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 light, operating, dental
Product CodeEAZ
Regulation Number 872.4630
Device Class 1

MDR Year MDR Reports MDR Events
2019 4 4
2020 3 3
2021 8 8
2023 2 2
2024 3 3

Device Problems MDRs with this Device Problem Events in those MDRs
Device Fell 14 14
Break 3 3
Device Handling Problem 2 2
Installation-Related Problem 1 1
Detachment of Device or Device Component 1 1
Misassembly During Maintenance/Repair 1 1
Therapeutic or Diagnostic Output Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 7 7
Bruise/Contusion 3 3
Burning Sensation 2 2
No Patient Involvement 2 2
No Known Impact Or Consequence To Patient 1 1
Concussion 1 1
Injury 1 1
Neck Pain 1 1
Laceration(s) 1 1
Pain 1 1
Swelling 1 1

-
-