Company ยท IL
Alpha Omega Engineering , Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1981 to 2025. Name variants (Inc, Corp, punctuation) are merged.
9510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 30, 2025 | K250601 | Neuro Omega System; NeuroSmart System Alpha Omega Engineering , Ltd., IL | GZL |
| Sep 16, 2022 | K220553 | Neuro Omega System, NeuroSmart System Alpha Omega Engineering , Ltd., IL | GZL |
| Jan 2, 2020 | K191739 | Sterile LeadConfirm Alpha Omega Engineering , Ltd., IL | GZL |
| Feb 27, 2018 | K172042 | NeuroNav System, NeuroSmart System Alpha Omega Engineering , Ltd., IL | GZL |
| Dec 22, 2017 | K171581 | Neuro Omega System Alpha Omega Engineering , Ltd., IL | GZL |
| Apr 5, 2013 | K123796 | NEURO OMEGA SYSTEM Alpha Omega Engineering , Ltd., IL | GZL |
| Jun 12, 2012 | K120098 | STERILE DISPOSABLES FOR MER Alpha Omega Engineering , Ltd., IL | GZL |
| Apr 12, 2006 | K052527 | NEUROPROBES Alpha Omega Engineering , Ltd., IL | GZL |
| Dec 31, 1981 | K813333 | ALPHATEMP CLINICAL THERMOMETER Alpha Omega Engineering Corp. | FLL |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 6, 2019 | Alpha Omega Engineering Neuro Omega System, incorporating HaGuide software.
For neurological and neurosurgical use.
To monitor, record and display bioelectric signals, and stimulate nerves and brain tissue. Terminated |
GZL | K123796 K171581 |