• 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
-
41 to 50 of 500 Results *
Decision Date To: 07/22/2019
 < 
 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]
celerity hp chemical indicator, celerity vaporized vh2o2 process indicator adhesive label, verify v24 self-contained biological indicator vial label STERIS Corporation K192020 09/05/2019
centrimag acute circulatory support system Thoratec Corporation (now part of Abbott) K191557 07/10/2019
cepheid xpert sa nasal complete control panel Microbiologics, Inc. K191168 06/25/2019
clarus Carl Zeiss Meditec, Inc K191194 06/25/2019
confirm rx insertable cardiac monitor Abbott K192593 10/18/2019
conformis benefit hip system ConforMIS, Inc. K190904 08/28/2019
cortrak* 2 equilateral enteral access system Avanos Medical, Inc. K191340 06/04/2019
crc pc smart chamber k1 Capintec, Inc. K192199 09/12/2019
cs-series-fp radiographic / fluoroscopic systems with optional ca-100s / fluoroshield™ (roi assembly) Omega Medical Imaging, LLC K191713 10/04/2019
deflectable brush biopsy set Cook Incorporated K191485 06/26/2019

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