Medical device makers in Costa Rica: 65 FDA-registered establishments

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

65 establishments in Costa Rica are registered with the FDA to make medical devices for the US market, listing 365 device types. 33 have a 510(k) clearance or PMA approval on file and 1 has 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
Wire, Guide, Catheter	DQX	9
Electrosurgical, Cutting & Coagulation & Accessories	GEI	8
Introducer, Catheter	DYB	7
Catheter, Percutaneous	DQY	7
Dilator, Vessel, For Percutaneous Catheterization	DRE	6
Arthroscope	HRX	5
Set, Administration, Intravascular	FPA	5
Catheter, Continuous Flush	KRA	5
Catheter, Electrode Recording, Or Probe, Electrode Recording	DRF	5
Instrument, Manual, Surgical, General Use	MDM	4
Catheter, Intravascular, Diagnostic	DQO	4
Bronchoscope (Flexible Or Rigid)	EOQ	4
Stents, Drains And Dilators For The Biliary Ducts	FGE	4
Peripheral Mechanical Thrombectomy With Aspiration	QEW	4
Accessories, Catheter	KGZ	4
Dentures, Full	NSL	4
Restoration, Porcelain	NSP	4
Dentures, Partial	NSK	4
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	3
Accessories, Arthroscopic	NBH	3
Cement, Bone, Vertebroplasty	NDN	3
Orthopedic Stereotaxic Instrument	OLO	3
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	3
Stent, Ureteral	FAD	3
Abutment, Implant, Dental, Endosseous	NHA	3
Endoscopic Guidewire, Gastroenterology-Urology	OCY	3
Device, Vascular, For Promoting Embolization	KRD	3
Pump, Infusion	FRN	3
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	3
Catheter, Nephrostomy, General & Plastic Surgery	GBO	3
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass	DWF	3
Stylet For Catheter, Gastro-Urology	EZB	3
Cardiac Ablation Percutaneous Catheter	LPB	3
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation	OAE	3
Restoration, Porcelain-Fused-To-Metal	NSO	3
Percutaneous Cardiac Ablation Catheter For Treatment Of Atrial Fibrillation With Irreversible Electroporation	QZI	3
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	3
Catheter, Ultrasound, Intravascular	OBJ	3
System, X-Ray, Tomography, Computed	JAK	3
Temporary Catheter, Embolic Protection, Transcatheter Intracardiac Procedures	PUM	3
Temporary Carotid Catheter For Embolic Capture	NTE	3
Screw, Fixation, Bone	HWC	2
Fastener, Fixation, Nondegradable, Soft Tissue	MBI	2
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	2
Laparoscope, General & Plastic Surgery	GCJ	2
Bit, Drill	HTW	2
Orthopedic Manual Surgical Instrument	LXH	2
Intervertebral Fusion Device With Bone Graft, Cervical	ODP	2
Accessory, Surgical Apparel	LYU	2
System, Facet Screw Spinal Device	MRW	2
Instrument, Biopsy	KNW	2
Hysteroscope (And Accessories)	HIH	2
Bronchoscope Accessory	KTI	2
Catheter, Percutaneous, Neurovasculature	QJP	2
Device, Neurovascular Embolization	HCG	2
Percutaneous Atrial Catheter Kit	OFK	2
System, Applicator, Radionuclide, Remote-Controlled	JAQ	2
Accessories, Implant, Dental, Endosseous	NDP	2
Device, Thermal Ablation, Endometrial	MNB	2
Transducer, Ultrasonic, Diagnostic	ITX	2
Cutter, Surgical	FZT	2
Tubing, Fluid Delivery	FPK	2
Endoscopic Tissue Approximation Device	OCW	2
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	KNS	2
Kit, Surgical Instrument, Disposable	KDD	2
Template	HWT	2
Catheter, Irrigation	GBX	2
Set, I.V. Fluid Transfer	LHI	2
Ventilator, Non-Continuous (Respirator)	BZD	2
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	2
Connector, Airway (Extension)	BZA	2
Continuous Measurement Thermometer	FLL	2
Instrument, Ent Manual Surgical	LRC	2
Cable, Electrode	IKD	2
Snare, Flexible	FDI	2
Catheter, Angioplasty, Peripheral, Transluminal	LIT	2
Device, Percutaneous Retrieval	MMX	2
Catheter, Nephrostomy	LJE	2
Dislodger, Stone, Basket, Ureteral, Metal	FFL	2
Endoscopic Injection Needle, Gastroenterology-Urology	FBK	2
Catheter, Septostomy	DXF	2
Forceps, Biopsy, Non-Electric	FCL	2
Stylet, Catheter	DRB	2
Mechanical Thrombolysis Catheter	QEY	2
Injector And Syringe, Angiographic	DXT	2
Ear, Nose, And Throat Stereotaxic Instrument	PGW	2
Oximeter	DQA	2
Aortic Valve, Prosthesis, Percutaneously Delivered	NPT	2
Catheters, Transluminal Coronary Angioplasty, Percutaneous	LOX	2
Heart-Valve, Non-Allograft Tissue	LWR	2
Protector, Skin Pressure	FMP	2
Negative Pressure Wound Therapy Powered Suction Pump	OMP	2
Stimulator, Spinal-Cord, Totally Implanted For Pain Relief	LGW	2
Restoration, Noble Metal	NSJ	2
Orthosis, Limb Brace	IQI	2
Transducer, Pressure, Catheter Tip	DXO	2
Catheter, Peripheral, Atherectomy	MCW	2
Stimulator, Peripheral Nerve, Implanted (Pain Relief)	GZF	2
Catheter, Intravascular Occluding, Temporary	MJN	2
Cable, Transducer And Electrode, Patient, (Including Connector)	DSA	2

