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AESCULAP
Model US751 · AESCULAP, INC. · DI 04038653473731
FRG — Wrap, Sterilization · Class II · 21 CFR 880.6850
KCT — Sterilization Wrap Containers, Trays, Cassettes & Other Accessories · Class II · 21 CFR 880.6850
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 (148)
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: 147 · Injury: 1
Monthly adverse-event reports for this device versus the product-code average.
Month
This device (reports)
Product-code average (reports per device)
2019-03
0
2
2019-04
0
3
2019-05
10
10
2019-06
4
4
2019-07
0
3
2019-09
4
3.33
2019-11
0
2
2020-01
0
1
2020-02
3
3
2020-03
0
1.5
2020-05
0
2
2020-06
0
1
2020-11
0
2
2020-12
0
28
2021-01
0
2
2021-02
0
6
2021-03
0
2.33
2021-05
0
3
2021-06
0
3.5
2021-07
0
3
2021-09
0
2.75
2021-10
0
6
2021-11
0
3
2021-12
0
3
2022-02
0
1
2022-05
0
6
2022-06
0
1.5
2022-08
0
6
2022-10
3
2.33
2023-04
0
3
2023-05
6
3.67
2023-06
3
2.2
2023-07
1
1.33
2023-08
0
1
2023-09
0
2
2023-11
25
17.33
2023-12
18
12.33
2024-01
1
1
2024-02
2
2
2024-03
0
1
2024-04
0
2
2024-05
0
1.6
2024-06
0
6.8
2024-07
0
2
2024-09
3
3
2024-10
0
1
2024-11
0
3
2024-12
0
1
2025-01
0
16.33
2025-02
3
2.33
2025-03
0
2.25
2025-04
3
4.4
2025-05
1
3.33
2025-06
28
10
2025-07
0
1
2025-08
12
6.4
2025-09
0
1
2025-10
0
1.67
2025-11
0
4.67
2025-12
0
1.5
2026-01
0
2.7
2026-02
6
3.14
2026-03
0
1
2026-04
0
1
2026-05
4
2.6
2026-06
8
3.57
This device (reports/month)Average device in FRG, KCT (reports/device/month)