Medical device makers in Spain: 134 FDA-registered establishments

Name: FDA-registered medical device makers in Spain
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

134 establishments in Spain are registered with the FDA to make medical devices for the US market, listing 313 device types. 62 have a 510(k) clearance or PMA approval on file and 5 have a recall event. FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

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Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Abutment, Implant, Dental, Endosseous	NHA	10
Accessories, Implant, Dental, Endosseous	NDP	10
Implant, Endosseous, Root-Form	DZE	8
Sunglasses (Non-Prescription Including Photosensitive)	HQY	8
Frame, Spectacle	HQZ	6
Powered Laser Surgical Instrument	GEX	5
Garment, Protective, For Incontinence	EYQ	5
System, Image Processing, Radiological	LLZ	4
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	4
Protector, Skin Pressure	FMP	4
Insoles, Medical	KYS	4
Massager, Vacuum, Radio Frequency Induced Heat	PBX	4
Set, I.V. Fluid Transfer	LHI	3
Sling, Arm	ILI	3
Tray, Surgical, Instrument	FSM	3
Automated Radiological Image Processing Software	QIH	3
Pad, Menstrual, Unscented	HHD	3
Orthosis, Lumbo-Sacral	IPY	3
Orthosis, Limb Brace	IQI	3
Joint, Ankle, External Brace	ITW	3
Orthosis, Truncal/Orthosis, Limb	MRI	3
Platelet And Plasma Separator For Bone Graft Handling	ORG	2
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2
Syringe, Piston	FMF	2
Orthopedic Manual Surgical Instrument	LXH	2
Sterilization Wrap Containers, Trays, Cassettes & Other Accessories	KCT	2
Slide Stainer, Automated	KPA	2
Equipment, Laboratory, General Purpose, Labeled Or Promoted For A Specific Medical Use	LXG	2
Test, Time, Prothrombin	GJS	2
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	2
Tape And Bandage, Adhesive	KGX	2
Bur, Dental	EJL	2
Splint, Hand, And Components	ILH	2
Handle, Instrument, Dental	EJB	2
Bandage, Elastic	FQM	2
Laryngoscope, Rigid	CCW	2
Massager, Therapeutic, Electric	ISA	2
Countersink	HWW	2
Orthosis, Lumbar	IQE	2
Joint, Knee, External Brace	ITQ	2
Crutch	IPR	2
Crown And Bridge, Temporary, Resin	EBG	2
Resin, Denture, Relining, Repairing, Rebasing	EBI	2
Cover, Limb	IPM	2
Stocking, Medical Support (For General Medical Purposes)	FQL	2
Dental Abutment Design Software For Dental Laboratory	PNP	2
System, Multipurpose For In Vitro Coagulation Studies	JPA	2
Walker, Mechanical	ITJ	2
Cup, Menstrual	HHE	2
Restraint, Wheelchair, Non-Protective	KID	2
Accessories, Wheelchair	KNO	2
Tissue Adhesive For The Topical Approximation Of Skin	MPN	2
Orthosis, Corrective Shoe	KNP	2
Helmet, Cranial, For Protective Use	NDA	2
System/Device, Pharmacy Compounding	NEP	2
System, Planning, Radiation Therapy Treatment	MUJ	2
Orthosis, Foot Drop	OHI	2
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	1
Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use	JQC	1
Bit, Drill	HTW	1
