Ortho Device, ADAPTIX 3D Orthopedic Imaging System
Pausch Medical GmbH
PAUSCH Medical GmbH
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 9610903 | 3002807145 | PAUSCH Medical GmbH | 1 | N | 2026-01-01 | GRAF-ZEPPELIN-STRASSE 1 ERLANGEN Bavaria DE 91056 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 164684 | 1452775295 | K180651 | Uroview FD II | JAA | 2018-04-12 |
| 164684 | 1523862221 | K161019 | Uroview FD | JAA | 2016-08-17 |
| 164684 | 1400352105 | ||||
| 164684 | 1677190933 | ||||
| 164684 | 1788997417 | ||||
| 164684 | 1893126136 |
Product Codes Associated With Registrations#
| Product code | Registration listing records | Latest decision |
|---|---|---|
| JAA | 2 | 2018-04-12 |
PMN#
Uroview FD II
Pausch Medical GmbH
Uroview FD
PAUSCH MEDICAL GMBH
GUDID#
N/A - Cosmos 2, DEL - Bucky left
2017-06-08
N/A - Uroview FD II Right Configuration. Part of 01169043-S.
2019-05-13
N/A - Complete System Uroview FD II Right Configuration
2019-05-13
N/A - Uroview FD II Left Configuration. Part of 01169044-S.
2019-05-13
N/A - Complete System Uroview FD II Left Configuration
2019-05-13
N/A - Complete System Uroview FD Left Configuration
2017-06-08
N/A - Uroview FD Right Configuration.Part of 01169033-S
2017-06-08
N/A - Complete System Uroview FD Right Configuration
2017-06-08
N/A - Uroview FD Left Configuration.Part of 01169034-S
2017-06-08
N/A - Complete System Uroview FD Left Configuration
2017-06-08
N/A - Cosmos 2, DEL - Bucky left
2017-06-08