|
Device Name
|
Requester
|
De Novo Number
|
510(k) Number
|
Decision Date
|
VERIFY CRONOS SELF-CONTAINED BIOLOGICAL
|
STERIS Corporation |
DEN110006 |
K102469 |
07/12/2013 |
VERICHIP HEALTH INFORMATION MICROTRANSPO
|
DIGITAL ANGEL CORPORATION |
DEN040007 |
K033440 |
10/12/2004 |
VENTANA anti-MLH-1(M1) Mouse Monoclonal
|
Ventana Medical Systems |
DEN170030 |
|
10/27/2017 |
VasQ
|
Laminate Medical Technologies Ltd. |
DEN220026 |
|
09/26/2023 |
Variola virus Real-Time PCR Assay
|
CENTERS FOR DISEASE CONTROL AND PREVENTI |
DEN160016 |
|
02/06/2017 |
UROSURGE PERCUTANEOUS SANS (STOLLER AFFE
|
UROSURGE, INC. |
DEN000002 |
K992069 |
02/09/2000 |
UROLIFT SYSTEM
|
NEOTRACT, INC. |
DEN130023 |
K130651 |
09/13/2013 |
Ultravision Visual Clearing System
|
Alesi Surgical Ltd. |
DEN150022 |
|
12/20/2016 |
ULTHERA SYSTEM, MODEL 8850-0001
|
ULTHERA, INC. |
DEN080006 |
K072505 |
09/11/2009 |
TrueTear Intranasal Tear Neurostimulator
|
Allergan |
DEN170086 |
|
05/17/2018 |