|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
APOLLO ESG System, APOLLO ESG SX System,
|
Apollo Endosurgery, Inc. |
DEN210045 |
|
07/12/2022 |
Irregular Rhythm Notification Feature
|
Apple Inc |
DEN180042 |
|
09/11/2018 |
ECG App
|
Apple Inc |
DEN180044 |
|
09/11/2018 |
EaseVRx
|
AppliedVR, Inc. |
DEN210014 |
|
11/16/2021 |
ARK Voriconazole II Assay Test System
|
ARK DIAGNOSTICS, INC |
DEN160033 |
|
05/05/2017 |
NEPHROCHECK TEST SYSTEM
|
ASTUTE MEDICAL, INC |
DEN130031 |
|
09/05/2014 |
Quantidex qPCR BCR-ABL IS Kit
|
ASURAGEN, INC. |
DEN160003 |
|
07/22/2016 |
AmplideX Fragile X Dx & Carrier Screen K
|
Asuragen, Inc. |
DEN190023 |
|
02/21/2020 |
SpaceOAR System
|
AUGMENIX , INC. |
DEN140030 |
|
04/01/2015 |
Ellipsys Vascular Access System
|
Avenu Medical, Inc |
DEN170004 |
|
06/22/2018 |
|