|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
allay Nerve Cap
|
Tulavi Therapeutics |
DEN230061 |
|
07/16/2024 |
ALLOMAP MOLECULAR EXPRESSION TESTING
|
XDX |
DEN080007 |
K073482 |
08/26/2008 |
AMIGO REMOTE CATHETER SYSTEM
|
CATHETER ROBOTICS INC |
DEN140009 |
|
12/18/2014 |
Amplichek II, Negative and Amplichek II,
|
Bio-Rad Laboratories |
DEN150058 |
|
03/28/2016 |
AMPLICHIP CYP450 TEST, MODEL 04381866190
|
ROCHE MOLECULAR SYSTEMS, INC. |
DEN040011 |
K042259 |
12/23/2004 |
AmplideX Fragile X Dx & Carrier Screen K
|
Asuragen, Inc. |
DEN190023 |
|
02/21/2020 |
Analytic for Hemodynamic Instability (AH
|
Fifth Eye Inc. |
DEN200022 |
|
03/01/2021 |
APAS Compact with Urine Analysis Module
|
CLEVER CULTURE SYSTEMS AG |
DEN150059 |
|
10/06/2016 |
APOLLO ESG System, APOLLO ESG SX System,
|
Apollo Endosurgery, Inc. |
DEN210045 |
|
07/12/2022 |
Aptima Mycoplasma genitalium Assay
|
Hologic, Inc. |
DEN180047 |
|
01/23/2019 |