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MITEK
Model 242018 · Medos International Sàrl · DI 10886705029150
EOB — Nasopharyngoscope (Flexible Or Rigid) · Class II · 21 CFR 874.4760
HRX — Arthroscope · Class II · 21 CFR 888.1100
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 (1070)
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: 1070
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
8
12.39
2019-02
4
3.26
2019-03
4
5.22
2019-04
14
11.02
2019-05
14
4.51
2019-06
5
3.78
2019-07
6
3.4
2019-08
17
4.19
2019-09
11
4.66
2019-10
27
5.25
2019-11
28
4.89
2019-12
11
5.36
2020-01
15
5.33
2020-02
0
6.43
2020-03
15
5.4
2020-04
6
5.06
2020-05
3
3.54
2020-06
11
5.69
2020-07
9
5.86
2020-08
8
5.71
2020-09
15
7.31
2020-10
39
9.04
2020-11
11
6.24
2020-12
43
9.15
2021-01
7
6.12
2021-02
19
5.8
2021-03
9
8.38
2021-04
13
6.07
2021-05
17
6.06
2021-06
7
5.79
2021-07
16
4.87
2021-08
7
5.68
2021-09
6
4.17
2021-10
12
5.76
2021-11
10
4.26
2021-12
15
5.67
2022-01
11
6.19
2022-02
9
4.9
2022-03
13
5.79
2022-04
21
5.93
2022-05
11
5.29
2022-06
20
6.05
2022-07
6
6.53
2022-08
9
6.1
2022-09
10
5.86
2022-10
13
5.71
2022-11
15
5.67
2022-12
11
5.81
2023-01
9
6.21
2023-02
3
5.34
2023-03
19
6.94
2023-04
12
6.22
2023-05
6
5.47
2023-06
9
5.4
2023-07
4
5.3
2023-08
32
7.29
2023-09
22
6.75
2023-10
16
6.22
2023-11
12
9.39
2023-12
28
8.66
2024-01
2
6.29
2024-02
41
8.31
2024-03
15
6.66
2024-04
9
7.15
2024-05
32
8.38
2024-06
11
8.9
2024-07
10
6.82
2024-08
11
6.97
2024-09
7
6.28
2024-10
13
7.28
2024-11
8
6.55
2024-12
10
6.38
2025-01
2
7.06
2025-02
2
5.16
2025-03
2
4.81
2025-04
12
5.58
2025-05
4
5.38
2025-06
18
5.12
2025-07
8
5.69
2025-08
8
4.24
2025-09
4
4.25
2025-10
2
4.8
2025-11
14
5.3
2025-12
2
5.31
2026-01
10
4.86
2026-02
4
5.37
2026-03
10
4.94
2026-04
9
6.83
2026-05
3
5.51
2026-06
4
4.93
This device (reports/month)Average device in EOB, HRX (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Predicate lineage
K080560 — cited as predicate by K093677, K122411, K142194, K170862, K181819, K200216, K201349, K223759
K981751 — cited as predicate by K200216
Lineage extracted from public 510(k) summary text (heuristic).
Manufacturer compliance record — Medos International Sàrl