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Alton
Model AF-GBW · Alton (Shanghai) Medical Instruments Co., Ltd. · DI 06970800686855
MNK — Endoscopic Bite Block · Class I · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-13 · 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)
2019-03
0
2
2019-05
0
1
2019-07
0
1
2019-09
0
2
2019-12
0
1
2020-01
0
2
2020-05
0
1
2020-07
0
1
2020-10
0
1.5
2021-03
0
1
2021-04
0
1
2021-06
0
1
2021-08
0
1
2021-11
0
1
2021-12
0
1
2022-01
0
1
2022-03
0
1
2022-05
0
1
2022-07
0
4
2022-08
0
1
2023-04
0
1
2023-06
0
1
2023-12
0
1
2024-01
0
1
2024-02
0
1
2024-03
0
1
2024-04
0
1
2024-05
0
1
2024-08
0
1
2024-10
0
3
2025-01
0
1
2025-02
0
1
2025-03
0
2
2025-04
0
3
2025-05
0
1
2025-06
0
2
2025-07
0
1.5
2025-11
0
1
2025-12
0
1
2026-02
0
1
2026-03
0
1
2026-04
0
1.5
2026-05
0
1
This device (reports/month)Average device in MNK (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Alton (Shanghai) Medical Instruments Co., Ltd.