FDA applicant

Medivision (U.S.A.), Inc.

West Chester, PA1 decision2001–20010 recalls

FDA records 1 decision for Medivision (U.S.A.), Inc. (West Chester, PA) in 2001: 1 510(k) clearance. All are in product code HAW (Neurological Stereotaxic Instrument). 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, neurology panel, where it files most

How often FDA has decided Medivision (U.S.A.), Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Medivision (U.S.A.), Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Medivision (U.S.A.), Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Medivision (U.S.A.), 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 “Medivision”

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

Medivision Scope Service Center, Inc. 5 Medivision Medical Imaging, Ltd. 4 Medivision Endoscopy 1

Medivision (U.S.A.), 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 “Medivision”