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StealthStation S8

Model 9735665 · MEDTRONIC NAVIGATION, INC. · DI 00763000359874

HAW — Neurological Stereotaxic Instrument · Class II · 21 CFR 882.4560

UDILibrary device dossier · generated 2026-09-13 · 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 (10189)

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: 9923 · Injury: 253 · Death: 13

771532303062019-01: 95 reports for this device; peer average 12.92/device2019-02: 85 reports for this device; peer average 14.35/device2019-03: 106 reports for this device; peer average 14.05/device2019-04: 134 reports for this device; peer average 18.63/device2019-05: 131 reports for this device; peer average 19.54/device2019-06: 144 reports for this device; peer average 20.19/device2019-07: 108 reports for this device; peer average 13.37/device2019-08: 79 reports for this device; peer average 11.15/device2019-09: 72 reports for this device; peer average 11.95/device2019-10: 68 reports for this device; peer average 9.58/device2019-11: 83 reports for this device; peer average 11.88/device2019-12: 96 reports for this device; peer average 14.46/device2020-01: 72 reports for this device; peer average 11.27/device2020-02: 94 reports for this device; peer average 12.22/device2020-03: 105 reports for this device; peer average 12.88/device2020-04: 65 reports for this device; peer average 10.44/device2020-05: 77 reports for this device; peer average 15.5/device2020-06: 71 reports for this device; peer average 12.21/device2020-07: 66 reports for this device; peer average 14.34/device2020-08: 69 reports for this device; peer average 12.98/device2020-09: 59 reports for this device; peer average 12.31/device2020-10: 80 reports for this device; peer average 12.61/device2020-11: 82 reports for this device; peer average 14.12/device2020-12: 93 reports for this device; peer average 12.64/device2021-01: 75 reports for this device; peer average 11.89/device2021-02: 84 reports for this device; peer average 14.14/device2021-03: 94 reports for this device; peer average 13.25/device2021-04: 87 reports for this device; peer average 13.21/device2021-05: 81 reports for this device; peer average 14.8/device2021-06: 97 reports for this device; peer average 18.26/device2021-07: 77 reports for this device; peer average 13.79/device2021-08: 83 reports for this device; peer average 17.29/device2021-09: 95 reports for this device; peer average 24.68/device2021-10: 75 reports for this device; peer average 14.32/device2021-11: 76 reports for this device; peer average 16.72/device2021-12: 82 reports for this device; peer average 12.67/device2022-01: 51 reports for this device; peer average 10.59/device2022-02: 59 reports for this device; peer average 13.53/device2022-03: 82 reports for this device; peer average 15.09/device2022-04: 70 reports for this device; peer average 12.75/device2022-05: 82 reports for this device; peer average 16.55/device2022-06: 81 reports for this device; peer average 15.68/device2022-07: 70 reports for this device; peer average 12.74/device2022-08: 93 reports for this device; peer average 13.73/device2022-09: 68 reports for this device; peer average 15.67/device2022-10: 95 reports for this device; peer average 18.18/device2022-11: 79 reports for this device; peer average 16.94/device2022-12: 91 reports for this device; peer average 16.56/device2023-01: 65 reports for this device; peer average 14/device2023-02: 68 reports for this device; peer average 12.62/device2023-03: 99 reports for this device; peer average 16.68/device2023-04: 89 reports for this device; peer average 14.38/device2023-05: 112 reports for this device; peer average 16.67/device2023-06: 132 reports for this device; peer average 24.22/device2023-07: 138 reports for this device; peer average 25.39/device2023-08: 145 reports for this device; peer average 21.23/device2023-09: 116 reports for this device; peer average 17.03/device2023-10: 137 reports for this device; peer average 17.29/device2023-11: 134 reports for this device; peer average 18.43/device2023-12: 145 reports for this device; peer average 20.54/device2024-01: 156 reports for this device; peer average 25.65/device2024-02: 161 reports for this device; peer average 20.49/device2024-03: 164 reports for