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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, depth
Regulation Description Depth electrode.
Product CodeGZL
Regulation Number 882.1330
Device Class 2


Premarket Reviews
ManufacturerDecision
AD-TECH MEDICAL INSTRUMENT CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ALPHA OMEGA ENGINEERING LTD.
  SUBSTANTIALLY EQUIVALENT 3
BEIJING SINOVATION MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DIXI MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
ICE NEUROSYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
NEUROONE MEDICAL TECHNOLOGIES CORP.
  SUBSTANTIALLY EQUIVALENT 2
SENSOMEDICAL LABS LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 24 24
2021 13 13
2022 10 10
2023 30 30
2024 16 16
2025 12 12

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Material Twisted/Bent 9 9
Material Integrity Problem 7 7
Fracture 7 7
Material Fragmentation 6 6
Material Separation 6 6
Signal Artifact/Noise 5 5
Defective Device 5 5
Break 3 3
Insufficient Information 3 3
Defective Component 3 3
Difficult to Remove 3 3
Appropriate Term/Code Not Available 3 3
Flaked 3 3
Disconnection 2 2
Separation Problem 1 1
Entrapment of Device 1 1
Mechanical Problem 1 1
Malposition of Device 1 1
Output Problem 1 1
Image Display Error/Artifact 1 1
Peeled/Delaminated 1 1
Energy Output Problem 1 1
Separation Failure 1 1
Positioning Problem 1 1
Positioning Failure 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Use of Device Problem 1 1
Structural Problem 1 1
Device Damaged by Another Device 1 1
Detachment of Device or Device Component 1 1
Material Protrusion/Extrusion 1 1
No Apparent Adverse Event 1 1
Missing Information 1 1
Inadequate or Insufficient Training 1 1
Inaccurate Information 1 1
Loss of or Failure to Bond 1 1
Noise, Audible 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 33 33
No Clinical Signs, Symptoms or Conditions 28 28
No Known Impact Or Consequence To Patient 16 16
Insufficient Information 10 10
Intracranial Hemorrhage 5 5
Hematoma 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Paresthesia 2 2
Paralysis 2 2
Unspecified Infection 1 1
Stroke/CVA 1 1
Speech Disorder 1 1
Fatigue 1 1
Fungal Infection 1 1
Dizziness 1 1
Purulent Discharge 1 1
Laceration(s) 1 1
Convulsion/Seizure 1 1
Hemorrhage/Bleeding 1 1
No Consequences Or Impact To Patient 1 1
Low Blood Pressure/ Hypotension 1 1
Device Embedded In Tissue or Plaque 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Oct-24-2024
2 DIXI MEDICAL USA II Jan-28-2022
3 FHC, Inc. II Jul-08-2020
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