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CONMED
Model 8191-11 · Conmed Corporation · DI 00845854024884
FET — Endoscopic Video Imaging System/Component, Gastroenterology-Urology · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-11 · 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)
2019-02
0
2
2019-03
0
2
2019-04
0
1.4
2019-05
0
1
2019-06
0
1
2019-07
0
1.25
2019-08
0
1
2019-09
0
2.5
2019-10
0
1.33
2019-11
0
2
2019-12
0
2
2020-02
0
1
2020-03
0
1
2020-04
0
2.2
2020-05
0
3.7
2020-06
0
4.5
2020-07
0
6.83
2020-08
0
6.25
2020-09
0
7.55
2020-10
0
8.78
2020-11
0
7.16
2020-12
0
9.11
2021-01
0
8.33
2021-02
0
7.13
2021-03
0
8.68
2021-04
0
9.32
2021-05
0
8.84
2021-06
0
5.87
2021-07
0
9.26
2021-08
0
10.23
2021-09
0
14.75
2021-10
0
9.8
2021-11
0
9.94
2021-12
0
14.47
2022-01
0
8.22
2022-02
0
10.15
2022-03
0
14.28
2022-04
0
15
2022-05
0
14.84
2022-06
0
15.35
2022-07
0
12.91
2022-08
0
12.68
2022-09
0
13.84
2022-10
0
13.21
2022-11
0
8.78
2022-12
0
11.75
2023-01
0
11.75
2023-02
0
13.29
2023-03
0
15.32
2023-04
0
17.12
2023-05
0
12.63
2023-06
0
11.04
2023-07
0
11.25
2023-08
0
16.39
2023-09
0
15.16
2023-10
0
15.68
2023-11
0
13
2023-12
0
14.56
2024-01
0
17.56
2024-02
0
20.52
2024-03
0
23.77
2024-04
0
21.62
2024-05
0
23.52
2024-06
0
27.62
2024-07
0
24.27
2024-08
0
19.61
2024-09
0
26.56
2024-10
0
25.44
2024-11
0
13.28
2024-12
0
15.48
2025-01
0
14.21
2025-02
0
8.03
2025-03
0
10.06
2025-04
0
11.1
2025-05
0
8.34
2025-06
0
8.78
2025-07
0
9.11
2025-08
0
12.18
2025-09
0
7.21
2025-10
0
9.89
2025-11
0
11.28
2025-12
0
20.43
2026-01
0
16.39
2026-02
0
8.64
2026-03
0
12.37
2026-04
0
17.42
2026-05
0
15.33
2026-06
0
12.69
This device (reports/month)Average device in FET (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Conmed Corporation