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Alpha Omega Engineering Corp.

Last updated May 24, 2026

Information

Country: US
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Catalogue (356)

Page 1 of 8

Device	Model / Reference	Registries	Class	Status
Sterile electrode's cable	Sterile electrode's cable	FDA UDI	Class II	Active
NeuroProbe	Shielded	FDA UDI	Class II	Active
NeuroProbe	Non-shielded	FDA UDI	Class II	Active
NeuroSmart Autoclavable Drive Headstage	NeuroSmart Autoclavable Drive Headstage	FDA UDI	Class II	Active
Neuro Omega Drive Headstage	Neuro Omega Drive Headstage	FDA UDI	Class II	Active
Neuro Omega Autoclavable Drive Headstage	Neuro Omega Autoclavable Drive Headstage	FDA UDI	Class II	Active
NexDrive Electrode Holder - Pack of 2	NexDrive Electrode Holder - Pack of 2	FDA UDI	Class II	Active
Sterile electrode's cable	Sterile electrode's cable	FDA UDI	Class II	Active
NeuroProbe	Non-shielded	FDA UDI	Class II	Active
Neuro Omega NeuroFortis Drive Headstage	Neuro Omega NeuroFortis Drive Headstage	FDA UDI	Class II	Active
Sterile electrode's cable	Sterile electrode's cable	FDA UDI	Class II	Active
NeuroProbe	Non-shielded	FDA UDI	Class II	Active
Cannula	Standard	FDA UDI	Class II	Active
Sterile electrode's cable	Sterile electrode's cable	FDA UDI	Class II	Active
NeuroProbe	MF-Non-Shielded	FDA UDI	Class II	Active
NeuroProbe	Non-shielded	FDA UDI	Class II	Active
NeuroProbe	Non-shielded	FDA UDI	Class II	Active
Cannula	Insertion Tube Set 20mm above	FDA UDI	Class II	Active
Neuro Omega with AutoClavable Drive Headstage	Neuro Omega with AutoClavable Drive Headstage	FDA UDI	Class II	Active
NeuroSmart / NeuroNav LeadConfirm A Adaptor	NeuroSmart / NeuroNav LeadConfirm A Adaptor	FDA UDI	Class II	Active
Cannula	Extractor	FDA UDI	Class II	Active
NeuroNav Drive Headstage	NeuroNav Drive Headstage	FDA UDI	Class II	Active
NeuroProbe	Non-shielded	FDA UDI	Class II	Active
Sterile electrode's cable	Sterile electrode's cable	FDA UDI	Class II	Active
NeuroFortis Neuro Omega Drive HeadStage KIT	NeuroFortis Neuro Omega Drive HeadStage KIT	FDA UDI	Class II	Active
NeuroProbe	Shielded	FDA UDI	Class II	Active
Cannula	Standard	FDA UDI	Class II	Active
Cannula	Standard Without Stylet	FDA UDI	Class II	Active
LeadConfirm	Sterile Neuro Omega LeadConfirm A Adaptor	FDA UDI	Class II	Active
Autoclavable Drive	Rev. 4	FDA UDI	Class II	Active
Neuro Omega MER HeadStage KIT	Neuro Omega MER HeadStage KIT	FDA UDI	Class II	Active
NeuroSmart / NeuroNav LeadConfirm B cable	NeuroSmart / NeuroNav LeadConfirm B cable	FDA UDI	Class II	Active
Cannula	Standard	FDA UDI	Class II	Active
Drive Headstage	Drive Headstage	FDA UDI	Class II	Active
Cannula	Insertion Tube Set 20mm above	FDA UDI	Class II	Active
NeuroSmart NeuroForits Drive Headstage	NeuroSmart NeuroForits Drive Headstage	FDA UDI	Class II	Active
NeuroSmart with AutoClavable Drive Headstage	NeuroSmart with AutoClavable Drive Headstage	FDA UDI	Class II	Active
HaGuide Software	HaGuide Software	FDA UDI	Class II	Active
Power cable	Plug Type L-4mm	FDA UDI	Class II	Active
Neuro Omega	Neuro Omega EMG- recording with Full Stimulation Source	FDA UDI	Class II	Active
NeuroSmart with NeuroFortis Drive Headstage	NeuroSmart with NeuroFortis Drive Headstage	FDA UDI	Class II	Active
NeuroProbe	Shielded	FDA UDI	Class II	Active
Sterile electrode's cable	Sterile Neuro Omega AlphaProbe electrode's cable 10 CH	FDA UDI	Class II	Active
Neuro Omega MER Headstage KIT	Neuro Omega MER Headstage KIT	FDA UDI	Class II	Active
NeuroNav with MER Headstage	NeuroNav with MER Headstage	FDA UDI	Class II	Active
Power cable	Plug Type J	FDA UDI	Class II	Active
NeuroSmart Main Unit	NeuroSmart Main Unit	FDA UDI	Class II	Active
Leksell Non-XY frame Mechanical Set Kit	Leksell Non-XY frame Mechanical Set KIT	FDA UDI	Class II	Active
NeuroSmart MER HeadStage Kit	NeuroSmart MER HeadStage Kit	FDA UDI	Class II	Active
NeuroSmart / NeuroNav LeadConfirm P Adaptor	NeuroSmart / NeuroNav LeadConfirm P Adaptor	FDA UDI	Class II	Active

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FDA Recalls (1)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Sep 4, 2018	Z-1216-2019	—	terminated	If cables are improperly connected, current may reach high charge density, causing tissue harm.