FDA.reportPublic FDA data

Auris Health, Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30174259753014447948Auris Health, Inc1N2026-01-015490 Great America Pkwy Santa Clara CA US 95054

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
3002261087565559K260382MONARCH™ Platform (MON-000008)EOQ2026-07-25
3002261836754522K243219MONARCH™ Platform (MON-000008)EOQ2025-01-23
3002261434563665K231473Monarch BronchoscopeQNW2023-11-28
3002261722187029K213334Monarch Platform, UrologyFGB2022-04-29
3002261053666072K211493Monarch PlatformEOQ2021-07-09
3002261924559901K203614Monarch BronchoscopeQNW2021-03-11
3002261017810595K193534Monarch PlatformEOQ2020-04-15
3002261263618012K173760Monarch Endoscopy Platform (Monarch Platform)EOQ2018-03-22
3002261844679569DEN250068OTTAVA™ Robotic Surgical SystemSIR2026-07-21
3002261223725904
3002261793892324
3002261932989262

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
EOQ52026-07-25
QNW22023-11-28
SIR12026-07-21
FGB12022-04-29