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AESCULAP
Model FV019T · Christoph Miethke GmbH & Co. KG · DI 04041906118907
JXG — Shunt, Central Nervous System And Components · Class II · 21 CFR 882.5550
UDILibrary device dossier · generated 2026-09-07 · 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
1.38
2019-02
0
2.07
2019-03
0
1.86
2019-04
0
1.8
2019-05
0
2.52
2019-06
0
1.81
2019-07
0
2.87
2019-08
0
2.39
2019-09
0
2.16
2019-10
0
2.25
2019-11
0
1.76
2019-12
0
1.96
2020-01
0
2.51
2020-02
0
2.24
2020-03
0
2.38
2020-04
0
1.71
2020-05
0
2.13
2020-06
0
2.92
2020-07
0
1.97
2020-08
0
2.47
2020-09
0
2.13
2020-10
0
2.37
2020-11
0
2.59
2020-12
0
2.07
2021-01
0
2.09
2021-02
0
2.25
2021-03
0
2.07
2021-04
0
3.48
2021-05
0
2.14
2021-06
0
2.22
2021-07
0
2.2
2021-08
0
2.39
2021-09
0
3.76
2021-10
0
3.29
2021-11
0
3.34
2021-12
0
4.77
2022-01
0
2.43
2022-02
0
2.09
2022-03
0
1.88
2022-04
0
1.84
2022-05
0
1.85
2022-06
0
2.07
2022-07
0
1.95
2022-08
0
2.16
2022-09
0
1.82
2022-10
0
2.64
2022-11
0
2.04
2022-12
0
2.33
2023-01
0
1.96
2023-02
0
2.4
2023-03
0
1.91
2023-04
0
2.09
2023-05
0
1.95
2023-06
0
2.06
2023-07
0
2
2023-08
0
2.32
2023-09
0
1.98
2023-10
0
2.02
2023-11
0
5.85
2023-12
0
2.78
2024-01
0
1.83
2024-02
0
1.93
2024-03
0
1.88
2024-04
0
2.01
2024-05
0
2.03
2024-06
0
1.82
2024-07
0
2.17
2024-08
0
1.84
2024-09
0
2.21
2024-10
0
2.08
2024-11
0
2.31
2024-12
0
2.14
2025-01
0
1.75
2025-02
0
2.61
2025-03
0
2.57
2025-04
0
2.4
2025-05
0
2.64
2025-06
0
2.82
2025-07
0
2.35
2025-08
0
1.95
2025-09
0
1.86
2025-10
0
2.57
2025-11
0
2.5
2025-12
0
2.67
2026-01
0
2.19
2026-02
0
2.52
2026-03
0
2.57
2026-04
0
1.95
2026-05
0
2.21
2026-06
0
1.92
This device (reports/month)Average device in JXG (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Christoph Miethke GmbH & Co. KG