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Regulatory presence across jurisdictions

The same device (matched on an identical UDI-DI) is registered in other jurisdictions. EU coverage (EUDAMED) is still phasing in — absence here does not mean a device is not marketed there.

  • European UnionT708858250000663S9
Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

1 linked reportMalfunction 1
369122019-01: 0 reports for this device; peer average 1.5/device2019-02: 0 reports for this device; peer average 3.33/device2019-03: 0 reports for this device; peer average 2/device2019-04: 0 reports for this device; peer average 1.44/device2019-05: 0 reports for this device; peer average 2/device2019-06: 0 reports for this device; peer average 2.33/device2019-07: 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 1.5/device2020-01: 0 reports for this device; peer average 1/device2020-02: 0 reports for this device; peer average 1.5/device2020-03: 0 reports for this device; peer average 2.14/device2020-04: 0 reports for this device; peer average 1/device2020-05: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 2/device2020-07: 0 reports for this device; peer average 1.75/device2020-09: 0 reports for this device; peer average 1/device2020-10: 0 reports for this device; peer average 1/device2021-01: 0 reports for this device; peer average 1.5/device2021-04: 0 reports for this device; peer average 3/device2021-06: 0 reports for this device; peer average 3/device2021-08: 0 reports for this device; peer average 1.5/device2021-10: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 3/device2023-03: 0 reports for this device; peer average 1/device2023-04: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 1.5/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 2/device2023-12: 0 reports for this device; peer average 2/device2024-02: 0 reports for this device; peer average 1/device2024-03: 0 reports for this device; peer average 1.75/device2024-04: 0 reports for this device; peer average 2/device2024-05: 0 reports for this device; peer average 2.5/device2024-06: 0 reports for this device; peer average 1.33/device2024-07: 0 reports for this device; peer average 1.33/device2024-09: 0 reports for this device; peer average 1.67/device2024-10: 0 reports for this device; peer average 2/device2024-12: 1 reports for this device2025-01: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 6/device2025-03: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1/device2025-05: 0 reports for this device; peer average 2/device2025-11: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 3/device2026-02: 0 reports for this device; peer average 4/device2026-04: 0 reports for this device; peer average 12/device2026-05: 0 reports for this device; peer average 2/device2026-06: 0 reports for this device; peer average 2/device010203040506071011120102030405060709100104060810071001020304091011120203040506070910120102030405111202040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0101.5
2019-0203.33
2019-0302
2019-0401.44
2019-0502
2019-0602.33
2019-0701
2019-1001
2019-1101
2019-1201.5
2020-0101
2020-0201.5
2020-0302.14
2020-0401
2020-0501
2020-0602
2020-0701.75
2020-0901
2020-1001
2021-0101.5
2021-0403
2021-0603
2021-0801.5
2021-1001
2022-0701
2022-1001
2023-0101
2023-0203
2023-0301
2023-0401
2023-0901.5
2023-1002
2023-1102
2023-1202
2024-0201
2024-0301.75
2024-0402
2024-0502.5
2024-0601.33
2024-0701.33
2024-0901.67
2024-1002
2024-121—
2025-0101
2025-0206
2025-0301
2025-0401
2025-0502
2025-1102
2025-1203
2026-0204
2026-04012
2026-0502
2026-0602
This device (reports/month)Average device in FYA (reports/device/month)
Recall history

No recalls linked.

Regulatory clearances

    Predicate lineage

    K200493

    Cited as predicate by: K241272

    Lineage each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

    Manufacturer compliance record
    DateTypeOutcomeFacilityCitations
    2026-06-18NAINo action indicatedInternational Life Sciences0
    2026-02-20VAIVoluntary action indicatedStryker Puerto Rico, LLC2
    2025-12-11NAINo action indicatedStryker Manufacturing Kalamazoo0
    2025-05-22NAINo action indicatedStryker Macroom0
    2025-03-27VAIVoluntary action indicatedStryker GmbH1
    2025-03-27VAIVoluntary action indicatedStryker GmbH1
    2025-02-27NAINo action indicatedStryker Leibinger GmbH & Co. KG0
    2025-01-30NAINo action indicatedSerf0
    2024-12-18VAIVoluntary action indicatedStryker Neurovascular1
    2024-11-15VAIVoluntary action indicatedStryker Medical Division of Stryker Corporation2
    2024-11-13NAINo action indicatedPOM Medical LLC0
    2024-07-25VAIVoluntary action indicatedStryker Ireland, Ltd., Instruments Division1
    2024-05-03NAINo action indicatedStryker Neurovascular, Inc.0
    2024-04-18NAINo action indicatedPhysio-Control, Inc.0
    2023-12-01VAIVoluntary action indicatedHowmedica Osteonics Corp.1
    2023-05-15VAIVoluntary action indicatedLimFlow, Inc.2
    2023-04-25NAINo action indicatedStryker Puerto Rico, LLC0
    2023-01-24VAIVoluntary action indicatedStryker Corporation2
    2023-01-24VAIVoluntary action indicatedStryker Corporation2
    2022-03-08VAIVoluntary action indicatedPOM Medical LLC0
    2017-04-06WLWarning LetterEntellus Medical Inc.—
    2015-04-08WLWarning LetterThermedx LLC—
    2013-11-26INJInjunctionPhysio-Control, Inc.—
    2013-03-06WLWarning LetterStryker Corporation—
    2013-03-06WLWarning LetterStryker Corporation—
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