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 table, cystometric, non-electric and accessories
Product CodeKQS
Regulation Number 876.4890
Device Class 1

MDR Year MDR Reports MDR Events
2014 1 1
2016 1 1
2020 2 2
2022 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
No Display/Image 2 2
Loose or Intermittent Connection 1 1
Defective Device 1 1
Adverse Event Without Identified Device or Use Problem 1 1
Output Problem 1 1
Protective Measures Problem 1 1
Physical Resistance/Sticking 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 2 2
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Laceration(s) 1 1

-
-