EBR Systems Inc – FDA Inspection, Sep 21, 2026

Record Details

This FDA Inspection record concerns EBR Systems Inc, with an inspection on September 21, 2026, issued by the San Francisco District Office, covering medical devices & rad health.

Company: EBR Systems Inc
Inspection Date: September 21, 2026
Product Type: Medical Devices & Rad Health
Office: San Francisco District Office
Person: Kenya Destin

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ID · d89d3ad1-de4e-499f-8c8b-4cfbe045712b

Inspection Facts

Inspection number: 1336808
FDA center: Medical Devices & Rad Health
Project area: Project Evaluation: Devices
Outcome: Form 483 issued

FDA Citations

21 CFR 803.50(a)(1)Report of Death or Serious Injury
ISO 13485:2016 Clause 7.5.1Production and service provision not adequate

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FDA Inspection

EBR Systems IncSeptember 21, 2026