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Unnamed device
Model 945OPM660LO · MEDTRONIC XOMED, INC. · DI 00643169553057
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
ITX — Transducer, Ultrasonic, Diagnostic · Class II · 21 CFR 892.1570
IYN — System, Imaging, Pulsed Doppler, Ultrasonic · Class II · 21 CFR 892.1550
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
2.48
2019-02
0
4.09
2019-03
0
3.54
2019-04
0
2.02
2019-05
0
2.54
2019-06
0
3.36
2019-07
0
3.3
2019-08
0
4.24
2019-09
0
2.55
2019-10
0
3.7
2019-11
0
4.49
2019-12
0
4.35
2020-01
0
3.27
2020-02
0
3.34
2020-03
0
4
2020-04
0
3.04
2020-05
0
2.08
2020-06
0
2.4
2020-07
0
3.97
2020-08
0
2.82
2020-09
0
2.2
2020-10
0
3.96
2020-11
0
3.24
2020-12
0
4.68
2021-01
0
4.74
2021-02
0
4.21
2021-03
0
5.7
2021-04
0
3.06
2021-05
0
4.7
2021-06
0
4.16
2021-07
0
6.09
2021-08
0
4.83
2021-09
0
8.04
2021-10
0
4.28
2021-11
0
5.35
2021-12
0
5.83
2022-01
0
4.77
2022-02
0
6.19
2022-03
0
5.8
2022-04
0
6.5
2022-05
0
7.18
2022-06
0
6.03
2022-07
0
5.4
2022-08
0
3.92
2022-09
0
4.01
2022-10
0
4.05
2022-11
0
4.08
2022-12
0
3.67
2023-01
0
4.1
2023-02
0
3.84
2023-03
0
4.32
2023-04
0
3.07
2023-05
0
4.94
2023-06
0
3.26
2023-07
0
3.35
2023-08
0
5.01
2023-09
0
5.01
2023-10
0
5.73
2023-11
0
5.18
2023-12
0
5.62
2024-01
0
4.66
2024-02
0
4.35
2024-03
0
6.12
2024-04
0
7.5
2024-05
0
5.86
2024-06
0
6.2
2024-07
0
6.78
2024-08
0
7.11
2024-09
0
9.87
2024-10
0
8.67
2024-11
0
6.81
2024-12
0
8.87
2025-01
0
5.29
2025-02
0
6.67
2025-03
0
11.1
2025-04
0
5.25
2025-05
0
5.12
2025-06
0
5.46
2025-07
0
6.56
2025-08
0
6.24
2025-09
0
6.46
2025-10
0
10.31
2025-11
0
11.33
2025-12
0
14.81
2026-01
0
9.71
2026-02
0
7.17
2026-03
0
8.55
2026-04
0
10.61
2026-05
0
16.06
2026-06
0
13.08
This device (reports/month)Average device in GWE, GWF, GWJ, GWQ, ITX, IYN (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 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