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" 5ml Syringe w/ 18g x 1"" Needle"
Model 1 · DISTRIBUTION UNLIMITED, LLC · DI 00850014433307
FMF — Syringe, Piston · Class II · 21 CFR 880.5860
FMI — Needle, Hypodermic, Single Lumen · Class II · 21 CFR 880.5570
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)
2019-01
0
2.66
2019-02
0
3.74
2019-03
0
2.85
2019-04
0
2.89
2019-05
0
3
2019-06
0
2.72
2019-07
0
2.92
2019-08
0
3.54
2019-09
0
3.63
2019-10
0
3.38
2019-11
0
3.04
2019-12
0
2.55
2020-01
0
2.92
2020-02
0
3.33
2020-03
0
2.88
2020-04
0
3.42
2020-05
0
3.5
2020-06
0
2.96
2020-07
0
3.39
2020-08
0
3.59
2020-09
0
3.49
2020-10
0
3.63
2020-11
0
3.12
2020-12
0
2.95
2021-01
0
3.04
2021-02
0
3.09
2021-03
0
3
2021-04
0
3.03
2021-05
0
3.05
2021-06
0
2.89
2021-07
0
2.96
2021-08
0
2.94
2021-09
0
3.61
2021-10
0
3.25
2021-11
0
2.45
2021-12
0
2.72
2022-01
0
2.91
2022-02
0
3.58
2022-03
0
2.7
2022-04
0
2.93
2022-05
0
2.77
2022-06
0
2.58
2022-07
0
2.88
2022-08
0
3.36
2022-09
0
3.75
2022-10
0
4.35
2022-11
0
5.94
2022-12
0
4.42
2023-01
0
3.92
2023-02
0
3.97
2023-03
0
4.78
2023-04
0
4.16
2023-05
0
4.42
2023-06
0
4.36
2023-07
0
4.73
2023-08
0
5.38
2023-09
0
4.79
2023-10
0
4.39
2023-11
0
4.08
2023-12
0
4.49
2024-01
0
3.99
2024-02
0
5.15
2024-03
0
6.68
2024-04
0
9.03
2024-05
0
10.93
2024-06
0
10.32
2024-07
0
8.91
2024-08
0
6.1
2024-09
0
4.97
2024-10
0
4.88
2024-11
0
3.58
2024-12
0
3.68
2025-01
0
2.83
2025-02
0
2.41
2025-03
0
2.34
2025-04
0
2.72
2025-05
0
2.96
2025-06
0
3.14
2025-07
0
2.15
2025-08
0
2.33
2025-09
0
2.29
2025-10
0
2.62
2025-11
0
2.99
2025-12
0
2.25
2026-01
0
2.52
2026-02
0
2.39
2026-03
0
2.32
2026-04
0
2.38
2026-05
0
2.36
2026-06
0
2.7
This device (reports/month)Average device in FMF, FMI (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — DISTRIBUTION UNLIMITED, LLC