Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 timer, clot, automated
Regulation Description Coagulation instrument.
Product CodeGKN
Regulation Number 864.5400
Device Class 2

MDR Year MDR Reports MDR Events
2021 12 12
2022 54 54
2023 120 120
2024 54 54
2025 51 51
2026 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Electrical /Electronic Property Problem 273 273
Mechanical Problem 21 21
Device Alarm System 13 13
Incorrect, Inadequate or Imprecise Result or Readings 12 12
Display or Visual Feedback Problem 3 3
Temperature Problem 3 3
Calibration Problem 2 2
Material Deformation 2 2
No Apparent Adverse Event 2 2
Smoking 1 1
Contamination 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 292 292
Stroke/CVA 1 1
Hemorrhage/Bleeding 1 1

-
-