Manufacturer Intelligence · Based on 154,904 FDA 510(k) records · 86 countries

FDA 510(k) Medical Device Manufacturers - Finland

Finnish medical device manufacturers ranked by FDA 510(k) submission volume. Rankings generated directly from FDA accessdata.gov — no editorial curation, no paid listings.

  • Compare manufacturers by FDA 510(k) submission activity
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Used by regulatory affairs teams and medtech consultants worldwide

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50
Manufacturers
Finland
Country

Finland FDA 510(k) Overview

50
Manufacturers
302
Submissions
99%
Clearance rate

Leading Finland FDA 510(k) manufacturers include Planmeca Oy, Inion , Ltd., Wallac OY and 47 others.

Finnish medical device manufacturers have submitted 302 FDA 510(k) notifications since 1985, with a 99% clearance rate across 50 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.

Search Finland devices in FDA 510(k) database
Ranking period: All time Last 5 yrs Last 3 yrs

FDA 510(k) Finland Manufacturers

1–50 of 50
# 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
Inion OY
Tampere
14 100%
DE NE OR
FI
8
Bionx Implants, Ltd.
Tampere
12 100%
DE OR
FI
9
Bioretec, Ltd.
Tampere
10 90%
OR
FI
10
Palodex Group OY
Tuusula
10 100%
RA
FI
11
Soredex Palodex Group OY
Helsinki
9 100%
RA
FI
12
Thermo Electron OY
Vantaa
9 100%
CH IM TX
FI
13
Vyaire Medical, Inc.
Helsinki
9 100%
AN CV
FI
14
Thermofisher Scientific OY
Vantaa
8 100%
CH
FI
15
Oriola OY Finndent
Finland
7 100%
DE
FI
16
Icare Finland OY
Vantaa
7 100%
OP
FI
17
Wipak OY
Nastola
7 100%
HO
FI
18
Instrumentarium Dental, Palodex Group OY
Tuusula
5 100%
RA
FI
19
Optomed OY
Oulu
5 100%
OP
FI
20
Orion Diagnostica, Div. Orion Corp.
02101 Espoo
4 100%
IM MI
FI
21
Elekta Neuromag OY
Helsinki
4 100%
NE
FI
22
Orion Diagnostica, OY
Espoo
4 100%
CH IM
FI
23
Surgify Medical OY
Espoo
4 100%
NE
FI
24
Orion Corporation Soredex
Helsinki
3 100%
RA
FI
25
Linvatec Biomaterials, Inc.
Tampere
3 100%
OR
FI
26
Bone Index Finland , Ltd.
Kuopio
3 100%
RA
FI
27
Combinostics OY
Tampere
3 100%
RA
FI
28
Medikro OY
Kuopio
2 100%
AN
FI
29
Delfin Technologies, Ltd.
Kuopio
2 100%
GU
FI
30
Nexstim Plc
Helsinki
2 100%
NE
FI
31
Bonalive Biomaterials, Ltd.
Turku
2 100%
OR
FI
32
Topcon Healthcare Solutions EMEA Oy
Oulu
2 100%
OP
FI
33
Mvision AI OY
Helsinki
2 100%
RA
FI
34
Nexstim Oyj
Helsinki
2 100%
NE
FI
35
Biomendex OY
Tampere
1 100%
OR
FI
36
Lasermatic OY
Finland
1 100%
SU
FI
37
Ventipress OY
Finland
1 100%
PM
FI
38
Conmed Linvatec Biomaterials
Tampere
1 100%
OR
FI
39
Innokas Yhtyma
Kempele, Oulu
1 100%
CV
FI
40
Ge Healthcare Filand OY
Helsinki
1 100%
NE
FI
41
Bittium Biosignals , Ltd.
Kuopio
1 100%
CV
FI
42
Mediracer OY
Oulu
1 100%
NE
FI
43
Optomed Oyj
Oulu
1 100%
OP
FI
44
Athlos OY
Espoo
1 100%
RA
FI
45
MVision AI
Helsinki
1 100%
RA
FI
46
Philips OY
Vantaa
1 100%
RA
FI
47
Ausculthing OY
Espoo
1 100%
CV
FI
48
Megin OY
Espoo
1 100%
NE
FI
49
Neuro Event Labs OY
Tampere
1 100%
NE
FI
50
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. Rankings reflect real regulatory activity — no paid placements, no self-reported data.

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

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