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Millennium

Model 9560565 · Avalign Technologies, Inc. · DI 00190776114596

HAE — Rongeur, Manual · Class II · 21 CFR 882.4840

UDILibrary device dossier · generated 2026-09-06 · 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 (2)

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: 2

12232019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2020-11: 0 reports for this device; peer average 1/device2020-12: 1 reports for this device; peer average 1/device2021-03: 1 reports for this device; peer average 1/device2021-04: 0 reports for this device; peer average 2/device2021-10: 0 reports for this device; peer average 1/device2022-01: 0 reports for this device; peer average 1/device2022-02: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 3/device2022-06: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 1/device2023-03: 0 reports for this device; peer average 2/device2023-04: 0 reports for this device; peer average 2/device2024-04: 0 reports for this device; peer average 1/device2025-11: 0 reports for this device; peer average 1/device2025-12: 0 reports for this device; peer average 1/device2026-01: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.5/device2026-03: 0 reports for this device; peer average 1.5/device2026-04: 0 reports for this device; peer average 2/device2026-05: 0 reports for this device; peer average 2/device06071112030410010203060103040411120102030405
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0601
2019-0701
2020-1101
2020-1211
2021-0311
2021-0402
2021-1001
2022-0101
2022-0201
2022-0303
2022-0601
2023-0101
2023-0302
2023-0402
2024-0401
2025-1101
2025-1201
2026-0101
2026-0201.5
2026-0301.5
2026-0402
2026-0502
This device (reports/month)Average device in HAE (reports/device/month)

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — Avalign Technologies, Inc.

  • Warning Letter 2014-03-28 Instrumed GmbH
  • VAI 2023-12-05 Instrumed International Inc · 5 citations
  • VAI 2022-06-28 Avalign Integrated Medical Solutions, Inc. · 3 citations
  • VAI 2019-11-20 Instrumed International Inc · 2 citations
  • NAI 2018-10-25 Instrumed GmbH · 0 citations
  • NAI 2016-11-30 Instrumed International Inc · 0 citations
  • NAI 2015-09-22 Millennium Surgical Corp · 0 citations
  • NAI 2015-01-29 Instrumed GmbH · 0 citations
  • VAI 2013-08-20 Instrumed International Inc · 17 citations
  • OAI 2013-08-01 Instrumed GmbH · 0 citations
  • VAI 2013-04-24 Avalign Integrated Medical Solutions, Inc. · 4 citations
  • NAI 2011-02-28 Instrumed International Inc · 0 citations