• 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: 06/03/2020
 < 
 1 
 2 
 3 
 4 
 5 
 6 
 7 
 8 
 9 
 10 
 > 
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]
Applicant
Sort by Applicant [A-Z]
Sort by Applicant [Z-A]
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]
stimuplex onvision system Philips Medical Systems Nederland B.V. K192914 05/27/2020
guardian needle electrode Rhythmlink International, LLC K200984 05/27/2020
ac3 iabp, ac3 optimus iabp, autocat2 wave iabp, autocat2 iabp Arrow International Inc. K201112 05/27/2020
megadyne telescoping smoke evacuation pencil - 10ft tubing, megadyne telescoping smoke evacuation pencil - 15ft tubing, megadyne telescoping smoke evacuation soft tissue dissector, megadyne telescoping soft tissue dissector Ethicon Endo-Surgery K200253 05/27/2020
diaplus Diadent Group International K192392 05/26/2020
maximus system Hill-Rom Services Pte Ltd K200988 05/26/2020
npseal Guard Medical Inc. K200305 05/26/2020
exacta external drainage and monitoring system, exacta pole with laser level, exacta system replacement drainage bag, replacement laser level Medtronic, Inc. K201118 05/26/2020
gentlemax pro plus Candela Corporation K201111 05/26/2020
rewalk p6.0 ReWalk Robotics Ltd. K200032 05/26/2020

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