• 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 camera, television, surgical, with audio
Regulation Description Surgical camera and accessories.
Product CodeFWC
Regulation Number 878.4160
Device Class 1

MDR Year MDR Reports MDR Events
2016 1 1
2018 5 5
2019 1 1
2020 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Device Emits Odor 3 3
Smoking 2 2
Poor Quality Image 2 2
Optical Problem 1 1
Loss of Power 1 1
Display or Visual Feedback Problem 1 1
Image Display Error/Artifact 1 1
Image Orientation Incorrect 1 1
Mechanical Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 5 5
No Consequences Or Impact To Patient 4 4
Irritation 1 1
No Patient Involvement 1 1

-
-