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
2010
2011
2012
2013
2014
2015
2016
2017
2018
2019
2020
2021
2022
2023
2024
2025
Back to Search Results
Device
audiometer
Regulation Description
Audiometer.
Product Code
EWO
Regulation Number
874.1050
Device Class
2
Premarket Reviews
Manufacturer
Decision
HEARX SA (PTY) LTD
SUBSTANTIALLY EQUIVALENT
1
OTODYNAMICS
SUBSTANTIALLY EQUIVALENT
1
OTODYNAMICS LTD
SUBSTANTIALLY EQUIVALENT
1
PATH MEDICAL GMBH
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
7
7
2021
3
3
2022
6
6
2023
3
3
2024
2
2
Device Problems
MDRs with this Device Problem
Events in those MDRs
Break
6
6
Melted
6
6
Battery Problem
4
4
Component Incompatible
3
3
Material Twisted/Bent
2
2
Device Displays Incorrect Message
1
1
Inappropriate/Inadequate Shock/Stimulation
1
1
Noise, Audible
1
1
Unintended Electrical Shock
1
1
Electrical /Electronic Property Problem
1
1
Charging Problem
1
1
Crack
1
1
Device Emits Odor
1
1
Device Markings/Labelling Problem
1
1
Electro-Static Discharge
1
1
No Apparent Adverse Event
1
1
Component or Accessory Incompatibility
1
1
Therapeutic or Diagnostic Output Failure
1
1
Fracture
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
16
16
Abrasion
4
4
Insufficient Information
2
2
Not Applicable
2
2
Laceration(s)
1
1
No Known Impact Or Consequence To Patient
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
PATH
II
Nov-25-2023
-
-