FDA applicant

Syntermed, Inc.

Anaheim, CA14 decisions2000–20230 recalls

FDA records 14 decisions for Syntermed, Inc. (Anaheim, CA) from 2000 to 2023: 14 510(k) clearances. Most are in product codes KPS (System, Tomography, Computed, Emission) and LLZ (System, Image Processing, Radiological). Its devices cite 27 predicates, 11 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Syntermed”.

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

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

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

FDA decisions per year

1in 2023

2007high 3 (2013) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Syntermed, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Syntermed, Inc.’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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Syntermed, Inc.

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?