Instrument, Manual, Surgical, General Use	MDM	1
Cerclage, Fixation	JDQ	1
Accessory, Surgical Apparel	LYU	1
Cover, Burr Hole	GXR	1
Light, Surgical, Instrument	FSQ	1
Ige, Antigen, Antiserum, Control	DGC	1
Multi-Analyte Controls, All Kinds (Assayed)	JJY	1
Calibrators, Drug Specific	DLJ	1
Radioimmunoassay, Testosterones And Dihydrotestosterone	CDZ	1
Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific	LGC	1
Lipoprotein, Low-Density, Antigen, Antiserum, Control	DFC	1
Calibrator, Multi-Analyte Mixture	JIX	1
Calibrator, Secondary	JIT	1
Calibrator, Primary	JIS	1
Colorimeter, Photometer, Spectrophotometer For Clinical Use	JJQ	1
System, Test, Rheumatoid Factor	DHR	1
Single (Specified) Analyte Controls (Assayed And Unassayed)	JJX	1
Urinary Homocystine (Nonquantitative) Test System	LPS	1
Ferritin, Antigen, Antiserum, Control	DBF	1
Antistreptolysin - Titer/Streptolysin O Reagent	GTQ	1
Controls For Blood-Gases, (Assayed And Unassayed)	JJS	1
System, Test, Beta-2-Microglobulin Immunological	JZG	1
Instrumentation For Clinical Multiplex Test Systems	NSU	1
Hematoxylin	HYJ	1
General Purpose Reagent	PPM	1
Reagents, Specific, Analyte	MVU	1
Device, Intravascular Catheter Securement	KMK	1
Needle, Hypodermic, Single Lumen	FMI	1
Probe, Uptake, Nuclear	IZD	1
Filter, Infusion Line	FPB	1
Saw, Powered, And Accessories	HAB	1
Bandage, Liquid	KMF	1
Calculator, Drug Dose	NDC	1
Guide, Needle, Surgical	GDF	1
Motor, Surgical Instrument, Ac-Powered	GEY	1
Regulator, Vacuum	KDP	1
Bone Wedge	PLF	1
File, Pulp Canal, Endodontic	EKS	1
Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate)	JKC	1
Radioimmunoassay, Parathyroid Hormone	CEW	1

Makers in Spain

Best documented first: most 510(k) clearances and PMA approvals.

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Biokit S.A.	LLISSA D AMUNT Barcelona, Spain	40	38	1	1	api.fda.gov
Terrats Medical, S.L.	Barbera del Valles Barcelona, Spain	4	23	0	0	api.fda.gov
B.T.I. Biotechnology Institute, S.L.	Miñano Alava, Spain	33	19	0	0	api.fda.gov
Sedecal S.A.	ALGETE Madrid(Province), Spain	9	18	0	11	api.fda.gov
Talladium Espana, SL	LLEIDA Lerida, Spain	3	9	0	0	api.fda.gov
Becton Dickinson, S.A.	SAN AGUSTIN DE GUADALIX Madrid(Province), Spain	6	7	0	0	api.fda.gov
Implant Protesis Dental 2004, S.L.	Premia de Dalt Barcelona, Spain	5	7	0	0	api.fda.gov
Termosalud S.L.	Gijon Asturias(Autonomous Community), Spain	5	7	0	0	api.fda.gov
Becton Dickinson, S.A.	FRAGA Huesca, Spain	7	6	0	0	api.fda.gov
Cotton High Tech S.L.	Balsareny Barcelona, Spain	3	6	0	0	api.fda.gov
Indiba	Sant Quirze del Valles Barcelona, Spain	3	6	0	0	api.fda.gov
Adas3d Medical S.L	Barcelona, Spain	2	5	0	0	api.fda.gov
Desarrollo E Investigacion Medica Aragonesa SL	CALATAYUD Zaragoza, Spain	5	5	0	0	api.fda.gov
General Equipment For Medical Imaging, S.A.	Valencia Valencia(Province), Spain	3	5	0	0	api.fda.gov
High Technology Products, Slu	Esplugues de Llobregat Barcelona, Spain	4	5	0	0	api.fda.gov
