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Monarch Bronchscope 2.0/Monarch Platform (P2)
Model MON-000006 · Auris Health, Inc. · DI B634MON0000060
EOQ — Bronchoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4680
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
UDILibrary device dossier · generated 2026-09-07 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.
Recall history (0)
No recalls linked in the loaded window.
Adverse-event reports — MAUDE (188)
Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.
Injury: 156 · Malfunction: 30 · Death: 2
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
0
3.15
2019-02
0
2.5
2019-03
0
5.48
2019-04
0
16.27
2019-05
0
3.61
2019-06
0
2.9
2019-07
0
2.56
2019-08
0
3.75
2019-09
0
2.5
2019-10
0
2.37
2019-11
0
2.18
2019-12
0
4.71
2020-01
0
2.5
2020-02
0
4.32
2020-03
0
2.27
2020-04
0
4.19
2020-05
0
2.58
2020-06
0
3.62
2020-07
0
3.35
2020-08
0
2.91
2020-09
0
2.95
2020-10
1
3.19
2020-11
0
3.67
2020-12
0
4.92
2021-01
0
3.4
2021-02
1
3.04
2021-03
5
4.43
2021-04
4
3.89
2021-05
3
4.53
2021-06
4
4.19
2021-07
2
3.18
2021-08
4
4
2021-09
2
3.48
2021-10
0
3.84
2021-11
2
3.48
2021-12
1
4.14
2022-01
4
4.11
2022-02
2
4
2022-03
2
5.42
2022-04
0
5.5
2022-05
0
5.16
2022-06
2
4.75
2022-07
11
5.57
2022-08
2
4.8
2022-09
8
4.56
2022-10
2
5
2022-11
6
4.97
2022-12
4
4.89
2023-01
8
6.88
2023-02
4
4.82
2023-03
2
6.39
2023-04
0
5.47
2023-05
0
5.6
2023-06
0
6.44
2023-07
2
5.21
2023-08
5
6.32
2023-09
4
5.97
2023-10
4
6.56
2023-11
4
6.24
2023-12
12
6.12
2024-01
0
5.8
2024-02
1
5.32
2024-03
6
6.14
2024-04
2
5.33
2024-05
0
5.3
2024-06
3
6.54
2024-07
1
5.29
2024-08
2
6.8
2024-09
0
6.15
2024-10
4
6.67
2024-11
0
8.77
2024-12
4
3.63
2025-01
0
3.43
2025-02
2
3.08
2025-03
2
3.36
2025-04
4
3.7
2025-05
2
4.57
2025-06
5
4.17
2025-07
0
4.7
2025-08
3
4.3
2025-09
1
3.83
2025-10
1
4.58
2025-11
2
5.2
2025-12
4
8.42
2026-01
2
7.63
2026-02
8
5.27
2026-03
2
5.85
2026-04
3
7.26
2026-05
5
7.81
2026-06
2
6.19
This device (reports/month)Average device in EOQ, JAK (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Auris Health, Inc.