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 otoscope
Regulation Description Otoscope.
Product CodeERA
Regulation Number 874.4770
Device Class 1

MDR Year MDR Reports MDR Events
2021 3 3
2022 3 3
2023 3 3
2024 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Material Split, Cut or Torn 2 2
Poor Quality Image 1 1
Device Markings/Labelling Problem 1 1
Smoking 1 1
Battery Problem 1 1
Use of Device Problem 1 1
Thermal Decomposition of Device 1 1
Sharp Edges 1 1
Excessive Heating 1 1
Intermittent Continuity 1 1
Melted 1 1
Optical Discoloration 1 1
Overheating of Device 1 1
Display or Visual Feedback Problem 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 4 4
Insufficient Information 3 3
Superficial (First Degree) Burn 1 1
Blister 1 1
Foreign Body In Patient 1 1
Scar Tissue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Baxter Healthcare Corporation II Jun-11-2025
-
-