Alpha Omega Engineering
FDA Regulatory Profile
Summary
- Total Recalls
- 1 (1 Class I)
- 510(k) Clearances
- 9
- Inspections
- 0
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1216-2019 | Class I | Neuro Omega System, incorporating HaGuide software. For neurological and neurosurgical use. T | September 4, 2018 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K250601 | Neuro Omega System; NeuroSmart System | March 30, 2025 |
| K220553 | Neuro Omega System, NeuroSmart System | September 16, 2022 |
| K191739 | Sterile LeadConfirm | January 2, 2020 |
| K172042 | NeuroNav System, NeuroSmart System | February 27, 2018 |
| K171581 | Neuro Omega System | December 22, 2017 |
| K123796 | NEURO OMEGA SYSTEM | April 5, 2013 |
| K120098 | STERILE DISPOSABLES FOR MER | June 12, 2012 |
| K052527 | NEUROPROBES | April 12, 2006 |
| K813333 | ALPHATEMP CLINICAL THERMOMETER | December 31, 1981 |