FDA applicant

EBR Systems, Inc.

Sunnyvale1 decision2025–20250 recalls

FDA records 1 decision for EBR Systems, Inc. (Sunnyvale) in 2025: 1 original PMA approval. All are in product code SEG (Leadless Cardiac Resynchronization Therapy (Crt)). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided EBR Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — EBR Systems, Inc. by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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EBR Systems, Inc.

Which product codes does it file in?

What has FDA decided for it lately?