• 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
31 to 40 of 500 Results *
Decision Date To: 05/20/2019
Results per Page
New Search  
Export all 500 Records to ExcelExport to Excel | Download Files | More About 510(k)
Device Name
Sort by Device Name [A-Z]
Sort by Device Name [Z-A]
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
Sort by 510(k) Number [0-9]
Sort by 510(k) Number [9-0]
Sort by Decision Date [0-9]
Sort by Decision Date [9-0]
recovery pump, 737r (rpx) Mego Afek AC Ltd. K190493 05/15/2019
sofia ex intracranial support catheter Micro Vention Inc. K182602 05/15/2019
spo2 sensor Shenzhen Upnmed Equipment Co., Ltd. K183277 05/15/2019
topaz mobile dr system DRGEM Corporation K183292 05/15/2019
bact/alert mp reagent system bioMerieux, Inc. K190405 05/15/2019
liba3 system National Cardiac, Inc. K182532 05/15/2019
vericlear digital early result pregnancy test True Diagnostics, Inc. K182328 05/15/2019
apas independence with urine analysis module Clever Culture Systems AG K183648 05/15/2019
cayman lp plate system K2m, Inc. K190584 05/15/2019
single use electrosurgical knife kd-625 , single use electrosurgical knife kd-645 Olympus Medical Systems Corp. K182408 05/15/2019

*   The maximium 500 devices meeting your search criteria returned. Please narrow your search.