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 dilator, esophageal, ent
Product CodeKCF
Regulation Number 874.4420
Device Class 1

MDR Year MDR Reports MDR Events
2019 2 2
2021 2 2
2023 2 2
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Material Rupture 2 2
Fluid/Blood Leak 2 2
Material Puncture/Hole 1 1
Inadequacy of Device Shape and/or Size 1 1
Difficult to Advance 1 1
Adverse Event Without Identified Device or Use Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3 3
No Known Impact Or Consequence To Patient 1 1
No Information 1 1
Stenosis of the esophagus 1 1
Swelling/ Edema 1 1

-
-