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ALM Tube
Model 520746 · inomed Medizintechnik GmbH · DI 04250307612802
BTR — Tube, Tracheal (W/Wo Connector) · Class II · 21 CFR 868.5730
ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820
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
2.16
2019-02
0
2.78
2019-03
0
2.43
2019-04
0
2.39
2019-05
0
2.33
2019-06
0
1.97
2019-07
0
2.09
2019-08
0
2.72
2019-09
0
3.69
2019-10
0
2.97
2019-11
0
3.03
2019-12
0
2.65
2020-01
0
2.44
2020-02
0
2.03
2020-03
0
2.49
2020-04
0
2.25
2020-05
0
2.68
2020-06
0
2.37
2020-07
0
2.51
2020-08
0
2.61
2020-09
0
2.28
2020-10
0
2.99
2020-11
0
2.63
2020-12
0
2.11
2021-01
0
2.06
2021-02
0
2.29
2021-03
0
2.03
2021-04
0
2.25
2021-05
0
2.06
2021-06
0
2.79
2021-07
0
2.75
2021-08
0
2.48
2021-09
0
2.59
2021-10
0
2.44
2021-11
0
2.33
2021-12
0
1.74
2022-01
0
1.9
2022-02
0
1.8
2022-03
0
1.72
2022-04
0
2.35
2022-05
0
2.71
2022-06
0
2.37
2022-07
0
1.82
2022-08
0
2.09
2022-09
0
2.22
2022-10
0
2.24
2022-11
0
2.06
2022-12
0
2.4
2023-01
0
2.52
2023-02
0
2.22
2023-03
0
2.4
2023-04
0
1.91
2023-05
0
2.68
2023-06
0
2.56
2023-07
0
2.13
2023-08
0
2.68
2023-09
0
2.9
2023-10
0
4.73
2023-11
0
4.45
2023-12
0
4.58
2024-01
0
3.65
2024-02
0
4.61
2024-03
0
3.99
2024-04
0
4.82
2024-05
0
4.6
2024-06
0
4.18
2024-07
0
5.75
2024-08
0
7.9
2024-09
0
8.64
2024-10
0
7.79
2024-11
0
6.84
2024-12
0
5.47
2025-01
0
5.99
2025-02
0
10.24
2025-03
0
8.02
2025-04
0
6.63
2025-05
0
5.88
2025-06
0
5.48
2025-07
0
9.18
2025-08
0
4.89
2025-09
0
5.37
2025-10
0
8.37
2025-11
0
6.34
2025-12
0
7.19
2026-01
0
5.24
2026-02
0
5.18
2026-03
0
7.44
2026-04
0
6.17
2026-05
0
6.51
2026-06
0
6.41
This device (reports/month)Average device in BTR, ETN (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — inomed Medizintechnik GmbH