|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
Sentosa SQ HIV Genotyping Assay
|
Vela Diagnostics USA Inc |
BR190330 |
|
11/05/2019 |
Sentinel Cerebral Protection System
|
Claret Medical, Inc. |
DEN160043 |
|
06/01/2017 |
Sensor Monitored Alimentary Restriction
|
SCIENTIFIC INTAKE |
DEN150033 |
|
09/26/2016 |
SENSIMED TRIGGERFISH
|
SENSIMED AG |
DEN140017 |
|
03/04/2016 |
SEM Scanner (Model 200)
|
Bruin Biometrics, LLC |
DEN170021 |
|
12/20/2018 |
SEEKER System
|
Baebies, Inc. |
DEN150035 |
|
02/03/2017 |
SeCore CDx HLA Sequencing System
|
One Lambda, Inc. |
BR220737 |
|
11/28/2022 |
ScanNav Anatomy Peripheral Nerve Block
|
Intelligent Ultrasound Limited |
DEN220024 |
|
10/18/2022 |
SafeBreak Vascular
|
Site Saver, Inc. d/b/a Lineus Medical |
DEN190043 |
|
05/27/2021 |
Ruthless Spine RJB
|
Ruthless, LLC dba Ruthless Spine |
DEN230012 |
|
07/14/2023 |