Medical Device Manufacturer · IL , Nazareth Illit

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

4 submissions · 4 cleared · Since 2000

Recent clearances: NEURONAV SYSTEM AND NEURONAV DRIVE, NEURODRIVE SYSTEM, ALPHA DRIVE SYSTEM

View 4 510(k) Devices ↓
4
Total
4
Cleared
0
Denied

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

4 devices
1-4 of 4
Cleared Dec 03, 2007
NEURONAV SYSTEM AND NEURONAV DRIVE
K071697 · GZL
Neurology · 166d
Cleared Sep 16, 2005
NEURODRIVE SYSTEM
K051830 · GZL
Neurology · 72d
Cleared Aug 07, 2002
ALPHA DRIVE SYSTEM
K013396 · HAW
Neurology · 296d
Cleared Jan 24, 2000
NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERY
K993622 · GZL
Neurology · 90d
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