Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in United StatesLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Johnson & Johnson. FDA records under 4 spellings of its name, each linked to the record. See the Johnson & Johnson group view.
As of Nov 15, 2026, FDA's public records list Auris Health with 8 device recalls and 7 510(k) clearances. The most recent is a 510(k) clearance dated Jul 25, 2026: MONARCH™ Platform (MON-000008).
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Jul 25, 2026 | MONARCH™ Platform (MON-000008)K260382 · EOQ | 510(k) clearances |
| Jan 21, 2026 | MONARCH Platform, Bronchoscopy, Catalog Numbers: MON-000005-01 , MON-000005-01R , MON-000006 , MON-000006-RFB, MON-000008 with softwareClass II · Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient- | Device recalls |
| Oct 18, 2025 | MONARCH Bronchoscope. Model Number: MBR-000211-BClass II · Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscope | Device recalls |
| Jan 23, 2025 | MONARCH™ Platform (MON-000008)K243219 · EOQ | 510(k) clearances |
| Nov 28, 2023 | Monarch BronchoscopeK231473 · QNW | 510(k) clearances |
| Apr 29, 2022 | Monarch Platform, UrologyK213334 · FGB | 510(k) clearances |
| Jul 9, 2021 | Monarch PlatformK211493 · EOQ | 510(k) clearances |
| Mar 11, 2021 | Monarch BronchoscopeK203614 · QNW | 510(k) clearances |
| Apr 15, 2020 | Monarch PlatformK193534 · EOQ | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
