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Manufacturers
IL
Alpha Omega , Ltd.
Medical Device Manufacturer
·
IL , Nazareth Illit
Alpha Omega , Ltd. - FDA 510(k) Cleared Devices
4 submissions
·
4 cleared
·
Since 2000
4
Total
4
Cleared
0
Denied
FDA 510(k) Regulatory Record - Alpha Omega , Ltd.
Neurology
✕
4
devices
1-4 of 4
Filters
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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4
Neurology
4