FDA applicant

Medical Systems Corp.

Greenvale, NY13 decisions1977–19980 recalls

FDA records 13 decisions for Medical Systems Corp. (Greenvale, NY) from 1977 to 1998: 13 510(k) clearances. Most are in product codes GEX (Powered Laser Surgical Instrument) and DRT (Monitor, Cardiac (Incl. Cardiotachometer &…). Its devices cite 2 predicates, 0 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Plc Medical Systems, Inc.”, “Medical Systems, Inc.”.

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 Medical Systems Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medical Systems Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Systems Corp.’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

Medical Systems Corp.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?