FDA applicant
Endymed Medical, Ltd.
FDA records 8 decisions for Endymed Medical, Ltd. (Caesarea, IL) from 2011 to 2025: 7 510(k) clearances and 1 De Novo grant. Most are in product codes OUH (Skin Resurfacing Rf Applicator) and GEI (Electrosurgical, Cutting & Coagulation &…). Since 2016 its 510(k)s took a median of 95 days from receipt to decision, against 130 for FDA’s reviews in the same codes and years. Its devices cite 15 predicates, 5 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
How often FDA has decided Endymed Medical, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2011.
Planning a device like Endymed 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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