Alpha Omega Engineering Corp.

Also registered as ALPHA OMEGA ENGINEERING CO. LTD.

Country not established

Alpha Omega Engineering Corp. is a medical device manufacturer, with 356 devices listed in FDA GUDID, EUDAMED and FDA 510(k) (FDA Class II) and 1 FDA recall as of 14 Nov 2026.

Devices: 356
FDA recalls: 1

Registry facts

Counted by deviCERTS from registry records, 14 Nov 2026

Registries: FDA GUDID 355
EUDAMED 58
FDA 510(k) 1

A device listed in two registries counts in both.
Device classes: FDA Class II 352
FDA recalls: 1 recall matched by name
Sites and related companies: Part of Alpha Omega Engineering Ltd

At a glance

Counted by deviCERTS from registry records

Market reach

United States: FDA recalls

What Alpha Omega Engineering Corp. makes

Alpha Omega Engineering Corp. manufactures depth electrodes, single-use electrical connection cables for medical devices, and implantable intracerebral cannulas. Their portfolio includes neurological stereotactic surgery systems, brain-responsive electrical stimulation devices, and electromyographs. Notable products include reusable and autoclavable drive headstages, electrode holders, and sterile electrode cables designed for neurosurgical and neurostimulation applications.

The company’s devices are classified as Class II under FDA regulations and are listed in the FDA’s Unique Device Identifier (UDI) database.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue356

Newest first, rows 1-50 of 356

Search and filter all 356 devices

Rows 1-50 of 356

Showing 1-50 of 356

FDA recalls1

Recalls are matched to the firm by name. FDA recall data as of 1 Nov 2026.

FDA recall records list 1 recall initiated by Alpha Omega Engineering Corp., initiated on 2018-09-04. By recorded status: 1 terminated. The reasons filed fall into these groups: other reasons as filed. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

Recalls initiated per year

2017 0
2018 1
2019 0
2020 0
2021 0
2022 0
2023 0
2024 0
2025 0
2026 0

2018
- 4 Sep 2018 Z-1216-2019 Class I Terminated If cables are improperly connected, current may reach high charge density, causing tissue harm. Distribution: US nationwide distribution: AL, AZ, CA, CO, GA, IL, LA, MD, MA, MI, MN, OH, PA, RI, TX, and VA Submission numbers: K123796, K171581

Frequently asked questions

How many devices does Alpha Omega Engineering Corp. have in the registry?

The registry currently lists 356 devices for Alpha Omega Engineering Corp.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Alpha Omega Engineering Corp.'s devices?

Among its 50 most recently registered devices, Alpha Omega Engineering Corp. has devices listed in EUDAMED (12 devices) and FDA GUDID (50 devices). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Alpha Omega Engineering Corp.'s devices fall under?

Among its 50 most recently registered devices, the classes recorded for Alpha Omega Engineering Corp.'s devices are Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for Alpha Omega Engineering Corp.?

FDA recall records list 1 recall initiated by Alpha Omega Engineering Corp., the most recent initiated on 4 Sep 2018. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from Alpha Omega Engineering Corp. in the registry?

The most recently registered devices listed for Alpha Omega Engineering Corp. include HaGuide Software, Sterile electrode's cable, NeuroProbe Shielded and NeuroProbe Non-shielded.

Generated automatically from registry data and not verified by a human reviewer.