Home › Device types › GZL
Electrode, Depth
FDA product code GZL · Class 2 · Neurology
1,879
Registered devices
223
Adverse events
24
Recalls
58
510(k) clearances
Devices with this code
Sterile LeadConfirm — ALPHA OMEGA ENGINEERING CO. LTD.DEPTHALON® — PMT CORPORATIONmicroTargeting™ Electrode Cable Adapter — FHC, INC.DEPTHALON® — PMT CORPORATIONPMT® CORPORATION - SPHENOIDAL — PMT CORPORATIONSpencer Probe Depth Electrode — Ad-Tech Medical Instrument CorporationNeuro Omega Drive Headstage Kit — ALPHA OMEGA ENGINEERING CO. LTD.DEPTHALON® — PMT CORPORATIONDEPTHALON® — PMT CORPORATIONDEPTHALON® — PMT CORPORATIONmicroTargeting™ Electrode — FHC, INC.DEPTHALON® — PMT CORPORATIONDEPTHALON® — PMT CORPORATIONGuideline 4000™ 5.0 — FHC, INC.NA — DIXI MEDICALNA — DIXI MEDICALSpencer Probe Depth Electrode — Ad-Tech Medical Instrument CorporationNeuroSmart Autoclavable Drive Headstage Kit — ALPHA OMEGA ENGINEERING CO. LTD.DEPTHALON® — PMT CORPORATIONSterile cannula — ALPHA OMEGA ENGINEERING CO. LTD.Sterile LeadConfirm — ALPHA OMEGA ENGINEERING CO. LTD.Leksell Non-XY frame Mechanical Set KIT — ALPHA OMEGA ENGINEERING CO. LTD.DEPTHALON® — PMT CORPORATIONmicroTargeting™ Electrode — FHC, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symb |
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symb |
| 2024-09-19 | Ad-Tech Medical Instrument Corporation | Ad-Tech is recalling these A-Style SD Depth Electrodes because a label discrepancy was identified on A style contact SD electrodes where the MR Conditional symb |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
| 2021-12-09 | DIXI MEDICAL USA | Potential deformation of the internal packaging (blister pack) could compromise sterile barrier of the device when removed from the Tyvek bag |
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