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
electrode, needle
Regulation Description
Needle electrode.
Product Code
GXZ
Regulation Number
882.1350
Device Class
2
Premarket Reviews
Manufacturer
Decision
RHYTHMLINK INTERNATIONAL, LLC
SUBSTANTIALLY EQUIVALENT
1
SUZHOU HAISHEN MEDICAL DEVICE ASSOCIATES CO., LTD
SUBSTANTIALLY EQUIVALENT
1
TECHNOMED EUROPE
SUBSTANTIALLY EQUIVALENT
1
TEDAN SURGICAL INNOVATIONS INC.
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
7
7
2021
9
9
2022
18
18
2023
21
21
2024
58
58
2025
4
4
Device Problems
MDRs with this Device Problem
Events in those MDRs
Incorrect, Inadequate or Imprecise Result or Readings
31
31
Detachment of Device or Device Component
23
23
False Negative Result
16
16
Use of Device Problem
8
8
Device Sensing Problem
8
8
Inappropriate Audible Prompt/Feedback
7
7
Failure to Sense
5
5
Unable to Obtain Readings
4
4
False Positive Result
4
4
Break
3
3
Material Separation
3
3
Adverse Event Without Identified Device or Use Problem
3
3
Material Fragmentation
3
3
Connection Problem
3
3
Product Quality Problem
2
2
Flaked
2
2
Device Unsafe to Use in Environment
2
2
Incomplete or Missing Packaging
1
1
Difficult to Open or Close
1
1
Physical Resistance/Sticking
1
1
Entrapment of Device
1
1
Intermittent Loss of Power
1
1
Defective Device
1
1
Fracture
1
1
Defibrillation/Stimulation Problem
1
1
Overheating of Device
1
1
Component Missing
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
72
72
Foreign Body In Patient
20
20
Nerve Damage
7
7
Burn(s)
4
4
No Consequences Or Impact To Patient
4
4
Device Embedded In Tissue or Plaque
3
3
No Known Impact Or Consequence To Patient
2
2
Discomfort
2
2
Needle Stick/Puncture
2
2
Paralysis
1
1
Perforation
1
1
Unspecified Tissue Injury
1
1
Insufficient Information
1
1
Laceration(s)
1
1
Paresis
1
1
Inflammation
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Technomed Europe
II
Jan-07-2022
-
-