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Avalign

Model VM46-9151 · Avalign Technologies, Inc. · DI 00190776005627

GEI — Electrosurgical, Cutting & Coagulation & Accessories · Class II · 21 CFR 878.4400

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.

Injury: 2

23572019-01: 0 reports for this device; peer average 6.86/device2019-02: 0 reports for this device; peer average 4.35/device2019-03: 0 reports for this device; peer average 4.42/device2019-04: 0 reports for this device; peer average 6.12/device2019-05: 0 reports for this device; peer average 4.8/device2019-06: 0 reports for this device; peer average 5.04/device2019-07: 0 reports for this device; peer average 5.86/device2019-08: 0 reports for this device; peer average 6.1/device2019-09: 0 reports for this device; peer average 4.99/device2019-10: 0 reports for this device; peer average 5.85/device2019-11: 0 reports for this device; peer average 5.62/device2019-12: 0 reports for this device; peer average 5.41/device2020-01: 0 reports for this device; peer average 4.81/device2020-02: 0 reports for this device; peer average 5.57/device2020-03: 0 reports for this device; peer average 5.68/device2020-04: 0 reports for this device; peer average 3.57/device2020-05: 0 reports for this device; peer average 3.76/device2020-06: 0 reports for this device; peer average 5.14/device2020-07: 0 reports for this device; peer average 6.56/device2020-08: 0 reports for this device; peer average 4.64/device2020-09: 0 reports for this device; peer average 5.86/device2020-10: 0 reports for this device; peer average 5.55/device2020-11: 0 reports for this device; peer average 5.14/device2020-12: 0 reports for this device; peer average 5.31/device2021-01: 0 reports for this device; peer average 5.17/device2021-02: 0 reports for this device; peer average 4.89/device2021-03: 0 reports for this device; peer average 5.7/device2021-04: 0 reports for this device; peer average 5.26/device2021-05: 0 reports for this device; peer average 5.14/device2021-06: 0 reports for this device; peer average 5.83/device2021-07: 0 reports for this device; peer average 4.89/device2021-08: 0 reports for this device; peer average 4.3/device2021-09: 0 reports for this device; peer average 4.77/device2021-10: 0 reports for this device; peer average 6.17/device2021-11: 0 reports for this device; peer average 5.57/device2021-12: 0 reports for this device; peer average 5.56/device2022-01: 0 reports for this device; peer average 5.04/device2022-02: 0 reports for this device; peer average 5.15/device2022-03: 0 reports for this device; peer average 5.75/device2022-04: 0 reports for this device; peer average 4.98/device2022-05: 0 reports for this device; peer average 5.78/device2022-06: 0 reports for this device; peer average 6.3/device2022-07: 0 reports for this device; peer average 4.36/device2022-08: 0 reports for this device; peer average 4.59/device2022-09: 0 reports for this device; peer average 5/device2022-10: 0 reports for this device; peer average 4.76/device2022-11: 0 reports for this device; peer average 4.61/device2022-12: 0 reports for this device; peer average 4.04/device2023-01: 0 reports for this device; peer average 5.52/device2023-02: 0 reports for this device; peer average 4.59/device2023-03: 0 reports for this device; peer average 4.87/device2023-04: 0 reports for this device; peer average 4.78/device2023-05: 0 reports for this device; peer average 5.14/device2023-06: 0 reports for this device; peer average 4.78/device2023-07: 0 reports for this device; peer average 4.82/device2023-08: 0 reports for this device; peer average 4.44/device2023-09: 0 reports for this device; peer average 5.23/device2023-10: 0 reports for this device; peer average 5.1/device2023-11: 0 reports for this device; peer average 4.38/device2023-12: 0 reports for this device; peer average 4.79/device2024-01: 2 reports for this device; peer average 5.54/device2024-02: 0 reports for this device; peer average 5.46/device2024-03: 0 reports for this device; peer average 6.16/device2024-04: 0 reports for this device; peer average 6.04/device2024-05: 0 reports for this device; peer average 6.28/device2024-06: 0 reports for this device; peer average 5.39/device2024-07: 0 reports for this device; peer average 5.05/device2024-08: 0 reports for this device; peer average 5.01/device2024-09: 0 reports for this device; peer average 5.19/device2024-10: 0 reports for this device; peer average 5.7/device2024-11: 0 reports for this device; peer average 5.29/device2024-12: 0 reports for this device; peer average 4.06/device2025-01: 0 reports for this device; peer average 5.17/device2025-02: 0 reports for this device; peer average 4.46/device2025-03: 0 reports for this device; peer average 6.28/device2025-04: 0 reports for this device; peer average 4.39/device2025-05: 0 reports for this device; peer average 5.16/device2025-06: 0 reports for this device; peer average 5.08/device2025-07: 0 reports for this device; peer average 5.2/device2025-08: 0 reports for this device; peer average 5.45/device2025-09: 0 reports for this device; peer average 4.85/device2025-10: 0 reports for this device; peer average 5.14/device2025-11: 0 reports for this device; peer average 5.55/device2025-12: 0 reports for this device; peer average 5.81/device2026-01: 0 reports for this device; peer average 5.63/device2026-02: 0 reports for this device; peer average 5.98/device2026-03: 0 reports for this device; peer average 6.2/device2026-04: 0 reports for this device; peer average 5.43/device2026-05: 0 reports for this device; peer average 6.19/device2026-06: 0 reports for this device; peer average 5.56/device010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506070809101112010203040506
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2019-0106.86
2019-0204.35
2019-0304.42
2019-0406.12
2019-0504.8
2019-0605.04
2019-0705.86
2019-0806.1
2019-0904.99
2019-1005.85
2019-1105.62
2019-1205.41
2020-0104.81
2020-0205.57
2020-0305.68
2020-0403.57
2020-0503.76
2020-0605.14
2020-0706.56
2020-0804.64
2020-0905.86
2020-1005.55
2020-1105.14
2020-1205.31
2021-0105.17
2021-0204.89
2021-0305.7
2021-0405.26
2021-0505.14
2021-0605.83
2021-0704.89
2021-0804.3
2021-0904.77
2021-1006.17
2021-1105.57
2021-1205.56
2022-0105.04
2022-0205.15
2022-0305.75
2022-0404.98
2022-0505.78
2022-0606.3
2022-0704.36
2022-0804.59
2022-0905
2022-1004.76
2022-1104.61
2022-1204.04
2023-0105.52
2023-0204.59
2023-0304.87
2023-0404.78
2023-0505.14
2023-0604.78
2023-0704.82
2023-0804.44
2023-0905.23
2023-1005.1
2023-1104.38
2023-1204.79
2024-0125.54
2024-0205.46
2024-0306.16
2024-0406.04
2024-0506.28
2024-0605.39
2024-0705.05
2024-0805.01
2024-0905.19
2024-1005.7
2024-1105.29
2024-1204.06
2025-0105.17
2025-0204.46
2025-0306.28
2025-0404.39
2025-0505.16
2025-0605.08
2025-0705.2
2025-0805.45
2025-0904.85
2025-1005.14
2025-1105.55
2025-1205.81
2026-0105.63
2026-0205.98
2026-0306.2
2026-0405.43
2026-0506.19
2026-0605.56
This device (reports/month)Average device in GEI (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