Manufacturer Intelligence · Based on 21,975 FDA 510(k) records · 72 countries

FDA 510(k) Medical Device Manufacturers - Poland

Polish 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.

  • Compare manufacturers by FDA 510(k) submission activity
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8
Manufacturers
Poland
Country

Poland FDA 510(k) Overview

8
Manufacturers
11
Submissions
100%
Clearance rate

Leading Poland FDA 510(k) manufacturers include Htl-Strefa S.A, Medinice S.A., Egzotech Sp. Z O. O. and 5 others.

Polish medical device manufacturers have submitted 11 FDA 510(k) notifications since 2020, with a 100% clearance rate across 8 manufacturers. Poland's emerging FDA presence reflects the country's growing medical device industry within the European medtech ecosystem, with initial U.S. market entry focused on Class II devices.

Active in FDA 510(k) submissions since 2020. Many Poland 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.