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Shaver System

Model SSB-12400-1, SSB-12400-5 · STRYKER CORPORATION · DI 00857326005789

EQJ — Bur, Ear, Nose And Throat · Class I · 21 CFR 874.4140

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 (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.

13452019-01: 0 reports for this device; peer average 1.63/device2019-02: 0 reports for this device; peer average 2.62/device2019-03: 0 reports for this device; peer average 1.5/device2019-04: 0 reports for this device; peer average 1.7/device2019-05: 0 reports for this device; peer average 1.54/device2019-06: 0 reports for this device; peer average 1.86/device2019-07: 0 reports for this device; peer average 1.63/device2019-08: 0 reports for this device; peer average 1.67/device2019-09: 0 reports for this device; peer average 1.6/device2019-10: 0 reports for this device; peer average 1.33/device2019-11: 0 reports for this device; peer average 1/device2019-12: 0 reports for this device; peer average 1.3/device2020-01: 0 reports for this device; peer average 1.25/device2020-02: 0 reports for this device; peer average 2/device2020-03: 0 reports for this device; peer average 1.9/device2020-06: 0 reports for this device; peer average 1/device2020-07: 0 reports for this device; peer average 1.71/device2020-08: 0 reports for this device; peer average 1/device2020-09: 0 reports for this device; peer average 1.38/device2020-10: 0 reports for this device; peer average 5/device2020-11: 0 reports for this device; peer average 3.67/device2020-12: 0 reports for this device; peer average 1.33/device2021-01: 0 reports for this device; peer average 1.33/device2021-02: 0 reports for this device; peer average 2/device2021-03: 0 reports for this device; peer average 2.11/device2021-04: 0 reports for this device; peer average 2.4/device2021-05: 0 reports for this device; peer average 1.5/device2021-06: 0 reports for this device; peer average 2.5/device2021-07: 0 reports for this device; peer average 1.44/device2021-08: 0 reports for this device; peer average 1.5/device2021-09: 0 reports for this device; peer average 1.25/device2021-10: 0 reports for this device; peer average 1.75/device2021-11: 0 reports for this device; peer average 1.5/device2021-12: 0 reports for this device; peer average 1.25/device2022-01: 0 reports for this device; peer average 1.5/device2022-02: 0 reports for this device; peer average 1.33/device2022-03: 0 reports for this device; peer average 1.17/device2022-04: 0 reports for this device; peer average 2.5/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1.29/device2022-07: 0 reports for this device; peer average 1.3/device2022-08: 0 reports for this device; peer average 1.92/device2022-09: 0 reports for this device; peer average 1.31/device2022-10: 0 reports for this device; peer average 1.18/device2022-11: 0 reports for this device; peer average 1.13/device2022-12: 0 reports for this device; peer average 1.17/device2023-01: 0 reports for this device; peer average 1.3/device2023-02: 0 reports for this device; peer average 1.14/device2023-03: 0 reports for this device; peer average 1.9/device2023-04: 0 reports for this device; peer average 1.4/device2023-05: 0 reports for this device; peer average 1.4/device2023-06: 0 reports for this device; peer average 1.29/device2023-07: 0 reports for this device; peer average 1.82/device2023-08: 0 reports for this device; peer average 1.5/device2023-09: 0 reports for this device; peer average 1.42/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 1.43/device2023-12: 0 reports for this device; peer average 1.63/device2024-01: 0 reports for this device; peer average 1.7/device2024-02: 0 reports for this device; peer average 2.77/device2024-03: 0 reports for this device; peer average 1.47/device2024-04: 0 reports for this device; peer average 1.32/device2024-05: 0 reports for this device; peer average 1.65/device2024-06: 0 reports for this device; peer average 1.69/device2024-07: 0 reports for this device; peer average 1.67/device2024-08: 0 reports for this device; peer average 1.83/device2024-09: 0 reports for this device; peer average 1.95/device2024-10: 0 reports for this device; peer average 1.94/device2024-11: 0 reports for this device; peer average 2/device2024-12: 0 reports for this device; peer average 2.08/device2025-01: 0 reports for this device; peer average 3.74/device2025-02: 0 reports for this device; peer average 3.29/device2025-03: 0 reports for this device; peer average 1.88/device2025-04: 0 reports for this device; peer average 1.85/device2025-05: 0 reports for this device; peer average 1.86/device2025-06: 0 reports for this device; peer average 1.44/device2025-07: 0 reports for this device; peer average 1.63/device2025-08: 0 reports for this device; peer average 3.59/device2025-09: 0 reports for this device; peer average 2.86/device2025-10: 0 reports for this device; peer average 1.33/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 2.94/device2026-01: 0 reports for this device; peer average 1.29/device2026-02: 0 reports for this device; peer average 1.77/device2026-03: 0 reports for this device; peer average 1.6/device2026-04: 0 reports for this device; peer average 1.7/device2026-05: 0 reports for this device; peer average 1.69/device2026-06: 0 reports for this device; peer average 1.33/device01020304050607080910111201020306070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.63
2019-0202.62
2019-0301.5
2019-0401.7
2019-0501.54
2019-0601.86
2019-0701.63
2019-0801.67
2019-0901.6
2019-1001.33
2019-1101
2019-1201.3
2020-0101.25
2020-0202
2020-0301.9
2020-0601
2020-0701.71
2020-0801
2020-0901.38
2020-1005
2020-1103.67
2020-1201.33
2021-0101.33
2021-0202
2021-0302.11
2021-0402.4
2021-0501.5
2021-0602.5
2021-0701.44
2021-0801.5
2021-0901.25
2021-1001.75
2021-1101.5
2021-1201.25
2022-0101.5
2022-0201.33
2022-0301.17
2022-0402.5
2022-0501
2022-0601.29
2022-0701.3
2022-0801.92
2022-0901.31
2022-1001.18
2022-1101.13
2022-1201.17
2023-0101.3
2023-0201.14
2023-0301.9
2023-0401.4
2023-0501.4
2023-0601.29
2023-0701.82
2023-0801.5
2023-0901.42
2023-1002
2023-1101.43
2023-1201.63
2024-0101.7
2024-0202.77
2024-0301.47
2024-0401.32
2024-0501.65
2024-0601.69
2024-0701.67
2024-0801.83
2024-0901.95
2024-1001.94
2024-1102
2024-1202.08
2025-0103.74
2025-0203.29
2025-0301.88
2025-0401.85
2025-0501.86
2025-0601.44
2025-0701.63
2025-0803.59
2025-0902.86
2025-1001.33
2025-1102
2025-1202.94
2026-0101.29
2026-0201.77
2026-0301.6
2026-0401.7
2026-0501.69
2026-0601.33
This device (reports/month)Average device in EQJ (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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  • 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