FDA applicant
Medelec Intl. Corp.
FDA records 15 decisions for Medelec Intl. Corp. (Miami Beach, FL) from 1985 to 1996: 15 510(k) clearances. Most are in product codes GES (Blade, Scalpel) and GWQ (Full-Montage Standard Electroencephalograph). 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 Medelec Intl. Corp.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Medelec Intl. Corp. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Medelec Intl. 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) ReportOther applicant names beginning “Medelec”
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