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HAVASU

Model FA64083 · STRYKER CORPORATION · DI 07613327282740

FMS — Bed, Pediatric Open Hospital · Class II · 21 CFR 880.5140

UDILibrary device dossier · generated 2026-09-15 · 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.

23562019-01: 0 reports for this device; peer average 4/device2019-04: 0 reports for this device; peer average 5/device2019-05: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 4/device2019-10: 0 reports for this device; peer average 6/device2019-11: 0 reports for this device; peer average 4/device2020-01: 0 reports for this device; peer average 3/device2020-04: 0 reports for this device; peer average 4/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 3/device2020-10: 0 reports for this device; peer average 4/device2021-01: 0 reports for this device; peer average 4/device2021-02: 0 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 3/device2021-07: 0 reports for this device; peer average 4/device2021-10: 0 reports for this device; peer average 3/device2022-01: 0 reports for this device; peer average 2/device2022-04: 0 reports for this device; peer average 3/device2022-07: 0 reports for this device; peer average 3/device2022-10: 0 reports for this device; peer average 3/device2023-01: 0 reports for this device; peer average 4/device2023-04: 0 reports for this device; peer average 3/device2023-05: 0 reports for this device; peer average 1/device2023-07: 0 reports for this device; peer average 4/device2023-10: 0 reports for this device; peer average 4/device2024-01: 0 reports for this device; peer average 3/device2024-04: 0 reports for this device; peer average 3/device2024-06: 0 reports for this device; peer average 2/device2024-07: 0 reports for this device; peer average 1/device2024-10: 0 reports for this device; peer average 5/device2025-01: 0 reports for this device; peer average 5/device2025-04: 0 reports for this device; peer average 6/device2025-07: 0 reports for this device; peer average 3/device2025-10: 0 reports for this device; peer average 4/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 3/device2026-04: 0 reports for this device; peer average 4/device01040507101101040607100102040710010407100104050710010406071001040710120104
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104
2019-0405
2019-0501
2019-0704
2019-1006
2019-1104
2020-0103
2020-0404
2020-0601
2020-0703
2020-1004
2021-0104
2021-0201
2021-0403
2021-0704
2021-1003
2022-0102
2022-0403
2022-0703
2022-1003
2023-0104
2023-0403
2023-0501
2023-0704
2023-1004
2024-0103
2024-0403
2024-0602
2024-0701
2024-1005
2025-0105
2025-0406
2025-0703
2025-1004
2025-1201
2026-0103
2026-0404
This device (reports/month)Average device in FMS (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