• 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 manometer, blood-pressure, venous
Product CodeKRK
Regulation Number 870.1140
Device Class 2

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

Device Problems MDRs with this Device Problem Events in those MDRs
Fluid/Blood Leak 2 2
Leak/Splash 1 1
Pressure Problem 1 1
Break 1 1
Mechanical Problem 1 1
Unsealed Device Packaging 1 1
Unable to Obtain Readings 1 1
Electrical /Electronic Property Problem 1 1
Deformation Due to Compressive Stress 1 1
No Device Output 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
No Patient Involvement 1 1
Insufficient Information 1 1
No Consequences Or Impact To Patient 1 1
Low Oxygen Saturation 1 1

-
-