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Unnamed device

Model 0390-019-000 · STRYKER CORPORATION · DI 07613327175257

FPO — Stretcher, Wheeled · Class II · 21 CFR 880.6910

INK — Stretcher, Wheeled, Powered · Class II · 21 CFR 890.3690

UDILibrary device dossier · generated 2026-09-12 · 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.

358102019-01: 0 reports for this device; peer average 2.6/device2019-02: 0 reports for this device; peer average 1.71/device2019-03: 0 reports for this device; peer average 3/device2019-04: 0 reports for this device; peer average 2.55/device2019-05: 0 reports for this device; peer average 1.89/device2019-06: 0 reports for this device; peer average 2/device2019-07: 0 reports for this device; peer average 2.61/device2019-08: 0 reports for this device; peer average 2/device2019-09: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 2.81/device2019-11: 0 reports for this device; peer average 1.8/device2019-12: 0 reports for this device; peer average 2.5/device2020-01: 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 1.17/device2020-04: 0 reports for this device; peer average 3.1/device2020-05: 0 reports for this device; peer average 2.8/device2020-06: 0 reports for this device; peer average 1.67/device2020-07: 0 reports for this device; peer average 3.07/device2020-08: 0 reports for this device; peer average 1.15/device2020-09: 0 reports for this device; peer average 1.5/device2020-10: 0 reports for this device; peer average 3.07/device2020-11: 0 reports for this device; peer average 2/device2020-12: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 5.31/device2021-02: 0 reports for this device; peer average 3.16/device2021-03: 0 reports for this device; peer average 1.5/device2021-04: 0 reports for this device; peer average 2.56/device2021-05: 0 reports for this device; peer average 2/device2021-06: 0 reports for this device; peer average 1.8/device2021-07: 0 reports for this device; peer average 2.68/device2021-08: 0 reports for this device; peer average 1.57/device2021-09: 0 reports for this device; peer average 1.33/device2021-10: 0 reports for this device; peer average 2.91/device2021-11: 0 reports for this device; peer average 1.17/device2021-12: 0 reports for this device; peer average 1.67/device2022-01: 0 reports for this device; peer average 2.93/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1.75/device2022-04: 0 reports for this device; peer average 3.26/device2022-05: 0 reports for this device; peer average 2/device2022-06: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 3.44/device2022-08: 0 reports for this device; peer average 1.75/device2022-09: 0 reports for this device; peer average 4/device2022-10: 0 reports for this device; peer average 3.43/device2022-11: 0 reports for this device; peer average 1.43/device2022-12: 0 reports for this device; peer average 2/device2023-01: 0 reports for this device; peer average 3.43/device2023-02: 0 reports for this device; peer average 1.4/device2023-03: 0 reports for this device; peer average 2.08/device2023-04: 0 reports for this device; peer average 3.87/device2023-05: 0 reports for this device; peer average 2.09/device2023-06: 0 reports for this device; peer average 2.4/device2023-07: 0 reports for this device; peer average 4/device2023-08: 0 reports for this device; peer average 1.63/device2023-09: 0 reports for this device; peer average 1.77/device2023-10: 0 reports for this device; peer average 3.79/device2023-11: 0 reports for this device; peer average 2.5/device2023-12: 0 reports for this device; peer average 2.4/device2024-01: 0 reports for this device; peer average 3.76/device2024-02: 0 reports for this device; peer average 3.17/device2024-03: 0 reports for this device; peer average 1.63/device2024-04: 0 reports for this device; peer average 4.26/device2024-05: 0 reports for this device; peer average 1.43/device2024-06: 0 reports for this device; peer average 2.3/device2024-07: 0 reports for this device; peer average 3.71/device2024-08: 0 reports for this device; peer average 1.57/device2024-09: 0 reports for this device; peer average 5.8/device2024-10: 0 reports for this device; peer average 4.21/device2024-11: 0 reports for this device; peer average 5.43/device2024-12: 0 reports for this device; peer average 4/device2025-01: 0 reports for this device; peer average 3.88/device2025-02: 0 reports for this device; peer average 6.67/device2025-03: 0 reports for this device; peer average 7.13/device2025-04: 0 reports for this device; peer average 3.93/device2025-05: 0 reports for this device; peer average 6/device2025-06: 0 reports for this device; peer average 2.75/device2025-07: 0 reports for this device; peer average 3/device2025-08: 0 reports for this device; peer average 5.67/device2025-09: 0 reports for this device; peer average 5/device2025-10: 0 reports for this device; peer average 3.38/device2025-11: 0 reports for this device; peer average 5.67/device2025-12: 0 reports for this device; peer average 3.22/device2026-01: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 4.67/device2026-03: 0 reports for this device; peer average 5.11/device2026-04: 0 reports for this device; peer average 3.51/device2026-05: 0 reports for this device; peer average 10.43/device2026-06: 0 reports for this device; peer average 7.43/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102.6
2019-0201.71
2019-0303
2019-0402.55
2019-0501.89
2019-0602
2019-0702.61
2019-0802
2019-0901
2019-1002.81
2019-1101.8
2019-1202.5
2020-0103
2020-0202
2020-0301.17
2020-0403.1
2020-0502.8
2020-0601.67
2020-0703.07
2020-0801.15
2020-0901.5
2020-1003.07
2020-1102
2020-1201
2021-0105.31
2021-0203.16
2021-0301.5
2021-0402.56
2021-0502
2021-0601.8
2021-0702.68
2021-0801.57
2021-0901.33
2021-1002.91
2021-1101.17
2021-1201.67
2022-0102.93
2022-0201
2022-0301.75
2022-0403.26
2022-0502
2022-0601
2022-0703.44
2022-0801.75
2022-0904
2022-1003.43
2022-1101.43
2022-1202
2023-0103.43
2023-0201.4
2023-0302.08
2023-0403.87
2023-0502.09
2023-0602.4
2023-0704
2023-0801.63
2023-0901.77
2023-1003.79
2023-1102.5
2023-1202.4
2024-0103.76
2024-0203.17
2024-0301.63
2024-0404.26
2024-0501.43
2024-0602.3
2024-0703.71
2024-0801.57
2024-0905.8
2024-1004.21
2024-1105.43
2024-1204
2025-0103.88
2025-0206.67
2025-0307.13
2025-0403.93
2025-0506
2025-0602.75
2025-0703
2025-0805.67
2025-0905
2025-1003.38
2025-1105.67
2025-1203.22
2026-0103
2026-0204.67
2026-0305.11
2026-0403.51
2026-05010.43
2026-0607.43
This device (reports/month)Average device in FPO, INK (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
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  • NAI 2025-01-30 Serf · 0 citations
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  • NAI 2024-11-13 POM Medical LLC · 0 citations
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