• 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
71 to 80 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]
electronic pulse stimulator Shenzhen Leading Perfection Technology Co., Ltd K183674 10/11/2019
reusable spo2 sensor Shenzhen Changke Connect Electronics Co., Ltd. K191420 10/11/2019
digifix sterile kit Virak Orthopedics, LLC K192465 10/10/2019
intelligent wireless fitness apparatus (model: ast-301, ast-302, ast-303) Shenzhen OSTO Technology Co., Ltd. K182136 10/10/2019
esotest multi esophageal temperature probe and temperature monitoring system Fiab SpA K192210 10/10/2019
belun ring Belun Technology Company Limited K191417 10/10/2019
instylla delivery kit Instylla, Inc. K191659 10/10/2019
palladium high flow therapy system Vapotherm, Inc. K191010 10/10/2019
spine wave navigated instruments Spine Wave, Inc. K192526 10/10/2019
surgical microscope system orbeye with ir OLYMPUS MEDICAL SYSTEMS CORP. K190772 10/10/2019

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