|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
ClearMate
|
Thornhill Research, Inc. |
DEN170044 |
|
03/14/2019 |
ClearUP Sinus Relief
|
Tivic Health Systems Inc. |
DEN200006 |
|
03/05/2021 |
cNEP Airway
|
Sommetrics |
DEN140024 |
|
12/23/2015 |
cobas EBV, cobas EBV/BKV Control Kit, co
|
Roche Molecular Systems, Inc. |
DEN200015 |
|
07/30/2020 |
cobas vivoDx MRSA
|
Roche Molecular Systems, Inc. |
DEN190016 |
|
12/05/2019 |
COGNIVUE
|
CEREBRAL ASSESSMENT SYSTEMS, INC |
DEN130033 |
|
06/05/2015 |
Cognoa ASD Diagnosis Aid
|
Cognoa, Inc. |
DEN200069 |
|
06/02/2021 |
Comaneci, Comaneci Petit, Comaneci 17
|
Rapid-Medical Ltd. |
DEN170064 |
|
04/24/2019 |
Comfort Marker 2.0.
|
Medical Precision B.V. |
DEN200041 |
|
12/10/2021 |
Companion
|
LGCH, INC |
DEN140033 |
|
02/16/2017 |
|