This page includes the latest FDA filings for Irras Usa Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.
| Registration Number | 3013508628 | 
| FEI Number | 3013508628 | 
| Name | IRRAS USA, Inc | 
| Owner & Operator | IRRAS USA | 
| Contact Address | 11975 El Camino Real, Suite 304 San Diego CA 92130 US | 
| Official Correspondent | 
 | 
| Registration Status | 1 | 
| Initial Importer | N | 
| Registration Expiration | 2020-04-25 | 
| Registration Address | 11975 El Camino Real, Suite 304 San Diego, CA 92130 US | 
| Establishment Type | Manufacture Medical Device | 
| Device Company | Device | Date | 
|---|---|---|
| Irras USA, Inc. | IRRAflow Cranial Access Bolt | 2025-08-01 | 
| Irras USA, Inc. | IRRAflow Catheter 2.0+ | 2025-05-15 | 
| Irras USA, Inc. | IRRAflow Laser Leveler Package ICLS 010 | 2024-06-18 | 
| IRRAS USA, Inc [IRRAS USA] | HICP200 Patient/Monitor Interconnect Cable | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | HUMMINGBIRD SUBDURAL H900DS (DRAINAGE AND ICP), HUMMINGBIRD SUBDURAL- H800S (ICP ONLY) | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | SYNERGY | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | MPS OXIPORT AND MPS OXIPORT PLUS | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | MPS (OR MPS-T) | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | ACT III VENTRICULAR CATHETER | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | ACT 11 MP VENTRICULAR CATHETER | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | ACT II ICP MONITORING SYSTEM AND VENTRICULAR CATHETER | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | ACTI-ICP MONITORING SYSTEM | 2019-05-28 | 
| IRRAS USA, Inc [IRRAS USA] | IRRAflow CNS System | 2018-08-02 | 
| IRRAS USA, Inc [IRRAS USA] | IRRAflow CNS System | 2018-08-02 |