# Alpha Omega, Ltd.

- Location (FDA's records): Nazareth Illit, IL
- FDA decisions: 5 (2000–2007): 5 510(k) clearances
- Names in FDA's records: Alpha Omega , Ltd. (4); Alpha Omega, Inc. (1)
- Product codes: GZL (3), DWC (1), HAW (1)
- Predicates its devices cite: 2 (0 its own); citations of its devices by later devices: 4 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Axon Instruments, Inc.: 1 (https://510kreport.com/company/axon-instruments)
- Radionics, Inc.: 1 (https://510kreport.com/company/radionics)

## Firms that cite its devices most
- FHC, Inc.: 1 (https://510kreport.com/company/fhc)
- Sorin Group Deutschland GmbH: 1 (https://510kreport.com/company/sorin-group-deutschland)
- Alsius Corp.: 1 (https://510kreport.com/company/alsius)
- Alpha Omega Engineering, Ltd.: 1 (https://510kreport.com/company/alpha-omega-engineering)

## Its most-cited devices
- K001520: Alpha Omega Dual Cooler-Heater (2000), cited by 2
- K071697: Neuronav System and Neuronav Drive (2007), cited by 1
- K993622: Neurotrek Physiological Navigation System for Neurosurgery (2000), cited by 1

## Recent decisions
- K071697: Neuronav System and Neuronav Drive (Dec 3, 2007)
- K051830: Neurodrive System (Sep 16, 2005)
- K013396: Alpha Drive System (Aug 7, 2002)
- K001520: Alpha Omega Dual Cooler-Heater (Nov 22, 2000)
- K993622: Neurotrek Physiological Navigation System for Neurosurgery (Jan 24, 2000)

Source page: https://510kreport.com/company/alpha-omega