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Avalign
Model VM104-1562 · Avalign Technologies, Inc. · DI 00190776351502
KAD — Elevator, Ent · Class I · 21 CFR 874.4420
UDILibrary device dossier · generated 2026-09-07 · 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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2025-05 | 0 | 2 |
| 2025-07 | 0 | 1 |
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