|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Sonu
|
Sound Health Systems, Inc. |
DEN230045 |
|
12/04/2023 |
Sonablate 450
|
SonaCare Medical, LLC. |
DEN150011 |
|
10/09/2015 |
REZA BAND(TM) UPPER ESOPHAGEAL (UES) SPH
|
SOMNA THERAPEUTICS, LLC |
DEN130046 |
|
03/06/2015 |
cNEP Airway
|
Sommetrics |
DEN140024 |
|
12/23/2015 |
SafeBreak Vascular
|
Site Saver, Inc. d/b/a Lineus Medical |
DEN190043 |
|
05/27/2021 |
DECAPINOL ORAL RINSE
|
SINCLAIR PHARMACEUTICALS LIMITED |
DEN050001 |
K041482 |
04/18/2005 |
eXciteOSA with remote and eXciteOSA with
|
Signifier Medical Technologies |
DEN200018 |
|
02/05/2021 |
INNOVANCE VWF Ac
|
Siemens Healthcare Diagnostics Products |
DEN200067 |
|
09/29/2022 |
ADVIA Centaur Enhanced Liver Fibrosis (E
|
Siemens Healthcare Diagnostics Inc. |
DEN190056 |
|
08/20/2021 |
SYMPHONY DEVICE
|
SENSORY MEDICAL, INC |
DEN110011 |
K102873 |
12/18/2013 |