FDA applicant

Apyx Medical Corporation

Clearwater, FL7 decisions2022–20260 recalls

FDA records 7 decisions for Apyx Medical Corporation (Clearwater, FL) from 2022 to 2026: 7 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and QPB (System, Suction, Lipoplasty For Removal). Since 2016 its 510(k)s took a median of 105 days from receipt to decision, against 127 for FDA’s reviews in the same codes and years. Its devices cite 9 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

1in 2025

2022high 3 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2022.

FIG. 1 — Apyx Medical Corporation by year, 2022–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Apyx Medical Corporation’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

Other applicant names beginning “Apyx”

FDA records each applicant name separately; these may or may not be the same firm.

Apyx Medical Corporation (Formerly Bovie Medical… 4

Apyx Medical Corporation

Which product codes does it file in?

How long do its 510(k) reviews take?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Apyx”