|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Parallel
|
Mahana Therapeutics, Inc. |
DEN200029 |
|
11/25/2020 |
BEAR (Bridge-Enhanced ACL Repair) Implan
|
Miach Orthopaedics, Inc. |
DEN200035 |
|
12/16/2020 |
Helix Laboratory Platform
|
Helix OpCo, LLC |
DEN190035 |
|
12/23/2020 |
EndoRotor Device
|
Interscope, Inc |
DEN200016 |
|
12/23/2020 |
eXciteOSA with remote and eXciteOSA with
|
Signifier Medical Technologies |
DEN200018 |
|
02/05/2021 |
Lumenis Stellar M22
|
Lumenis Ltd. |
DEN200028 |
|
02/23/2021 |
Hominis Surgical System
|
Memic Innovative Surgery Ltd. |
DEN190022 |
|
02/26/2021 |
Q-Collar
|
Q30 Sports Science, LLC |
DEN200017 |
|
02/26/2021 |
Analytic for Hemodynamic Instability (AH
|
Fifth Eye Inc. |
DEN200022 |
|
03/01/2021 |
ClearUP Sinus Relief
|
Tivic Health Systems Inc. |
DEN200006 |
|
03/05/2021 |