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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.

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.

20 linked reportsMalfunction 11Injury 9
23562020-10: 6 reports for this device2020-12: 1 reports for this device2021-06: 1 reports for this device2021-07: 1 reports for this device2021-09: 2 reports for this device2022-05: 1 reports for this device2022-06: 1 reports for this device2023-09: 1 reports for this device2023-10: 1 reports for this device2023-12: 1 reports for this device2024-04: 1 reports for this device2024-05: 1 reports for this device2025-06: 1 reports for this device2025-07: 1 reports for this device1012060709050609101204050607
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2020-106—
2020-121—
2021-061—
2021-071—
2021-092—
2022-051—
2022-061—
2023-091—
2023-101—
2023-121—
2024-041—
2024-051—
2025-061—
2025-071—
This device (reports/month)Average device in its product code (reports/device/month)
Failure-mode summaryAI-generated

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

Recall history

No recalls linked.

Individual MAUDE reports
DateReport #TypeNarrativeLink basis
2025-07-010001625425-2025-01046MalfunctionAvailableexact di
2025-06-200001625425-2025-01042MalfunctionAvailableexact di
2024-05-080001625425-2024-01018MalfunctionAvailableexact di
2024-04-030001625425-2024-00976MalfunctionAvailableexact di
2023-12-020001625425-2023-01250MalfunctionAvailableexact di
2023-10-020001625425-2023-01212MalfunctionAvailableexact di
2023-09-270001625425-2023-01206MalfunctionAvailableexact di
2022-06-200001625425-2022-01026MalfunctionAvailableexact di
2022-05-240001625425-2022-01010MalfunctionAvailableexact di
2021-09-230001625425-2021-01084MalfunctionAvailableexact di
2021-09-030001625425-2021-01074InjuryAvailableexact di
2021-07-210001625425-2021-01037MalfunctionAvailableexact di
2021-06-030001625425-2021-00972InjuryAvailableexact di
2020-12-161625425-2020-00792InjuryAvailableexact di
2020-10-201625425-2020-00661InjuryAvailableexact di
Showing 1–15 of 20
Regulatory clearances

None linked.

Manufacturer compliance record
DateTypeOutcomeFacilityCitations
2021-11-04NAINo action indicatedArgon Medical Devices, Inc0
2021-11-04NAINo action indicatedArgon Medical Devices, Inc0
2016-05-27VAIVoluntary action indicatedArgon Medical Devices, Inc2
2016-05-27VAIVoluntary action indicatedArgon Medical Devices, Inc2
2016-05-04NAINo action indicatedArgon Medical Devices Inc.0
2016-05-04NAINo action indicatedArgon Medical Devices Inc.0
2014-07-03WLWarning LetterArgon Medical Devices, Inc—
2014-07-03WLWarning LetterArgon Medical Devices, Inc—
2013-12-13VAIVoluntary action indicatedArgon Medical Devices, Inc3
2013-12-13VAIVoluntary action indicatedArgon Medical Devices, Inc3
2012-01-18VAIVoluntary action indicatedArgon Medical Devices Inc.3
2012-01-18VAIVoluntary action indicatedArgon Medical Devices Inc.3
2011-05-18VAIVoluntary action indicatedArgon Medical Devices, Inc1
2011-05-18VAIVoluntary action indicatedArgon Medical Devices, Inc1
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