• 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 clamp, line
Product CodeFKK
Regulation Number 876.4730
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 4 4
2021 1 1
2022 1 1
2023 2 2
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 8 8
Free or Unrestricted Flow 2 2
Difficult to Open or Close 2 2
Loose or Intermittent Connection 2 2
Disconnection 1 1
Mechanical Problem 1 1
Defective Component 1 1
Device Dislodged or Dislocated 1 1
Connection Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 7 7
No Clinical Signs, Symptoms or Conditions 6 6
No Patient Involvement 1 1

-
-