Oventus Manufacturing Pty L T D

FDA Filings

This page includes the latest FDA filings for Oventus Manufacturing 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 Number3015656655
FEI Number3015656655
NameOventus Medical USA, Inc.
Owner & OperatorOventus Manufacturing Pty Ltd
Contact Address1 Swann Road
Indooroopilly AU-QLD Queensland 4068 AU
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address400 Spectrum Center Drive, Ste 1900
Irvine, CA 92618 US
Establishment TypeComplaint File Establishment per 21 CFR 820.198



Registration Number3012539501
FEI Number3012539501
NameOVENTUS MANUFACTURING PTY LTD
Owner & OperatorOventus Manufacturing Pty Ltd
Contact Address1 Swann Road
Indooroopilly AU-QLD Queensland 4068 AU
US Agent
Importing Logistics Registration
ImporterOventus Medical USA Inc
Address600 B Street Ste 300
San Diego, CA 92101 UNITED STATES
Registration Status1
Initial ImporterN
Registration Expiration2020-04-25
Registration Address1 Swann Road
Indooroopilly Queensland, 4068 AU
Establishment TypeManufacture Medical Device



FDA Filings

Device
Company
DeviceDate
OVENTUS MANUFACTURING PTY LTD
O2Vent Optima O2VBM2021-12-10
OVENTUS MANUFACTURING PTY LTD
O2Vent Optima 2020-01-13
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd]
O2Vent Optima2019-09-03
OVENTUS MANUFACTURING PTY LTD
O2Vent Optima2019-09-03
Oventus Manufacturing PTY LTD
O2Vent Optima2019-08-29
OVENTUS MANUFACTURING PTY LTD
O2Vent Mono (OVENT) 2019-06-07
OVENTUS MANUFACTURING PTY LTD
O2Vent W 2019-05-08
OVENTUS MANUFACTURING PTY LTD
O2Vent T 2019-05-08
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd]
Oventus Bite Fork2019-03-26
OVENTUS MANUFACTURING PTY LTD
Oventus Bite Fork2019-03-26
Oventus Manufacturing Pty Ltd
O2Vent W2017-07-11
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd]
O2Vent T2016-10-12
OVENTUS MANUFACTURING PTY LTD
O2Vent T2016-10-12
OVENTUS MANUFACTURING PTY LTD
O2VENT T2016-09-23
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd]
OVENT2016-06-13
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd]
O2Vent MONO2016-06-13
OVENTUS MANUFACTURING PTY LTD
OVENT2016-06-13
OVENTUS MANUFACTURING PTY LTD
O2Vent MONO2016-06-13
OVENTUS MANUFACTURING PTY LTD
OVENT2016-03-17

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