FDA applicant

Synemed, Inc.

Walker, MI9 decisions1981–19950 recalls

FDA records 9 decisions for Synemed, Inc. (Walker, MI) from 1981 to 1995: 8 510(k) clearances and 1 original PMA approval. Most are in product codes HPT (Perimeter, Automatic, Ac-Powered) and LOI (Laser, Neodymium:Yag, Ophthalmic For Uses…). 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Synemed, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Synemed, Inc.

Which product codes does it file in?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?