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ActivL

Model FK392R-HM · Highridge Medical, LLC · DI 03662663083577

GAC — Rasp, Surgical, General & Plastic Surgery · Class I · 21 CFR 878.4800

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 (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.

12232019-10: 0 reports for this device; peer average 1.33/device2023-05: 0 reports for this device; peer average 3/device2024-03: 0 reports for this device; peer average 1.17/device2024-04: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 3/device2025-10: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 2/device2026-03: 0 reports for this device; peer average 1/device2026-04: 0 reports for this device; peer average 2/device100503040610020304
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-1001.33
2023-0503
2024-0301.17
2024-0401
2024-0603
2025-1001
2026-0202
2026-0301
2026-0402
This device (reports/month)Average device in GAC (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Highridge Medical, LLC

  • VAI 2018-03-01 Highridge Medical LLC · 2 citations
  • VAI 2018-03-01 Highridge Medical LLC · 2 citations
  • NAI 2017-09-14 Highridge Medical LLC · 0 citations
  • NAI 2014-12-04 LDR Medical · 0 citations
  • VAI 2014-10-06 Highridge Medical LLC · 4 citations
  • VAI 2014-10-06 Highridge Medical LLC · 4 citations
  • NAI 2011-02-24 Highridge Medical LLC · 0 citations
  • NAI 2011-02-24 Highridge Medical LLC · 0 citations