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AESCULAP
Model GC768R · Aesculap AG · DI 04046963413958
HAB — Saw, Powered, And Accessories · Class I · 21 CFR 878.4820
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 (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
7.44
2019-02
0
7.8
2019-03
0
21
2019-04
0
5.71
2019-05
0
6.73
2019-06
0
6.3
2019-07
0
12.5
2019-08
0
7.93
2019-09
0
9.8
2019-10
0
10.9
2019-11
0
11.36
2019-12
0
16.25
2020-01
0
15.13
2020-02
0
12.13
2020-03
0
25.29
2020-04
0
11
2020-05
0
14.4
2020-06
0
22.8
2020-07
0
35.09
2020-08
0
34.87
2020-09
0
42.23
2020-10
0
62.11
2020-11
0
28.19
2020-12
0
40.09
2021-01
0
48.14
2021-02
0
47.63
2021-03
0
59.5
2021-04
0
54.5
2021-05
0
50.13
2021-06
0
16.15
2021-07
0
15.29
2021-08
0
10.08
2021-09
0
9.64
2021-10
0
24.2
2021-11
0
18.67
2021-12
0
28.4
2022-01
0
23
2022-02
0
24.33
2022-03
0
12.43
2022-04
0
9.67
2022-05
0
13.83
2022-06
0
11.44
2022-07
0
12
2022-08
0
13.17
2022-09
0
18.25
2022-10
0
12.44
2022-11
0
16.43
2022-12
0
13.63
2023-01
0
36
2023-02
0
16.2
2023-03
0
13.44
2023-04
0
15
2023-05
0
10.56
2023-06
0
57.5
2023-07
0
21.67
2023-08
0
22.71
2023-09
0
16.5
2023-10
0
10.91
2023-11
0
16.56
2023-12
0
8.87
2024-01
0
13.38
2024-02
0
8.85
2024-03
0
11.83
2024-04
0
11.93
2024-05
0
10.59
2024-06
0
9.9
2024-07
0
8
2024-08
0
6.15
2024-09
0
3.67
2024-10
0
5.14
2024-11
0
7
2024-12
0
6.58
2025-01
0
5.56
2025-02
0
5.86
2025-03
0
9.22
2025-04
0
4.85
2025-05
0
5.42
2025-06
0
4.5
2025-07
0
6.82
2025-08
0
4.38
2025-09
0
7.64
2025-10
0
8.78
2025-11
0
5.15
2025-12
0
4.82
2026-01
0
5.82
2026-02
0
8.3
2026-03
0
6.31
2026-04
0
5.42
2026-05
0
6.56
2026-06
0
7.18
This device (reports/month)Average device in HAB (reports/device/month)