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Unnamed device

Model 945CUSB100 · MEDTRONIC SOFAMOR DANEK, INC. · DI 00643169523548

GWE — Stimulator, Photic, Evoked Response · Class II · 21 CFR 882.1890

GWF — Stimulator, Electrical, Evoked Response · Class II · 21 CFR 882.1870

GWJ — Stimulator, Auditory, Evoked Response · Class II · 21 CFR 882.1900

GWQ — Full-Montage Standard Electroencephalograph · Class II · 21 CFR 882.1400

GWS — Analyzer, Spectrum, Electroencephalogram Signal · Class I · 21 CFR 882.1420

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 (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.

4812162019-01: 0 reports for this device; peer average 2.55/device2019-02: 0 reports for this device; peer average 3.86/device2019-03: 0 reports for this device; peer average 3.18/device2019-04: 0 reports for this device; peer average 1.58/device2019-05: 0 reports for this device; peer average 1.81/device2019-06: 0 reports for this device; peer average 1.6/device2019-07: 0 reports for this device; peer average 2.48/device2019-08: 0 reports for this device; peer average 3.54/device2019-09: 0 reports for this device; peer average 2.29/device2019-10: 0 reports for this device; peer average 4.32/device2019-11: 0 reports for this device; peer average 5.27/device2019-12: 0 reports for this device; peer average 4.37/device2020-01: 0 reports for this device; peer average 4.12/device2020-02: 0 reports for this device; peer average 2.3/device2020-03: 0 reports for this device; peer average 3.85/device2020-04: 0 reports for this device; peer average 2.5/device2020-05: 0 reports for this device; peer average 1.41/device2020-06: 0 reports for this device; peer average 1.6/device2020-07: 0 reports for this device; peer average 3.71/device2020-08: 0 reports for this device; peer average 2.97/device2020-09: 0 reports for this device; peer average 2.5/device2020-10: 0 reports for this device; peer average 4.32/device2020-11: 0 reports for this device; peer average 2.44/device2020-12: 0 reports for this device; peer average 3.42/device2021-01: 0 reports for this device; peer average 1.33/device2021-02: 0 reports for this device; peer average 2.64/device2021-03: 0 reports for this device; peer average 2.96/device2021-04: 0 reports for this device; peer average 1.98/device2021-05: 0 reports for this device; peer average 2.15/device2021-06: 0 reports for this device; peer average 2.06/device2021-07: 0 reports for this device; peer average 3.76/device2021-08: 0 reports for this device; peer average 2.17/device2021-09: 0 reports for this device; peer average 4.18/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2.29/device2021-12: 0 reports for this device; peer average 1.68/device2022-01: 0 reports for this device; peer average 2.04/device2022-02: 0 reports for this device; peer average 2.89/device2022-03: 0 reports for this device; peer average 1.63/device2022-04: 0 reports for this device; peer average 2.93/device2022-05: 0 reports for this device; peer average 2.68/device2022-06: 0 reports for this device; peer average 2.12/device2022-07: 0 reports for this device; peer average 1.93/device2022-08: 0 reports for this device; peer average 1.91/device2022-09: 0 reports for this device; peer average 2.08/device2022-10: 0 reports for this device; peer average 2.32/device2022-11: 0 reports for this device; peer average 2.41/device2022-12: 0 reports for this device; peer average 2.13/device2023-01: 0 reports for this device; peer average 2.65/device2023-02: 0 reports for this device; peer average 1.98/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 1.63/device2023-05: 0 reports for this device; peer average 2.03/device2023-06: 0 reports for this device; peer average 1.49/device2023-07: 0 reports for this device; peer average 1.68/device2023-08: 0 reports for this device; peer average 3.29/device2023-09: 0 reports for this device; peer average 3.56/device2023-10: 0 reports for this device; peer average 5/device2023-11: 0 reports for this device; peer average 5.14/device2023-12: 0 reports