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AQ-Flex™19
Model 211-0128 · MAUNA KEA TECHNOLOGIES · DI 03760187910109
OWN — Confocal Optical Imaging · Class II · 21 CFR 876.1500
UDILibrary device dossier · generated 2026-09-06 · 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
2019-03
0
1
2019-04
0
2
2019-05
0
2
2019-06
0
1.67
2019-07
0
1.5
2019-08
0
1.5
2019-09
0
1
2019-10
0
2.75
2019-11
0
2.5
2019-12
0
5
2020-01
0
1.67
2020-02
0
2.5
2020-03
0
1.67
2020-04
0
1
2020-05
0
1.5
2020-06
0
4
2020-07
0
2.17
2020-08
0
2.2
2020-09
0
2.6
2020-10
0
3.33
2020-11
0
2
2020-12
0
2.33
2021-01
0
3.4
2021-02
0
2
2021-03
0
3.43
2021-04
0
5.4
2021-05
0
2.88
2021-06
0
2.88
2021-07
0
3.29
2021-08
0
3.38
2021-09
0
4.25
2021-10
0
3
2021-11
0
3.29
2021-12
0
6
2022-01
0
3.71
2022-02
0
8.4
2022-03
0
6.33
2022-04
0
5.83
2022-05
0
12.63
2022-06
0
10.83
2022-07
0
5.57
2022-08
0
4.4
2022-09
0
3.9
2022-10
0
4.38
2022-11
0
5.9
2022-12
0
4.75
2023-01
0
5.29
2023-02
0
4.63
2023-03
0
6.27
2023-04
0
7.25
2023-05
0
7.75
2023-06
0
4.7
2023-07
0
6.75
2023-08
0
8
2023-09
0
10.14
2023-10
0
7.44
2023-11
0
8.22
2023-12
0
8.88
2024-01
0
7.91
2024-02
0
15.86
2024-03
0
14
2024-04
0
11.11
2024-05
0
11.71
2024-06
0
18.83
2024-07
0
22.4
2024-08
0
13
2024-09
0
12.86
2024-10
0
13.71
2024-11
0
6.25
2024-12
0
9.67
2025-01
0
8
2025-02
0
3.63
2025-03
0
5.5
2025-04
0
4.33
2025-05
0
4.4
2025-06
0
5
2025-07
0
6.88
2025-08
0
4.8
2025-09
0
3.83
2025-10
0
4.23
2025-11
0
3.71
2025-12
0
4.79
2026-01
0
4.9
2026-02
0
3.5
2026-03
0
4
2026-04
0
6.21
2026-05
0
4.2
2026-06
0
3.87
This device (reports/month)Average device in OWN (reports/device/month)
Regulatory clearances
None linked in the loaded window.
Manufacturer compliance record — MAUNA KEA TECHNOLOGIES
NAI 2024-07-04 Mauna Kea Technologies · 0 citations
NAI 2024-07-04 Mauna Kea Technologies · 0 citations
VAI 2018-05-17 Mauna Kea Technologies · 0 citations
VAI 2018-05-17 Mauna Kea Technologies · 0 citations
VAI 2014-01-30 Mauna Kea Technologies · 2 citations
VAI 2014-01-30 Mauna Kea Technologies · 2 citations