Manufacturer Intelligence · Based on 21,251 FDA 510(k) records · 72 countries

FDA 510(k) Medical Device Manufacturers - Spain

Spanish 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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50
Manufacturers
Spain
Country

Spain FDA 510(k) Overview

50
Manufacturers
126
Submissions
100%
Clearance rate

Leading Spain FDA 510(k) manufacturers include Terrats Medical SL, Talladium Espa?a, SL, B.T.I. Biotechnology Institute, Sl. and 47 others.

Spanish medical device manufacturers have submitted 126 FDA 510(k) notifications since 2019, with a 100% clearance rate across 50 manufacturers. Spain's FDA-active medtech sector shows activity in dental devices, imaging systems and surgical instruments, reflecting growing investment in medical technology development and U.S. market entry.

Active in FDA 510(k) submissions since 2019. Many Spain manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Spain Manufacturers

1–50 of 50
# Manufacturer Submissions Cleared Active panels Country
1
Terrats Medical SL
Montcada I Reixac
20 100%
DE
ES
2
Talladium Espa?a, SL
Lleida
7 100%
DE HO
ES
3
B.T.I. Biotechnology Institute, Sl.
01510 Minano (Alava)
6 100%
DE
ES
4
Implant Protesis Dental 2004, S.L.
Mataro
6 100%
DE
ES
5
Biokit, S.A.
Barcelona
5 100%
IM MI
ES
6
Termosalud
Gijon
5 100%
PM SU
ES
7
Cotton High Tech S.L.
Barcelona
4 100%
OB
ES
8
Iline Microsystems, S.L.
Donostia-San Sebastian
4 100%
HE
ES
9
Chip Ideas Electronics S.L.
Valencia
4 100%
CV
ES
10
Software Nemotec S.L.
Arroyomolinos, Madrid
4 100%
DE RA
ES
11
Adas3D Medical S.L.
Barcelona
4 100%
RA
ES
12
Abanza Tecnomed S.L
Mutilva
4 100%
OR
ES
13
Quibim S.L.
Valencia
3 100%
RA
ES
14
Indiba S. A. U.
Sant Quirze Del Vall?s (Barcelona)
3 100%
SU
ES
15
Termosalud S.L.
Gijon
2 100%
PM SU
ES
16
Biosystems S.A.
Barcelona
2 100%
CH IM
ES
17
Progenika Biopharma S.A., A Grifols Company
Derio
2 100%
IM
ES
18
Capenergy Medical S.L.
Sant Joan Despi, Barcelona
2 100%
SU
ES
19
High Technology Products S.L.U
Barcelona
2 100%
SU
ES
20
Avinent Implant System S.L.U.
Santpedor
2 100%
HO
ES
21
Orthoapnea S.L.
Malaga
2 100%
DE
ES
22
Graphenano Dental S.L.
Yecla
2 100%
DE
ES
23
3D-Shaper Medical S.L
Barcelona
2 100%
RA
ES
24
Mentice Spain S.L.
Barcelona
2 100%
NE
ES
25
Methinks Software, S.L
Barcelona
2 100%
RA
ES
26
Augmented Reality Software S.L.
Salamanca
1 100%
RA
ES
27
Talladium Espana, SL
Lleida
1 100%
DE
ES
28
General Equipment For Medical Imaging, S.A.
Valencia
1 100%
RA
ES
29
Smart Solutions Technologies SL
Madrid
1 100%
CV
ES
30
Medical Cables S.L.
Malaga
1 100%
PM
ES
31
Galgo Medical S.L
Barcelona
1 100%
RA
ES
32
B. Bruan Surgical, SA
Rubi
1 100%
SU
ES
33
Global Med Systems SL
Leon
1 100%
SU
ES
34
I-Motion Group Global Iberica S.L.
Alcorcon
1 100%
PM
ES
35
Leaseir Technologies, Slu
Gij?n
1 100%
SU
ES
36
Creative Fitness Developments S.L.
Valencia
1 100%
PM
ES
37
Mozograu S.A.
Valladolid
1 100%
DE
ES
38
Geniova Technologies Sociedad Limitada
Madrid
1 100%
DE
ES
39
Ames Medical Prosthetic Solutions, S.A.U.
Sant Feliu De Llobregat
1 100%
OR
ES
40
Batec Mobility, S.L.
Sant Quirze Del Vall?s
1 100%
PM
ES
41
Novasonix Technology S.L.
Granollers
1 100%
SU
ES
42
Insulcloud S.L.
Bibao
1 100%
HO
ES
43
Implant Microdent System S.L.U.
Santa Eulalia De Ron?ana
1 100%
HO
ES
44
Ceraroot SL
Les Franqueses Del Valles
1 100%
DE
ES
45
Xplora 3D Europe S.L
Madrid
1 100%
DE
ES
46
Synthon Hispania S.L.
Sant Boi De Llobregat
1 100%
HO
ES
47
Avizor S.A.
Legan?s
1 100%
OP
ES
48
Infomed Software, S.L.
Barcelona
1 100%
RA
ES
49
Iconic Solutions by Murcia, SL
Murcia
1 100%
AN
ES
50
Corify Care S.L
Madrid
1 100%
CV
ES

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.