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TPLC
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show TPLC since
2009
2010
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2019
2020
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2024
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Device
electrode, depth
Product Code
GZL
Regulation Number
882.1330
Device Class
2
Premarket Reviews
Manufacturer
Decision
AD-TECH MEDICAL INSTRUMENT CORPORATION
SUBSTANTIALLY EQUIVALENT
5
ALPHA OMEGA ENGINEERING LTD,
SUBSTANTIALLY EQUIVALENT
1
ALPHA OMEGA ENGINEERING LTD.
SUBSTANTIALLY EQUIVALENT
4
ALPHA OMEGA ENGINEERING, LTD.
SUBSTANTIALLY EQUIVALENT
1
ALPINE BIOMED APS
SUBSTANTIALLY EQUIVALENT
1
BLACKROCK MICROSYSTEMS, INC
SUBSTANTIALLY EQUIVALENT
1
DIXI MEDICAL
SUBSTANTIALLY EQUIVALENT
2
FHC, INC.
SUBSTANTIALLY EQUIVALENT
1
ICE NEUROSYSTEMS, INC.
SUBSTANTIALLY EQUIVALENT
2
MICROPROBES FOR LIFE SCIENCE, INC. DBA NEURON
SUBSTANTIALLY EQUIVALENT
1
NEUROONE MEDICAL TECHNOLOGIES CORP.
SUBSTANTIALLY EQUIVALENT
2
1. K211367
Evo sEEG System
2. K222404
Evo® sEEG System
PMT CORPORATION
SUBSTANTIALLY EQUIVALENT
1
SENSOMEDICAL LABS LTD
SUBSTANTIALLY EQUIVALENT
1
WE SENSE LTD
SUBSTANTIALLY EQUIVALENT
1
MDR Year
MDR Reports
MDR Events
2014
7
7
2015
14
14
2016
9
9
2017
3
3
2018
2
2
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
28
28
Material Separation
11
11
Material Twisted/Bent
9
9
Material Integrity Problem
7
7
Break
7
7
Material Fragmentation
5
5
Difficult to Remove
5
5
Defective Device
5
5
Malposition of Device
4
4
Insufficient Information
4
4
Material Protrusion/Extrusion
3
3
Fracture
3
3
Defective Component
3
3
Flaked
3
3
Disconnection
2
2
Signal Artifact/Noise
2
2
Inadequacy of Device Shape and/or Size
2
2
Device Operates Differently Than Expected
2
2
Off-Label Use
2
2
Sticking
2
2
Positioning Problem
2
2
Temperature Problem
1
1
Unintended Movement
1
1
Output Problem
1
1
Detachment of Device or Device Component
1
1
Appropriate Term/Code Not Available
1
1
Noise, Audible
1
1
Separation Problem
1
1
Inaccurate Information
1
1
Inadequate or Insufficient Training
1
1
Use of Device Problem
1
1
Metal Shedding Debris
1
1
Improper or Incorrect Procedure or Method
1
1
Self-Activation or Keying
1
1
Device Damaged by Another Device
1
1
Device Contamination with Chemical or Other Material
1
1
Human Factors Issue
1
1
Impedance Problem
1
1
Incorrect Device Or Component Shipped
1
1
Device Slipped
1
1
Structural Problem
1
1
Separation Failure
1
1
Bent
1
1
Loss of or Failure to Bond
1
1
Positioning Failure
1
1
No Display/Image
1
1
Entrapment of Device
1
1
Fluid/Blood Leak
1
1
High impedance
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
Patient Problems
MDRs with this Patient Problem
Events in those MDRs
No Known Impact Or Consequence To Patient
38
38
Foreign Body In Patient
27
27
No Clinical Signs, Symptoms or Conditions
18
18
Insufficient Information
9
9
Intracranial Hemorrhage
9
9
Hemorrhage/Bleeding
7
7
Device Embedded In Tissue or Plaque
4
4
No Information
4
4
No Consequences Or Impact To Patient
3
3
Death
2
2
Hematoma
2
2
Paresthesia
2
2
Cramp(s) /Muscle Spasm(s)
2
2
No Code Available
1
1
Speech Disorder
1
1
Not Applicable
1
1
Bradycardia
1
1
Fatigue
1
1
Fever
1
1
Malaise
1
1
Dyskinesia
1
1
Fungal Infection
1
1
Confusion/ Disorientation
1
1
Hematuria
1
1
Hemorrhage, Subarachnoid
1
1
Hemorrhage, Subdural
1
1
Low Blood Pressure/ Hypotension
1
1
Laceration(s)
1
1
Memory Loss/Impairment
1
1
Muscle Spasm(s)
1
1
Paresis
1
1
Tissue Damage
1
1
Urinary Tract Infection
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
Ad-Tech Medical Instrument Corporation
II
Oct-21-2014
5
Alpha Omega Engineering
I
May-06-2019
6
Cyberkinetics Neurotechnology Systems, Inc.
II
Jul-07-2009
7
DIXI MEDICAL USA
II
Jan-28-2022
8
FHC, Inc.
II
Jul-08-2020
9
FHC, Inc.
II
Mar-16-2010
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