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Bovie Medical Corporation

USA · Clearwater

✓ Record-verifiedregistrations found in 3 markets

This company has registrations in United States, Brazil, Canada — 3 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

29510(k) clearances

Class I 0Class II 0Class III 0

plus 0 registration records and 29 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

10registered devices

Class I 8Class II 2

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

0registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

8active device licences

Class II 3Class III 5

9 including historic records

TWTaiwanTFDA

pendingnot queried

SGSingaporeHSA SMDR

pendingnot queried

KRSouth KoreaMFDS GMP

pendingnot queried

AUAustraliaTGA ARTG

pendingnot queried

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

pendingnot queried

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States0 registration records, 29 510(k), 0 PMA

Brazil10 confirmed, 0 excluded

Canada8 confirmed, 0 excluded

Manufacturer names merged into this page: BOVIE MEDICAL CORPORATION · Bovie Medical Corporation

Same-named companies — This database also contains companies with near-identical names: Apyx Medical Corporation (Formerly Bovie Medical Corporation, Bovie Medical Corporation Dba Apyx Medical Corporation. Company name alone cannot separate their registrations, so the figures below may include either.

Registration details (sample)

Market	Identifier	Name	Class / date
US	K220970	Renuvion APR Handpiece	2022-07-15
US	K211652	Renuvion Dermal Handpiece, Renuvion Dermal System	2022-05-25
US	K202880	J-Plasma Precise FLEX Handpiece	2021-01-04
BR	81832580054	Tubo Descartável para Evacuação de Fumaça ou Aerossóis com Ponteira	Class I
BR	81832580055	Tubo Descartável para Evacuação de Fumaça ou Aerossóis resistente a la	Class I
BR	81832580056	Tubo Descartável para Evacuação com Encaixe Redutor	Class I
CA	1833	DISPOSABLE CAUTERIZER	Class II
CA	37482	AARON 900 ELECTROSURGICAL GENERATOR	Class III
CA	70991	BOVIE BUTTON REMOTE HAND SWITCH	Class II

Bovie Medical Corporation

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

Registration details (sample)

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