510(k) Report

FDA applicant

Medovations, Inc.

Mchenry, IL31 decisions1983–20150 recalls

FDA records 31 decisions for Medovations, Inc. (Mchenry, IL) from 1983 to 2015: 31 510(k) clearances. Most are in product codes KNT (Tubes, Gastrointestinal (And Accessories)) and KNQ (Dilator, Esophageal). Its devices cite 1 predicate, 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

1in 2015

2015: 1
2007high 1 (2015) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Medovations, 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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