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Unnamed device
Model A-001-256 · Doppkon GmbH & Co. KG · DI 04262494462733
MDM — Instrument, Manual, Surgical, General Use · Class I · 21 CFR 878.4800
UDILibrary device dossier · generated 2026-09-12 · 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
8.4
2019-02
0
3.5
2019-03
0
3.8
2019-04
0
6.67
2019-05
0
6.2
2019-06
0
3.8
2019-07
0
5
2019-08
0
7
2019-09
0
2.86
2019-10
0
2.22
2019-11
0
1.83
2019-12
0
7.17
2020-01
0
2.8
2020-02
0
4
2020-03
0
3.75
2020-04
0
3.67
2020-05
0
1.5
2020-06
0
5.67
2020-07
0
2.29
2020-08
0
3.4
2020-09
0
3.5
2020-10
0
5
2020-11
0
4
2020-12
0
3.57
2021-01
0
7
2021-02
0
2.67
2021-03
0
3.08
2021-04
0
3.17
2021-05
0
2.33
2021-06
0
2.78
2021-07
0
2.5
2021-08
0
6.83
2021-09
0
5.8
2021-10
0
4.63
2021-11
0
2.57
2021-12
0
4.22
2022-01
0
2.88
2022-02
0
6.33
2022-03
0
5.43
2022-04
0
4.89
2022-05
0
4.6
2022-06
0
5.25
2022-07
0
2.92
2022-08
0
3.5
2022-09
0
3.2
2022-10
0
2.9
2022-11
0
2.91
2022-12
0
2.8
2023-01
0
4.38
2023-02
0
3.86
2023-03
0
4
2023-04
0
5
2023-05
0
2.92
2023-06
0
3.86
2023-07
0
3.8
2023-08
0
3.91
2023-09
0
3.45
2023-10
0
5.46
2023-11
0
9.63
2023-12
0
22.25
2024-01
0
8.78
2024-02
0
7.85
2024-03
0
11
2024-04
0
10.04
2024-05
0
3.78
2024-06
0
3.98
2024-07
0
9.5
2024-08
0
3.92
2024-09
0
3
2024-10
0
4.15
2024-11
0
5.27
2024-12
0
2.94
2025-01
0
3.75
2025-02
0
3.18
2025-03
0
5.89
2025-04
0
6.2
2025-05
0
6.73
2025-06
0
8.08
2025-07
0
6.76
2025-08
0
9.17
2025-09
0
7.75
2025-10
0
8.44
2025-11
0
7.14
2025-12
0
13.42
2026-01
0
8.25
2026-02
0
9.08
2026-03
0
10
2026-04
0
9.77
2026-05
0
3.31
2026-06
0
3.57
This device (reports/month)Average device in MDM (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Doppkon GmbH & Co. KG