Skip to content
Print-ready dossier — use your browser's print dialog to save as PDF.

L9000

Model 0220210000 · STRYKER CORPORATION · DI 07613327051339

FCW — Light Source, Fiberoptic, Routine · Class II · 21 CFR 876.1500

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 (101)

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: 96 · Injury: 5

4811152019-01: 1 reports for this device; peer average 1/device2019-02: 0 reports for this device; peer average 1/device2019-03: 1 reports for this device; peer average 1/device2019-04: 2 reports for this device; peer average 1.67/device2019-05: 1 reports for this device; peer average 1.2/device2019-06: 1 reports for this device; peer average 1.75/device2019-07: 0 reports for this device; peer average 4/device2019-08: 2 reports for this device; peer average 1.8/device2019-09: 5 reports for this device; peer average 2.67/device2019-10: 3 reports for this device; peer average 4.5/device2019-11: 0 reports for this device; peer average 6.5/device2019-12: 4 reports for this device; peer average 2.33/device2020-01: 5 reports for this device; peer average 4/device2020-02: 0 reports for this device; peer average 1/device2020-03: 6 reports for this device; peer average 2.67/device2020-04: 2 reports for this device; peer average 1.33/device2020-05: 8 reports for this device; peer average 8/device2020-06: 3 reports for this device; peer average 2.25/device2020-07: 2 reports for this device; peer average 1.75/device2020-08: 1 reports for this device; peer average 2/device2020-09: 2 reports for this device; peer average 1.5/device2020-10: 3 reports for this device; peer average 3.75/device2020-11: 1 reports for this device; peer average 1/device2020-12: 2 reports for this device; peer average 1.25/device2021-01: 2 reports for this device; peer average 2/device2021-02: 5 reports for this device; peer average 3.25/device2021-03: 4 reports for this device; peer average 4/device2021-04: 2 reports for this device; peer average 1.5/device2021-05: 1 reports for this device; peer average 1.5/device2021-06: 4 reports for this device; peer average 3.67/device2021-07: 0 reports for this device; peer average 1.33/device2021-08: 4 reports for this device; peer average 3.5/device2021-09: 3 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 3/device2021-11: 4 reports for this device; peer average 1.43/device2021-12: 0 reports for this device; peer average 1.25/device2022-01: 2 reports for this device; peer average 4/device2022-02: 1 reports for this device; peer average 2.5/device2022-03: 0 reports for this device; peer average 8/device2022-04: 0 reports for this device; peer average 1.5/device2022-05: 1 reports for this device; peer average 7.5/device2022-06: 2 reports for this device; peer average 4.71/device2022-07: 0 reports for this device; peer average 2.5/device2022-08: 1 reports for this device; peer average 3.8/device2022-09: 0 reports for this device; peer average 7.5/device2022-10: 0 reports for this device; peer average 7/device2022-11: 0 reports for this device; peer average 4.25/device2022-12: 0 reports for this device; peer average 6.8/device2023-01: 0 reports for this device; peer average 2.5/device2023-02: 0 reports for this device; peer average 3.33/device2023-03: 1 reports for this device; peer average 2.67/device2023-04: 1 reports for this device; peer average 2.25/device2023-05: 1 reports for this device; peer average 4.5/device2023-06: 0 reports for this device; peer average 3.5/device2023-07: 0 reports for this device; peer average 6/device2023-08: 0 reports for this device; peer average 8/device2023-09: 0 reports for this device; peer average 8.67/device2023-10: 0 reports for this device; peer average 4.75/device2023-11: 0 reports for this device; peer average 9.33/device2023-12: 1 reports for this device; peer average 1.8/device2024-01: 0 reports for this device; peer average 10/device2024-02: 0 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 5.5/device2024-04: 0 reports for this device; peer average 7/device2024-05: 0 reports for this device; peer average 3/device2024-06: 1 reports for this device; peer average 5/device2024-07: 0 reports for this device; peer average 8.33/device2024-08: 1 reports for this device; peer average 9/device2024-09: 0 reports for this device; peer average 4.33/device2024-10: 0 reports for this device; peer average 2.75/device2024-11: 1 reports for this device; peer average 1.25/device2024-12: 0 reports for this device; peer average 4.25/device2025-01: 0 reports for this device; peer average 3.83/device2025-02: 0 reports for this device; peer average 5.17/device2025-03: 0 reports for this device; peer average 5.8/device2025-04: 0 reports for this device; peer average 6/device2025-05: 3 reports for this device; peer average 11.33/device2025-06: 0 reports for this device; peer average 5.67/device2025-07: 0 reports for this device; peer average 13/device2025-08: 0 reports for this device; peer average 15/device2025-09: 0 reports for this device; peer average 5.8/device2025-10: 0 reports for this device; peer average 3.33/device2025-11: 0 reports for this device; peer average 6.67/device2025-12: 0 reports for this device; peer average 1.67/device2026-01: 0 reports for this device; peer average 4.14/device2026-02: 0 reports for this device; peer average 3.67/device2026-03: 0 reports for this device; peer average 14.5/device2026-04: 0 reports for this device; peer average 9.33/device2026-05: 0 reports for this device; peer average 2.71/device2026-06: 0 reports for this device; peer average 3.13/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0111
2019-0201
2019-0311
2019-0421.67
2019-0511.2
2019-0611.75
2019-0704
2019-0821.8
2019-0952.67
2019-1034.5
2019-1106.5
2019-1242.33
2020-0154
2020-0201
2020-0362.67
2020-0421.33
2020-0588
2020-0632.25
2020-0721.75
2020-0812
2020-0921.5
2020-1033.75
2020-1111
2020-1221.25
2021-0122
2021-0253.25
2021-0344
2021-0421.5
2021-0511.5
2021-0643.67
2021-0701.33
2021-0843.5
2021-0932
2021-1003
2021-1141.43
2021-1201.25
2022-0124
2022-0212.5
2022-0308
2022-0401.5
2022-0517.5
2022-0624.71
2022-0702.5
2022-0813.8
2022-0907.5
2022-1007
2022-1104.25
2022-1206.8
2023-0102.5
2023-0203.33
2023-0312.67
2023-0412.25
2023-0514.5
2023-0603.5
2023-0706
2023-0808
2023-0908.67
2023-1004.75
2023-1109.33
2023-1211.8
2024-01010
2024-0203
2024-0305.5
2024-0407
2024-0503
2024-0615
2024-0708.33
2024-0819
2024-0904.33
2024-1002.75
2024-1111.25
2024-1204.25
2025-0103.83
2025-0205.17
2025-0305.8
2025-0406
2025-05311.33
2025-0605.67
2025-07013
2025-08015
2025-0905.8
2025-1003.33
2025-1106.67
2025-1201.67
2026-0104.14
2026-0203.67
2026-03014.5
2026-0409.33
2026-0502.71
2026-0603.13
This device (reports/month)Average device in FCW (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Predicate lineage

K082813 — cited as predicate by K101734, K121724, K131226, K142922

Lineage extracted from public 510(k) summary text (heuristic).

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