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Alleset
Model Model 25-3011-S2 · GRI Medical & Electronic Technology Co., Ltd. · DI 16931918173153
FTA — Light, Surgical, Accessories · Class II · 21 CFR 878.4580
UDILibrary device dossier · generated 2026-09-12 · 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)
2019-08
0
2
2020-04
0
2
2020-09
0
1
2020-12
0
2
2021-05
0
2
2021-07
0
3
2021-09
0
1
2021-11
0
3
2021-12
0
1
2022-02
0
1
2022-07
0
1
2023-01
0
2
2023-02
0
23.5
2023-03
0
15
2023-04
0
6
2023-05
0
2
2023-06
0
1
2023-07
0
1
2023-08
0
1
2023-10
0
9
2024-01
0
8.67
2024-02
0
1
2024-03
0
9
2024-04
0
3.5
2024-05
0
1
2024-06
0
2
2024-09
0
1
2024-10
0
1
2025-01
0
3
2025-02
0
2.67
2025-03
0
1
2025-04
0
1.5
2025-05
0
1.5
2025-08
0
1.33
2025-10
0
1.5
2025-11
0
1
2025-12
0
6
2026-01
0
6
2026-02
0
1.5
2026-03
0
4.4
2026-04
0
5.33
2026-05
0
2.2
2026-06
0
4
This device (reports/month)Average device in FTA (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — GRI Medical & Electronic Technology Co., Ltd.
Warning Letter 2013-05-01 GRI Medical & Electronic Technology Co., Ltd.
NAI 2016-09-22 GRI Medical & Electronic Technology Co., Ltd. · 0 citations
NAI 2014-08-14 GRI Medical & Electronic Technology Co., Ltd. · 0 citations