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Bassinest
Model 3957 · HALO INNOVATIONS, INC. · DI 00818771039606
FMS — Bed, Pediatric Open Hospital · Class II · 21 CFR 880.5140
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
4
2019-04
0
5
2019-05
0
1
2019-07
0
4
2019-10
0
6
2019-11
0
4
2020-01
0
3
2020-04
0
4
2020-06
0
1
2020-07
0
3
2020-10
0
4
2021-01
0
4
2021-02
0
1
2021-04
0
3
2021-07
0
4
2021-10
0
3
2022-01
0
2
2022-04
0
3
2022-07
0
3
2022-10
0
3
2023-01
0
4
2023-04
0
3
2023-05
0
1
2023-07
0
4
2023-10
0
4
2024-01
0
3
2024-04
0
3
2024-06
0
2
2024-07
0
1
2024-10
0
5
2025-01
0
5
2025-04
0
6
2025-07
0
3
2025-10
0
4
2025-12
0
1
2026-01
0
3
2026-04
0
4
This device (reports/month)Average device in FMS (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — HALO INNOVATIONS, INC.