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BPX

Model 7900012000 · STRYKER CORPORATION · DI 07613327656763

GEY — Motor, Surgical Instrument, Ac-Powered · Class I · 21 CFR 878.4820

UDILibrary device dossier · generated 2026-09-07 · 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.

51116212019-01: 0 reports for this device; peer average 4.33/device2019-02: 0 reports for this device; peer average 8.89/device2019-03: 0 reports for this device; peer average 15.63/device2019-04: 0 reports for this device; peer average 12.56/device2019-05: 0 reports for this device; peer average 12.29/device2019-06: 0 reports for this device; peer average 12.2/device2019-07: 0 reports for this device; peer average 11.78/device2019-08: 0 reports for this device; peer average 21.4/device2019-09: 0 reports for this device; peer average 12.86/device2019-10: 0 reports for this device; peer average 15.88/device2019-11: 0 reports for this device; peer average 14.71/device2019-12: 0 reports for this device; peer average 19.43/device2020-01: 0 reports for this device; peer average 13.13/device2020-02: 0 reports for this device; peer average 13.63/device2020-03: 0 reports for this device; peer average 14/device2020-04: 0 reports for this device; peer average 9.63/device2020-05: 0 reports for this device; peer average 6.56/device2020-06: 0 reports for this device; peer average 10.17/device2020-07: 0 reports for this device; peer average 8.15/device2020-08: 0 reports for this device; peer average 8/device2020-09: 0 reports for this device; peer average 11.11/device2020-10: 0 reports for this device; peer average 8.46/device2020-11: 0 reports for this device; peer average 12/device2020-12: 0 reports for this device; peer average 12.17/device2021-01: 0 reports for this device; peer average 12.75/device2021-02: 0 reports for this device; peer average 10.11/device2021-03: 0 reports for this device; peer average 12.1/device2021-04: 0 reports for this device; peer average 10.2/device2021-05: 0 reports for this device; peer average 7.09/device2021-06: 0 reports for this device; peer average 15.33/device2021-07: 0 reports for this device; peer average 9.64/device2021-08: 0 reports for this device; peer average 9.67/device2021-09: 0 reports for this device; peer average 11.08/device2021-10: 0 reports for this device; peer average 10.11/device2021-11: 0 reports for this device; peer average 6.83/device2021-12: 0 reports for this device; peer average 13.22/device2022-01: 0 reports for this device; peer average 7.85/device2022-02: 0 reports for this device; peer average 8.38/device2022-03: 0 reports for this device; peer average 12/device2022-04: 0 reports for this device; peer average 12.22/device2022-05: 0 reports for this device; peer average 7.2/device2022-06: 0 reports for this device; peer average 12.31/device2022-07: 0 reports for this device; peer average 14.44/device2022-08: 0 reports for this device; peer average 9.57/device2022-09: 0 reports for this device; peer average 10.73/device2022-10: 0 reports for this device; peer average 7.71/device2022-11: 0 reports for this device; peer average 8.2/device2022-12: 0 reports for this device; peer average 15.55/device2023-01: 0 reports for this device; peer average 7.92/device2023-02: 0 reports for this device; peer average 9.18/device2023-03: 0 reports for this device; peer average 6.95/device2023-04: 0 reports for this device; peer average 8.75/device2023-05: 0 reports for this device; peer average 12.15/device2023-06: 0 reports for this device; peer average 11/device2023-07: 0 reports for this device; peer average 12.67/device2023-08: 0 reports for this device; peer average 9.09/device2023-09: 0 reports for this device; peer average 9.9/device2023-10: 0 reports for this device; peer average 8.36/device2023-11: 0 reports for this device; peer average 10.69/device2023-12: 0 reports for this device; peer average 6.69/device2024-01: 0 reports for this device; peer average 7.56/device2024-02: 0 reports for this device; peer average 7.4/device2024-03: 0 reports for this device; peer average 7.54/device2024-04: 0 reports for this device; peer average 9.17/device2024-05: 0 reports for this device; peer average 5.46/device2024-06: 0 reports for this device; peer average 9.64/device2024-07: 0 reports for this device; peer average 7.5/device2024-08: 0 reports for this device; peer average 7/device2024-09: 0 reports for this device; peer average 8.67/device2024-10: 0 reports for this device; peer average 7.76/device2024-11: 0 reports for this device; peer average 6.55/device2024-12: 0 reports for this device; peer average 7.25/device2025-01: 0 reports for this device; peer average 7.27/device2025-02: 0 reports for this device; peer average 7.08/device2025-03: 0 reports for this device; peer average 6.46/device2025-04: 0 reports for this device; peer average 8.09/device2025-05: 0 reports for this device; peer average 8.18/device2025-06: 0 reports for this device; peer average 9.1/device2025-07: 0 reports for this device; peer average 7.64/device2025-08: 0 reports for this device; peer average 5.93/device2025-09: 0 reports for this device; peer average 6.64/device2025-10: 0 reports for this device; peer average 5.57/device2025-11: 0 reports for this device; peer average 7.88/device2025-12: 0 reports for this device; peer average 7.69/device2026-01: 0 reports for this device; peer average 8.42/device2026-02: 0 reports for this device; peer average 6/device2026-03: 0 reports for this device; peer average 6.45/device2026-04: 0 reports for this device; peer average 8.83/device2026-05: 0 reports for this device; peer average 7.08/device2026-06: 0 reports for this device; peer average 10.43/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0104.33
2019-0208.89
2019-03015.63
2019-04012.56
2019-05012.29
2019-06012.2
2019-07011.78
2019-08021.4
2019-09012.86
2019-10015.88
2019-11014.71
2019-12019.43
2020-01013.13
2020-02013.63
2020-03014
2020-0409.63
2020-0506.56
2020-06010.17
2020-0708.15
2020-0808
2020-09011.11
2020-1008.46
2020-11012
2020-12012.17
2021-01012.75
2021-02010.11
2021-03012.1
2021-04010.2
2021-0507.09
2021-06015.33
2021-0709.64
2021-0809.67
2021-09011.08
2021-10010.11
2021-1106.83
2021-12013.22
2022-0107.85
2022-0208.38
2022-03012
2022-04012.22
2022-0507.2
2022-06012.31
2022-07014.44
2022-0809.57
2022-09010.73
2022-1007.71
2022-1108.2
2022-12015.55
2023-0107.92
2023-0209.18
2023-0306.95
2023-0408.75
2023-05012.15
2023-06011
2023-07012.67
2023-0809.09
2023-0909.9
2023-1008.36
2023-11010.69
2023-1206.69
2024-0107.56
2024-0207.4
2024-0307.54
2024-0409.17
2024-0505.46
2024-0609.64
2024-0707.5
2024-0807
2024-0908.67
2024-1007.76
2024-1106.55
2024-1207.25
2025-0107.27
2025-0207.08
2025-0306.46
2025-0408.09
2025-0508.18
2025-0609.1
2025-0707.64
2025-0805.93
2025-0906.64
2025-1005.57
2025-1107.88
2025-1207.69
2026-0108.42
2026-0206
2026-0306.45
2026-0408.83
2026-0507.08
2026-06010.43
This device (reports/month)Average device in GEY (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