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Unnamed device
Model 242437 · Medos International Sàrl · DI 10886705028610
FEM — Accessories, Photographic, For Endoscope (Exclude Light Sources) · Class I · 21 CFR 876.1500
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 (270)
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: 270
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-06
0
3
2019-08
0
3
2020-01
0
6
2020-02
0
3
2020-03
0
3
2020-07
0
4
2020-08
0
4.5
2020-09
0
3
2020-10
0
3.5
2020-11
0
2
2020-12
3
3
2021-01
1
1
2021-02
0
2
2021-03
0
2.5
2021-04
0
1
2021-06
0
1
2021-07
0
2
2021-08
1
1
2021-09
0
2
2021-10
2
2
2021-11
1
1
2021-12
2
3.5
2022-01
5
3.5
2022-03
4
2.5
2022-05
3
2.33
2022-06
3
2
2022-07
1
1
2022-08
0
2
2022-09
7
4
2022-10
8
7
2022-11
4
2.5
2022-12
8
4
2023-01
11
4.25
2023-02
7
5.67
2023-03
6
6
2023-04
7
7
2023-05
3
3
2023-06
8
3
2023-07
4
5
2023-08
10
10
2023-09
8
4.5
2023-10
1
2.75
2023-11
7
5.5
2023-12
8
5
2024-01
4
2.33
2024-02
5
5
2024-03
6
2.67
2024-04
1
2.75
2024-05
2
1.5
2024-06
3
3
2024-07
1
1
2024-08
5
3.5
2024-09
0
1.75
2024-10
5
2.25
2024-11
9
7
2024-12
8
8
2025-01
1
1
2025-02
6
6
2025-03
0
1
2025-04
6
4.5
2025-05
6
4
2025-06
10
5.5
2025-07
12
12
2025-08
2
2
2025-09
8
5
2025-10
4
4.5
2025-11
3
3
2025-12
0
4
2026-01
8
8
2026-02
2
2
2026-03
6
6
2026-04
8
4.5
2026-06
6
4
This device (reports/month)Average device in FEM (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Medos International Sàrl