|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
NON-VARIOLA ORTHOPOXVIRUS REAL-TIME PCR
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN070001 |
|
09/21/2018 |
Variola virus Real-Time PCR Assay
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN160016 |
|
02/06/2017 |
COGNIVUE
|
CEREBRAL ASSESSMENT SYSTEMS, INC |
DEN130033 |
|
06/05/2015 |
Cereve Sleep System
|
CEREVE, INC. |
DEN140032 |
|
05/13/2016 |
Sentinel Cerebral Protection System
|
Claret Medical, Inc. |
DEN160043 |
|
06/01/2017 |
APAS Compact with Urine Analysis Module
|
CLEVER CULTURE SYSTEMS AG |
DEN150059 |
|
10/06/2016 |
Cognoa ASD Diagnosis Aid
|
Cognoa, Inc. |
DEN200069 |
|
06/02/2021 |
Modified Trevo ProVue Retriever, Trevo X
|
CONCENTRIC MEDICAL, INC. |
DEN150049 |
|
09/02/2016 |
Gili Pro BioSensor (also known as “Gili
|
ContinUse Biometrics Ltd. |
DEN200038 |
|
04/01/2021 |
Retrograde Intubation Set
|
Cook Incorporated |
DEN170055 |
|
12/12/2018 |