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 transducer, ultrasonic, obstetric
Regulation Description Obstetric ultrasonic transducer and accessories.
Product CodeHGL
Regulation Number 884.2960
Device Class 2

MDR Year MDR Reports MDR Events
2024 14 16
2025 16 16
2026 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
High Readings 12 14
Incorrect Measurement 7 8
Incorrect, Inadequate or Imprecise Result or Readings 5 5
No Audible Alarm 4 5
Unable to Obtain Readings 2 2
Adverse Event Without Identified Device or Use Problem 2 2
No Audible Prompt/Feedback 2 2
Poor Quality Image 1 1
Insufficient Information 1 1
Low Readings 1 1
Overheating of Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28 30
Burn(s) 2 2
Hypoxia 1 1
Skin Inflammation/ Irritation 1 1
Insufficient Information 1 1

-
-