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A Plus

Model 1 · A PLUS INTERNATIONAL INC. · DI 00683534860182

GDY — Gauze/Sponge, Internal, X-Ray Detectable · Class I · 21 CFR 878.4450

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.

91726342019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 1/device2019-04: 0 reports for this device; peer average 1/device2019-05: 0 reports for this device; peer average 1.67/device2019-06: 0 reports for this device; peer average 1.25/device2019-07: 0 reports for this device; peer average 1.3/device2019-08: 0 reports for this device; peer average 1.5/device2019-09: 0 reports for this device; peer average 1.57/device2019-10: 0 reports for this device; peer average 1.89/device2019-11: 0 reports for this device; peer average 5/device2019-12: 0 reports for this device; peer average 1.13/device2020-01: 0 reports for this device; peer average 2.83/device2020-02: 0 reports for this device; peer average 1.14/device2020-03: 0 reports for this device; peer average 2.11/device2020-04: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2.67/device2020-07: 0 reports for this device; peer average 1.8/device2020-08: 0 reports for this device; peer average 2.2/device2020-09: 0 reports for this device; peer average 1.4/device2020-10: 0 reports for this device; peer average 1.6/device2020-11: 0 reports for this device; peer average 3/device2020-12: 0 reports for this device; peer average 1.29/device2021-01: 0 reports for this device; peer average 1.67/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 2.25/device2021-04: 0 reports for this device; peer average 2.25/device2021-05: 0 reports for this device; peer average 1/device2021-06: 0 reports for this device; peer average 1.71/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-09: 0 reports for this device; peer average 1.4/device2021-10: 0 reports for this device; peer average 2/device2021-11: 0 reports for this device; peer average 2.5/device2021-12: 0 reports for this device; peer average 2.5/device2022-01: 0 reports for this device; peer average 2.33/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 2.8/device2022-04: 0 reports for this device; peer average 4.75/device2022-05: 0 reports for this device; peer average 4/device2022-06: 0 reports for this device; peer average 2/device2022-07: 0 reports for this device; peer average 1.5/device2022-08: 0 reports for this device; peer average 3.5/device2022-09: 0 reports for this device; peer average 34/device2022-10: 0 reports for this device; peer average 1.78/device2022-11: 0 reports for this device; peer average 3.25/device2022-12: 0 reports for this device; peer average 5.8/device2023-01: 0 reports for this device; peer average 4/device2023-02: 0 reports for this device; peer average 3.6/device2023-03: 0 reports for this device; peer average 2.75/device2023-04: 0 reports for this device; peer average 1.5/device2023-05: 0 reports for this device; peer average 1.67/device2023-06: 0 reports for this device; peer average 2/device2023-07: 0 reports for this device; peer average 1.75/device2023-08: 0 reports for this device; peer average 1.8/device2023-09: 0 reports for this device; peer average 3.33/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2.6/device2023-12: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 3.14/device2024-02: 0 reports for this device; peer average 1.67/device2024-03: 0 reports for this device; peer average 1.33/device2024-04: 0 reports for this device; peer average 1.5/device2024-05: 0 reports for this device; peer average 2/device2024-06: 0 reports for this device; peer average 2.25/device2024-07: 0 reports for this device; peer average 1.6/device2024-08: 0 reports for this device; peer average 2.25/device2024-09: 0 reports for this device; peer average 1.8/device2024-10: 0 reports for this device; peer average 2/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 1.67/device2025-01: 0 reports for this device; peer average 1.5/device2025-02: 0 reports for this device; peer average 1.67/device2025-03: 0 reports for this device; peer average 3/device2025-04: 0 reports for this device; peer average 3.29/device2025-05: 0 reports for this device; peer average 4.5/device2025-06: 0 reports for this device; peer average 4.25/device2025-07: 0 reports for this device; peer average 1.67/device2025-08: 0 reports for this device; peer average 2.8/device2025-09: 0 reports for this device; peer average 7/device2025-10: 0 reports for this device; peer average 1.44/device2025-11: 0 reports for this device; peer average 2.5/device2025-12: 0 reports for this device; peer average 2.8/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 3.33/device2026-03: 0 reports for this device; peer average 1.83/device2026-04: 0 reports for this device; peer average 5.33/device2026-05: 0 reports for this device; peer average 2.5/device2026-06: 0 reports for this device; peer average 3.2/device01020405060708091011120102030406070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201
2019-0401
2019-0501.67
2019-0601.25
2019-0701.3
2019-0801.5
2019-0901.57
2019-1001.89
2019-1105
2019-1201.13
2020-0102.83
2020-0201.14
2020-0302.11
2020-0401
2020-0602.67
2020-0701.8
2020-0802.2
2020-0901.4
2020-1001.6
2020-1103
2020-1201.29
2021-0101.67
2021-0202
2021-0302.25
2021-0402.25
2021-0501
2021-0601.71
2021-0702
2021-0801
2021-0901.4
2021-1002
2021-1102.5
2021-1202.5
2022-0102.33
2022-0201
2022-0302.8
2022-0404.75
2022-0504
2022-0602
2022-0701.5
2022-0803.5
2022-09034
2022-1001.78
2022-1103.25
2022-1205.8
2023-0104
2023-0203.6
2023-0302.75
2023-0401.5
2023-0501.67
2023-0602
2023-0701.75
2023-0801.8
2023-0903.33
2023-1002
2023-1102.6
2023-1202
2024-0103.14
2024-0201.67
2024-0301.33
2024-0401.5
2024-0502
2024-0602.25
2024-0701.6
2024-0802.25
2024-0901.8
2024-1002
2024-1102
2024-1201.67
2025-0101.5
2025-0201.67
2025-0303
2025-0403.29
2025-0504.5
2025-0604.25
2025-0701.67
2025-0802.8
2025-0907
2025-1001.44
2025-1102.5
2025-1202.8
2026-0103
2026-0203.33
2026-0301.83
2026-0405.33
2026-0502.5
2026-0603.2
This device (reports/month)Average device in GDY (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — A PLUS INTERNATIONAL INC.

  • VAI 2025-09-05 A Plus International, Inc · 1 citations
  • VAI 2025-09-05 A Plus International, Inc · 1 citations
  • NAI 2017-03-08 A Plus International, Inc · 0 citations
  • NAI 2017-03-08 A Plus International, Inc · 0 citations
  • NAI 2013-11-06 A Plus International, Inc · 0 citations
  • NAI 2013-11-06 A Plus International, Inc · 0 citations
  • VAI 2013-04-04 A Plus International, Inc · 6 citations
  • VAI 2013-04-04 A Plus International, Inc · 6 citations