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Unnamed device
Model 214646 · Medos International Sàrl · DI 10886705004270
FZT — Cutter, Surgical · Class I · 21 CFR 878.4800
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 (352)
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: 352
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-01
4
3
2019-03
1
1
2019-04
2
2
2019-05
2
2
2019-06
0
2
2019-07
1
1
2019-09
6
2
2019-10
9
9
2019-11
0
1
2019-12
1
1
2020-01
2
1.5
2020-02
2
2
2020-03
5
3
2020-05
4
4
2020-06
1
1
2020-07
7
4
2020-08
1
1
2020-09
1
1
2020-10
3
2.67
2020-11
5
3
2020-12
7
7
2021-01
3
3
2021-02
3
2
2021-03
7
4.5
2021-04
3
3.75
2021-05
4
4
2021-06
7
4
2021-07
5
5
2021-08
2
2
2021-09
2
2
2021-10
3
2.5
2021-11
2
2
2021-12
1
1
2022-01
4
2
2022-02
3
2
2022-03
1
1.5
2022-04
6
3.5
2022-05
4
4
2022-06
6
6
2022-07
5
2.67
2022-08
10
5.5
2022-09
4
2.33
2022-10
6
6
2022-11
7
7
2022-12
6
6
2023-01
5
5
2023-02
2
2
2023-03
5
3
2023-04
4
4
2023-05
8
8
2023-06
5
5
2023-07
4
4
2023-08
5
3
2023-09
1
1
2023-10
7
4
2023-11
3
3
2023-12
2
2
2024-01
3
2
2024-02
5
3
2024-03
4
4
2024-04
4
4
2024-05
2
2
2024-06
15
15
2024-07
14
14
2024-08
9
5.5
2024-09
5
5
2024-10
6
6
2024-11
3
3
2024-12
3
2
2025-01
6
6
2025-02
2
1.5
2025-03
7
7
2025-04
2
2
2025-06
8
8
2025-07
10
10
2025-08
5
5
2025-09
2
2
2025-10
2
2
2025-11
2
2
2025-12
3
3
2026-02
1
1
2026-03
5
3
2026-04
2
1.5
2026-05
1
1
2026-06
2
2
This device (reports/month)Average device in FZT (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Medos International Sàrl