• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device filter, blood, dialysis
Regulation Description Hemodialysis system and accessories.
Product CodeFKJ
Regulation Number 876.5820
Device Class 2

Device Problems
Filtration Problem 33
Inadequate Ultra Filtration 12
Calibration Problem 5
Device Alarm System 4
Use of Device Problem 2
Device Sensing Problem 1
Computer Software Problem 1
Insufficient Information 1
Device Operational Issue 1
Temperature Problem 1
Display Difficult to Read 1
Adverse Event Without Identified Device or Use Problem 1
Total Device Problems 63


-
-