|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
EchoTip Insight Portosystemic Pressure G
|
Cook Ireland Ltd. |
DEN180062 |
|
11/20/2019 |
Sentosa SQ HIV Genotyping Assay
|
Vela Diagnostics USA Inc |
BR190330 |
|
11/05/2019 |
OraQuick Ebola Rapid Antigen Test
|
OraSure Technologies, Inc. |
DEN190025 |
|
10/10/2019 |
IB-Stim
|
Innovative Health Solutions (IHS), Inc. |
DEN180057 |
|
06/07/2019 |
Synovasure Alpha Defensin Lateral Flow T
|
CD Diagnostics Inc. |
DEN180032 |
|
05/23/2019 |
ZIKV Detect 2.0 IgM Capture ELISA
|
InBios International, Inc. |
DEN180069 |
|
05/23/2019 |
Nerivio Migra
|
Theranica Bioelectronics ltd |
DEN180059 |
|
05/20/2019 |
Comaneci, Comaneci Petit, Comaneci 17
|
Rapid-Medical Ltd. |
DEN170064 |
|
04/24/2019 |
PREVENA 125 and PREVENA PLUS 125 Therapy
|
KCI USA, Inc. |
DEN180013 |
|
04/19/2019 |
Monarch eTNS System
|
NeuroSigma, Inc |
DEN180041 |
|
04/19/2019 |