|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Revi System
|
BlueWind Medical Ltd. |
DEN220073 |
|
08/16/2023 |
Osteoboost Belt
|
Bone Health Technologies, Inc |
DEN230015 |
|
01/12/2024 |
CERAMENT G
|
BoneSupport AB |
DEN210044 |
|
05/17/2022 |
Bose Hearing Aid
|
Bose Corporation |
DEN180026 |
|
10/05/2018 |
WallFlex Biliary RX Fully Covered Stent
|
BOSTON SCIENTIFIC |
DEN150040 |
|
06/03/2016 |
AXIOS Stent and Electrocautery-Enhanced
|
Boston Scientific Corporation |
DEN230019 |
|
08/18/2023 |
BrachyGel Vaginal Hydrogel Packing Syste
|
BrachyFoam, Inc. d/b/a Advaray |
DEN220052 |
|
08/22/2023 |
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test Sy
|
BRAHMS GmbH, Part of Thermo Fisher Scien |
DEN220027 |
|
05/18/2023 |
BrainTemp Neonate System (BTNeo System)
|
Brain Temp Inc. |
DEN200042 |
|
03/29/2022 |
The Cooral System
|
BrainCool AB |
DEN210027 |
|
10/14/2022 |