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AESCULAP
Model PL549S · Aesculap AG · DI 04046963094096
DXC — Clamp, Vascular · Class II · 21 CFR 870.4450
UDILibrary device dossier · generated 2026-09-10 · 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
2.6
2019-02
0
4.67
2019-03
0
6.25
2019-04
0
6.57
2019-05
0
3.38
2019-06
0
3.64
2019-07
0
6.88
2019-08
0
5.29
2019-09
0
3.67
2019-10
0
3.88
2019-11
0
4.67
2019-12
0
6.5
2020-01
0
6
2020-02
0
5.14
2020-03
0
6
2020-04
0
5.2
2020-05
0
3.29
2020-06
0
8
2020-07
0
5.89
2020-08
0
12.6
2020-09
0
6.71
2020-10
0
7.14
2020-11
0
9.14
2020-12
0
7.38
2021-01
0
3.25
2021-02
0
7
2021-03
0
6.44
2021-04
0
6.29
2021-05
0
3.8
2021-06
0
7.7
2021-07
0
7.5
2021-08
0
7
2021-09
0
2.57
2021-10
0
7.2
2021-11
0
14.6
2021-12
0
6.75
2022-01
0
5.78
2022-02
0
8.6
2022-03
0
4
2022-04
0
3.6
2022-05
0
6.8
2022-06
0
9
2022-07
0
3.25
2022-08
0
3
2022-09
0
5.75
2022-10
0
2.4
2022-11
0
6.8
2022-12
0
5.2
2023-01
0
9.5
2023-02
0
20.83
2023-03
0
14.86
2023-04
0
12.29
2023-05
0
19.6
2023-06
0
35.88
2023-07
0
25.71
2023-08
0
9.36
2023-09
0
8.5
2023-10
0
7
2023-11
0
8.42
2023-12
0
14.86
2024-01
0
9
2024-02
0
9.83
2024-03
0
12.13
2024-04
0
11
2024-05
0
14.63
2024-06
0
15.25
2024-07
0
15.25
2024-08
0
21
2024-09
0
16
2024-10
0
12
2024-11
0
17.43
2024-12
0
12.33
2025-01
0
10.5
2025-02
0
16.5
2025-03
0
10.7
2025-04
0
10.5
2025-05
0
10.6
2025-06
0
21.71
2025-07
0
13.92
2025-08
0
8.56
2025-09
0
12.86
2025-10
0
10
2025-11
0
9.38
2025-12
0
6.46
2026-01
0
8.5
2026-02
0
4
2026-03
0
16
2026-04
0
17.09
2026-05
0
8.71
2026-06
0
15.71
This device (reports/month)Average device in DXC (reports/device/month)