This page includes the latest FDA filings for Oventus Medical Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
Oventus Medical Usa Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:
| Registration Number | 3015656655 |
| FEI Number | 3015656655 |
| Name | Oventus Medical USA, Inc. |
| Owner & Operator | Oventus Manufacturing Pty Ltd |
| Contact Address | 1 Swann Road Indooroopilly AU-QLD Queensland 4068 AU |
| Registration Status | 1 |
| Initial Importer | N |
| Registration Expiration | 2020-04-25 |
| Registration Address | 400 Spectrum Center Drive, Ste 1900 Irvine, CA 92618 US |
| Establishment Type | Complaint File Establishment per 21 CFR 820.198 |
Device Company | Device | Date |
|---|---|---|
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd] | O2Vent Optima | 2019-09-03 |
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd] | Oventus Bite Fork | 2019-03-26 |
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd] | O2Vent T | 2016-10-12 |
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd] | OVENT | 2016-06-13 |
Oventus Medical USA, Inc. [Oventus Manufacturing Pty Ltd] | O2Vent MONO | 2016-06-13 |