|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
DuraGraft
|
Marizyme, Inc. |
DEN230002 |
|
10/04/2023 |
Invitae Common Hereditary Cancers Panel
|
Invitae Corporation |
DEN210011 |
|
09/29/2023 |
Procise IFX
|
ProciseDx Inc. |
DEN210056 |
|
09/29/2023 |
Procise ADL
|
ProciseDx Inc. |
DEN220023 |
|
09/29/2023 |
VasQ
|
Laminate Medical Technologies Ltd. |
DEN220026 |
|
09/26/2023 |
Hemanext ONE
|
Hemanext, Inc. |
BR220665 |
|
09/15/2023 |
ensoETM
|
Advanced Cooling Therapy, Inc. d/b/a Att |
DEN230021 |
|
09/13/2023 |
esolution
|
S4 Medical Corp |
DEN230006 |
|
09/06/2023 |
LightStrike+ (MXSUV1-SL and MXSUV1-FT)
|
Xenex Disinfection Services, Inc. |
DEN230007 |
|
09/01/2023 |
BrachyGel Vaginal Hydrogel Packing Syste
|
BrachyFoam, Inc. d/b/a Advaray |
DEN220052 |
|
08/22/2023 |