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Cadwell Guardian
Model 199335-000-008 · CADWELL INDUSTRIES, INC. · DI 00840067103562
ETN — Stimulator, Nerve · Class II · 21 CFR 874.1820
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
GZO — Device, Galvanic Skin Response Measurement · Class II · 21 CFR 882.1540
IKN — Electromyograph, Diagnostic · Class II · 21 CFR 890.1375
JXE — Device, Nerve Conduction Velocity Measurement · Class II · 21 CFR 882.1550
OLT — Non-Normalizing Quantitative Electroencephalograph Software · Class II · 21 CFR 882.1400
PDQ — Neurosurgical Nerve Locator · Class II · 21 CFR 874.1820
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
2.61
2019-02
0
3.68
2019-03
0
2.96
2019-04
0
1.63
2019-05
0
1.97
2019-06
0
1.57
2019-07
0
1.97
2019-08
0
3.67
2019-09
0
2.46
2019-10
0
3.91
2019-11
0
4.6
2019-12
0
4.32
2020-01
0
3.38
2020-02
0
2.06
2020-03
0
3.58
2020-04
0
2.45
2020-05
0
1.42
2020-06
0
1.61
2020-07
0
3.22
2020-08
0
2.85
2020-09
0
2.55
2020-10
0
3.95
2020-11
0
2.52
2020-12
0
3.04
2021-01
0
1.27
2021-02
0
2.22
2021-03
0
2.4
2021-04
0
1.91
2021-05
0
1.84
2021-06
0
2.08
2021-07
0
3.4
2021-08
0
2.2
2021-09
0
3.78
2021-10
0
2.27
2021-11
0
2.07
2021-12
0
1.6
2022-01
0
2
2022-02
0
2.24
2022-03
0
1.5
2022-04
0
2.7
2022-05
0
2.65
2022-06
0
2.11
2022-07
0
1.83
2022-08
0
2.04
2022-09
0
2.06
2022-10
0
2.35
2022-11
0
2.23
2022-12
0
2.05
2023-01
0
2.59
2023-02
0
2.01
2023-03
0
2.34
2023-04
0
1.71
2023-05
0
2.29
2023-06
0
1.81
2023-07
0
1.71
2023-08
0
2.92
2023-09
0
3.31
2023-10
0
5.88
2023-11
0
5.37
2023-12
0
6.27
2024-01
0
4.18
2024-02
0
5.22
2024-03
0
5.83
2024-04
0
8.26
2024-05
0
7.96
2024-06
0
6.26
2024-07
0
9.17
2024-08
0
10.11
2024-09
0
15.22
2024-10
0
12.01
2024-11
0
10.42
2024-12
0
7.85
2025-01
0
7.32
2025-02
0
12.72
2025-03
0
13.53
2025-04
0
8.82
2025-05
0
7.2
2025-06
0
7.79
2025-07
0
13.71
2025-08
0
7.81
2025-09
0
7.77
2025-10
0
12.12
2025-11
0
10.43
2025-12
0
9.73
2026-01
0
7.4
2026-02
0
8.03
2026-03
0
9.32
2026-04
0
9.23
2026-05
0
11.38
2026-06
0
9.91
This device (reports/month)Average device in ETN, GWE, GWF, GWJ, GWQ, GZO, IKN, JXE, OLT, PDQ (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — CADWELL INDUSTRIES, INC.
VAI 2017-08-16 Cadwell Industries Inc · 3 citations
VAI 2017-08-16 Cadwell Industries Inc · 3 citations
VAI 2013-04-30 Cadwell Industries Inc · 3 citations
VAI 2013-04-30 Cadwell Industries Inc · 3 citations