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AESCULAP
Model GD685 · Aesculap AG · DI 04046963336257
HBC — Motor, Drill, Electric · Class II · 21 CFR 882.4360
UDILibrary device dossier · generated 2026-09-11 · 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 (14)
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: 10 · Injury: 4
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
1.69
2019-02
0
3.17
2019-03
0
8.24
2019-04
0
4.93
2019-05
0
3.58
2019-06
0
4.13
2019-07
4
3.46
2019-08
0
4.29
2019-09
0
3.62
2019-10
0
3.65
2019-11
0
4
2019-12
0
4.41
2020-01
0
4.42
2020-02
0
3.64
2020-03
0
4.46
2020-04
0
3.95
2020-05
0
2.68
2020-06
0
5.32
2020-07
0
5
2020-08
4
3.79
2020-09
0
4.43
2020-10
0
4.07
2020-11
4
3.86
2020-12
0
5.38
2021-01
2
3.38
2021-02
0
4.09
2021-03
0
5.17
2021-04
0
3.69
2021-05
0
4.2
2021-06
0
5.35
2021-07
0
4.37
2021-08
0
4.07
2021-09
0
3.4
2021-10
0
2.62
2021-11
0
4.2
2021-12
0
3.1
2022-01
0
3.23
2022-02
0
3.12
2022-03
0
3.19
2022-04
0
3.41
2022-05
0
2.68
2022-06
0
4.21
2022-07
0
3
2022-08
0
4.21
2022-09
0
3.56
2022-10
0
3.26
2022-11
0
4.74
2022-12
0
4.26
2023-01
0
3.58
2023-02
0
3.65
2023-03
0
3.45
2023-04
0
4.71
2023-05
0
4.52
2023-06
0
3.91
2023-07
0
5.19
2023-08
0
3.08
2023-09
0
4.05
2023-10
0
3.11
2023-11
0
3.2
2023-12
0
3.5
2024-01
0
3.95
2024-02
0
4.11
2024-03
0
3.56
2024-04
0
4
2024-05
0
2.63
2024-06
0
3.5
2024-07
0
3.28
2024-08
0
3.17
2024-09
0
5.39
2024-10
0
3.38
2024-11
0
3.32
2024-12
0
4.15
2025-01
0
4
2025-02
0
7.82
2025-03
0
9.65
2025-04
0
2.83
2025-05
0
3.21
2025-06
0
3
2025-07
0
4.3
2025-08
0
3.48
2025-09
0
3.33
2025-10
0
4.67
2025-11
0
2.91
2025-12
0
2.64
2026-01
0
2.6
2026-02
0
2.94
2026-03
0
3.8
2026-04
0
3.86
2026-05
0
3
2026-06
0
1.85
This device (reports/month)Average device in HBC (reports/device/month)