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 lamp, operating-room
Product CodeFQP
Regulation Number 878.4580
Device Class 2

MDR Year MDR Reports MDR Events
2019 1 1
2020 19 19
2021 1 1
2022 2 2
2023 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Device-Device Incompatibility 14 14
Compatibility Problem 10 10
Material Integrity Problem 3 3
Detachment of Device or Device Component 2 2
Break 2 2
Mechanical Problem 1 1
Melted 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Consequences Or Impact To Patient 15 15
No Clinical Signs, Symptoms or Conditions 10 10
No Patient Involvement 5 5
Insufficient Information 3 3

-
-