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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device electrode, needle
Regulation Description Needle electrode.
Product CodeGXZ
Regulation Number 882.1350
Device Class 2


Premarket Reviews
ManufacturerDecision
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
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