FDA applicant

Ocean Medical Products, Ltd.

Mchenry, IL9 decisions1981–19882 recalls

FDA records 9 decisions for Ocean Medical Products, Ltd. (Mchenry, IL) from 1981 to 1988: 9 510(k) clearances. Most are in product codes GAA (Needle, Aspiration And Injection, Disposable) and FMI (Needle, Hypodermic, Single Lumen). 2 recalls are 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 Ocean Medical Products, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Ocean Medical Products, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Ocean Medical Products, Ltd.’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 “Ocean”

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

Ocean Scientific, Inc. 6 Ocean Pacific Med Tec 1 Ocean Optical Co., Inc. 1

Ocean Medical Products, Ltd.

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?

What has been recalled?

Other applicant names beginning “Ocean”