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Auris Health, Inc

Last updated September 17, 2026

Information

Country: US
Address: 5490 Great America Pkwy, Santa Clara, CA, 95054
Website: —
LinkedIn: —
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Email: —
Phone: —
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: 3014447948
DUNS Number: —

Catalogue (44)

Device	Model / Reference	Registries	Class	Status
Monarch Software Tower v2.1.6	Version 2.1.6	FDA UDI	Class II	Active
Monarch Bronchoscope	MBR-000211-B	FDA UDI	Class II	Active
Monarch Platform, Bronchoscopy 4.1, Refurbished	MON-000008-RFB	FDA UDI	Class II	Active
Monarch™ Software Cart v2.1.5	Version 2.1.5	FDA UDI	Class II	Active
Monarch™ Software Laptop v2.1.4	Version 2.1.4	FDA UDI	Class II	Active
Monarch™ Software Laptop v2.1.5	Version 2.1.5	FDA UDI	Class II	Active
Monarch™ Laptop P17/P73 Linux USB Image v2.2.4	Version 2.2.4	FDA UDI	Class II	Active
Biopsy Forceps - Smooth Cup	MBR-000014	FDA UDI	Class II	Active
Monarch™ Software Cart v2.2.5	Version 2.2.5	FDA UDI	Class II	Active
Monarch™ Tower Software v4.1.0	Version 4.1.0	FDA UDI	Class II	Active
Cytology Brush	MBR-000015	FDA UDI	Class II	Active
Monarch™ Cart Software v4.1.1	Version 4.1.1	FDA UDI	Class II	Active
Bronchoscope Patient Introducer Kit	MBR-000017	FDA UDI	Class II	Active
Monarch™ Software Tower v2.1.4	Version 2.1.4	FDA UDI	Class II	Active
Bronchoscope Sheath Valve	MBR-000020	FDA UDI	Class II	Active
Monarch Software Laptop v2.2.1	Version 2.2.1	FDA UDI	Class II	Active
Monarch™ Laptop P70 Linux USB Image v2.2.4	Version 2.2.4	FDA UDI	Class II	Active
Monarch Software Laptop v2.1.6	Version 2.1.6	FDA UDI	Class II	Active
Monarch™ Platform (Refurbished)	MON000005R	FDA UDI	Class II	Active
Monarch™ Software Cart v2.1.4	Version 2.1.4	FDA UDI	Class II	Active
Monarch™ Bronchoscope System	MBR-000011	FDA UDI	Class II	Active
Monarch™ Platform	MON000005	FDA UDI	Class II	Active
Monarch™ Laptop P70 Linux USB Image v2.2.5	Version 2.2.5	FDA UDI	Class II	Active
Monarch™ Cart Software v4.1.0	Version 4.1.0	FDA UDI	Class II	Active
Bronchoscope Fluidics Tubing	MBR-000218	FDA UDI	Class II	Active
Monarch Bronchoscope	MBR-000211-A	FDA UDI	Class II	Active
Monarch Bronchscope 2.0/Monarch Platform (P2), Refurbished	MON-000006-RFB	FDA UDI	Class II	Active
Monarch™ Software Cart v2.1.2	Version 2.1.2	FDA UDI	Class II	Active
Monarch™ Software Tower v2.2.4	Version 2.2.4	FDA UDI	Class II	Active
Bronchoscope Valve	MBR-000019	FDA UDI	Class II	Active
Bronchoscope Sheath Valve	MBR-000020	FDA UDI	Class II	Active
Monarch™ Software Cart v2.1.3	Version 2.1.3	FDA UDI	Class II	Active
Monarch™ Tower Software v4.1.1	Version 4.1.1	FDA UDI	Class II	Active
Monarch™ Laptop P17 Software v4.1.0	Version 4.1.0	FDA UDI	Class II	Active
Monarch™ Laptop P17 Software v4.1.1	Version 4.1.1	FDA UDI	Class II	Active
Monarch Endoscopy Platform (P1) Tower Upgrade	MON-000005-01	FDA UDI	Class II	Active
Monarch™ Software Cart v2.2.4	Version 2.2.4	FDA UDI	Class II	Active
Monarch™ Software Tower v2.2.5	Version 2.2.5	FDA UDI	Class II	Active
Monarch™ Software Tower v2.1.5	Version 2.1.5	FDA UDI	Class II	Active
Monarch™ Laptop P16 Software v4.1.1	Version 4.1.1	FDA UDI	Class II	Active
Monarch Platform, Urology	K213334	FDA 510(k)	Class II	Active
Monarch Platform	K193534	FDA 510(k)	Class II	Active
Monarch Platform	K211493	FDA 510(k)	Class II	Active
MONARCH™ Platform (MON-000008)	K243219	FDA 510(k)	Class II	Active

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FDA Recalls (8)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Date	Recall No.	Class	Status	Reason
Jan 21, 2026	Z-1383-2026	—	open, classified	Device for bronchoscopic visualization, patient airway access has software issue: if application restarts after patient-side selection, prior to bronchoscope loading, application will re-initialize to patient-left position; and if right position was previously selected, this may lead to unanticipated robotic arm positioning toward patient-left, may result in contact with patient/endotracheal tube.
Oct 18, 2025	Z-0543-2026	—	open, classified	Potential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.
Aug 2, 2024	Z-0052-2025	—	open, classified	Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Aug 2, 2024	Z-0051-2025	—	open, classified	Endoscopy/bronchoscopy/urology devices may have a strain relief defect with some cart and tower power cords that may cause an electrical short, which may lead to system shutdown, which can lead to prolonged procedure or case conversion, and if the user (e.g., operating room staff) touches exposed wires or conductive fluids in contact with the exposed wires, there is a chance of electrical shock.
Oct 18, 2023	Z-0450-2024	—	open, classified	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Oct 18, 2023	Z-0449-2024	—	open, classified	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Oct 18, 2023	Z-0448-2024	—	open, classified	Their is the potential that software issues may result in flipped image of the virtual Bronchoscope view.
Apr 19, 2019	Z-0025-2020	—	terminated	Reports of aspirating biopsy needle breakage