for this device; peer average 5.78/device2024-01: 0 reports for this device; peer average 3.49/device2024-02: 0 reports for this device; peer average 4.42/device2024-03: 0 reports for this device; peer average 6.29/device2024-04: 0 reports for this device; peer average 9.33/device2024-05: 0 reports for this device; peer average 8.26/device2024-06: 0 reports for this device; peer average 6.64/device2024-07: 0 reports for this device; peer average 9.16/device2024-08: 0 reports for this device; peer average 8.75/device2024-09: 0 reports for this device; peer average 15.18/device2024-10: 0 reports for this device; peer average 11.48/device2024-11: 0 reports for this device; peer average 9.62/device2024-12: 0 reports for this device; peer average 7.22/device2025-01: 0 reports for this device; peer average 6.53/device2025-02: 0 reports for this device; peer average 9.88/device2025-03: 0 reports for this device; peer average 15.99/device2025-04: 0 reports for this device; peer average 7.77/device2025-05: 0 reports for this device; peer average 6.45/device2025-06: 0 reports for this device; peer average 7.48/device2025-07: 0 reports for this device; peer average 11.44/device2025-08: 0 reports for this device; peer average 7.68/device2025-09: 0 reports for this device; peer average 6.75/device2025-10: 0 reports for this device; peer average 10.98/device2025-11: 0 reports for this device; peer average 9.31/device2025-12: 0 reports for this device; peer average 8.86/device2026-01: 0 reports for this device; peer average 6.61/device2026-02: 0 reports for this device; peer average 8.19/device2026-03: 0 reports for this device; peer average 8.72/device2026-04: 0 reports for this device; peer average 8.64/device2026-05: 0 reports for this device; peer average 13.19/device2026-06: 0 reports for this device; peer average 8.78/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.55
2019-0203.86
2019-0303.18
2019-0401.58
2019-0501.81
2019-0601.6
2019-0702.48
2019-0803.54
2019-0902.29
2019-1004.32
2019-1105.27
2019-1204.37
2020-0104.12
2020-0202.3
2020-0303.85
2020-0402.5
2020-0501.41
2020-0601.6
2020-0703.71
2020-0802.97
2020-0902.5
2020-1004.32
2020-1102.44
2020-1203.42
2021-0101.33
2021-0202.64
2021-0302.96
2021-0401.98
2021-0502.15
2021-0602.06
2021-0703.76
2021-0802.17
2021-0904.18
2021-1002
2021-1102.29
2021-1201.68
2022-0102.04
2022-0202.89
2022-0301.63
2022-0402.93
2022-0502.68
2022-0602.12
2022-0701.93
2022-0801.91
2022-0902.08
2022-1002.32
2022-1102.41
2022-1202.13
2023-0102.65
2023-0201.98
2023-0302
2023-0401.63
2023-0502.03
2023-0601.49
2023-0701.68
2023-0803.29
2023-0903.56
2023-1005
2023-1105.14
2023-1205.78
2024-0103.49
2024-0204.42
2024-0306.29
2024-0409.33
2024-0508.26
2024-0606.64
2024-0709.16
2024-0808.75
2024-09015.18
2024-10011.48
2024-1109.62
2024-1207.22
2025-0106.53
2025-0209.88
2025-03015.99
2025-0407.77
2025-0506.45
2025-0607.48
2025-07011.44
2025-0807.68
2025-0906.75
2025-10010.98
2025-1109.31
2025-1208.86
2026-0106.61
2026-0208.19
2026-0308.72
2026-0408.64
2026-05013.19
2026-0608.78
This device (reports/month)Average device in GWE, GWF, GWJ, GWQ, GWS (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K050798 — cited as predicate by K142624

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

Manufacturer compliance record — MEDTRONIC SOFAMOR DANEK, INC.

  • NAI 2026-02-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2017-10-26 Medtronic Sofamor Danek USA, Inc · 0 citations
  • VAI 2015-11-03 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2015-10-23 Medtronic Sofamor Danek USA Inc · 1 citations
  • VAI 2014-03-11 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA, Inc · 0 citations
  • NAI 2013-07-15 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2012-06-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2011-02-23 Medtronic Sofamor Danek Usa Inc · 0 citations
  • VAI 2010-08-06 Medtronic Sofamor Danek USA Inc · 0 citations
  • VAI 2010-03-04 Medtronic Sofamor Danek USA Inc · 0 citations
  • NAI 2010-02-25 Medtronic Sofamor Danek USA Inc · 0 citations