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Model 2863-000-000 · STRYKER CORPORATION · DI 07613327499735

IOQ — Bed, Flotation Therapy, Powered · Class II · 21 CFR 890.5170

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 (6)

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.

Malfunction: 6

51015202019-03: 0 reports for this device; peer average 2/device2019-05: 0 reports for this device; peer average 1/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 3/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2021-02: 2 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 1.33/device2021-04: 0 reports for this device; peer average 3.25/device2021-05: 0 reports for this device; peer average 2.33/device2021-06: 0 reports for this device; peer average 10/device2021-07: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 2/device2021-09: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 1.5/device2021-11: 0 reports for this device; peer average 4/device2021-12: 0 reports for this device; peer average 5.5/device2022-01: 0 reports for this device; peer average 4/device2022-02: 0 reports for this device; peer average 4.33/device2022-03: 0 reports for this device; peer average 1.5/device2022-04: 0 reports for this device; peer average 2.75/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 3.67/device2022-07: 0 reports for this device; peer average 2.25/device2022-08: 0 reports for this device; peer average 2.2/device2022-09: 0 reports for this device; peer average 2.2/device2022-10: 0 reports for this device; peer average 3.25/device2022-11: 0 reports for this device; peer average 3.67/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 2.25/device2023-02: 0 reports for this device; peer average 2.4/device2023-03: 0 reports for this device; peer average 6.6/device2023-04: 0 reports for this device; peer average 8/device2023-05: 0 reports for this device; peer average 8/device2023-06: 0 reports for this device; peer average 13.25/device2023-07: 1 reports for this device; peer average 7.2/device2023-08: 0 reports for this device; peer average 8.67/device2023-09: 0 reports for this device; peer average 6.75/device2023-10: 0 reports for this device; peer average 5/device2023-11: 0 reports for this device; peer average 8.5/device2023-12: 0 reports for this device; peer average 5/device2024-01: 0 reports for this device; peer average 9/device2024-02: 0 reports for this device; peer average 2.33/device2024-03: 0 reports for this device; peer average 7.6/device2024-04: 0 reports for this device; peer average 4.5/device2024-05: 0 reports for this device; peer average 5.13/device2024-06: 0 reports for this device; peer average 6.11/device2024-07: 0 reports for this device; peer average 7.17/device2024-08: 0 reports for this device; peer average 6.13/device2024-09: 0 reports for this device; peer average 5.14/device2024-10: 1 reports for this device; peer average 5/device2024-11: 0 reports for this device; peer average 14.89/device2024-12: 0 reports for this device; peer average 7.33/device2025-01: 0 reports for this device; peer average 12/device2025-02: 0 reports for this device; peer average 9.85/device2025-03: 0 reports for this device; peer average 9.55/device2025-04: 1 reports for this device; peer average 9.44/device2025-05: 0 reports for this device; peer average 8/device2025-06: 0 reports for this device; peer average 11.38/device2025-07: 0 reports for this device; peer average 10.25/device2025-08: 0 reports for this device; peer average 7.75/device2025-09: 0 reports for this device; peer average 9.67/device2025-10: 0 reports for this device; peer average 7.7/device2025-11: 0 reports for this device; peer average 12.82/device2025-12: 0 reports for this device; peer average 20/device2026-01: 0 reports for this device; peer average 9.92/device2026-02: 0 reports for this device; peer average 18.33/device2026-03: 0 reports for this device; peer average 19.1/device2026-04: 1 reports for this device; peer average 13.36/device2026-05: 0 reports for this device; peer average 14.08/device2026-06: 0 reports for this device; peer average 16.11/device0305091011120203040607110203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0302
2019-0501
2019-0901
2019-1001
2019-1101
2019-1203
2020-0202
2020-0301
2020-0401
2020-0601
2020-0701
2020-1101
2021-0222
2021-0301.33
2021-0403.25
2021-0502.33
2021-06010
2021-0703
2021-0802
2021-0901.5
2021-1001.5
2021-1104
2021-1205.5
2022-0104
2022-0204.33
2022-0301.5
2022-0402.75
2022-0502
2022-0603.67
2022-0702.25
2022-0802.2
2022-0902.2
2022-1003.25
2022-1103.67
2022-1202
2023-0102.25
2023-0202.4
2023-0306.6
2023-0408
2023-0508
2023-06013.25
2023-0717.2
2023-0808.67
2023-0906.75
2023-1005
2023-1108.5
2023-1205
2024-0109
2024-0202.33
2024-0307.6
2024-0404.5
2024-0505.13
2024-0606.11
2024-0707.17
2024-0806.13
2024-0905.14
2024-1015
2024-11014.89
2024-1207.33
2025-01012
2025-0209.85
2025-0309.55
2025-0419.44
2025-0508
2025-06011.38
2025-07010.25
2025-0807.75
2025-0909.67
2025-1007.7
2025-11012.82
2025-12020
2026-0109.92
2026-02018.33
2026-03019.1
2026-04113.36
2026-05014.08
2026-06016.11
This device (reports/month)Average device in IOQ (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
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  • 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
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  • VAI 2022-03-08 POM Medical LLC · 0 citations