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"10-0 BK MONO NYL 12""/30CM 2MI-500"
Model CDM-9804 · Surgical Specialties México, S. de R.L. de C.V. · DI 00848782023417
GAR — Suture, Nonabsorbable, Synthetic, Polyamide · Class II · 21 CFR 878.5020
UDILibrary device dossier · generated 2026-09-14 · 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
1.4
2019-02
0
2.86
2019-03
0
2.2
2019-04
0
3.25
2019-05
0
2.55
2019-06
0
2.82
2019-07
0
2.55
2019-08
0
3.14
2019-09
0
1.82
2019-10
0
2.06
2019-11
0
2.38
2019-12
0
2.89
2020-01
0
3
2020-02
0
2.94
2020-03
0
3.83
2020-04
0
3
2020-05
0
2.46
2020-06
0
2.4
2020-07
0
2.33
2020-08
0
4.17
2020-09
0
4
2020-10
0
4.57
2020-11
0
3.14
2020-12
0
4.2
2021-01
0
3.5
2021-02
0
3.5
2021-03
0
9.33
2021-04
0
1.83
2021-05
0
4.5
2021-06
0
5.54
2021-07
0
2.29
2021-08
0
4.18
2021-09
0
2.45
2021-10
0
2.86
2021-11
0
3
2021-12
0
4.57
2022-01
0
1.8
2022-02
0
8.5
2022-03
0
2.43
2022-04
0
2.43
2022-05
0
6.21
2022-06
0
3.6
2022-07
0
4
2022-08
0
3.06
2022-09
0
3.71
2022-10
0
4.7
2022-11
0
14.73
2022-12
0
5.31
2023-01
0
4.54
2023-02
0
8.43
2023-03
0
4
2023-04
0
5.62
2023-05
0
6.33
2023-06
0
5.13
2023-07
0
3.6
2023-08
0
2.67
2023-09
0
4
2023-10
0
2.93
2023-11
0
3.25
2023-12
0
4.93
2024-01
0
3.75
2024-02
0
4.54
2024-03
0
3.69
2024-04
0
3.06
2024-05
0
2.13
2024-06
0
3.76
2024-07
0
3.8
2024-08
0
3.75
2024-09
0
2.71
2024-10
0
2.93
2024-11
0
5.69
2024-12
0
2.75
2025-01
0
3.9
2025-02
0
2.67
2025-03
0
3.38
2025-04
0
3
2025-05
0
5.19
2025-06
0
3.6
2025-07
0
2.23
2025-08
0
3.36
2025-09
0
2.89
2025-10
0
5.24
2025-11
0
3.94
2025-12
0
3.88
2026-01
0
12.36
2026-02
0
4.08
2026-03
0
4.73
2026-04
0
4.64
2026-05
0
6.05
2026-06
0
7.92
This device (reports/month)Average device in GAR (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Surgical Specialties México, S. de R.L. de C.V.