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Ceiling Column Long
Model 017413 · Bracco Injeneering SA · DI 37630039300655
DSB — Plethysmograph, Impedance · Class II · 21 CFR 870.2770
IZQ — Injector, Contrast Medium, Automatic · Class II · 21 CFR 870.1650
JAK — System, X-Ray, Tomography, Computed · Class II · 21 CFR 892.1750
UDILibrary device dossier · generated 2026-09-14 · 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
5
2019-02
0
2.69
2019-03
0
3.36
2019-04
0
5.52
2019-05
0
3.06
2019-06
0
3.69
2019-07
0
2.65
2019-08
0
2.92
2019-09
0
2.14
2019-10
0
3.42
2019-11
0
2.1
2019-12
0
4.78
2020-01
0
2
2020-02
0
2.6
2020-03
0
2.13
2020-04
0
4.5
2020-05
0
2.1
2020-06
0
2.31
2020-07
0
3.27
2020-08
0
3.1
2020-09
0
2.4
2020-10
0
2.61
2020-11
0
3.52
2020-12
0
3.16
2021-01
0
2
2021-02
0
2.96
2021-03
0
2.91
2021-04
0
3.45
2021-05
0
4.56
2021-06
0
5.37
2021-07
0
3.62
2021-08
0
4.54
2021-09
0
2.88
2021-10
0
2.47
2021-11
0
3.56
2021-12
0
4.09
2022-01
0
3.43
2022-02
0
3.71
2022-03
0
4.36
2022-04
0
3.48
2022-05
0
4
2022-06
0
1.93
2022-07
0
3.24
2022-08
0
1.8
2022-09
0
2.7
2022-10
0
2.07
2022-11
0
1.86
2022-12
0
1.86
2023-01
0
2.04
2023-02
0
2.22
2023-03
0
2.82
2023-04
0
2
2023-05
0
2.52
2023-06
0
6.36
2023-07
0
2.1
2023-08
0
3.2
2023-09
0
2.68
2023-10
0
4.44
2023-11
0
2.54
2023-12
0
2.68
2024-01
0
1.92
2024-02
0
1.79
2024-03
0
1.68
2024-04
0
1.63
2024-05
0
2.46
2024-06
0
2.53
2024-07
0
2.28
2024-08
0
1.75
2024-09
0
1.27
2024-10
0
3.48
2024-11
0
3.33
2024-12
0
3.19
2025-01
0
3.28
2025-02
0
2.92
2025-03
0
3.18
2025-04
0
3.17
2025-05
0
4.56
2025-06
0
3.67
2025-07
0
3.1
2025-08
0
3.07
2025-09
0
3.53
2025-10
0
3.45
2025-11
0
4.5
2025-12
0
4.17
2026-01
0
6.89
2026-02
0
3.84
2026-03
0
5.65
2026-04
0
3.93
2026-05
0
5.15
2026-06
0
2.9
This device (reports/month)Average device in DSB, IZQ, JAK (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Bracco Injeneering SA
NAI 2017-02-01 Bracco Injeneering S.A. · 0 citations