FDA applicant

Medical Sterile Products, Inc.

Rincon, PR2 decisions1993–20000 recalls

FDA records 2 decisions for Medical Sterile Products, Inc. (Rincon, PR) from 1993 to 2000: 2 510(k) clearances. Most are in product codes HNA (Spud, Ophthalmic) and HNO (Keratome, Ac-Powered). Its devices cite 4 predicates, 0 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, ophthalmic panel, where it files most

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

FDA decisions per year

No FDA decision for Medical Sterile Products, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Medical Sterile Products, Inc.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?