Software Nemotec, S.L.	Leganes Madrid(Province), Spain	3	5	0	0	api.fda.gov
Abanza Tecnomed, S.L.	MUTILVA Navarra, Spain	10	4	0	0	api.fda.gov
Avinent Implant System S.L.U.	Santpedor Barcelona, Spain	4	4	0	0	api.fda.gov
Laboratorios Grifols, S.A.	PARETS DEL VALLES Barcelona, Spain	4	4	0	1	api.fda.gov
GMV Soluciones Global Internet SAU	Tres Cantos Madrid(Province), Spain	1	3	0	0	api.fda.gov
Iline Microsystems S.L.	Donostia - San Sebastian Guipuzcoa, Spain	1	3	0	0	api.fda.gov
Neos Surgery S.L.	Cerdanyola del Vallès Barcelona, Spain	3	3	0	0	api.fda.gov
Progenika Biopharma S.A.	Derio Vizcaya, Spain	5	3	0	0	api.fda.gov
Quibim S.L.	Valencia Valencia(Province), Spain	3	3	0	0	api.fda.gov
3d-Shaper Medical S.L.	Barcelona, Spain	1	2	0	0	api.fda.gov
Bio Cosmetics S.L.	Madrid Madrid(Province), Spain	1	2	0	0	api.fda.gov
Biomerieux Spain	Tres Cantos Madrid(Province), Spain	6	2	0	0	api.fda.gov
Capenergy Medical, S.L.	Sant Joan Despi Barcelona, Spain	2	2	0	0	api.fda.gov
Graphenano Dental, SL	Paterna Valencia(Province), Spain	3	2	0	1	api.fda.gov
Intermedic Arfran, S.A.	Cerdanyola del Valles Barcelona, Spain	1	2	0	0	api.fda.gov
Leaseir Technologies Slu	Gijon Asturias(Autonomous Community), Spain	1	2	0	1	api.fda.gov
Meiji Pharma Spain	Alcala de Henares Madrid(Province), Spain	1	0	2	0	api.fda.gov
Orthoapnea S.L.	Malaga, Spain	1	2	0	0	api.fda.gov
Union Dental S.A.	TIELMES Madrid(Province), Spain	6	2	0	0	api.fda.gov
Agupunt S.L.	Santa Barbara Tarragona, Spain	2	1	0	0	api.fda.gov
Ames Medical Prosthetic Solutions, S.A.U.	St. Feliu del Llobregat Barcelona, Spain	1	1	0	0	api.fda.gov
Anatomical Geometry S.L.	MAIRENA DEL ALJARAFE Sevilla, Spain	3	1	0	0	api.fda.gov
Batec Mobility S.L	Sant Quirze Del Valles Barcelona, Spain	1	1	0	0	api.fda.gov
Ceraroot S.L.	Les Franqueses del Valles Barcelona, Spain	3	1	0	0	api.fda.gov
Creative Fitness Developments SL	Valencia Valencia(Province), Spain	1	1	0	0	api.fda.gov
Gmi Dental Implantology, S.L.	Lleida Lerida, Spain	3	1	0	0	api.fda.gov
Hersill, S.L.	MOSTOLES (MADRID) Madrid(Province), Spain	8	1	0	0	api.fda.gov
I-Motion Group Global Iberica SL.	Madrid Madrid(Autonomous Community), Spain	1	1	0	0	api.fda.gov
Iconic Solutions By Murcia SL	Murcia Murcia(Autonomous Community), Spain	1	1	0	0	api.fda.gov
International Emergency Services S.L	Derio Bizkaia Vizcaya, Spain	1	1	0	0	api.fda.gov
Kiro Grifols, S.L.	Arrasate-Mondragon Guipuzcoa, Spain	2	1	0	0	api.fda.gov
Luna Aesthetic Group SL	Ajalvir Madrid(Autonomous Community), Spain	1	1	0	0	api.fda.gov
Medical Cables S.L.	Malaga, Spain	1	1	0	0	api.fda.gov
Mentice Spain S.L.	Barcelona Catalonia, Spain	1	1	0	0	api.fda.gov
Mozo-Grau SA	Valladolid, Spain	4	1	0	0	api.fda.gov
Neuroelectrics Barcelona S.L.U.	Barcelona Catalonia, Spain	3	1	0	0	api.fda.gov
Novaf Andalucia 2007, S.L.	Rota Cadiz, Spain	4	1	0	0	api.fda.gov
Prodol Meditec S.A.	LAS ARENAS Vizcaya, Spain	1	1	0	0	api.fda.gov
