Skip to content

Auris Health, Inc.

255 adverse events · 15 recalls · 5 clearances · 5 inspections · aggregated across 3 source records

Scorecard
Events per device across the 86-device portfolio, trailing 12 months. Arrows compare the last 90 days with the 90 before.

MAUDE reports per device

0.67

58 in the last 12 months

Higher volume than 97% of companies with 10+ devices

Recalls per device

0.035

3 in the last 12 months

Higher volume than 99% of companies with 10+ devices

These are reporting-volume percentiles, not safety rankings — MAUDE counts have no denominator of devices in use, and recall attribution follows resolved links. A high percentile means more reports per registered device than peers, which can reflect market size, device criticality, or reporting practice as much as anything else.

Devices
86 device records · ordered by linked event volume.
BrandModelProduct codesPrimary DILinked events
Monarch Bronchscope 2.0/Monarch Platform (P2)MON-000006EOQ JAKB634MON0000060188
Monarch™ PlatformMON000005EOQ JAKB634MON0000050109
Monarch Bronchscope 2.0/Monarch Platform (P2)MON-000006EOQ JAK1081006881080375
Monarch Endoscopy Platform (P1) Tower UpgradeMON-000005-01EOQ JAKB634MON00000501038
Monarch BronchoscopeMBR-000211-AEOQB634MBR000211A027
Monarch BronchoscopeMBR-000211-AEOQB623MBR000211A020
Monarch Endoscopy Platform (P1) Tower UpgradeMON-000005-01EOQ JAKB634MON0000050118
Monarch BronchoscopeMBR-000211-AEOQ1081006881086515
Monarch BronchoscopeMBR-000211-BQNWB634MBR000211B015
Aspirating Biopsy NeedleMBR-000012EOQB634MBR000012013
MONARCH™ BronchoscopeMBR-000211-BQNW1081006881113813
Monarch Endoscopy Platform (P1) System, RefurbishedMON-000005-01REOQ JAKB634MON00000501R07
MONARCH™ Navigation SensorsMON-000705EOQ JAK108100688108415
MONARCH™Platform, UrologyMON-000007FGB LJH108100688110465
Monarch Platform, BronchoscopyMON-000008EOQ JAK108100688109885
Biopsy Forceps - Smooth CupMBR-000014EOQB634MBR00001404
Cytology BrushMBR-000015EOQB634MBR00001503
Monarch® Ureteroscopy KitMUR-000011FGB LJH108100688110533
MONARCH™ Ureteroscope ValveMUR-000026FGB108100688111212
MONARCH™ Urology Irrigation CartridgeMUR-000016FGB108100688111072
Monarch™ Platform (Refurbished)MON000005REOQ JAKB634MON000005R02
Monarch™ Bronchoscope SystemMBR-000011EOQB634MBR00001101
BIOPSY FORCEPS - SMOOTH CUP0
BRONCHOSCOPE FLUIDICS TUBING0
BRONCHOSCOPE PATIENT INTRODUCER KIT0
BRONCHOSCOPE SHEATH VALVE0
Bronchoscope Fluidics TubingMBR-000218EOQB634MBR00021800
Bronchoscope Fluidics TubingMBR-000218EOQ108100688108340
Bronchoscope Fluidics TubingMBR-000018EOQB634MBR00001800
Bronchoscope Patient Introducer KitMBR-000017EOQB634MBR00001700
Showing 1–30 of 86Next →
Facilities
Registered establishments with their latest FDA inspection outcome.
FEINameLocationLast inspectionWatch
3014447948Auris Health, IncSanta Clara, CA, USNAI
3023460764Auris Health, Inc.San Jose, CA, US