Alpha Omega Engineering , Ltd.

Medical device manufacturer in Nof Hagalil (Nazareth Illit), IL.

9510(k) clearances
0PMA approvals
1recalls

Device types

510(k) clearances

510(k)DeviceDecision
K250601Neuro Omega System; NeuroSmart SystemGZL · Special 03/30/2025SE
K220553Neuro Omega System, NeuroSmart SystemGZL · Special 09/16/2022SE
K191739Sterile LeadConfirmGZL · Traditional 01/02/2020SE
K172042NeuroNav System, NeuroSmart SystemGZL · Traditional 02/27/2018SE
K171581Neuro Omega SystemGZL · Traditional 12/22/2017SE
K123796Neuro Omega SystemGZL · Traditional 04/05/2013SE
K120098Sterile Disposables for MerGZL · Traditional 06/12/2012SE
K052527NeuroprobesGZL · Traditional 04/12/2006SE
K813333Alphatemp Clinical ThermometerFLL · Traditional 12/31/1981SE

Recalls

RecallProductInitiated
Z-1216-2019 Class INeuro Omega System, incorporating HaGuide software. For neurological and neurosurgical…If cables are improperly connected, current may reach high charge density, causing tissue harm. 09/04/2018Terminated