Manufacturer Intelligence · Based on 109,383 FDA 510(k) records · 77 countries

FDA 510(k) Medical Device Manufacturers - Finland

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

Finnish 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

Finland

Country

Finland FDA 510(k) Overview

Manufacturers

191

Submissions

98%

Clearance rate

Leading Finland FDA 510(k) manufacturers include Planmeca Oy, Inion , Ltd., Wallac OY and 30 others.

Finnish medical device manufacturers have submitted 191 FDA 510(k) notifications since 1985, with a 98.4% clearance rate across 33 manufacturers. Finland's medtech sector shows concentration in patient monitoring, neurology devices and diagnostic imaging, reflecting the country's strength in technology-driven healthcare solutions.

Active in FDA 510(k) submissions since 1985. Many Finland manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Finland Manufacturers

1–33 of 33

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Planmeca Oy Helsinki	28	100%	DE RA	FI
2	Inion , Ltd. Tampere	23	100%	DE OR	FI
3	Wallac OY Finland	22	95%	CH HE PA +1	FI
4	Orion Corp. 20101 Turku	21	95%	IM MI RA	FI
5	Planmed OY Helsinki	20	100%	RA	FI
6	Bionx Implants, Inc. Tampere	18	100%	DE OR	FI
7	Vyaire Medical, Inc. Helsinki	9	100%	AN CV	FI
8	Wipak OY Nastola	7	100%	HO	FI
9	Icare Finland OY Vantaa	5	100%	OP	FI
10	Inion OY Tampere	4	100%	DE NE OR	FI
11	Surgify Medical OY Espoo	4	100%	NE	FI
12	Palodex Group OY Tuusula	3	100%	RA	FI
13	Combinostics OY Tampere	3	100%	RA	FI
14	Bonalive Biomaterials, Ltd. Turku	2	100%	OR	FI
15	Topcon Healthcare Solutions EMEA Oy Oulu	2	100%	OP	FI
16	Mvision AI OY Helsinki	2	100%	RA	FI
17	Nexstim Oyj Helsinki	2	100%	NE	FI
18	Biomendex OY Tampere	1	100%	OR	FI
19	Bioretec, Ltd. Tampere	1	0%	OR	FI
20	Optomed OY Oulu	1	100%	OP	FI
21	Delfin Technologies, Ltd. Kuopio	1	100%	GU	FI
22	Bone Index Finland , Ltd. Kuopio	1	100%	RA	FI
23	Nexstim Plc Helsinki	1	100%	NE	FI
24	Bittium Biosignals , Ltd. Kuopio	1	100%	CV	FI
25	Mediracer OY Oulu	1	100%	NE	FI
26	Optomed Oyj Oulu	1	100%	OP	FI
27	Athlos OY Espoo	1	100%	RA	FI
28	MVision AI Helsinki	1	100%	RA	FI
29	Philips OY Vantaa	1	100%	RA	FI
30	Ausculthing OY Espoo	1	100%	CV	FI
31	Megin OY Espoo	1	100%	NE	FI
32	Neuro Event Labs OY Tampere	1	100%	NE	FI
33	Bonalive , Ltd. Turku	1	100%	DE	FI

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.