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Reprocessed Bronchoscope

FDA product code QNW · Class 2 · Ear, Nose, Throat

2
Registered devices
20
Adverse events
1
Recalls
2
510(k) clearances

Devices with this code

Monarch Bronchoscope — Auris Health, Inc.MONARCH™ Bronchoscope — Auris Health, Inc.

Recent recalls

DateFirmReason
2025-10-18Auris Health, IncPotential that product was leak tested with equipment outside of its expected operating range, resulting in bronchoscopes that may not be susceptible to leaks.

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Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.

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Sourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.