FDA applicant

Sola Medical Devices, LLC

Irvine, CA1 decision2003–20030 recalls

FDA records 1 decision for Sola Medical Devices, LLC (Irvine, CA) in 2003: 1 510(k) clearance. All are in product code DRN (Device, Counter-Pulsating, External). 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 Sola Medical Devices, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Sola Medical Devices, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Sola”

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

Sola-Tan Intl. 3 Sola Ophthalmics 1 Sola-Syntex Ophthalmics 1

Sola Medical Devices, LLC

Which product codes does it file in?

What has FDA decided for it lately?

Other applicant names beginning “Sola”