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Audion

Model AET-100 · STRYKER CORPORATION · DI 00850002250428

PNZ — Eustachian Tube Balloon Dilation Device · Class II · 21 CFR 874.4180

UDILibrary device dossier · generated 2026-09-13 · 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 (1)

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.

Injury: 1

23562019-04: 0 reports for this device; peer average 2/device2020-09: 0 reports for this device; peer average 1/device2021-08: 0 reports for this device; peer average 3/device2021-10: 0 reports for this device; peer average 3/device2022-03: 0 reports for this device; peer average 6/device2022-06: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 1/device2022-12: 1 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 3/device2023-06: 0 reports for this device; peer average 6/device2023-08: 0 reports for this device; peer average 2/device2024-01: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1/device2024-08: 0 reports for this device; peer average 2/device2025-05: 0 reports for this device; peer average 1/device2025-06: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device0409081003061012030506080102040708050612
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0402
2020-0901
2021-0803
2021-1003
2022-0306
2022-0603
2022-1001
2022-1211
2023-0301
2023-0503
2023-0606
2023-0802
2024-0102
2024-0202
2024-0402
2024-0701
2024-0802
2025-0501
2025-0601
2025-1201
This device (reports/month)Average device in PNZ (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — STRYKER CORPORATION

  • Warning Letter 2017-04-06 Entellus Medical Inc.
  • Warning Letter 2015-04-08 Thermedx LLC
  • Injunction 2013-11-26 Physio-Control, Inc.
  • Warning Letter 2013-03-06 Stryker Corporation
  • Warning Letter 2013-03-06 Stryker Corporation
  • NAI 2026-06-18 International Life Sciences · 0 citations
  • VAI 2026-02-20 Stryker Puerto Rico, LLC · 2 citations
  • NAI 2025-12-11 Stryker Manufacturing Kalamazoo · 0 citations
  • NAI 2025-05-22 Stryker Macroom · 0 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • VAI 2025-03-27 Stryker GmbH · 1 citations
  • NAI 2025-02-27 Stryker Leibinger GmbH & Co. KG · 0 citations
  • NAI 2025-01-30 Serf · 0 citations
  • VAI 2024-12-18 Stryker Neurovascular · 1 citations
  • VAI 2024-11-15 Stryker Medical Division of Stryker Corporation · 2 citations
  • NAI 2024-11-13 POM Medical LLC · 0 citations
  • VAI 2024-07-25 Stryker Ireland, Ltd., Instruments Division · 1 citations
  • NAI 2024-05-03 Stryker Neurovascular, Inc. · 0 citations
  • NAI 2024-04-18 Physio-Control, Inc. · 0 citations
  • VAI 2023-12-01 Howmedica Osteonics Corp. · 1 citations
  • VAI 2023-05-15 LimFlow, Inc. · 2 citations
  • NAI 2023-04-25 Stryker Puerto Rico, LLC · 0 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2023-01-24 Stryker Corporation · 2 citations
  • VAI 2022-03-08 POM Medical LLC · 0 citations