510(k) Report

FDA applicant

Medical Soft, Inc.

Ellicott City, MD1 decision1995–19950 recalls

FDA records 1 decision for Medical Soft, Inc. (Ellicott City, MD) in 1995: 1 510(k) clearance. All are in product code HEM (Imager, Ultrasonic Obstetric-Gynecologic). 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, obstetrics and gynecology panel, where it files most

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

FDA decisions per year

No FDA decision for Medical Soft, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medical Soft, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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