FDA applicant

Braemar Manufacturing, LLC

San Diego, CA3 decisions2013–20180 recalls

FDA records 3 decisions for Braemar Manufacturing, LLC (San Diego, CA) from 2013 to 2018: 3 510(k) clearances. Most are in product codes MWJ (Electrocardiograph, Ambulatory (Without…) and DSI (Detector And Alarm, Arrhythmia). Its devices cite 4 predicates, 0 of them its own earlier devices. 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 Braemar Manufacturing, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2013high 1 (2013) · low 0 (2014)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2013.

FIG. 1 — Braemar Manufacturing, LLC by year, 2013–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Braemar Manufacturing, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Braemar”

FDA records each applicant name separately; these may or may not be the same firm.

Braemar, Inc. 10

Braemar Manufacturing, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Braemar”