Manufacturer Intelligence · Based on 130,418 FDA 510(k) records · 83 countries

FDA 510(k) Medical Device Manufacturers - Hungary

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

Hungarian 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

Hungary

Country

Hungary FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading Hungary FDA 510(k) manufacturers include Xbody Hungary Kft., Kinepict Health, Ltd., Labtech Kft. and 7 others.

Hungarian medical device manufacturers have submitted 13 FDA 510(k) notifications since 2014, achieving a 100% clearance rate across 10 manufacturers. Hungary's recent entry into the FDA 510(k) dataset reflects the country's developing medical device sector and increasing interest in U.S. regulatory market access.

Active in FDA 510(k) submissions since 2014. Many Hungary manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Hungary Manufacturers

1–10 of 10

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Xbody Hungary Kft. Budapest	3	100%	PM	HU
2	Kinepict Health, Ltd. Budakeszi	2	100%	RA	HU
3	Labtech Kft. Debrecen	1	100%	CV	HU
4	Meditech , Ltd. Budapest	1	100%	CV	HU
5	Fit-Pro , Ltd. Budapest	1	100%	PM	HU
6	Emd Endoszkop Muszer Gyarto ES Kereskedelmi Kft. Debrecen	1	100%	NE	HU
7	Mediso Medical Imaging Systems, Lttd. Budapest	1	100%	RA	HU
8	Qx World, Ltd. Budapest	1	100%	NE	HU
9	Mde Orvosbiol?giai Kutat?, Fejleszto, Budapest	1	100%	NE	HU
10	Mediso Medical Imaging Systems, Ltd. Budapest	1	100%	RA	HU

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.