Picis Clinical Solutions, S.A.U.	Barcelona, Spain	1	1	0	0	api.fda.gov
QMENTA Imaging SL	Barcelona, Spain	1	1	0	0	api.fda.gov
Smart Solutions Technologies S.L. (nuubo)	madrid Madrid(Province), Spain	2	1	0	0	api.fda.gov
Synthon Hispania S.L.	Sant Boi de Llobregat Barcelona, Spain	1	1	0	0	api.fda.gov
Toskani	Barcelona, Spain	2	1	0	0	api.fda.gov
Transcendencias Comerciales S.L	Ergobia-Astigarraga Guipuzcoa, Spain	1	1	0	0	api.fda.gov
Xplora 3D Europe SL	Madrid Madrid(Province), Spain	2	1	0	0	api.fda.gov
Ziacom Implants Slu	Pinto Madrid(Province), Spain	5	1	0	0	api.fda.gov
ZimVie Spain S.L.U.	Paterna Valencia(Province), Spain	4	1	0	0	api.fda.gov
AB Medica Group S. A.	Barcelona, Spain	1	0	0	0	api.fda.gov
Ajl Ophthalmic, S.A.	MINANO Alava, Spain	3	0	0	0	api.fda.gov
Antoni Carles, S.A.	VILASSAR DE MAR Barcelona, Spain	3	0	0	0	api.fda.gov
Aquisel S.L.	Abrera Barcelona, Spain	3	0	0	0	api.fda.gov
Amino Frequency Corporation SL.	Marbella Malaga, Spain	1	0	0	0	api.fda.gov
B. Braun Surgical, S.A.	Rubi Barcelona, Spain	1	0	0	0	api.fda.gov
Biostar Laboratorios Slu	Pinto Madrid(Autonomous Community), Spain	1	0	0	0	api.fda.gov
Botiquin Sans	Castellar del Valles Catalonia, Spain	1	0	0	0	api.fda.gov
Brill Pharma SL	Barcelona, Spain	1	0	0	0	api.fda.gov
Celestica	Valencia Valencia(Province), Spain	5	0	0	0	api.fda.gov
Clip-Fab R&D Medical Instruments, S.L.	Barcelona Catalonia, Spain	1	0	0	0	api.fda.gov
Cytognos, S.L.	Santa Marta de Tormes Salamanca, Spain	1	0	0	0	api.fda.gov
D & R Optical S.L.	Bellaterra Barcelona, Spain	2	0	0	0	api.fda.gov
Diagnostic Grifols, S.A.	PARETS DEL VALLES Barcelona, Spain	5	0	0	0	api.fda.gov
Drylock Technologies SL.	Hontoria Segovia, Spain	3	0	0	0	api.fda.gov
DSD Planning Center SL	Madrid Madrid(Province), Spain	7	0	0	0	api.fda.gov
E-Health Technical Solutions S.L.	Barcelona, Spain	2	0	0	0	api.fda.gov
Ecareyou Innovation S.L.	Madrid Madrid(Province), Spain	1	0	0	0	api.fda.gov
Edser Insoles S.L.	ESPLUGUES DE LLOBREGAT Barcelona, Spain	10	0	0	0	api.fda.gov
Especialidades Medicas Myr SL	Llorenc del Pendes Tarragona, Spain	6	0	0	0	api.fda.gov
Farmaban S.A.	SANT FRUITOS DE BAGES Barcelona, Spain	2	0	0	0	api.fda.gov
Fresco International 2005 S.A.	Barcelona, Spain, Spain	4	0	0	0	api.fda.gov
Flexor SA	Barbera del Valles Barcelona, Spain	1	0	0	0	api.fda.gov
Geroa Diagnostics Sociedad Limitada	Vitoria Alava, Spain	1	0	0	0	api.fda.gov
Halotech Dna	MADRID Madrid(Autonomous Community), Spain	1	0	0	0	api.fda.gov
Iditec North West S.L.	TORRELODONES Madrid(Autonomous Community), Spain	3	0	0	0	api.fda.gov
Ikor Sistemas Electronicos, SL	San Sebastian Guipuzcoa, Spain	1	0	0	0	api.fda.gov
Improving Mobility Development SL	LLIRIA Valencia(Province), Spain	18	0	0	0	api.fda.gov
Innovaciones Disras S L	Don Benito Badajoz, Spain	1	0	0	0	api.fda.gov
Instituto De Investigacion En Ortopedia Avanzada S.L	Cuarte Huesca, Spain	2	0	0	0	api.fda.gov
