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TPLC
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Device
generator, lesion, radiofrequency
Regulation Description
Radiofrequency lesion generator.
Product Code
GXD
Regulation Number
882.4400
Device Class
2
Premarket Reviews
Manufacturer
Decision
ABBOTT MEDICAL
SUBSTANTIALLY EQUIVALENT
2
AVANOS MEDICAL, INC.
SUBSTANTIALLY EQUIVALENT
2
EPIMED INTERNATIONAL
SUBSTANTIALLY EQUIVALENT
1
NEUROONE MEDICAL TECHNOLOGIES CORP.
SUBSTANTIALLY EQUIVALENT
1
RF INNOVATIONS, INC
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2020
138
138
2021
154
154
2022
84
84
2023
54
54
2024
64
64
2025
11
11
Device Problems
MDRs with this Device Problem
Events in those MDRs
Insufficient Heating
98
98
Output Problem
64
64
Adverse Event Without Identified Device or Use Problem
53
53
Fracture
40
40
Thermal Decomposition of Device
39
39
Communication or Transmission Problem
31
31
Smoking
24
24
Temperature Problem
24
24
Unexpected Shutdown
21
21
Failure to Deliver Energy
18
18
Device Emits Odor
15
15
Failure to Power Up
13
13
High impedance
12
12
Overheating of Device
12
12
Insufficient Information
11
11
Noise, Audible
11
11
Connection Problem
9
9
Mechanical Problem
8
8
Unintended Electrical Shock
7
7
Grounding Malfunction
6
6
No Display/Image
6
6
Power Problem
5
5
Impedance Problem
5
5
Defective Device
4
4
Display or Visual Feedback Problem
4
4
Energy Output Problem
3
3
Structural Problem
3
3
Device Handling Problem
2
2
Disconnection
2
2
Loss of Threshold
2
2
Use of Device Problem
2
2
Defibrillation/Stimulation Problem
2
2
No Apparent Adverse Event
2
2
Electrical /Electronic Property Problem
2
2
Degraded
2
2
Appropriate Term/Code Not Available
2
2
No Tactile Prompts/Feedback
2
2
Intermittent Loss of Power
1
1
Application Program Freezes, Becomes Nonfunctional
1
1
Low impedance
1
1
Detachment of Device or Device Component
1
1
Patient-Device Incompatibility
1
1
Lack of Effect
1
1
Fail-Safe Did Not Operate
1
1
Fluid/Blood Leak
1
1
Fire
1
1
Audible Prompt/Feedback Problem
1
1
Improper or Incorrect Procedure or Method
1
1
Break
1
1
Sparking
1
1
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Clinical Signs, Symptoms or Conditions
330
330
No Consequences Or Impact To Patient
108
108
Partial thickness (Second Degree) Burn
32
32
Burn(s)
15
15
Pain
11
11
No Known Impact Or Consequence To Patient
8
8
Superficial (First Degree) Burn
7
7
Full thickness (Third Degree) Burn
7
7
Electric Shock
5
5
Insufficient Information
5
5
Inadequate Pain Relief
4
4
No Patient Involvement
4
4
Muscle Weakness
4
4
No Information
3
3
Spinal Cord Injury
2
2
Speech Disorder
2
2
Burning Sensation
2
2
Erythema
2
2
Numbness
1
1
Paraplegia
1
1
Burn, Thermal
1
1
Foreign Body In Patient
1
1
Shock from Patient Lead(s)
1
1
Not Applicable
1
1
No Code Available
1
1
Constipation
1
1
Movement Disorder
1
1
Paresthesia
1
1
Peeling
1
1
Shock
1
1
Urinary Retention
1
1
Bacterial Infection
1
1
Cellulitis
1
1
Fever
1
1
Bone Fracture(s)
1
1
Cramp(s) /Muscle Spasm(s)
1
1
Osteomyelitis
1
1
Blister
1
1
Recalls
Manufacturer
Recall Class
Date Posted
1
Abbott
II
Nov-02-2023
2
Abbott Laboratories Inc. (St Jude Medical)
II
May-10-2021
3
Avanos Medical, Inc.
II
Sep-21-2023
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