|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
iotaSOFT Insertion System - Drive Unit,
|
IotaMotion, Inc. |
DEN190055 |
|
10/01/2021 |
Paige Prostate
|
Paige.AI |
DEN200080 |
|
09/21/2021 |
FEops HEARTguide
|
FEops NV |
DEN200030 |
|
09/08/2021 |
Canary Tibial Extension with Canary Heal
|
Canary Medical, Inc. |
DEN200064 |
|
08/27/2021 |
SureTune4 Software
|
Medtronic Neuromodulation |
DEN210003 |
|
08/23/2021 |
ADVIA Centaur Enhanced Liver Fibrosis (E
|
Siemens Healthcare Diagnostics Inc. |
DEN190056 |
|
08/20/2021 |
OsteoProbe
|
Active Life Scientific, Inc. |
DEN210013 |
|
08/19/2021 |
InSpace Subacromial Tissue Spacer System
|
Ortho-Space Ltd. |
DEN200039 |
|
07/12/2021 |
Cognoa ASD Diagnosis Aid
|
Cognoa, Inc. |
DEN200069 |
|
06/02/2021 |
SafeBreak Vascular
|
Site Saver, Inc. d/b/a Lineus Medical |
DEN190043 |
|
05/27/2021 |