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FMS VUE II
Model 284004 · Medos International Sàrl · DI 10886705027934
HRX — Arthroscope · Class II · 21 CFR 888.1100
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 (902)
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.
Malfunction: 838 · Injury: 64
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
13.41
2019-02
5
3.29
2019-03
3
3.78
2019-04
3
4.27
2019-05
8
4.18
2019-06
2
3.67
2019-07
10
3.38
2019-08
5
3.9
2019-09
7
4.55
2019-10
13
5.02
2019-11
8
4.63
2019-12
9
5.21
2020-01
17
5.18
2020-02
9
5.84
2020-03
3
5.61
2020-04
0
5
2020-05
1
3.51
2020-06
6
5.69
2020-07
10
6.15
2020-08
3
5.71
2020-09
15
7.49
2020-10
12
8.72
2020-11
12
5.95
2020-12
9
8.86
2021-01
3
6.31
2021-02
9
5.77
2021-03
2
7.8
2021-04
7
6.1
2021-05
3
5.63
2021-06
3
5.7
2021-07
2
4.96
2021-08
2
5.25
2021-09
4
3.47
2021-10
3
5.1
2021-11
2
3.78
2021-12
3
5.41
2022-01
0
4.97
2022-02
7
3.74
2022-03
5
4.39
2022-04
6
4.17
2022-05
13
4.13
2022-06
6
4.35
2022-07
7
4.38
2022-08
3
4.33
2022-09
10
4.16
2022-10
20
4.1
2022-11
8
4.7
2022-12
8
4.67
2023-01
11
5.09
2023-02
3
4.36
2023-03
10
5.24
2023-04
6
4.82
2023-05
6
4.84
2023-06
7
4.5
2023-07
15
4.29
2023-08
12
5.05
2023-09
4
4.83
2023-10
8
4.41
2023-11
20
7.93
2023-12
17
8.8
2024-01
17
6.2
2024-02
25
6.57
2024-03
20
5.26
2024-04
20
5.97
2024-05
8
8.82
2024-06
25
8.82
2024-07
20
4.91
2024-08
13
4.86
2024-09
31
4.76
2024-10
19
6.15
2024-11
12
5.22
2024-12
11
7.58
2025-01
12
8.91
2025-02
10
6.11
2025-03
13
5.08
2025-04
25
5.43
2025-05
17
5.98
2025-06
20
5.09
2025-07
18
5.28
2025-08
11
4.37
2025-09
10
4.58
2025-10
11
5.09
2025-11
9
5.68
2025-12
20
5.94
2026-01
7
5.53
2026-02
11
5.56
2026-03
9
5.59
2026-04
23
7
2026-05
19
4.7
2026-06
11
4.85
This device (reports/month)Average device in HRX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Medos International Sàrl