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ACE
Model 0034227 · ACE SURGICAL SUPPLY CO., INC. · DI 00614950000159
GAM — Suture, Absorbable, Synthetic, Polyglycolic Acid · Class II · 21 CFR 878.4493
KGN — Wound Dressing With Animal-Derived Material(S)
NPL — Barrier, Animal Source, Intraoral · Class II · 21 CFR 872.3930
NPM — Bone Grafting Material, Animal Source · Class II · 21 CFR 872.3930
UDILibrary device dossier · generated 2026-09-12 · 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
2.98
2019-02
0
3.07
2019-03
0
2.23
2019-04
0
2.67
2019-05
0
3.34
2019-06
0
3.11
2019-07
0
2.77
2019-08
0
2.71
2019-09
0
3.01
2019-10
0
2.55
2019-11
0
2.97
2019-12
0
2.82
2020-01
0
3.38
2020-02
0
3.37
2020-03
0
3.43
2020-04
0
4.75
2020-05
0
3.59
2020-06
0
2.6
2020-07
0
4.91
2020-08
0
3.19
2020-09
0
4.29
2020-10
0
3.91
2020-11
0
2.97
2020-12
0
4.34
2021-01
0
4.87
2021-02
0
4.14
2021-03
0
4.07
2021-04
0
3.74
2021-05
0
4.65
2021-06
0
3.65
2021-07
0
4.86
2021-08
0
4.07
2021-09
0
4.92
2021-10
0
3.63
2021-11
0
3.52
2021-12
0
4.93
2022-01
0
3.88
2022-02
0
3.4
2022-03
0
4.38
2022-04
0
4.56
2022-05
0
4.2
2022-06
0
3.78
2022-07
0
4.06
2022-08
0
5.99
2022-09
0
6.05
2022-10
0
4.21
2022-11
0
5.24
2022-12
0
6.06
2023-01
0
4.36
2023-02
0
4.87
2023-03
0
5.48
2023-04
0
4.63
2023-05
0
4.54
2023-06
0
5.05
2023-07
0
3.84
2023-08
0
3.47
2023-09
0
4.15
2023-10
0
3.44
2023-11
0
4.05
2023-12
0
4.75
2024-01
0
3.68
2024-02
0
3.98
2024-03
0
4.39
2024-04
0
4.63
2024-05
0
2.97
2024-06
0
5.15
2024-07
0
4.27
2024-08
0
4.49
2024-09
0
4.42
2024-10
0
3.36
2024-11
0
4.08
2024-12
0
4.21
2025-01
0
5.99
2025-02
0
4.46
2025-03
0
5.24
2025-04
0
5.8
2025-05
0
4.84
2025-06
0
4.94
2025-07
0
4.24
2025-08
0
4.46
2025-09
0
4.15
2025-10
0
4.32
2025-11
0
4.65
2025-12
0
5.73
2026-01
0
5.23
2026-02
0
4.96
2026-03
0
4.15
2026-04
0
4.28
2026-05
0
4.16
2026-06
0
4.79
This device (reports/month)Average device in GAM, KGN, NPL, NPM (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — ACE SURGICAL SUPPLY CO., INC.
VAI 2015-07-23 Ace Surgical Supply Co., Inc. · 5 citations