FDA applicant
Makol Medical Instruments Corp.
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
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.
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.
See the 510(k) Report