• 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 *
Decision Date To: 04/12/2021
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]
velocity alpha highspeed surgical drill system adeor Medical AG K191479 04/11/2021
disposable medical mask Diasia Biomedical Technology Co., Ltd. K210018 04/11/2021
medical surgical mask (non-sterile) Guangdong GoodFeeling Hygiene Material Tec Co., Ltd. K202761 04/11/2021
surgical mask Customfab, INC. K203012 04/11/2021
easypoint blood collection plus Retractable Technologies, Inc. K202325 04/09/2021
endoscope model ei-740d/s FUJIFILM Corporation K210162 04/09/2021
enteral feeding catheter Medcaptain Life Science Co., Ltd. K202748 04/09/2021
hekadrill Zethon Ltd K193630 04/09/2021
hs50 diagnostic ultrasound system, hs60 diagnostic ultrasound system Samsung Medison CO., LTD. K210068 04/09/2021
pure pmma disc Quest Dental USA Corp. K201563 04/09/2021

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