510(k) Report

FDA applicant

Makol Medical Instruments Corp.

Miami, FL1 decision1995–19950 recalls

FDA records 1 decision for Makol Medical Instruments Corp. (Miami, FL) in 1995: 1 510(k) clearance. All are in product code FLK (Thermometer, Clinical Mercury). 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, general hospital panel, where it files most

How often FDA has decided Makol Medical Instruments Corp.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Makol Medical Instruments Corp. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Makol Medical Instruments Corp.’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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