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AESCULAP
Model GE244SU · Aesculap AG · DI 04046963728496
GFA — Blade, Saw, General & Plastic Surgery, Surgical · Class I · 21 CFR 878.4820
UDILibrary device dossier · generated 2026-09-06 · 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
1.53
2019-02
0
1.38
2019-03
0
1.55
2019-04
0
1.93
2019-05
0
1.19
2019-06
0
2.08
2019-07
0
4.69
2019-08
0
1.33
2019-09
0
1.46
2019-10
0
1.57
2019-11
0
2.21
2019-12
0
1.67
2020-01
0
1.41
2020-02
0
1.9
2020-03
0
1.45
2020-04
0
1.43
2020-05
0
1.4
2020-06
0
2.09
2020-07
0
1.8
2020-08
0
3.45
2020-09
0
1.74
2020-10
0
2.25
2020-11
0
1.29
2020-12
0
2.54
2021-01
0
1.29
2021-02
0
1.81
2021-03
0
1.63
2021-04
0
1.95
2021-05
0
2.07
2021-06
0
2
2021-07
0
2.46
2021-08
0
2.06
2021-09
0
2
2021-10
0
2.07
2021-11
0
1.81
2021-12
0
2
2022-01
0
2.79
2022-02
0
2.19
2022-03
0
1.89
2022-04
0
2.05
2022-05
0
2.54
2022-06
0
2.68
2022-07
0
2
2022-08
0
2.05
2022-09
0
1.79
2022-10
0
2.17
2022-11
0
2
2022-12
0
1.75
2023-01
0
1.67
2023-02
0
1.4
2023-03
0
1.96
2023-04
0
1.54
2023-05
0
1.89
2023-06
0
1.67
2023-07
0
1.37
2023-08
0
1.83
2023-09
0
2.38
2023-10
0
1.44
2023-11
0
2.5
2023-12
0
1.88
2024-01
0
2.1
2024-02
0
2.38
2024-03
0
2.5
2024-04
0
2
2024-05
0
2.95
2024-06
0
1.83
2024-07
0
1.64
2024-08
0
2
2024-09
0
2.56
2024-10
0
1.58
2024-11
0
1.56
2024-12
0
1.94
2025-01
0
1.49
2025-02
0
2
2025-03
0
1.5
2025-04
0
1.47
2025-05
0
4.14
2025-06
0
3
2025-07
0
1.23
2025-08
0
1.93
2025-09
0
1.6
2025-10
0
1.57
2025-11
0
1.77
2025-12
0
2.74
2026-01
0
1.71
2026-02
0
1.88
2026-03
0
2.22
2026-04
0
1.83
2026-05
0
2.06
2026-06
0
1.87
This device (reports/month)Average device in GFA (reports/device/month)