Ellex Iscience Inc

FDA Filings

This page includes the latest FDA filings for Ellex Iscience Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Registration(s)

• Registration Number: 3005641545
• FEI Number: 3005641545
• Name: ELLEX ISCIENCE INC.
• Owner & Operator: ELLEX MEDICAL PTY. LTD.
• Contact Address: 3-4 Second Avenue --; Mawson Lakes AU-SA South Australia 5095 AU
• Registration Status: 1
• Initial Importer: N
• Registration Expiration: 2020-04-25
• Registration Address: 41316 Christy St ; Fremont, CA 94538 US
• Establishment Type: Manufacture Medical Device

FDA Filings

Device Company	Device	Date
PMN K041108 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack	2017-12-04
PMN K041108 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Ophthalmic Microcannula	2017-12-04
PMN K080067 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack Canaloplasty Microcatheter Kit	2014-01-08
PMN K080067 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack 250A	2014-01-08
PMN K080067 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Canaloplasty Microcatheter	2014-01-08
PMN K080067 | HMX ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack Canaloplasty Microcatheter Kit	2014-01-08
PMN K080067 | HMX ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iTrack 250A	2014-01-08
PMN K080067 | HMX ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Canaloplasty Microcatheter	2014-01-08
PMN K062259 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	iLumin	2014-01-05
PMN K062259 | MPA ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Ellex iScience iLumin Fiberoptic illuminator	2014-01-05
PMN K050716 | MRH ELLEX ISCIENCE INC. [ELLEX MEDICAL PTY. LTD.]	Opthalmic Viscoinjector	2014-01-05