FDA applicant
Bovie Medical Corporation
FDA records 23 decisions for Bovie Medical Corporation (Clearwater, FL) from 2006 to 2019: 23 510(k) clearances. Most are in product codes GEI (Electrosurgical, Cutting & Coagulation &…) and HQP (Unit, Cautery, Thermal, Battery-Powered). Since 2016 its 510(k)s took a median of 55 days from receipt to decision, against 93 for FDA’s reviews in the same codes and years. Its devices cite 56 predicates, 19 of them its own earlier devices. 15 recalls are linked to its devices.
FDA’s records also spell it “Bovie Medical”, “Bovie Medical Corp.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Bovie Medical Corporation’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
3in 2021
Class I Class II/III not classified
Planning a device like Bovie 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) ReportOther applicant names beginning “Bovie”
FDA records each applicant name separately; these may or may not be the same firm.