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Neuroline ConcentricNeurology Needle Electrodes
Model 74025-30/25 · Ambu A/S · DI 05707480023653
IKT — Electrode, Needle, Diagnostic Electromyograph · Class II · 21 CFR 890.1385
UDILibrary device dossier · generated 2026-09-15 · 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 (6)
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.
Malfunction: 4 · Injury: 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
1.14
2019-02
0
1.33
2019-04
0
1.22
2019-05
0
1.25
2019-06
0
1
2019-07
0
4
2019-10
0
1.11
2020-04
0
1.25
2020-05
0
4
2020-06
0
2
2021-01
0
2
2021-02
0
4
2021-03
0
2
2021-05
0
1
2021-11
0
1
2021-12
0
1
2022-03
0
1
2022-04
0
1.75
2022-07
0
1
2022-09
0
1
2023-01
2
1.2
2023-02
4
1.6
2023-03
0
1
2023-06
0
1
2023-08
0
1
2023-10
0
3
2023-12
0
1
2024-01
0
1
2024-02
0
1
2024-03
0
1
2024-07
0
1
2024-09
0
2
2024-10
0
1.38
2024-12
0
4
2025-02
0
1
2025-03
0
1.33
2025-04
0
2.13
2025-06
0
1
2025-08
0
1
2025-09
0
1
2025-12
0
1.2
2026-01
0
1
2026-02
0
1
2026-03
0
1.8
2026-04
0
1
This device (reports/month)Average device in IKT (reports/device/month)