|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
PROLONG
|
ERGON MEDICAL LTD. |
DEN130047 |
|
03/20/2015 |
Pill Sense System
|
EnteraSense Ltd. |
DEN220065 |
|
02/24/2023 |
Mucosal Integrity Conductivity (MI) Test
|
Diversatek Healthcare Inc. |
DEN180067 |
|
12/23/2019 |
ProdiGI
|
Covidien LLC |
DEN220006 |
|
06/13/2022 |
GI Genius
|
Cosmo Artificial Intelligence - AI, LTD |
DEN200055 |
|
04/09/2021 |
EchoTip Insight Portosystemic Pressure G
|
Cook Ireland Ltd. |
DEN180062 |
|
11/20/2019 |
SEM Scanner (Model 200)
|
Bruin Biometrics, LLC |
DEN170021 |
|
12/20/2018 |
AXIOS Stent and Electrocautery-Enhanced
|
Boston Scientific Corporation |
DEN230019 |
|
08/18/2023 |
WallFlex Biliary RX Fully Covered Stent
|
BOSTON SCIENTIFIC |
DEN150040 |
|
06/03/2016 |
Revi System
|
BlueWind Medical Ltd. |
DEN220073 |
|
08/16/2023 |