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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device electrode, depth
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 2
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
2019 13 13
2020 24 24
2021 13 13
2022 10 10
2023 30 30
2024 6 6

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 13 13
Material Separation 10 10
Material Twisted/Bent 9 9
Material Integrity Problem 7 7
Break 6 6
Defective Device 5 5
Material Fragmentation 4 4
Difficult to Remove 3 3
Flaked 3 3
Fracture 3 3
Defective Component 3 3
Insufficient Information 2 2
Disconnection 2 2
Signal Artifact/Noise 2 2
Off-Label Use 2 2
Loss of or Failure to Bond 1 1
Positioning Failure 1 1
Entrapment of Device 1 1
Self-Activation or Keying 1 1
Inadequate or Insufficient Training 1 1
Image Display Error/Artifact 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Energy Output Problem 1 1
Failure to Power Up 1 1
Device Difficult to Setup or Prepare 1 1
Appropriate Term/Code Not Available 1 1
Noise, Audible 1 1
Separation Problem 1 1
Inaccurate Information 1 1
Output Problem 1 1
Positioning Problem 1 1
Temperature Problem 1 1
Unintended Movement 1 1
Structural Problem 1 1
Separation Failure 1 1
Material Protrusion/Extrusion 1 1
Malposition of Device 1 1
Detachment of Device or Device Component 1 1
Device Damaged by Another Device 1 1
Device Contamination with Chemical or Other Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Foreign Body In Patient 27 27
No Known Impact Or Consequence To Patient 25 25
No Clinical Signs, Symptoms or Conditions 18 18
Insufficient Information 9 9
Intracranial Hemorrhage 6 6
Hematoma 2 2
Hemorrhage/Bleeding 2 2
No Consequences Or Impact To Patient 2 2
Paresthesia 2 2
Cramp(s) /Muscle Spasm(s) 2 2
Death 1 1
Device Embedded In Tissue or Plaque 1 1
Not Applicable 1 1
Speech Disorder 1 1
Fungal Infection 1 1
Low Blood Pressure/ Hypotension 1 1
Laceration(s) 1 1
Dizziness 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Ad-Tech Medical Instrument Corporation II Aug-28-2019
2 Ad-Tech Medical Instrument Corporation II Aug-26-2019
3 Ad-Tech Medical Instrument Corporation II Aug-06-2019
4 Alpha Omega Engineering I May-06-2019
5 DIXI MEDICAL USA II Jan-28-2022
6 FHC, Inc. II Jul-08-2020
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