|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
RELIZORB
|
ALCRESTA, INC. |
DEN150001 |
|
11/20/2015 |
NaviCam ProScan
|
Ankon Technologies Co., Ltd |
DEN230027 |
|
12/12/2023 |
NaviCam Capsule Endoscope System with Na
|
AnX Robotica, Inc. |
DEN190037 |
|
05/22/2020 |
APOLLO ESG System, APOLLO ESG SX System,
|
Apollo Endosurgery, Inc. |
DEN210045 |
|
07/12/2022 |
Theranova Dialyzers, Theranova 400 Dialy
|
Baxter Healthcare Corporation |
DEN190042 |
|
08/28/2020 |
CARPEDIEM System
|
Bellco srl (now part of Medtronic, Inc) |
DEN180055 |
|
04/29/2020 |
Innovo
|
Bio-Medical Research Ltd. |
DEN170049 |
|
11/06/2018 |
Embosphere Microspheres
|
Biosphere Medical S.A. |
DEN160040 |
|
06/21/2017 |
Revi System
|
BlueWind Medical Ltd. |
DEN220073 |
|
08/16/2023 |
WallFlex Biliary RX Fully Covered Stent
|
BOSTON SCIENTIFIC |
DEN150040 |
|
06/03/2016 |