Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
TPLC - Total Product Life Cycle
FDA Home
medical devices
databases
-
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
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
Back to Search Results
Device
heat source for bleaching teeth
Product Code
EEG
Regulation Number
872.6475
Device Class
1
MDR Year
MDR Reports
MDR Events
2019
3
3
2020
6
6
2021
6
6
2022
4
4
2024
1
1
Device Problems
MDRs with this Device Problem
Events in those MDRs
Adverse Event Without Identified Device or Use Problem
10
10
Unintended Electrical Shock
2
2
Improper or Incorrect Procedure or Method
2
2
Patient Device Interaction Problem
2
2
Inadequate Instructions for Non-Healthcare Professional
1
1
Patient-Device Incompatibility
1
1
Smoking
1
1
Use of Device Problem
1
1
Product Quality Problem
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
Patient Problem/Medical Problem
5
5
Pain
4
4
No Clinical Signs, Symptoms or Conditions
3
3
Tooth Fracture
2
2
Burn(s)
2
2
Burning Sensation
2
2
Sensitivity of Teeth
2
2
Dysphasia
1
1
Sleep Dysfunction
1
1
Arrhythmia
1
1
Hypersensitivity/Allergic reaction
1
1
Complaint, Ill-Defined
1
1
Electric Shock
1
1
Burn, Thermal
1
1
Blister
1
1
Erythema
1
1
Discomfort
1
1
Numbness
1
1
Swelling/ Edema
1
1
Tissue Damage
1
1
Unspecified Respiratory Problem
1
1
Headache
1
1
-
-