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StealthStation
Model 9735920 · MEDTRONIC NAVIGATION, INC. · DI 00763000075217
OLO — Orthopedic Stereotaxic Instrument · Class II · 21 CFR 882.4560
PGW — Ear, Nose, And Throat Stereotaxic Instrument · Class II · 21 CFR 882.4560
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 (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
2.67
2019-02
0
3.6
2019-03
0
3.24
2019-04
0
2.72
2019-05
0
3.32
2019-06
0
2.83
2019-07
0
3.31
2019-08
0
2.98
2019-09
0
2.85
2019-10
0
3.75
2019-11
0
5.24
2019-12
0
3.58
2020-01
0
3.25
2020-02
0
4.45
2020-03
0
4.43
2020-04
0
7.43
2020-05
0
2.36
2020-06
0
3.45
2020-07
0
3.9
2020-08
0
2.68
2020-09
0
3.81
2020-10
0
5.64
2020-11
0
5.39
2020-12
0
4.35
2021-01
0
4.59
2021-02
0
4.09
2021-03
0
3.97
2021-04
0
3.92
2021-05
0
4.31
2021-06
0
3.88
2021-07
0
3.39
2021-08
0
3.2
2021-09
0
2.95
2021-10
0
2.32
2021-11
0
4.17
2021-12
0
2.75
2022-01
0
2.53
2022-02
0
3.2
2022-03
0
3.39
2022-04
0
2.46
2022-05
0
3.93
2022-06
0
4.06
2022-07
0
3.36
2022-08
0
2.9
2022-09
0
2.32
2022-10
0
3.83
2022-11
0
3.73
2022-12
0
4.1
2023-01
0
3.38
2023-02
0
3.33
2023-03
0
3.7
2023-04
0
3.3
2023-05
0
3.23
2023-06
0
2.65
2023-07
0
2.77
2023-08
0
2.62
2023-09
0
3.88
2023-10
0
3.14
2023-11
0
7.55
2023-12
0
4.01
2024-01
0
3.52
2024-02
0
4.06
2024-03
0
4.11
2024-04
0
3.97
2024-05
0
4.52
2024-06
0
4.21
2024-07
0
3.77
2024-08
0
4.68
2024-09
0
4.06
2024-10
0
6.11
2024-11
0
4.74
2024-12
0
4
2025-01
0
7.8
2025-02
0
4.28
2025-03
0
3.59
2025-04
0
3.86
2025-05
0
4.61
2025-06
0
4.23
2025-07
0
3.97
2025-08
0
5.01
2025-09
0
3.81
2025-10
0
3.88
2025-11
0
4.13
2025-12
0
4.43
2026-01
0
4.25
2026-02
0
4.19
2026-03
0
4.13
2026-04
0
3.68
2026-05
0
4.94
2026-06
0
3.95
This device (reports/month)Average device in OLO, PGW (reports/device/month)