Ellex Medical Pty L T D

FDA Filings

This page includes the latest FDA filings for Ellex Medical Pty 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 Number3005641545
FEI Number3005641545
NameELLEX ISCIENCE INC.
Owner & OperatorELLEX MEDICAL PTY. LTD.
Contact Address3-4 Second Avenue --
Mawson Lakes AU-SA South Australia 5095 AU
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address41316 Christy St
Fremont, CA 94538 US
Establishment TypeManufacture Medical Device



Registration Number3013515803
FEI Number3002806902
NameEllex Medical Pty Ltd
Owner & OperatorELLEX MEDICAL PTY. LTD.
Contact Address3-4 Second Avenue --
Mawson Lakes AU-SA South Australia 5095 AU
US Agent
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address3-4 Second Avenue
Mawson Lakes South Australia, 5095 AU
Establishment Type
  • Export Device to the United States But Perform No Other Operation on Device
  • Manufacture Medical Device
  • Develop Specifications But Do Not Manufacture At This Facility



FDA Filings

Device
Company
DeviceDate
Ellex Medical Pty Ltd
Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo2021-12-16
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex INTEGRESCAN-RG2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-04-21
ELLEX MEDICAL PTY LTD
Ellex 2021-02-19
ELLEX MEDICAL PTY LTD
Ellex 2021-02-19
ELLEX MEDICAL PTY LTD
Ellex 2021-02-19
ELLEX MEDICAL PTY LTD
Ellex 2021-02-19
ELLEX MEDICAL PTY LTD
Ellex 2019-11-18
ELLEX MEDICAL PTY LTD
Ellex 2019-11-18
Ellex Medical Pty Ltd.
Eye Prime2019-04-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Prime2019-04-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Prime Diagnostic ophthalmic ultrasound system2019-04-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Prime2019-04-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Prime Diagnostic ophthalmic ultrasound system2019-04-11
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
iTrack2017-12-04
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
Ophthalmic Microcannula2017-12-04
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Laser/Illumination Probe2017-06-20
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Laser/Aspiration probe2017-06-20
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Laser Probe2017-06-20
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
I3 System2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye One Diagnostic Ultrasound System2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Cubed-ABDU Diagnostic Ultrasound2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Cubed V42016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Cubed New Generation2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
EYE CUBED System -ABD Diagnostic Ultrasound2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
I3 System2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye One Diagnostic Ultrasound System2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Cubed-ABDU Diagnostic Ultrasound2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Cubed V42016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Eye Cubed New Generation2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
EYE CUBED System -ABD Diagnostic Ultrasound2016-04-18
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre Pro Scan2015-07-30
Ellex Medical Pty. Ltd.
Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow2015-07-14
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
iTrack Canaloplasty Microcatheter Kit2014-01-08
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
iTrack 250A2014-01-08
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
Canaloplasty Microcatheter2014-01-08
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
iTrack Canaloplasty Microcatheter Kit2014-01-08
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
iTrack 250A2014-01-08
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
Canaloplasty Microcatheter2014-01-08
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
iLumin2014-01-05
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
Ellex iScience iLumin Fiberoptic illuminator2014-01-05
ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]
Opthalmic Viscoinjector2014-01-05
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
LR15322013-09-09
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
2RT2013-09-09
Ellex Medical Pty. Ltd.
ELLEX 2RT2013-07-01
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre Yellow Pro LP5612008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre Red/Yellow Pro L2RY2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre Pro family2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre Pro LP55322008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre Pro LP1RG2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre Pro LP1RG2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre LP55322008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre Pro LP1RG2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre LP55322008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Solitaire LP45322008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Integre family2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Ultra Q Reflex LQP3106-U2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Ultra Q LQP3106-U2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Tango Reflex LT5106-T2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Tango LT5106-T2008-11-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Solo LT5106-S2008-11-11
Ellex Medical Pty. Ltd.
INTEGRE PRO, MODEL L2RY2008-07-02
Ellex Medical Pty. Ltd.
INTEGRE, MODEL LP5812008-03-11
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Ophthalmic Slit Lamp2007-10-25
Ellex Medical Pty. Ltd.
LASEREX DUO FAMILY OF DUAL WAVELENGTH OPHTHALMIC LASERS INCLUDING MODELS INTEGRE DUO LP1RG-S, LP1RG-D2006-03-16
Ellex Medical Pty. Ltd.
LASEREX, MODEL LP45322004-10-06
Ellex Medical Pty. Ltd.
LUMENIS SELECTA DUET2002-08-09
Ellex Medical Pty Ltd [ELLEX MEDICAL PTY. LTD.]
Ellex Total Solution Tables2000-05-16
Ellex Medical Pty. Ltd.
LASEREX ND:YAG OPHTHALMIC LASER (LQ2106), ALCON ND:YAG OPHTHALMIC LASER (3000LE), LASEREX ND:YAG OPHTHALMIC LASER, MODEL1999-11-17
Ellex Medical Pty. Ltd.
LASEREX LP1532 PHOTOCOAGULATOR1997-10-03

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