|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
APTIMA TRICHOMONAS VAGINALIS ASSAY
|
GEN-PROBE INCORPORATED |
DEN110012 |
K102911 |
04/19/2011 |
APTUS STEERABLE ENDOGUIDE WITH OBTURATOR
|
APTUS ENDOSYSTEMS, INC. |
DEN100026 |
K102333 |
11/21/2011 |
AQUABEAM System
|
PROCEPT BioRobotics Corporation |
DEN170024 |
|
12/21/2017 |
ARK Voriconazole II Assay Test System
|
ARK DIAGNOSTICS, INC |
DEN160033 |
|
05/05/2017 |
AXIOS STENT AND DELIVERY SYSTEM
|
XLUMENA, INC |
DEN130007 |
K123250 |
12/18/2013 |
AXIOS Stent and Electrocautery-Enhanced
|
Boston Scientific Corporation |
DEN230019 |
|
08/18/2023 |
B.R.A.H.M.S PCT sensitive KRYPTOR
|
B.R.A.H.M.S GMBH |
DEN150009 |
|
02/20/2016 |
B·R·A·H·M·S sFlt-1/ PlGF KRYPTOR Test Sy
|
BRAHMS GmbH, Part of Thermo Fisher Scien |
DEN220027 |
|
05/18/2023 |
Banyan BTI
|
Banyan Biomarkers, Inc. |
DEN170045 |
|
02/14/2018 |
BD MAX Vaginal Panel, BD MAX Instrument
|
GENEOHM SCIENCES CANADA , INC (BD DIAGNO |
DEN160001 |
|
10/28/2016 |