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10K
Model 10K · Conmed Corporation · DI 20845854041106
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
HRX — Arthroscope · Class II · 21 CFR 888.1100
UDILibrary device dossier · generated 2026-09-06 · 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
7.08
2019-02
0
3.45
2019-03
0
3.23
2019-04
0
3.53
2019-05
0
3.07
2019-06
0
3.61
2019-07
0
2.74
2019-08
0
3.03
2019-09
0
3.21
2019-10
0
3.53
2019-11
0
3.04
2019-12
0
3.15
2020-01
0
3.46
2020-02
0
3.59
2020-03
0
3.32
2020-04
0
3.38
2020-05
0
2.77
2020-06
0
3.77
2020-07
0
3.67
2020-08
0
4.8
2020-09
0
5.62
2020-10
0
5.6
2020-11
0
5.07
2020-12
0
5.81
2021-01
0
4.82
2021-02
0
4.61
2021-03
0
6.05
2021-04
0
5.29
2021-05
0
4.67
2021-06
0
4.79
2021-07
0
4.25
2021-08
0
4.26
2021-09
0
3.76
2021-10
0
4.35
2021-11
0
3.58
2021-12
0
4.74
2022-01
0
4.68
2022-02
0
4.66
2022-03
0
5.12
2022-04
0
5.69
2022-05
0
5.08
2022-06
0
5.46
2022-07
0
5.77
2022-08
0
5.72
2022-09
0
5.05
2022-10
0
5.01
2022-11
0
5.22
2022-12
0
5.62
2023-01
0
5.56
2023-02
0
4.73
2023-03
0
5.68
2023-04
0
5.29
2023-05
0
5.59
2023-06
0
6.21
2023-07
0
5.47
2023-08
0
5.94
2023-09
0
5.58
2023-10
0
5.75
2023-11
0
6.37
2023-12
0
6.93
2024-01
0
5.76
2024-02
0
6.29
2024-03
0
5.47
2024-04
0
6.21
2024-05
0
6.22
2024-06
0
7.63
2024-07
0
5.51
2024-08
0
6.04
2024-09
0
5.78
2024-10
0
6.83
2024-11
0
4.76
2024-12
0
5.69
2025-01
0
5.65
2025-02
0
4.71
2025-03
0
5.14
2025-04
0
4.89
2025-05
0
5.07
2025-06
0
4.75
2025-07
0
4.87
2025-08
0
5.09
2025-09
0
4.18
2025-10
0
4.75
2025-11
0
5.1
2025-12
0
6.08
2026-01
0
5.11
2026-02
0
5.21
2026-03
0
5.71
2026-04
0
6.43
2026-05
0
5.5
2026-06
0
4.97
This device (reports/month)Average device in GCJ, HRX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Conmed Corporation