Alpha Omega Engineering Ltd.
Nof HaGalil Northern, IL
ALPHA OMEGA ENGINEERING LTD. appears in FDA device records in Nof HaGalil Northern, IL. FDA records list 9 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show one recall for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 9 510(k) clearances for Alpha Omega Engineering Ltd. between 1981 and 2025. The busiest year on record is 1981, with 1. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 1 |
| 2006 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 1 |
| 2022 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K250601 | Neuro Omega System; NeuroSmart System | GZL | Substantially Equivalent | |
| K220553 | Neuro Omega System, NeuroSmart System | GZL | Substantially Equivalent | |
| K191739 | Sterile LeadConfirm | GZL | Substantially Equivalent | |
| K172042 | NeuroNav System, NeuroSmart System | GZL | Substantially Equivalent | |
| K171581 | Neuro Omega System | GZL | Substantially Equivalent | |
| K123796 | NEURO OMEGA SYSTEM | GZL | Substantially Equivalent | |
| K120098 | STERILE DISPOSABLES FOR MER | GZL | Substantially Equivalent | |
| K052527 | NEUROPROBES | GZL | Substantially Equivalent | |
| K813333 | ALPHATEMP CLINICAL THERMOMETER | FLL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 9615126 | 3001610756 | ALPHA OMEGA ENGINEERING LTD. | Hamerkava St. 6, Nof HaGalil Northern 1789062 IL | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1216-2019 | Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue. | If cables are improperly connected, current may reach high charge density, causing tissue harm. | Class I | Terminated |
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.
MDM coverage
MDM coverage of this company lists here, newest first. Submit news.
Is this your company?
This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.
Claiming lets Alpha Omega Engineering Ltd. edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.
Data as of , FDA export datePage updated Source: openFDA, public domain