Manufacturer Intelligence · Based on 176,583 FDA 510(k) records · 90 countries

FDA 510(k) Medical Device Manufacturers - Slovenia

Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

Slovenian medical device manufacturers ranked by FDA 510(k) submission volume. Rankings generated directly from FDA accessdata.gov — no editorial curation, no paid listings.

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Slovenia

Country

Slovenia FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading Slovenia FDA 510(k) manufacturers include Fotona D.D., Fotona D.O.O., Tosama, D.O.O. and 9 others.

Slovenian medical device manufacturers have submitted 62 FDA 510(k) notifications since 1998, achieving a 100% clearance rate across 12 manufacturers. Slovenia's compact but highly specialized medtech sector reflects the country's strength in electrotherapy devices, dental equipment and precision surgical instruments.

Active in FDA 510(k) submissions since 1998. Many Slovenia manufacturers work with FDA regulatory consultants to support U.S. market entry.

Search Slovenia devices in FDA 510(k) database

Ranking period: All time Last 5 yrs Last 3 yrs

FDA 510(k) Slovenia Manufacturers

1–12 of 12

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Fotona D.D. Ljubljana	27	100%	SU	SI
2	Fotona D.O.O. Ljubljana	17	100%	GU PM SU	SI
3	Tosama, D.O.O. Vir, Domzale	5	100%	OB	SI
4	Tosama D.D. Vir, Domzale	2	100%	OB	SI
5	Polident D.O.O., Dental Products Industry Volcja Draga	2	100%	DE	SI
6	Mesi D.O.O.; Mesi, Development of Medical Devices, Ltd. Ljubljana	2	100%	CV	SI
7	Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O. Ljubljana	2	100%	CV	SI
8	Mesi D.O.O. Ljubljana	1	100%	AN	SI
9	Mojca Valijavec Ljublijana	1	100%	SU	SI
10	Iskra Medical, D.O.O. Ljubljana	1	100%	SU	SI
11	Audax D.O.O. Ljubljana	1	100%	RA	SI
12	Cosylab Jsc, Control System Laboratory Ljubljana	1	100%	RA	SI

About This FDA 510(k) Manufacturer Database

Data Source and Methodology

Rankings are based on the total number of published FDA 510(k) submissions per manufacturer in the 510k Database dataset, derived from FDA 510(k) public files. Rankings reflect real regulatory activity — no paid placements, no self-reported data.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.

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