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MILLENNIUM

Model 0-47130 · Avalign Technologies, Inc. · DI 00190776341381

GEN — Forceps, General & Plastic Surgery · Class I · 21 CFR 878.4800

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

12342019-01: 0 reports for this device; peer average 2/device2019-02: 0 reports for this device; peer average 1/device2019-03: 0 reports for this device; peer average 1/device2019-06: 0 reports for this device; peer average 1/device2019-07: 0 reports for this device; peer average 1/device2019-08: 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 4/device2019-12: 0 reports for this device; peer average 1/device2020-03: 0 reports for this device; peer average 1/device2020-06: 0 reports for this device; peer average 1/device2020-08: 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/device2021-04: 0 reports for this device; peer average 1/device2021-05: 0 reports for this device; peer average 1.33/device2021-06: 0 reports for this device; peer average 1/device2021-07: 0 reports for this device; peer average 2.5/device2021-10: 0 reports for this device; peer average 1/device2022-03: 0 reports for this device; peer average 1/device2022-04: 0 reports for this device; peer average 1/device2022-05: 0 reports for this device; peer average 1/device2022-06: 0 reports for this device; peer average 1/device2022-08: 0 reports for this device; peer average 1/device2022-09: 0 reports for this device; peer average 1/device2022-10: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-01: 0 reports for this device; peer average 2/device2023-03: 0 reports for this device; peer average 2.5/device2023-04: 0 reports for this device; peer average 1/device2023-05: 0 reports for this device; peer average 3.5/device2023-06: 0 reports for this device; peer average 3.5/device2023-08: 0 reports for this device; peer average 1/device2023-09: 0 reports for this device; peer average 2/device2023-10: 0 reports for this device; peer average 2/device2023-11: 0 reports for this device; peer average 3/device2024-01: 0 reports for this device; peer average 1/device2024-02: 0 reports for this device; peer average 1/device2024-04: 0 reports for this device; peer average 1/device2024-05: 0 reports for this device; peer average 1/device2024-06: 0 reports for this device; peer average 1/device2024-07: 0 reports for this device; peer average 1/device2024-11: 0 reports for this device; peer average 1/device2024-12: 0 reports for this device; peer average 1/device2025-02: 0 reports for this device; peer average 1/device2025-04: 0 reports for this device; peer average 1.5/device2025-05: 0 reports for this device; peer average 2/device2025-06: 0 reports for this device; peer average 2/device2025-07: 0 reports for this device; peer average 2/device2025-08: 0 reports for this device; peer average 1.67/device2025-09: 0 reports for this device; peer average 2/device2025-12: 0 reports for this device; peer average 1/device2026-02: 0 reports for this device; peer average 1.33/device2026-03: 2 reports for this device; peer average 1.33/device2026-05: 0 reports for this device; peer average 1/device2026-06: 0 reports for this device; peer average 1.5/device010203060708101112030608100104050607100304050608091011120103040506080910110102040506071112020405060708091202030506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0102
2019-0201
2019-0301
2019-0601
2019-0701
2019-0801
2019-1001
2019-1104
2019-1201
2020-0301
2020-0601
2020-0801
2020-1001
2021-0101
2021-0401
2021-0501.33
2021-0601
2021-0702.5
2021-1001
2022-0301
2022-0401
2022-0501
2022-0601
2022-0801
2022-0901
2022-1001
2022-1101
2022-1201
2023-0102
2023-0302.5
2023-0401
2023-0503.5
2023-0603.5
2023-0801
2023-0902
2023-1002
2023-1103
2024-0101
2024-0201
2024-0401
2024-0501
2024-0601
2024-0701
2024-1101
2024-1201
2025-0201
2025-0401.5
2025-0502
2025-0602
2025-0702
2025-0801.67
2025-0902
2025-1201
2026-0201.33
2026-0321.33
2026-0501
2026-0601.5
This device (reports/month)Average device in GEN (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