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Model M12 Rev.V24 · MEDEON BIODESIGN, INC. · DI 04719872920328
GCJ — Laparoscope, General & Plastic Surgery · Class II · 21 CFR 876.1500
HCF — Instrument, Ligature Passing And Knot Tying · Class I · 21 CFR 878.4800
OCW — Endoscopic Tissue Approximation Device · Class II · 21 CFR 876.1500
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.
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
2.52
2019-02
0
3.65
2019-03
0
3.18
2019-04
0
3.52
2019-05
0
2.85
2019-06
0
3.81
2019-07
0
2.73
2019-08
0
2.53
2019-09
0
2.61
2019-10
0
2.9
2019-11
0
2.26
2019-12
0
2.67
2020-01
0
2.79
2020-02
0
2.69
2020-03
0
2.48
2020-04
0
2.62
2020-05
0
2.05
2020-06
0
2.71
2020-07
0
2.85
2020-08
0
4.1
2020-09
0
4.37
2020-10
0
3.94
2020-11
0
4.45
2020-12
0
3.73
2021-01
0
3.94
2021-02
0
3.71
2021-03
0
4.68
2021-04
0
4.51
2021-05
0
3.88
2021-06
0
4.23
2021-07
0
3.68
2021-08
0
3.88
2021-09
0
3.8
2021-10
0
3.84
2021-11
0
3.41
2021-12
0
4.37
2022-01
0
4.51
2022-02
0
4.9
2022-03
0
5.17
2022-04
0
5.89
2022-05
0
5.33
2022-06
0
5.95
2022-07
0
6.24
2022-08
0
5.88
2022-09
0
5.05
2022-10
0
5.14
2022-11
0
5.14
2022-12
0
5.66
2023-01
0
5.56
2023-02
0
4.53
2023-03
0
5.42
2023-04
0
5.27
2023-05
0
5.49
2023-06
0
6.4
2023-07
0
5.71
2023-08
0
5.9
2023-09
0
5.56
2023-10
0
6.24
2023-11
0
5.54
2023-12
0
5.89
2024-01
0
5.4
2024-02
0
5.86
2024-03
0
5.33
2024-04
0
5.9
2024-05
0
5.05
2024-06
0
6.73
2024-07
0
5.35
2024-08
0
5.86
2024-09
0
5.86
2024-10
0
6.74
2024-11
0
4.54
2024-12
0
4.4
2025-01
0
4.4
2025-02
0
4.08
2025-03
0
5.1
2025-04
0
4.64
2025-05
0
4.58
2025-06
0
4.57
2025-07
0
4.79
2025-08
0
5.2
2025-09
0
3.78
2025-10
0
4.39
2025-11
0
4.86
2025-12
0
6.02
2026-01
0
4.84
2026-02
0
4.9
2026-03
0
5.61
2026-04
0
6.15
2026-05
0
6.21
2026-06
0
5.13
This device (reports/month)Average device in GCJ, HCF, OCW (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — MEDEON BIODESIGN, INC.