Manufacturer Intelligence · Based on 58,115 FDA 510(k) records · 74 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.

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56
Manufacturers
Spain
Country

Spain FDA 510(k) Overview

56
Manufacturers
148
Submissions
100%
Clearance rate

Leading Spain FDA 510(k) manufacturers include Terrats Medical SL, B.T.I. Biotechnology Institute, Sl., Biokit, S.A. and 53 others.

Spanish medical device manufacturers have submitted 148 FDA 510(k) notifications since 2018, with a 100% clearance rate across 56 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 2018. Many Spain manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Spain Manufacturers

1–50 of 56
# Manufacturer Submissions Cleared Active panels Country
1
Terrats Medical SL
Montcada I Reixac
21 100%
DE
ES
2
B.T.I. Biotechnology Institute, Sl.
01510 Minano (Alava)
7 100%
DE
ES
3
Biokit, S.A.
Barcelona
7 100%
IM MI
ES
4
Talladium Espa?a, SL
Lleida
7 100%
DE HO
ES
5
Implant Protesis Dental 2004, S.L.
Mataro
6 100%
DE
ES
6
Cotton High Tech S.L.
Barcelona
5 100%
OB
ES
7
Iline Microsystems, S.L.
Donostia-San Sebastian
5 100%
HE
ES
8
Chip Ideas Electronics S.L.
Valencia
5 100%
CV
ES
9
Software Nemotec S.L.
Arroyomolinos, Madrid
5 100%
DE RA
ES
10
Termosalud
Gijon
5 100%
PM SU
ES
11
Biosystems S.A.
Barcelona
4 100%
CH IM
ES
12
Adas3D Medical S.L.
Barcelona
4 100%
RA
ES
13
Abanza Tecnomed S.L
Mutilva
4 100%
OR
ES
14
Progenika Biopharma S.A., A Grifols Company
Derio
3 100%
IM
ES
15
High Technology Products S.L.U
Barcelona
3 100%
SU
ES
16
Quibim S.L.
Valencia
3 100%
RA
ES
17
Indiba S. A. U.
Sant Quirze Del Vall?s (Barcelona)
3 100%
SU
ES
18
Termosalud S.L.
Gijon
2 100%
PM SU
ES
19
Talladium Espana, SL
Lleida
2 100%
DE
ES
20
Smart Solutions Technologies SL
Madrid
2 100%
CV
ES
21
Medical Cables S.L.
Malaga
2 100%
PM
ES
22
Capenergy Medical S.L.
Sant Joan Despi, Barcelona
2 100%
SU
ES
23
Avinent Implant System S.L.U.
Santpedor
2 100%
HO
ES
24
Orthoapnea S.L.
Malaga
2 100%
DE
ES
25
Leaseir Technologies, Slu
Gij?n
2 100%
SU
ES
26
Graphenano Dental S.L.
Yecla
2 100%
DE
ES
27
3D-Shaper Medical S.L
Barcelona
2 100%
RA
ES
28
Mentice Spain S.L.
Barcelona
2 100%
NE
ES
29
Methinks Software, S.L
Barcelona
2 100%
RA
ES
30
Augmented Reality Software S.L.
Salamanca
1 100%
RA
ES
31
General Equipment For Medical Imaging, S.A.
Valencia
1 100%
RA
ES
32
Better Care, S.L.
Sabadell
1 100%
CV
ES
33
Casgarum Investment, S.L.
Illescas
1 100%
PM
ES
34
Rgb Medical Devices SA
Madrid
1 100%
AN
ES
35
Ziacom Medical, S.L.
Pinto
1 100%
DE
ES
36
Diagnostic Grifols, S.A.
Partes Del Valles
1 100%
HE
ES
37
Galgo Medical S.L
Barcelona
1 100%
RA
ES
38
B. Bruan Surgical, SA
Rubi
1 100%
SU
ES
39
Global Med Systems SL
Leon
1 100%
SU
ES
40
I-Motion Group Global Iberica S.L.
Alcorcon
1 100%
PM
ES
41
Creative Fitness Developments S.L.
Valencia
1 100%
PM
ES
42
Mozograu S.A.
Valladolid
1 100%
DE
ES
43
Geniova Technologies Sociedad Limitada
Madrid
1 100%
DE
ES
44
Ames Medical Prosthetic Solutions, S.A.U.
Sant Feliu De Llobregat
1 100%
OR
ES
45
Batec Mobility, S.L.
Sant Quirze Del Vall?s
1 100%
PM
ES
46
Novasonix Technology S.L.
Granollers
1 100%
SU
ES
47
Insulcloud S.L.
Bibao
1 100%
HO
ES
48
Implant Microdent System S.L.U.
Santa Eulalia De Ron?ana
1 100%
HO
ES
49
Ceraroot SL
Les Franqueses Del Valles
1 100%
DE
ES
50
Xplora 3D Europe S.L
Madrid
1 100%
DE
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.