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Avenir
Model 10USH01001 · Shanghai Wallaby Medical Technologies Co., Inc. · DI 06970908212444
HCG — Device, Neurovascular Embolization · Class II · 21 CFR 882.5950
KRD — Device, Vascular, For Promoting Embolization · Class II · 21 CFR 870.3300
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
1.41
2019-02
0
1.41
2019-03
0
1.49
2019-04
0
1.52
2019-05
0
1.13
2019-06
0
1.09
2019-07
0
1.08
2019-08
0
1.1
2019-09
0
1.56
2019-10
0
1.56
2019-11
0
2.7
2019-12
0
1.18
2020-01
0
1.17
2020-02
0
2
2020-03
0
2.01
2020-04
0
2.78
2020-05
0
1.62
2020-06
0
1.19
2020-07
0
2.24
2020-08
0
2.06
2020-09
0
4.96
2020-10
0
2.47
2020-11
0
1.33
2020-12
0
2.3
2021-01
0
1.26
2021-02
0
1.24
2021-03
0
1.41
2021-04
0
2.04
2021-05
0
2.13
2021-06
0
1.34
2021-07
0
2.06
2021-08
0
2.11
2021-09
0
1.31
2021-10
0
2.54
2021-11
0
2.5
2021-12
0
4.07
2022-01
0
3.43
2022-02
0
1.45
2022-03
0
1.87
2022-04
0
1.42
2022-05
0
1.08
2022-06
0
1.08
2022-07
0
1.31
2022-08
0
1.87
2022-09
0
1.06
2022-10
0
3.49
2022-11
0
1.09
2022-12
0
1.08
2023-01
0
1.08
2023-02
0
1.06
2023-03
0
1.89
2023-04
0
2.75
2023-05
0
1.07
2023-06
0
1.83
2023-07
0
1.93
2023-08
0
1.51
2023-09
0
1.31
2023-10
0
1.44
2023-11
0
1.53
2023-12
0
1.24
2024-01
0
1.54
2024-02
0
1.28
2024-03
0
1.33
2024-04
0
1.35
2024-05
0
1.37
2024-06
0
1.32
2024-07
0
1.34
2024-08
0
1.31
2024-09
0
1.45
2024-10
0
1.45
2024-11
0
1.53
2024-12
0
1.59
2025-01
0
1.46
2025-02
0
1.69
2025-03
0
1.57
2025-04
0
1.53
2025-05
0
1.52
2025-06
0
1.79
2025-07
0
1.67
2025-08
0
1.56
2025-09
0
1.51
2025-10
0
1.61
2025-11
0
1.41
2025-12
0
1.81
2026-01
0
1.54
2026-02
0
1.63
2026-03
0
1.6
2026-04
0
1.83
2026-05
0
1.69
2026-06
0
1.64
This device (reports/month)Average device in HCG, KRD (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Shanghai Wallaby Medical Technologies Co., Inc.