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Montgomery® Long-Term Cannula

Model 330449 · Boston Medical Products, Inc. · DI EBES3304490

BTO — Tube, Tracheostomy (W/Wo Connector) · Class II · 21 CFR 868.5800

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 (0)

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.

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	1.8
2019-02	0	1.75
2019-03	0	1.75
2019-04	0	2
2019-05	0	1
2019-06	0	1
2019-07	0	7.5
2019-08	0	1.6
2019-09	0	1
2019-10	0	1
2019-11	0	1
2019-12	0	2
2020-01	0	1
2020-02	0	2
2020-03	0	1
2020-04	0	1
2020-05	0	1
2020-06	0	1.5
2020-07	0	2
2020-08	0	3
2020-09	0	1.6
2020-10	0	2
2020-11	0	1.4
2020-12	0	1.75
2021-01	0	1.67
2021-02	0	1
2021-03	0	1.5
2021-04	0	2
2021-05	0	1
2021-06	0	1.67
2021-07	0	1
2021-08	0	1.2
2021-09	0	2.67
2021-10	0	1.88
2021-11	0	2.86
2021-12	0	2.56
2022-01	0	1.7
2022-02	0	1.82
2022-03	0	2.33
2022-04	0	2.18
2022-05	0	1.45
2022-06	0	1.92
2022-07	0	3
2022-08	0	1.17
2022-09	0	1.57
2022-10	0	1.28
2022-11	0	2.83
2022-12	0	1.43
2023-01	0	2.09
2023-02	0	2
2023-03	0	2.64
2023-04	0	1.5
2023-05	0	2.18
2023-06	0	2.23
2023-07	0	1.5
2023-08	0	1.57
2023-09	0	1
2023-10	0	1.13
2023-11	0	2.08
2023-12	0	2
2024-01	0	1.31
2024-02	0	1.13
2024-03	0	1.33
2024-04	0	1.8
2024-05	0	1.7
2024-06	0	1
2024-07	0	1.36
2024-08	0	2
2024-09	0	2.76
2024-10	0	1.82
2024-11	0	1.83
2024-12	0	1.11
2025-01	0	1.5
2025-02	0	1.57
2025-03	0	1
2025-04	0	1.33
2025-05	0	1.29
2025-06	0	1.7
2025-07	0	1.45
2025-08	0	1.36
2025-09	0	1.2
2025-10	0	1
2025-11	0	1
2025-12	0	1.18
2026-01	0	1.23
2026-02	0	1
2026-03	0	1.46
2026-04	0	1.78
2026-05	0	1.6
2026-06	0	1.5

This device (reports/month)Average device in BTO (reports/device/month)

Regulatory clearances

None linked in the loaded window.

Manufacturer compliance record — Boston Medical Products, Inc.

NAI 2013-03-20 Boston Medical Products, Inc. · 0 citations
NAI 2013-03-20 Boston Medical Products, Inc. · 0 citations