FDA applicant

Odyssey Medical, Inc.

Memphis, TN4 decisions1997–20090 recalls

FDA records 4 decisions for Odyssey Medical, Inc. (Memphis, TN) from 1997 to 2009: 4 510(k) clearances. Most are in product codes LZU (Plug, Punctum) and KKX (Drape, Surgical, Antimicrobial). Its devices cite 1 predicate, 1 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2009

2007high 1 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Odyssey”

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

Odyssey Technologies, Inc. 2 Odyssey Medical Technologies 1 Odyssey Optical Systems, LLC 1

Odyssey Medical, 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?

Other applicant names beginning “Odyssey”