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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.

6 linked reportsMalfunction 6
01112019-04: 0 reports for this device; peer average 1/device2019-10: 0 reports for this device; peer average 1/device2020-04: 0 reports for this device; peer average 1/device2022-07: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-10: 1 reports for this device; peer average 1/device2024-01: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-10: 1 reports for this device; peer average 1/device2024-11: 1 reports for this device2025-01: 1 reports for this device; peer average 1/device2025-04: 1 reports for this device; peer average 1/device2025-07: 1 reports for this device; peer average 1/device0410040701100104071011010407
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0401
2019-1001
2020-0401
2022-0701
2023-0101
2023-1011
2024-0101
2024-0401
2024-0701
2024-1011
2024-111—
2025-0111
2025-0411
2025-0711
This device (reports/month)Average device in FXY (reports/device/month)
Failure-mode summaryAI-generated

5 linked report narratives available — no AI summary generated yet.

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-07-293015967359-2025-99232MalfunctionAvailableexact di
2025-04-213015967359-2025-00909MalfunctionAvailableexact di
2025-01-223015967359-2025-00326MalfunctionAvailableexact di
2024-10-223015967359-2024-02210MalfunctionAvailableexact di
2023-10-233015967359-2023-02277MalfunctionAvailableexact di

Showing the most recent 5 of 6 linked reports.

Regulatory clearances
  • 510(k)K200493Substantially equivalent (SESE) · 2020-03-21clearance family

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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