• 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 brush, biopsy, general & plastic surgery
Product CodeGEE
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 1 1
2021 5 5
2022 1 1
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Material Twisted/Bent 3 3
Break 2 2
Material Deformation 2 2
Detachment of Device or Device Component 2 2
Leak/Splash 1 1
Material Fragmentation 1 1
Material Too Rigid or Stiff 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Perforation of Esophagus 3 3
Insufficient Information 2 2
Perforation 1 1
Foreign Body In Patient 1 1
Hemorrhage/Bleeding 1 1
Device Embedded In Tissue or Plaque 1 1

-
-