Medical Device Manufacturer · IL , Nazareth Illit

Alpha Omega Engineering , Ltd. - FDA 510(k) Cleared Devices

8 submissions · 8 cleared · Since 2006

Recent clearances: Neuro Omega System, Neuro Omega System, NeuroSmart System, Sterile LeadConfirm

8
Total
8
Cleared
0
Denied

FDA 510(k) Regulatory Record - Alpha Omega Engineering , Ltd. Neurology ✕

8 devices
1-8 of 8
Cleared Mar 30, 2025
Neuro Omega System
K250601 · GZL
Neurology · 30d
Cleared Sep 16, 2022
Neuro Omega System, NeuroSmart System
K220553 · GZL
Neurology · 200d
Cleared Jan 02, 2020
Sterile LeadConfirm
K191739 · GZL
Neurology · 188d
Cleared Feb 27, 2018
NeuroNav System, NeuroSmart System
K172042 · GZL
Neurology · 236d
Cleared Dec 22, 2017
Neuro Omega System
K171581 · GZL
Neurology · 205d
Cleared Apr 05, 2013
NEURO OMEGA SYSTEM
K123796 · GZL
Neurology · 116d
Cleared Jun 12, 2012
STERILE DISPOSABLES FOR MER
K120098 · GZL
Neurology · 152d
Cleared Apr 12, 2006
NEUROPROBES
K052527 · GZL
Neurology · 212d
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