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A&D Medical

Model UM-211 · A&D COMPANY, LIMITED · DI 05060006581335

DXN — System, Measurement, Blood-Pressure, Non-Invasive · Class II · 21 CFR 870.1130

DXQ — Blood Pressure Cuff · Class II · 21 CFR 870.1120

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.

24672019-01: 0 reports for this device; peer average 4.67/device2019-02: 0 reports for this device; peer average 1.71/device2019-03: 0 reports for this device; peer average 4/device2019-04: 0 reports for this device; peer average 2.4/device2019-05: 0 reports for this device; peer average 2.33/device2019-06: 0 reports for this device; peer average 5.25/device2019-07: 0 reports for this device; peer average 3.5/device2019-08: 0 reports for this device; peer average 3/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 5.29/device2019-11: 0 reports for this device; peer average 2.67/device2019-12: 0 reports for this device; peer average 2/device2020-01: 0 reports for this device; peer average 1.5/device2020-02: 0 reports for this device; peer average 2.22/device2020-03: 0 reports for this device; peer average 2/device2020-04: 0 reports for this device; peer average 1.67/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 2.18/device2020-08: 0 reports for this device; peer average 3.25/device2020-09: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 2.75/device2020-11: 0 reports for this device; peer average 6.5/device2020-12: 0 reports for this device; peer average 3.17/device2021-01: 0 reports for this device; peer average 2.5/device2021-02: 0 reports for this device; peer average 2.5/device2021-03: 0 reports for this device; peer average 1.67/device2021-04: 0 reports for this device; peer average 2.75/device2021-05: 0 reports for this device; peer average 2.25/device2021-06: 0 reports for this device; peer average 2.33/device2021-07: 0 reports for this device; peer average 1.67/device2021-08: 0 reports for this device; peer average 5/device2021-09: 0 reports for this device; peer average 4/device2021-10: 0 reports for this device; peer average 2.17/device2021-11: 0 reports for this device; peer average 2.25/device2021-12: 0 reports for this device; peer average 4.25/device2022-01: 0 reports for this device; peer average 3/device2022-02: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 4.83/device2022-04: 0 reports for this device; peer average 1.38/device2022-05: 0 reports for this device; peer average 6/device2022-06: 0 reports for this device; peer average 2.78/device2022-07: 0 reports for this device; peer average 1.91/device2022-08: 0 reports for this device; peer average 2.57/device2022-09: 0 reports for this device; peer average 2.14/device2022-10: 0 reports for this device; peer average 2/device2022-11: 0 reports for this device; peer average 2/device2022-12: 0 reports for this device; peer average 2.14/device2023-01: 0 reports for this device; peer average 2.38/device2023-02: 0 reports for this device; peer average 4/device2023-03: 0 reports for this device; peer average 4/device2023-04: 0 reports for this device; peer average 1.86/device2023-05: 0 reports for this device; peer average 2.27/device2023-06: 0 reports for this device; peer average 2.5/device2023-07: 0 reports for this device; peer average 4/device2023-08: 0 reports for this device; peer average 2.17/device2023-09: 0 reports for this device; peer average 1.33/device2023-10: 0 reports for this device; peer average 1.64/device2023-11: 0 reports for this device; peer average 4/device2023-12: 0 reports for this device; peer average 2.29/device2024-01: 0 reports for this device; peer average 2.5/device2024-02: 0 reports for this device; peer average 1.13/device2024-03: 0 reports for this device; peer average 1.91/device2024-04: 0 reports for this device; peer average 1.56/device2024-05: 0 reports for this device; peer average 7.36/device2024-06: 0 reports for this device; peer average 2.92/device2024-07: 0 reports for this device; peer average 5.64/device2024-08: 0 reports for this device; peer average 3.6/device2024-09: 0 reports for this device; peer average 1.33/device2024-10: 0 reports for this device; peer average 2.25/device2024-11: 0 reports for this device; peer average 3.54/device2024-12: 0 reports for this device; peer average 5.09/device2025-01: 0 reports for this device; peer average 2.85/device2025-02: 0 reports for this device; peer average 3.25/device2025-03: 0 reports for this device; peer average 2.31/device2025-04: 0 reports for this device; peer average 2.79/device2025-05: 0 reports for this device; peer average 5.73/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 3.78/device2025-08: 0 reports for this device; peer average 2.5/device2025-09: 0 reports for this device; peer average 1.84/device2025-10: 0 reports for this device; peer average 1.5/device2025-11: 0 reports for this device; peer average 3.86/device2025-12: 0 reports for this device; peer average 2.09/device2026-01: 0 reports for this device; peer average 3.28/device2026-02: 0 reports for this device; peer average 3.39/device2026-03: 0 reports for this device; peer average 2.5/device2026-04: 0 reports for this device; peer average 3.52/device2026-05: 0 reports for this device; peer average 5.88/device2026-06: 0 reports for this device; peer average 6.74/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.67
2019-0201.71
2019-0304
2019-0402.4
2019-0502.33
2019-0605.25
2019-0703.5
2019-0803
2019-0901
2019-1005.29
2019-1102.67
2019-1202
2020-0101.5
2020-0202.22
2020-0302
2020-0401.67
2020-0501
2020-0602
2020-0702.18
2020-0803.25
2020-0903
2020-1002.75
2020-1106.5
2020-1203.17
2021-0102.5
2021-0202.5
2021-0301.67
2021-0402.75
2021-0502.25
2021-0602.33
2021-0701.67
2021-0805
2021-0904
2021-1002.17
2021-1102.25
2021-1204.25
2022-0103
2022-0203
2022-0304.83
2022-0401.38
2022-0506
2022-0602.78
2022-0701.91
2022-0802.57
2022-0902.14
2022-1002
2022-1102
2022-1202.14
2023-0102.38
2023-0204
2023-0304
2023-0401.86
2023-0502.27
2023-0602.5
2023-0704
2023-0802.17
2023-0901.33
2023-1001.64
2023-1104
2023-1202.29
2024-0102.5
2024-0201.13
2024-0301.91
2024-0401.56
2024-0507.36
2024-0602.92
2024-0705.64
2024-0803.6
2024-0901.33
2024-1002.25
2024-1103.54
2024-1205.09
2025-0102.85
2025-0203.25
2025-0302.31
2025-0402.79
2025-0505.73
2025-0602
2025-0703.78
2025-0802.5
2025-0901.84
2025-1001.5
2025-1103.86
2025-1202.09
2026-0103.28
2026-0203.39
2026-0302.5
2026-0403.52
2026-0505.88
2026-0606.74
This device (reports/month)Average device in DXN, DXQ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — A&D COMPANY, LIMITED

  • Warning Letter 2012-11-13 A & D Electronics (Shenzhen) Co., Ltd.
  • VAI 2024-08-01 A&D Vietnam Limited · 3 citations
  • VAI 2023-03-17 A&D Company Manufacturing, Ltd. · 3 citations
  • NAI 2023-03-13 A&D Company, Limited - Tech Center · 0 citations
  • VAI 2019-06-21 A&D Engineering, Inc. · 1 citations
  • NAI 2018-06-21 A&D Company Manufacturing, Ltd. · 0 citations
  • VAI 2016-07-22 A&D Company Manufacturing, Ltd. · 2 citations
  • NAI 2015-04-28 A&D Engineering, Inc. · 0 citations
  • VAI 2014-06-06 A&D Company Manufacturing, Ltd. · 1 citations
  • VAI 2014-06-03 A&D Company, Limited - Tech Center · 1 citations
  • VAI 2012-08-09 A & D Electronics (Shenzhen) Co., Ltd. · 0 citations