Model EUS-19-0-FS2 · Micro-Tech (Nanjing) Co., Ltd. · DI 06932503534864
ODG — Endoscopic Ultrasound System, Gastroenterology-Urology · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-15 · 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
1.75
2019-02
0
1.33
2019-03
0
1
2019-04
0
2.25
2019-05
0
2.67
2019-06
0
5.5
2019-07
0
3.5
2019-08
0
1.5
2019-09
0
3.17
2019-10
0
3.75
2019-11
0
3
2019-12
0
2.83
2020-01
0
1.2
2020-02
0
6.5
2020-03
0
2.88
2020-04
0
4.6
2020-05
0
3.5
2020-06
0
5.71
2020-07
0
7.38
2020-08
0
4.09
2020-09
0
2.71
2020-10
0
7.36
2020-11
0
6.07
2020-12
0
13.83
2021-01
0
11.41
2021-02
0
7.46
2021-03
0
10.73
2021-04
0
9.44
2021-05
0
11.73
2021-06
0
20.57
2021-07
0
11.88
2021-08
0
13.75
2021-09
0
16.1
2021-10
0
9
2021-11
0
9.18
2021-12
0
15.75
2022-01
0
10.15
2022-02
0
12.21
2022-03
0
11.14
2022-04
0
14.19
2022-05
0
13.56
2022-06
0
12.25
2022-07
0
13
2022-08
0
8.09
2022-09
0
7
2022-10
0
6.13
2022-11
0
6.57
2022-12
0
9.18
2023-01
0
8.09
2023-02
0
7.17
2023-03
0
7.58
2023-04
0
5.92
2023-05
0
6.36
2023-06
0
5.64
2023-07
0
5.85
2023-08
0
7.36
2023-09
0
7.77
2023-10
0
9.42
2023-11
0
6.31
2023-12
0
7.17
2024-01
0
11.25
2024-02
0
7.5
2024-03
0
7.15
2024-04
0
7.08
2024-05
0
6.45
2024-06
0
9.55
2024-07
0
6.46
2024-08
0
13
2024-09
0
4.5
2024-10
0
6.95
2024-11
0
5.33
2024-12
0
4.67
2025-01
0
3.08
2025-02
0
3.22
2025-03
0
3.56
2025-04
0
4.57
2025-05
0
4.89
2025-06
0
4.56
2025-07
0
5.17
2025-08
0
7.17
2025-09
0
14.86
2025-10
0
26.13
2025-11
0
63.14
2025-12
0
71.58
2026-01
0
47.4
2026-02
0
15.25
2026-03
0
20.25
2026-04
0
37.55
2026-05
0
35
2026-06
0
35.85
This device (reports/month)Average device in ODG (reports/device/month)