Print-ready dossier — use your browser's print dialog to save as PDF.
ACE
Model 3005119 · ACE SURGICAL SUPPLY CO., INC. · DI 00614950023929
HXK — Holder, Needle; Orthopedic · Class I · 21 CFR 888.4540
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
2
2019-02
0
1
2019-04
0
2
2019-05
0
2
2019-06
0
1
2019-11
0
2
2019-12
0
1
2020-01
0
2
2020-05
0
2.5
2020-06
0
2
2020-07
0
2
2020-10
0
2
2020-11
0
2.5
2020-12
0
1
2021-01
0
2
2021-03
0
2
2021-04
0
3
2021-09
0
2
2021-10
0
3
2021-11
0
4.5
2022-03
0
3
2022-05
0
2
2022-07
0
2
2022-10
0
4
2022-11
0
1
2023-01
0
2
2023-05
0
1.5
2023-06
0
3
2023-07
0
1
2023-08
0
1
2023-09
0
2
2024-05
0
2
2024-06
0
2
2025-05
0
1
2025-06
0
2
2025-07
0
1.5
2025-10
0
1
2026-02
0
4
This device (reports/month)Average device in HXK (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