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
stethoscope, esophageal, with electrical conductors
Product Code
BZT
Regulation Number
868.1920
Device Class
2
Premarket Reviews
Manufacturer
Decision
DEROYAL INDUSTRIES, INC.
SUBSTANTIALLY EQUIVALENT
1
STARBOARD MEDICAL, LLC
SUBSTANTIALLY EQUIVALENT
2
TRUER MEDICAL INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
1
1
2015
2
2
2017
2
2
2018
1
1
2019
3
3
2021
3
3
2022
1
1
2024
3
3
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
4
4
Incorrect Measurement
3
3
Output Problem
3
3
Adverse Event Without Identified Device or Use Problem
2
2
Defective Component
1
1
Positioning Problem
1
1
Device Inoperable
1
1
Electrical /Electronic Property Problem
1
1
Display or Visual Feedback Problem
1
1
Compatibility Problem
1
1
Improper Device Output
1
1
Unintended Movement
1
1
Low Readings
1
1
Device Sensing Problem
1
1
Erratic or Intermittent Display
1
1
Sensing Intermittently
1
1
High Readings
1
1
Unable to Obtain Readings
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
4
4
No Clinical Signs, Symptoms or Conditions
2
2
No Known Impact Or Consequence To Patient
2
2
Insufficient Information
2
2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available
1
1
No Information
1
1
Laceration(s) of Esophagus
1
1
Alteration In Body Temperature
1
1
Foreign Body In Patient
1
1
Alteration in Body Temperature
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Cincinnati Sub-Zero Products Inc
II
Jan-11-2012
-
-