Alpha Omega Engineering L T D

FDA Filings

This page includes the latest FDA filings for Alpha Omega Engineering L T D. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)
Registration Number9615126
FEI Number3001610756
NameReem Younis
Owner & OperatorALPHA OMEGA ENGINEERING LTD.
Contact AddressHamerkava St. 6 Tsiporit Industrial Zone
Nof HaGalil IL-Z Ha Zafon 1789062 IL
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address5755 North Point Pkwy, Suite 229
Alpharetta, GA 30022 US
Establishment TypeManufacture Medical Device



Registration Number1066695
FEI Number3003172841
NameALPHA OMEGA CO. USA INC.
Owner & OperatorALPHA OMEGA ENGINEERING LTD.
Contact AddressHamerkava St. 6 Tsiporit Industrial Zone
Nof HaGalil IL-Z Ha Zafon 1789062 IL
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address5755 North Point Pkwy Suite 229
ALPHARETTA, GA 30022 US



FDA Filings

Device
Company
DeviceDate
Alpha Omega Engineering Ltd.
Neuro Omega System, NeuroSmart System2022-09-16
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Sterile LeadConfirm M Cable2020-01-06
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Sterile LeadConfirm M Adaptor2020-01-06
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Sterile LeadConfirm B Cable2020-01-06
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Sterile LeadConfirm A Cable2020-01-06
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Sterile LeadConfirm A Adaptor2020-01-06
Alpha Omega Engineering Ltd.
Sterile LeadConfirm2020-01-02
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroSmart2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroSmart MER Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroNav2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroNav MER Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroNav Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroFortis NeuroSmart Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroFortis Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega MER Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Autoclavable Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Autoclavable Drive2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroFortis Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega MER Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Autoclavable Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Autoclavable Drive2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroFortis Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega MER Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Autoclavable Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Autoclavable Drive2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroFortis Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega MER Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Autoclavable Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Autoclavable Drive2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroFortis Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega MER Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega Autoclavable Drive Headstage2018-03-13
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Autoclavable Drive2018-03-13
Alpha Omega Engineering Ltd.
NeuroNav System, NeuroSmart System2018-02-27
Alpha Omega Engineering Ltd,
Neuro Omega System2017-12-22
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2013-05-23
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2013-05-23
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2013-05-23
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Neuro Omega2013-05-23
ALPHA OMEGA ENGINEERING LTD.
NEURO OMEGA SYSTEM2013-04-05
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Sterile NeuroProbe2013-03-07
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Sterile Electrode Cable2013-03-07
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Sterile Cannula2013-03-07
ALPHA OMEGA ENGINEERING, LTD.
STERILE DISPOSABLES FOR MER2012-06-12
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Cannula2011-11-15
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
MicroGuide2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroNav2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroProbe2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Starfix frame Mechanical Set Kit2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NexFrame Mechanical Set Kit2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
NeuroDrive2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Libenger ZD frame Mechanical Set Kit2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Libenger RM frame Mechanical Set Kit2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
Leksell Non-XY frame Mechanical Set Kit2008-03-19
Reem Younis [ALPHA OMEGA ENGINEERING LTD.]
CRW Non-XY frame Mechanical Set Kit2008-03-19
ALPHA OMEGA ENGINEERING, LTD.
NEUROPROBES2006-04-12

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