Apnomed, Inc. – FDA Inspection, May 28, 2026

Record Details

This FDA Inspection record concerns Apnomed, Inc., with an inspection on May 28, 2026, issued by the Center for Devices and Radiological Health, covering medical devices & rad health.

Company: Apnomed, Inc.
Inspection Date: May 28, 2026
Product Type: Medical Devices & Rad Health
Office: Center for Devices and Radiological Health
Person: Brian R. Hendricks (Investigator)

View Company Profile

ID · 74e83bbb-a5e6-4af6-b52b-1a6aa7617642

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number: 1319428
FDA center: Medical Devices & Rad Health
Project area: Postmarket Assurance: Devices
Outcome: Form 483 issued

FDA Citations

ISO 13485:2016 Clause 7.5.8No documented system to assign unique device identification (UDI)
ISO 13485:2016 Clause 7.3.10Design and development files not maintained

Full citation text and observation details available on the Dashboard.

Discuss this record with AI

KeyPedia

ChatGPT

Claude

Perplexity

Grok

Copilot

Document or profile

One record shows the event. A profile shows the pattern.

Buy this document for the source file and details behind this single event.

Choose full profile access to connect related records, sites, people, citations, and enforcement history in one view.

Explore Apnomed, Inc.

FDA Inspection

Apnomed, Inc.May 28, 2026