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Bioseal Inc.
Model 19986/50 · BIOSEAL · DI 00630094199863
KGS — Retention Device, Suture · Class I · 21 CFR 878.4930
UDILibrary device dossier · generated 2026-09-14 · 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)
2020-05
0
2.5
2020-09
0
6
2021-01
0
2
2021-04
0
3
2022-06
0
2
2022-08
0
2
2022-10
0
2
2023-07
0
2
2023-10
0
2
2023-11
0
2
2023-12
0
4
2024-04
0
4
2024-05
0
4
2024-06
0
2
2024-10
0
4
2025-02
0
4
2025-05
0
2
2025-07
0
2
2025-09
0
1
2025-11
0
2
This device (reports/month)Average device in KGS (reports/device/month)