Irisbond Crowdbonding, S.L.	Donostia San Sebastian Guipuzcoa, Spain	1	0	0	0	api.fda.gov
Iul SA	Barcelona, Spain	2	0	0	0	api.fda.gov
J. Mainat S.A.	Canet de Mar Barcelona, Spain	1	0	0	0	api.fda.gov
Kaleos Eyehunters SL	Barcelona, Spain	2	0	0	0	api.fda.gov
Laboratories Quinton International S. L.	Valencia Alicante, Spain	1	0	0	0	api.fda.gov
Laboratorios Indas SA	Noves Toledo, Spain	1	0	0	0	api.fda.gov
Lightfield Medical Europe, S.L.U.	Viladecans Barcelona, Spain	1	0	0	0	api.fda.gov
Maison Nina, SL	Madrid Madrid(Autonomous Community), Spain	2	0	0	0	api.fda.gov
Marsibionics	MADRID Madrid(Autonomous Community), Spain	1	0	0	0	api.fda.gov
Medi Care System S.L.U.	Mataro Barcelona, Spain	5	0	0	0	api.fda.gov
Medtech Catalonia SA	Girona Gerona, Spain	1	0	0	0	api.fda.gov
Ngny Devices S.L.	Esplugues de Llobregat Barcelona, Spain	1	0	0	0	api.fda.gov
Offview SL	Cerdanyola del Valles Barcelona, Spain	2	0	0	0	api.fda.gov
Ontex Peninsular Sau	Segovia, Spain	2	0	0	0	api.fda.gov
Operon, S.A.	CUARTE DE HUERVA Zaragoza, Spain	1	0	0	0	api.fda.gov
Optomic Espana, S.A.	COLMENAR VIEJO Madrid(Province), Spain	11	0	0	0	api.fda.gov
Orliman Slu	La Pobla de Vallbona Valencia(Province), Spain	27	0	0	0	api.fda.gov
Paul Hartmann S.A.	Mataro Barcelona, Spain	2	0	0	0	api.fda.gov
Play Hawkers S.L.	Elche Alicante, Spain	1	0	0	0	api.fda.gov
Plenoptika Europe Slu	Madrid Madrid(Province), Spain	1	0	0	0	api.fda.gov
Prim, S.A.	Casarrubios del Monte Toledo, Spain	2	0	0	0	api.fda.gov
Prim,s.a.	Mostoles Madrid(Province), Spain	12	0	0	0	api.fda.gov
Paul Hartmann Iberia S.A.	Montornes del Valles Barcelona, Spain	1	0	0	0	api.fda.gov
Radiochromic SL	Benifaio Valencia(Province), Spain	1	0	0	0	api.fda.gov
Ros Estetica SL	Castelldefels Barcelona, Spain	1	0	0	0	api.fda.gov
Roche Diagnostics S.L.	Sant Cugat del Valles Barcelona, Spain	1	0	0	0	api.fda.gov
Sibel S.A.	Sabadell Barcelona, Spain	1	0	0	0	api.fda.gov
Solo Gafas S.L.	Barcelona, Spain	2	0	0	0	api.fda.gov
Spumatex SL	Crevillente Alicante, Spain	1	0	0	0	api.fda.gov
STAT-Dx Life, S.L.	Barcelona, Spain	7	0	0	0	api.fda.gov
Sunrise Technologies, S.A.U.	Sant Esteve Sesrovires Barcelona, Spain	2	0	0	0	api.fda.gov
Swan Medical SL	Barcelona, Spain	1	0	0	0	api.fda.gov
Synkotech Biocompatible Materials	Reus Tarragona, Spain	2	0	0	0	api.fda.gov
Shanae S.G. S.L.	Pamplona Navarra, Spain	1	0	0	0	api.fda.gov
Teckel Medical S.L.	Barcelona, Spain	1	0	0	0	api.fda.gov
Tecnologia Sostenible Y Responsable S.L.	Madrid Madrid(Autonomous Community), Spain	2	0	0	0	api.fda.gov
Telic, S.A.U.	Bigues i Riells Barcelona, Spain	1	0	0	0	api.fda.gov
Tressol S.A.	ESPLUGUES DE LLOBREGAT Barcelona, Spain	2	0	0	0	api.fda.gov
Vecmedical Spain, S.L.	Montcada i Reixac Barcelona, Spain	1	0	0	0	api.fda.gov
Vitro S.A.	Sevilla, Spain	4	0	0	0	api.fda.gov
Voe, S.A.	Barcelona, Spain	3	0	0	0	api.fda.gov
Zarc4endo	GIJON Asturias(Autonomous Community), Spain	9	0	0	0	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.