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"Ds26 2-0 Uctd Whtbrdpvn 18""/45"
Model F665D · Surgical Specialties México, S. de R.L. de C.V. · DI 00848782014019
GAT — Suture, Nonabsorbable, Synthetic, Polyethylene · Class II · 21 CFR 878.5000
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
6.09
2019-02
0
5.59
2019-03
0
6.19
2019-04
0
7.81
2019-05
0
6.19
2019-06
0
4
2019-07
0
6.26
2019-08
0
7.14
2019-09
0
8.45
2019-10
0
6.87
2019-11
0
8.74
2019-12
0
7.84
2020-01
0
7.88
2020-02
0
5.09
2020-03
0
11.85
2020-04
0
10.61
2020-05
0
8.36
2020-06
0
6.16
2020-07
0
7.48
2020-08
0
8.52
2020-09
0
7.38
2020-10
0
10
2020-11
0
11.68
2020-12
0
11.65
2021-01
0
15.59
2021-02
0
13.16
2021-03
0
9.9
2021-04
0
11.75
2021-05
0
9.33
2021-06
0
7.84
2021-07
0
12.05
2021-08
0
9.17
2021-09
0
9.29
2021-10
0
11.68
2021-11
0
9.78
2021-12
0
10
2022-01
0
7.76
2022-02
0
11.54
2022-03
0
10.67
2022-04
0
6.19
2022-05
0
8.31
2022-06
0
7.57
2022-07
0
6.16
2022-08
0
8.39
2022-09
0
6.64
2022-10
0
8.06
2022-11
0
11.06
2022-12
0
8.96
2023-01
0
11.86
2023-02
0
12.58
2023-03
0
14.73
2023-04
0
14.78
2023-05
0
13.18
2023-06
0
16.77
2023-07
0
17.81
2023-08
0
20.46
2023-09
0
13.43
2023-10
0
16.51
2023-11
0
9.24
2023-12
0
15.57
2024-01
0
10.25
2024-02
0
16.66
2024-03
0
40.35
2024-04
0
61.7
2024-05
0
72.31
2024-06
0
69.97
2024-07
0
55.17
2024-08
0
32.98
2024-09
0
28.96
2024-10
0
17.14
2024-11
0
15.37
2024-12
0
10.96
2025-01
0
8.77
2025-02
0
7.59
2025-03
0
7.76
2025-04
0
10.04
2025-05
0
12.83
2025-06
0
13.22
2025-07
0
7.86
2025-08
0
7.7
2025-09
0
7
2025-10
0
7.05
2025-11
0
16.97
2025-12
0
8.75
2026-01
0
8.62
2026-02
0
18.97
2026-03
0
8.78
2026-04
0
11.63
2026-05
0
11.57
2026-06
0
14.08
This device (reports/month)Average device in GAT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Surgical Specialties México, S. de R.L. de C.V.