510(k) Report

FDA applicant

Florence Medical, Ltd.

Ra'Ananna 43373, IL3 decisions2001–20020 recalls

FDA records 3 decisions for Florence Medical, Ltd. (Ra'Ananna 43373, IL) from 2001 to 2002: 3 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and DSK (Computer, Blood-Pressure). Its devices cite 3 predicates, 3 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, cardiovascular panel, where it files most

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

FDA decisions per year

No FDA decision for Florence Medical, Ltd. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Florence Medical, Ltd.’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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