this device; peer average 21.69/device2024-04: 144 reports for this device; peer average 22.32/device2024-05: 147 reports for this device; peer average 18.44/device2024-06: 104 reports for this device; peer average 19.81/device2024-07: 152 reports for this device; peer average 23.6/device2024-08: 279 reports for this device; peer average 29.73/device2024-09: 203 reports for this device; peer average 22.75/device2024-10: 255 reports for this device; peer average 27.4/device2024-11: 161 reports for this device; peer average 14.37/device2024-12: 159 reports for this device; peer average 16.74/device2025-01: 180 reports for this device; peer average 16.27/device2025-02: 306 reports for this device; peer average 21.38/device2025-03: 189 reports for this device; peer average 25.24/device2025-04: 208 reports for this device; peer average 23.34/device2025-05: 207 reports for this device; peer average 20.44/device2025-06: 255 reports for this device; peer average 33.41/device2025-07: 160 reports for this device; peer average 20.35/device2025-08: 129 reports for this device; peer average 17.63/device2025-09: 153 reports for this device; peer average 19.99/device2025-10: 152 reports for this device; peer average 18.6/device2025-11: 126 reports for this device; peer average 16.83/device2025-12: 104 reports for this device; peer average 15.93/device2026-01: 117 reports for this device; peer average 17/device2026-02: 75 reports for this device; peer average 14.12/device2026-03: 102 reports for this device; peer average 15.06/device2026-04: 84 reports for this device; peer average 11.52/device2026-05: 61 reports for this device; peer average 11.51/device2026-06: 55 reports for this device; peer average 8.95/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-019512.92
2019-028514.35
2019-0310614.05
2019-0413418.63
2019-0513119.54
2019-0614420.19
2019-0710813.37
2019-087911.15
2019-097211.95
2019-10689.58
2019-118311.88
2019-129614.46
2020-017211.27
2020-029412.22
2020-0310512.88
2020-046510.44
2020-057715.5
2020-067112.21
2020-076614.34
2020-086912.98
2020-095912.31
2020-108012.61
2020-118214.12
2020-129312.64
2021-017511.89
2021-028414.14
2021-039413.25
2021-048713.21
2021-058114.8
2021-069718.26
2021-077713.79
2021-088317.29
2021-099524.68
2021-107514.32
2021-117616.72
2021-128212.67
2022-015110.59
2022-025913.53
2022-038215.09
2022-047012.75
2022-058216.55
2022-068115.68
2022-077012.74
2022-089313.73
2022-096815.67
2022-109518.18
2022-117916.94
2022-129116.56
2023-016514
2023-026812.62
2023-039916.68
2023-048914.38
2023-0511216.67
2023-0613224.22
2023-0713825.39
2023-0814521.23
2023-0911617.03
2023-1013717.29
2023-1113418.43
2023-1214520.54
2024-0115625.65
2024-0216120.49
2024-0316421.69
2024-0414422.32
2024-0514718.44
2024-0610419.81
2024-0715223.6
2024-0827929.73
2024-0920322.75
2024-1025527.4
2024-1116114.37
2024-1215916.74
2025-0118016.27
2025-0230621.38
2025-0318925.24
2025-0420823.34
2025-0520720.44
2025-0625533.41
2025-0716020.35
2025-0812917.63
2025-0915319.99
2025-1015218.6
2025-1112616.83
2025-1210415.93
2026-0111717
2026-027514.12
2026-0310215.06
2026-048411.52
2026-056111.51
2026-06558.95
This device (reports/month)Average device in HAW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K162309 — cites (transitively): K050438 (d1), K133444 (d1), K153660 (d1), K150216 (d2), K992927 (d2) — cited as predicate by K170018, K182077, K182104, K191597, K200047, K200791, K201175, K211064, K212194, K220241, K221344, K230087, K231527, K241130, K241333, K253381

Lineage extracted from public 510(k) summary text (heuristic).

Manufacturer compliance record — MEDTRONIC NAVIGATION, INC.

  • Warning Letter 2010-05-07 Medtronic Navigation, Inc.
  • VAI 2024-02-09 Medtronic Navigation, Inc. · 3 citations
  • VAI 2021-06-29 Medtronic Navigation, Inc. · 3 citations
  • VAI 2019-09-30 Medtronic Navigation, Inc. · 1 citations
  • VAI 2016-08-18 Medtronic Navigation, Inc. · 0 citations
  • NAI 2014-12-15 Medtronic Navigation, Inc. · 0 citations
  • VAI 2014-02-19 Medtronic Navigation, Inc. · 5 citations
  • NAI 2012-09-06 Medtronic Navigation, Inc. · 0 citations
  • NAI 2012-05-01 Medtronic Navigation, Inc. · 0 citations
  • VAI 2011-03-24 Medtronic Navigation, Inc. · 1 citations
  • OAI 2010-02-04 Medtronic Navigation, Inc. · 9 citations