Model 3642 · Dynarex Corporation · DI 00616784364216
KGX — Tape And Bandage, Adhesive · Class I · 21 CFR 880.5240
NAD — Dressing, Wound, Occlusive · Class I · 21 CFR 878.4020
UDILibrary device dossier · generated 2026-09-15 · 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
1.5
2019-02
0
1.3
2019-03
0
1.14
2019-04
0
2.09
2019-05
0
1.7
2019-06
0
2.33
2019-07
0
1.5
2019-08
0
2.5
2019-09
0
2
2019-10
0
1.2
2019-11
0
1.25
2019-12
0
1
2020-01
0
1.67
2020-02
0
1.29
2020-03
0
4.11
2020-04
0
1.5
2020-05
0
1.5
2020-06
0
2.2
2020-07
0
2.44
2020-08
0
1.62
2020-09
0
4.37
2020-10
0
5
2020-11
0
3.76
2020-12
0
11.64
2021-01
0
3.53
2021-02
0
3.38
2021-03
0
4.42
2021-04
0
8.09
2021-05
0
3.75
2021-06
0
3.08
2021-07
0
1.75
2021-08
0
4.3
2021-09
0
3.4
2021-10
0
3.6
2021-11
0
3
2021-12
0
3
2022-01
0
3.75
2022-02
0
3
2022-03
0
2.82
2022-04
0
2
2022-05
0
2.25
2022-06
0
5.33
2022-07
0
3
2022-08
0
1.2
2022-09
0
30.33
2022-10
0
5
2022-11
0
3.5
2022-12
0
1
2023-01
0
3.67
2023-02
0
2
2023-03
0
2.25
2023-04
0
2.38
2023-05
0
2.43
2023-06
0
4
2023-07
0
2.5
2023-08
0
3.57
2023-09
0
94
2023-10
0
130.33
2023-11
0
51.25
2023-12
0
10
2024-01
0
5.5
2024-02
0
37
2024-03
0
2
2024-04
0
5
2024-05
0
2.33
2024-06
0
9.63
2024-07
0
19.64
2024-08
0
4.8
2024-09
0
41.86
2024-10
0
17.35
2024-11
0
3.89
2024-12
0
1.43
2025-01
0
33.58
2025-02
0
152.67
2025-03
0
11.67
2025-04
0
1.88
2025-05
0
17.43
2025-06
0
16.44
2025-07
0
5.53
2025-08
0
8.78
2025-09
0
21.18
2025-10
0
5.2
2025-11
0
35.13
2025-12
0
18.11
2026-01
0
18.73
2026-02
0
7
2026-03
0
5.7
2026-04
0
18.82
2026-05
0
6.68
2026-06
0
3.37
This device (reports/month)Average device in KGX, NAD (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — Dynarex Corporation