• 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: 05/21/2019
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]
sandshark injectable anchor (sia) system Stimwave Technologies Inc. K191466 11/07/2019
elevation breast biopsy driver, elevation breast biopsy probe - 10g, elevation breast biopsy probe - 14g Bard Peripheral Vascular, Inc. K192948 11/07/2019
precice plating system NuVasive Specialized Orthopedics, Inc. K192181 11/07/2019
salem sump dual lumen stomach tube with enfit connection Cardinal Health K190923 11/07/2019
digital radiography cxdi-702c wireless, digital radiography cxdi-402c wireless Canon, Inc. K192632 11/07/2019
hydrofera blue ready - border Hydrofera, LLC K190268 11/06/2019
sensititre 18-24 hour mic or breakpoint susceptibility system with lefamulin in the dilution range of 0.008-16ug/ml Thermo Fisher Scientific K192729 11/06/2019
somatom x.cite Siemens Medical Solutions USA, Inc. K191891 11/06/2019
conformis hip system Conformis, Inc. K192198 11/06/2019
bio-ray a-1 anchor screw system Microware Precision Co., Ltd. K182929 11/06/2019

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