Manufacturer Intelligence · Based on 58,864 FDA 510(k) records · 74 countries

FDA 510(k) Medical Device Manufacturers - Poland

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

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.

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Manufacturers

Poland

Country

Poland FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading Poland FDA 510(k) manufacturers include Htl-Strefa S.A, Medinice S.A., Comarch Healthcare SA and 7 others.

Polish medical device manufacturers have submitted 14 FDA 510(k) notifications since 2018, with a 100% clearance rate across 10 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 2018. Many Poland manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Poland Manufacturers

1–10 of 10

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Htl-Strefa S.A Ozorkow	5	100%	HO SU	PL
2	Medinice S.A. Warsaw	1	100%	CV	PL
3	Comarch Healthcare SA Krakow	1	100%	CV	PL
4	Egzotech Sp. Z O. O. Gliwice	1	100%	PM	PL
5	Chm Sp. Z O.O. Juchnowiec Koscielny	1	100%	OR	PL
6	Htl Strefa SA Ozork?w	1	100%	HO	PL
7	Naser Dib Gabinet Lekarksi Nasmed Warszawa	1	100%	GU	PL
8	Medapp S.A. Krakow	1	100%	RA	PL
9	Mim Fertility Warszawa	1	100%	RA	PL
10	FindAir Sp. z o.o. Kraków	1	100%	AN	PL

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.