Data / Medical devices / Israel / Alpha Omega Engineering Ltd.
Alpha Omega Engineering Ltd.: FDA-registered device maker in Nof HaGalil Northern, Israel, 11 510(k) clearances
Alpha Omega Engineering Ltd. is registered with the FDA (registration 9615126) in Nof HaGalil Northern, Israel. It lists 7 device types. The FDA files 11 510(k) clearances under its listings, the newest dated March 30, 2025. 1 recall event names it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9615126
- FEI number
- 3001610756
- Address
- Hamerkava St. 6 Tsiporit Industrial Zone, Nof HaGalil Northern, Israel, 1789062
- Owner or operator
- ALPHA OMEGA ENGINEERING LTD. (9039414)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- March 19, 2008
- Registered through
- 2026
- Brand names listed
- Autoclavable Drive, CRW Non-XY frame Mechanical Set Kit, Cannula, Leksell Non-XY frame Mechanical Set Kit, Libenger RM frame Mechanical Set Kit, Libenger ZD frame Mechanical Set Kit, MicroGuide, Neuro Omega and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Surgical, General & Plastic Surgery | GEA | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Cortical | GYC | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electrode, Depth | GZL | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Electromyograph, Diagnostic | IKN | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Full-Montage Standard Electroencephalograph | GWQ | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Manufacturer | accessdata.fda.gov |
| Stimulator, Electrical, Evoked Response | GWF | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 30, 2025 | K250601 | Neuro Omega System; NeuroSmart System | GZL | Substantially Equivalent | Alpha Omega Engineering , Ltd. | accessdata.fda.gov |
| September 16, 2022 | K220553 | Neuro Omega System, NeuroSmart System | GZL | Substantially Equivalent | Alpha Omega Engineering , Ltd. | accessdata.fda.gov |
| January 2, 2020 | K191739 | Sterile LeadConfirm | GZL | Substantially Equivalent | Alpha Omega Engineering , Ltd. | accessdata.fda.gov |
| February 27, 2018 | K172042 | NeuroNav System, NeuroSmart System | GZL | Substantially Equivalent | Alpha Omega Engineering , Ltd. | accessdata.fda.gov |
| December 22, 2017 | K171581 | Neuro Omega System | GZL | Substantially Equivalent | Alpha Omega Engineering , Ltd. | accessdata.fda.gov |
| April 5, 2013 | K123796 | NEURO OMEGA SYSTEM | GZL | Substantially Equivalent | Alpha Omega Engineering , Ltd. | accessdata.fda.gov |
| June 12, 2012 | K120098 | STERILE DISPOSABLES FOR MER | GZL | Substantially Equivalent | Alpha Omega Engineering , Ltd. | accessdata.fda.gov |
| December 3, 2007 | K071697 | NEURONAV SYSTEM AND NEURONAV DRIVE | GZL | Substantially Equivalent | Alpha Omega , Ltd. | accessdata.fda.gov |
| April 12, 2006 | K052527 | NEUROPROBES | GZL | Substantially Equivalent | Alpha Omega Engineering , Ltd. | accessdata.fda.gov |
| September 16, 2005 | K051830 | NEURODRIVE SYSTEM | GZL | Substantially Equivalent | Alpha Omega , Ltd. | accessdata.fda.gov |
| January 24, 2000 | K993622 | NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY | GZL | Substantially Equivalent | Alpha Omega , Ltd. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 4, 2018 | 82540 | Class I | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Medical Device Data System
- All makers of Electrode, Depth
- All makers of Cannula, Surgical, General & Plastic Surgery
- All makers of Stimulator, Electrical, Evoked Response
- All makers of Electromyograph, Diagnostic
- All makers of Electrode, Cortical
Updated March 30, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.