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Auris Health, Inc.

FDA 510(k) & PMA Approved Devices — 5 products

Total Devices5
Categories2
Latest FDA decision2026-07-25
TypeNumberDevice NameCodeDateActions
510(k) K260382 MONARCH™ Platform (MON-000008)EOQ2026-07-25 View
510(k) K243219 MONARCH™ Platform (MON-000008)EOQ2025-01-23 View
510(k) K213334 Monarch Platform, UrologyFGB2022-04-29 View
510(k) K211493 Monarch PlatformEOQ2021-07-09 View
510(k) K193534 Monarch PlatformEOQ2020-04-15 View

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