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A Plus

Model 1 · A PLUS INTERNATIONAL INC. · DI 00683534840467

NAB — Gauze / Sponge,Nonresorbable For External Use · Class I · 21 CFR 878.4014

UDILibrary device dossier · generated 2026-09-07 · 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.

12232019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 2/device2020-02: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 2/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1.5/device2021-02: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 2/device2021-08: 0 reports for this device; peer average 1/device2021-12: 0 reports for this device; peer average 2/device2022-03: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 2.5/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2/device2023-06: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 1/device2023-11: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 3/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 1.33/device2024-10: 0 reports for this device; peer average 1/device2025-01: 0 reports for this device; peer average 3/device2025-02: 0 reports for this device; peer average 1/device2025-03: 0 reports for this device; peer average 3/device2025-05: 0 reports for this device; peer average 1.5/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-09: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 3/device2025-12: 0 reports for this device; peer average 2/device2026-01: 0 reports for this device; peer average 1.5/device2026-02: 0 reports for this device; peer average 1/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 1.5/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device050708091102030607080910110204060708120305060812010203060711010506070810010203050607091112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0501
2019-0701
2019-0801
2019-0901
2019-1102
2020-0201
2020-0302
2020-0602
2020-0701
2020-0801
2020-0901
2020-1001
2020-1101.5
2021-0201
2021-0403
2021-0601
2021-0702
2021-0801
2021-1202
2022-0301
2022-0501
2022-0601
2022-0802.5
2022-1201
2023-0101
2023-0202
2023-0302
2023-0601
2023-0701
2023-1102
2024-0101
2024-0501
2024-0603
2024-0701
2024-0801.33
2024-1001
2025-0103
2025-0201
2025-0303
2025-0501.5
2025-0602
2025-0702
2025-0901
2025-1103
2025-1202
2026-0101.5
2026-0201
2026-0301
2026-0401.5
2026-0502
2026-0602
This device (reports/month)Average device in NAB (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