|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
BrachyGel Vaginal Hydrogel Packing Syste
|
BrachyFoam, Inc. d/b/a Advaray |
DEN220052 |
|
08/22/2023 |
AXIOS Stent and Electrocautery-Enhanced
|
Boston Scientific Corporation |
DEN230019 |
|
08/18/2023 |
Revi System
|
BlueWind Medical Ltd. |
DEN220073 |
|
08/16/2023 |
Viz HCM
|
Viz.ai, Inc. |
DEN230003 |
|
08/03/2023 |
Galen ES Cooperative Surgical Assistant
|
Galen Robotics |
DEN220047 |
|
07/19/2023 |
Ruthless Spine RJB
|
Ruthless, LLC dba Ruthless Spine |
DEN230012 |
|
07/14/2023 |
BT-001
|
Better Therapeutics |
DEN220058 |
|
07/07/2023 |
KidneyIntelX.dkd
|
Renalytix AI, Inc. |
DEN200052 |
|
06/29/2023 |
Neoasis
|
Invictus Medical, Inc. |
DEN220048 |
|
06/16/2023 |
Eroxon
|
Futura Medical Developments Limited |
DEN220078 |
|
06/09/2023 |