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 dissector, surgical, general & plastic surgery
Product CodeGDI
Regulation Number 878.4800
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2020 4 4
2023 6 6
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Mechanical Jam 3 3
Fracture 2 2
Material Fragmentation 1 1
Mechanical Problem 1 1
Material Integrity Problem 1 1
Device Handling Problem 1 1
Positioning Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Cardiac Perforation 4 4
No Clinical Signs, Symptoms or Conditions 4 4
No Consequences Or Impact To Patient 2 2
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 2 2
No Patient Involvement 1 1
Foreign Body In Patient 1 1

-
-