• 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 tube, ear suction
Regulation Description Ear, nose, and throat manual surgical instrument.
Product CodeJZF
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2016 5 5
2017 2 2
2018 2 2
2019 1 1
2021 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Break 8 8
Suction Problem 2 2
Contamination /Decontamination Problem 2 2
Device Contamination with Chemical or Other Material 1 1
Failure to Clean Adequately 1 1
Improper or Incorrect Procedure or Method 1 1
Device Operates Differently Than Expected 1 1
Problem with Sterilization 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 6 6
No Clinical Signs, Symptoms or Conditions 2 2
No Consequences Or Impact To Patient 2 2
Exposure to Body Fluids 1 1
Brain Injury 1 1
No Code Available 1 1

-
-