# Auris Health, Inc (manufacturer, Santa Clara, CA): 3 new FDA device listings, incl. integrated operating table-electromechanical surgical system

**Score:** 85/100

| Field | Value |
|---|---|
| Establishment | Auris Health, Inc |
| Owner / operator | Auris Health, Inc. |
| Role | Manufacturer |
| Establishment types | Manufacture Medical Device; Develop Specifications But Do Not Manufacture At This Facility |
| Location | Santa Clara, CA, US |
| New listings | 3 |
| Devices | Integrated Operating Table-Electromechanical Surgical System; System, X-Ray, Tomography, Computed; Bronchoscope (Flexible Or Rigid) |
| Product codes | SIR, JAK, EOQ |
| Device classes | Class II |
| Medical specialties | General, Plastic Surgery, Radiology, Ear, Nose, Throat |
| Brand names | OTTAVA™ Robotic Surgical System; Monarch Platform |
| First new listing | 2026-08-10 |
| Latest new listing | 2026-08-27 |
| FDA registration number | 3017425975 |
| Registration expires | 2026-12-31 |

## Why this score
- Brings its own devices to market: buys manufacturing, sterilization and QMS help.
- Class II or III devices: QMS and regulatory demands.
- Several new listings at once.
- U.S. establishment.

Source: openFDA device registration and listing endpoint (U.S. Food and Drug Administration) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRL/rl.cfm). Last refreshed: 2026-10-28T20:51:27.468Z.
From the openFDA device registration and listing data, refreshed weekly. A listing shows a device an establishment says it makes or handles for the U.S. market; it is not FDA clearance or approval. Contact persons and street addresses are not stored. Verify in the FDA Establishment Registration and Device Listing database.