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TPLC
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show TPLC since
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2019
2020
2021
2022
2023
2024
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Device
electrode, needle
Product Code
GXZ
Regulation Number
882.1350
Device Class
2
Premarket Reviews
Manufacturer
Decision
DAEHAN MEDICAL SYSTEMS CO., LTD.
SUBSTANTIALLY EQUIVALENT
1
1. K161566
DMS Disposable Subdermal Needle Electrodes
KIRWAN SURGICAL PRODUCTS, INC.
SUBSTANTIALLY EQUIVALENT
1
NEUROINVENT INC.
SUBSTANTIALLY EQUIVALENT
2
PERSYST DEVELOPMENT CORP.
SUBSTANTIALLY EQUIVALENT
1
RHYTHMLINK INTERNATIONAL, LLC
SUBSTANTIALLY EQUIVALENT
4
SPES MEDICA S.R.L.
SUBSTANTIALLY EQUIVALENT
1
STRYKER SPINE
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
2014
8
8
2015
12
12
2016
11
11
2017
6
6
2018
9
9
2019
14
14
2020
7
7
2021
9
9
2022
18
18
2023
21
21
2024
19
19
Device Problems
MDRs with this Device Problem
Events in those MDRs
Detachment of Device or Device Component
20
20
Adverse Event Without Identified Device or Use Problem
14
14
Device Sensing Problem
12
12
Break
11
11
Failure to Sense
11
11
Material Separation
11
11
Use of Device Problem
9
9
Unable to Obtain Readings
7
7
Incorrect, Inadequate or Imprecise Result or Readings
7
7
False Negative Result
5
5
Device Operates Differently Than Expected
5
5
Inappropriate Audible Prompt/Feedback
5
5
Material Fragmentation
3
3
Lead(s), burn(s) from
3
3
Flaked
2
2
Device Unsafe to Use in Environment
2
2
Connection Problem
2
2
Material Integrity Problem
2
2
Noise, Audible
2
2
Physical Resistance/Sticking
1
1
Intermittent Loss of Power
1
1
Appropriate Term/Code Not Available
1
1
Difficult to Advance
1
1
Low impedance
1
1
Defective Component
1
1
Component Missing
1
1
Incomplete or Missing Packaging
1
1
Defective Device
1
1
Component or Accessory Incompatibility
1
1
Improper or Incorrect Procedure or Method
1
1
Fracture
1
1
Smoking
1
1
Failure to Analyze Signal
1
1
Sensing Intermittently
1
1
Loose or Intermittent Connection
1
1
Mechanical Problem
1
1
Melted
1
1
Overheating of Device
1
1
Unsealed Device Packaging
1
1
Fire
1
1
Contamination
1
1
Entrapment of Device
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
39
39
No Consequences Or Impact To Patient
19
19
Foreign Body In Patient
17
17
No Known Impact Or Consequence To Patient
13
13
Burn(s)
12
12
Needle Stick/Puncture
7
7
Device Embedded In Tissue or Plaque
5
5
No Information
5
5
Nerve Damage
5
5
Discomfort
3
3
Skin Discoloration
3
3
Bradycardia
1
1
Injury
1
1
Pain
1
1
Paralysis
1
1
Paresis
1
1
Perforation
1
1
Seizures
1
1
Cellulitis
1
1
Ecchymosis
1
1
Facial Nerve Paralysis
1
1
Fall
1
1
Low Blood Pressure/ Hypotension
1
1
Unspecified Infection
1
1
Inflammation
1
1
Laceration(s)
1
1
No Code Available
1
1
Unspecified Tissue Injury
1
1
Insufficient Information
1
1
Full thickness (Third Degree) Burn
1
1
Lead(s), Burn(s) From
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Stryker Instruments Div. of Stryker Corporation
II
Sep-03-2010
2
Technomed Europe
II
Jan-07-2022
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