|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
TrueGene HIV Genotyping Kit and OpenGene
|
Visible Genetics, Inc. |
|
BK000038 |
06/27/2001 |
Tristel Duo ULT
|
Tristel Solutions Limited |
DEN220041 |
|
06/02/2023 |
TRIAGE B-TYPE NATRIURETIC PEPTIDE (BNP)
|
BIOSITE INCORPORATED |
DEN000010 |
K003475 |
11/20/2000 |
Tornier Pyrocarbon Humeral Head
|
Tornier SAS |
DEN220012 |
|
12/16/2022 |
ToothWave™
|
Home Skinovations Ltd. |
DEN190039 |
|
09/17/2020 |
TINA-QUANT HBA1C GEN. 2 TEST SYSTEM
|
Roche Diagnostics |
DEN130002 |
K121291 |
05/23/2013 |
ThermoNeuroModulation Device, TNM Device
|
Scion NeuroStim, LLC |
DEN170023 |
|
03/26/2018 |
Theranova Dialyzers, Theranova 400 Dialy
|
Baxter Healthcare Corporation |
DEN190042 |
|
08/28/2020 |
The N-SWEAT Patch
|
Candesant Biomedical, Inc. |
DEN210055 |
|
04/07/2023 |
The Cooral System
|
BrainCool AB |
DEN210027 |
|
10/14/2022 |