|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
XPERT EV, MODEL GXEV-100N-10; GENEXPERT
|
CEPHEID |
DEN070004 |
K061062 |
03/16/2007 |
X100 with Full Field Bone Marrow Aspirat
|
Scopio Labs Ltd. |
DEN230034 |
|
03/22/2024 |
WOUNDCHEK Bacterial Status
|
Alere Scarborough, Inc. |
DEN180014 |
|
12/02/2019 |
WIDEXLINK IN CLEAR SERIES HEARING AIDS
|
OFFICE RESEARCH IN CLINICAL AMPLIFICTION |
DEN100025 |
K101699 |
03/31/2011 |
WEST NILE VIRUS IGM CAPTURE ELISA
|
PANBIO LIMITED |
DEN030004 |
K031703 |
07/08/2003 |
WallFlex Biliary RX Fully Covered Stent
|
BOSTON SCIENTIFIC |
DEN150040 |
|
06/03/2016 |
WALLAC NEONATAL BIOTINIDASE TEST KIT, MO
|
WALLAC, INC. |
DEN990008 |
K992284 |
02/15/2000 |
VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN
|
ABBOTT MOLECULAR, INC. |
DEN130010 |
K123951 |
07/29/2013 |
VYSIS AUTOVYSION SYSTEM
|
VYSIS |
DEN040010 |
K041875 |
12/13/2004 |
vPatch
|
Virility Medical |
DEN210012 |
|
11/23/2021 |