|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Tangible Boost
|
Tangible Science, Inc. |
DEN200002 |
|
09/24/2020 |
Spineology Interbody Fusion System
|
Spineology, Inc. |
DEN200010 |
|
09/18/2020 |
ToothWave™
|
Home Skinovations Ltd. |
DEN190039 |
|
09/17/2020 |
HemosIL Liquid Anti-Xa
|
Instrumentation Laboratory Co. |
DEN190032 |
|
09/17/2020 |
Theranova Dialyzers, Theranova 400 Dialy
|
Baxter Healthcare Corporation |
DEN190042 |
|
08/28/2020 |
Cell-Free DNA BCT
|
Streck, Inc. |
DEN200001 |
|
08/07/2020 |
cobas EBV, cobas EBV/BKV Control Kit, co
|
Roche Molecular Systems, Inc. |
DEN200015 |
|
07/30/2020 |
EndeavorRx
|
Akili Interactive Labs Inc. |
DEN200026 |
|
06/15/2020 |
NaviCam Capsule Endoscope System with Na
|
AnX Robotica, Inc. |
DEN190037 |
|
05/22/2020 |
NP Screen
|
Advance Sentry Corporation |
DEN190031 |
|
05/11/2020 |