FDA applicant

Versamed Medical Systems, Inc.

Pearl River, NY8 decisions2004–20120 recalls

FDA records 8 decisions for Versamed Medical Systems, Inc. (Pearl River, NY) from 2004 to 2012: 8 510(k) clearances. All are in product code CBK (Ventilator, Continuous, Facility Use). Its devices cite 15 predicates, 6 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Versamed Medical Systems , Ltd.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2012

2007high 2 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Versamed Medical Systems, 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 “Versamed”

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

Versamed, Ltd. 3

Versamed Medical Systems, Inc.

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Versamed”