Manufacturer Intelligence · Based on 149,661 FDA 510(k) records · 85 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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85
Manufacturers
Spain
Country

Spain FDA 510(k) Overview

85
Manufacturers
228
Submissions
100%
Clearance rate

Leading Spain FDA 510(k) manufacturers include Biokit, S.A., Terrats Medical SL, B.T.I. Biotechnology Institute, Sl. and 82 others.

Spanish medical device manufacturers have submitted 228 FDA 510(k) notifications since 2000, with a 100% clearance rate across 85 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 2000. Many Spain manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Spain Manufacturers

1–50 of 85
# Manufacturer Submissions Cleared Active panels Country
1
Biokit, S.A.
Barcelona
23 100%
CH IM MI +1
ES
2
Terrats Medical SL
Montcada I Reixac
23 100%
DE
ES
3
B.T.I. Biotechnology Institute, Sl.
01510 Minano (Alava)
15 100%
DE RA
ES
4
Laboratorios Grifols, S.A.
Parets Del Valles, Barcelona
9 100%
HO
ES
5
Cotton High Tech S.L.
Barcelona
7 100%
OB
ES
6
Talladium Espa?a, SL
Lleida
7 100%
DE HO
ES
7
Implant Protesis Dental 2004, S.L.
Mataro
6 100%
DE
ES
8
Iline Microsystems, S.L.
Donostia-San Sebastian
5 100%
HE
ES
9
Chip Ideas Electronics S.L.
Valencia
5 100%
CV
ES
10
Software Nemotec S.L.
Arroyomolinos, Madrid
5 100%
DE RA
ES
11
Termosalud
Gijon
5 100%
PM SU
ES
12
Biosystems S.A.
Barcelona
4 100%
CH IM
ES
13
Progenika Biopharma S.A., A Grifols Company
Derio
4 100%
IM
ES
14
Adas3D Medical S.L.
Barcelona
4 100%
RA
ES
15
Abanza Tecnomed S.L
Mutilva
4 100%
OR
ES
16
Termosalud S.L.
Gijon
3 100%
PM SU
ES
17
Leventon, S.A.
Barcelona
3 100%
AN HO
ES
18
Simuplan S.L.
La Eliana Valencia
3 100%
RA
ES
19
Talladium Espana, SL
Lleida
3 100%
DE
ES
20
General Equipment For Medical Imaging, S.A.
Valencia
3 100%
RA
ES
21
General Equipment For Medical Imaging (Oncovision-
Valencia
3 100%
RA
ES
22
Capenergy Medical S.L.
Sant Joan Despi, Barcelona
3 100%
SU
ES
23
High Technology Products S.L.U
Barcelona
3 100%
SU
ES
24
Avinent Implant System S.L.U.
Santpedor
3 100%
DE HO
ES
25
Quibim S.L.
Valencia
3 100%
RA
ES
26
Indiba S. A. U.
Sant Quirze Del Vall?s (Barcelona)
3 100%
SU
ES
27
Hersill, S.L.
Mostoles ( Madrid)
2 100%
AN SU
ES
28
Neuroelectrics Barcelona S.L.U.
Barcelona
2 100%
NE
ES
29
Smart Solutions Technologies SL
Madrid
2 100%
CV
ES
30
Medical Cables S.L.
Malaga
2 100%
PM
ES
31
Orthoapnea S.L.
Malaga
2 100%
DE
ES
32
Leaseir Technologies, Slu
Gij?n
2 100%
SU
ES
33
Graphenano Dental S.L.
Yecla
2 100%
DE
ES
34
3D-Shaper Medical S.L
Barcelona
2 100%
RA
ES
35
Mentice Spain S.L.
Barcelona
2 100%
NE
ES
36
Methinks Software, S.L
Barcelona
2 100%
RA
ES
37
Augmented Reality Software S.L.
Salamanca
1 100%
RA
ES
38
Uroan Xxi Electromedicina
Baleares
1 100%
GU
ES
39
Tecnilatex S.A.
Madrid
1 100%
OB
ES
40
Optilasa, S.L.
Madrid
1 100%
OP
ES
41
Uroan 21
Palma De Mallorca
1 100%
GU
ES
42
Union Dental S.A./Unidesa.Odi
Tielmes, Madrid
1 100%
DE
ES
43
Impladent, S.L.
Sentmenat, Barcelona
1 100%
DE
ES
44
Gem-Med S.L.
Barcelona
1 100%
CV
ES
45
Aguiflai Iberica S.L.
Vilassar De Mar (Barcelona)
1 100%
CV
ES
46
Novaf Andalucia 2007, SL
Rota
1 100%
PM
ES
47
Avinent Implant System S.L.
Santpedor
1 100%
DE
ES
48
Core 3D Protech, S.L.
Santpedor
1 100%
DE
ES
49
Infomed Servicios Informaticos S.L.
Barcelona
1 100%
RA
ES
50
Transcendencias Comerciales SL Transcom
San Sebastian, Guipuzcoa
1 100%
GU
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.