Manufacturer Intelligence · Based on 21,859 FDA 510(k) records · 72 countries

FDA 510(k) Medical Device Manufacturers - Slovenia

Slovenian medical device manufacturers ranked by FDA 510(k) submission volume. This is not a curated directory - rankings reflect real submission activity extracted from FDA accessdata.gov records.

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8
Manufacturers
Slovenia
Country

Slovenia FDA 510(k) Overview

7
Manufacturers
20
Submissions
100%
Clearance rate

Leading Slovenia FDA 510(k) manufacturers include Fotona D.O.O., Mesi, Development of Medical Devices, Ltd.; Mesi D.O.O., Mesi D.O.O. and 5 others.

Slovenian medical device manufacturers have submitted 20 FDA 510(k) notifications since 2019, achieving a 100% clearance rate across 7 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 2019. Many Slovenia manufacturers work with FDA regulatory consultants to support U.S. market entry.

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. This is not a curated or paid listing - manufacturer rankings reflect real regulatory activity.

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