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ACCUGUIDE®
Model 8263210 · MEDTRONIC XOMED, INC. · DI 20643169344994
GXZ — Electrode, Needle · Class II · 21 CFR 882.1350
IKN — Electromyograph, Diagnostic · Class II · 21 CFR 890.1375
IKT — Electrode, Needle, Diagnostic Electromyograph · Class II · 21 CFR 890.1385
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
1.17
2019-02
0
1.2
2019-04
0
1.17
2019-05
0
1.29
2019-06
0
1
2019-07
0
4
2019-09
0
2
2019-10
0
1.07
2019-11
0
1
2019-12
0
1
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
1.5
2021-07
0
1
2021-10
0
6
2021-11
0
1.33
2021-12
0
1
2022-02
0
2
2022-03
0
1.11
2022-04
0
2
2022-05
0
1.75
2022-06
0
2
2022-07
0
2
2022-08
0
2
2022-09
0
1
2022-10
0
4
2022-11
0
3
2022-12
0
2.67
2023-01
0
1.1
2023-02
0
1.33
2023-03
0
1.57
2023-05
0
2
2023-06
0
1
2023-08
0
1.25
2023-09
0
2
2023-10
0
2.67
2023-11
0
2
2023-12
0
1
2024-01
0
1.1
2024-02
0
1.2
2024-03
0
1.2
2024-04
0
1
2024-06
0
2
2024-07
0
1
2024-09
0
1.67
2024-10
0
1.36
2024-12
0
3
2025-01
0
4
2025-02
0
1.25
2025-03
0
1.29
2025-04
0
2
2025-06
0
1
2025-07
0
4
2025-08
0
1.25
2025-09
0
1
2025-10
0
1
2025-12
0
1.93
2026-01
0
2
2026-02
0
1.33
2026-03
0
1.83
2026-04
0
1.13
2026-05
0
2
This device (reports/month)Average device in GXZ, IKN, IKT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — MEDTRONIC XOMED, INC.
VAI 2024-06-17 Medtronic Xomed, Inc. · 1 citations
VAI 2021-10-29 Medtronic Xomed, Inc. · 5 citations
VAI 2015-09-21 Medtronic Xomed, Inc. · 1 citations
VAI 2012-07-03 Medtronic Xomed, Inc. · 8 citations
NAI 2012-06-06 Medtronic Xomed, Inc. · 0 citations
VAI 2010-08-05 Medtronic Xomed, Inc. · 4 citations