse hoplus ASCLEPION LASER TECHNOLOGIES GMBH k161257 03/31/2017
amsco v-pro 1 low temperature sterilization system, amsco v-pro 1 plus low temperature sterilization system, v-pro max low temperature sterilization system, v-pro 60 low temperature sterilization system STERIS Corporation k162413 03/31/2017
3.3 mm laurimed microdebrider; 4.0 mm laurimed microdebrider LAURIMED LLC k163247 03/09/2017
my patch sl DMS-SERVICE LLC k163535 02/22/2017
nitrile powder free examination gloves tested for use with chemotherapy drugs (white); dark violet blue (dvbu); dark blue (dkbu) HARTALEGA SDB. BHD. k162924 01/24/2017

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