FDA.reportPublic FDA data

ALPHA OMEGA CO. USA INC.

Matched from indexed company URL: ALPHA OMEGA LTD.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
10666953003172841ALPHA OMEGA CO. USA INC.1Y2026-01-013160 Campus Drive Suite 200 Norcross GA US 30071
96151263001610756ALPHA OMEGA ENGINEERING LTD.1N2026-01-01Hamerkava St. 6 Tsiporit Industrial Zone Nof HaGalil Northern IL 1789062

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
187701463989167K993622NEUROTREK PHYSIOLOGICAL NAVIGATION SYSTEM FOR NEUROSURGERYGZL2000-01-24
187701633867854K250601Neuro Omega System; NeuroSmart SystemGZL2025-03-30
187701693650685K220553Neuro Omega System, NeuroSmart SystemGZL2022-09-16
187701901056850K191739Sterile LeadConfirmGZL2020-01-02
187701102127241K172042NeuroNav System, NeuroSmart SystemGZL2018-02-27
187701571962477K171581Neuro Omega SystemGZL2017-12-22
187702001763556K123796NEURO OMEGA SYSTEMGZL2013-04-05
187701816509038K120098STERILE DISPOSABLES FOR MERGZL2012-06-12
187701908449307K071697NEURONAV SYSTEM AND NEURONAV DRIVEGZL2007-12-03
187701280639590K052527NEUROPROBESGZL2006-04-12
187701397904987K051830NEURODRIVE SYSTEMGZL2005-09-16
187701778631265
187701838146291

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GZL112025-03-30

PMN#

GUDID#

Ruler

ALPHA OMEGA ENGINEERING CO. LTD.

2024-01-08

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