• 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
91 to 100 of 500 Results *
Decision Date To: 07/22/2019
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]
bp-bt kiosk LD Technology LLC K200287 05/15/2020
caricloud Caristo Diagnostics K200274 05/21/2020
carnation ambulatory monitor Bardy Diagnostics, Inc K200870 05/01/2020
centrimag circulatory support system, centrimag return (arterial) cannula kit, centrimag drainage (venous) cannula kit Abbott (formerly Thoratec Corporation) K200306 03/06/2020
continuum pacs Integrated Ophthalmic Systems, Inc. K200385 03/16/2020
dr-id 1200sdk system FUJIFILM Corporation K200668 04/10/2020
e>eyec E-SWIN K200616 06/11/2020
emba hourglass peripheral embolization device (ped) Embolic Acceleration, LLC K200083 02/14/2020
ensite velocity cardiac mapping system, ensite precision cardiac mapping system Abbott Medical K201181 06/26/2020
epm series patient monitors Shenzhen Mindray Bio-Medical Electronics Co., Ltd. K200015 06/08/2020

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