Makers in Costa Rica

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

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Medtronic Medical Costa Rica S.R.L.	Coyol Alajuela, Costa Rica	33	143	0	0	api.fda.gov
Arthrocare Corporation	Coyol Alajuela, Costa Rica	42	132	0	0	api.fda.gov
Boston Scientific Corporation	El Coyol Alajuela, Costa Rica	58	84	4	0	api.fda.gov
Boston Scientific Corporation	La Aurora Heredia, Costa Rica	35	72	5	1	api.fda.gov
ICU Medical Costa Rica Ltd.	La Aurora de Heredia, Costa Rica	12	39	0	0	api.fda.gov
Abbott Medical Costa Rica Ltda.	El Coyol Alajuela, Costa Rica	11	29	4	0	api.fda.gov
Hologic Surgical Products Costa Rica, S.R.L.	El Coyol Alajuela, Costa Rica	13	28	1	0	api.fda.gov
Cardinal Health Costa Rica, S.A.	-- Alajuela, Costa Rica	27	26	0	0	api.fda.gov
Baxter Productos Medicos, Ltda.	1-7052 Cartago, Costa Rica	8	21	0	0	api.fda.gov
Volcano Corporation by Volcarica S.R.L.	Coyol Alajuela, Costa Rica	12	21	0	0	api.fda.gov
Laboratorios Dentales De Zona Franca, S.A.	Cartago, Costa Rica	15	15	0	0	api.fda.gov
Allergan	La Aurora De Heredia, Costa Rica	9	10	3	0	api.fda.gov
Edwards Lifesciences	Guadalupe Cartago, Costa Rica	5	9	3	0	api.fda.gov
Penumbra Costa Rica, S.R.L.	Guadalupe Cartago, Costa Rica	3	12	0	0	api.fda.gov
Abbott Vascular	El Coyol Alajuela, Costa Rica	6	11	0	0	api.fda.gov
Deroyal Cientifica De Latinoamerica S.R.L.	La Aurora, Heredia, Costa Rica	17	11	0	0	api.fda.gov
Boston Scientific Corporation	Cartago, Costa Rica	6	10	0	0	api.fda.gov
Terumo Cardiovascular Costa Rica LLC	Zona Franca La Lima Cartago, Costa Rica	8	10	0	0	api.fda.gov
Horizons Intl. Corp.	Heredia, Costa Rica	11	9	0	0	api.fda.gov
Riverpoint Medical CR S.R.L.	Coyol Alajuela, Costa Rica	4	9	0	0	api.fda.gov
Abbott Medical Costa Rica Limitada (Structural Heart)	El Coyol Alajuela, Costa Rica	9	0	6	0	api.fda.gov
Respironics, Inc.	Coyol Alajuela, Costa Rica	1	6	0	0	api.fda.gov
Theragenics Costa Rica Limitada	El Coyol Alajuela, Costa Rica	3	6	0	0	api.fda.gov
Coloplast Costa Rica SA	La Lima, Guadalupe Cartago, Costa Rica	3	5	0	0	api.fda.gov
CooperVision Manufacturing Costa Rica SRL	Alajuela, Costa Rica	2	3	0	0	api.fda.gov
Establishment Labs S.A.	Coyol Alajuela, Costa Rica	4	2	1	0	api.fda.gov
Inari Medical, Costa Rica S.R.L.	Grecia Alajuela, Costa Rica	2	3	0	0	api.fda.gov
Laboratorios Zepol S.A.	Curridabat San Jose, Costa Rica	1	2	0	0	api.fda.gov
Microport Orthopedics, S.A.	Sabana Norte San Jose, Costa Rica	3	2	0	0	api.fda.gov
Swav CR SRL	Alajuela, Costa Rica	2	1	1	0	api.fda.gov
Theragenics Costa Rica Limitada	El Coyol, Alajuela, Costa Rica	5	2	0	0	api.fda.gov
Cooper Medical, SRL	La Garita Alajuela, Costa Rica	11	1	0	0	api.fda.gov
Nevro Medical S.R.L.	El Coyol Alajuela, Costa Rica	2	0	1	0	api.fda.gov
ATL Technology CR Limitada	Alajuela, Costa Rica	16	0	0	0	api.fda.gov
Bayer Medical SRL	Barreal de Heredia, Costa Rica	4	0	0	0	api.fda.gov
Biomerics Alajuela	Alajuela, Costa Rica	31	0	0	0	api.fda.gov
Biomerics Cartago	Cartago, Costa Rica	14	0	0	0	api.fda.gov
Confortex, S.A.	San Jose, Costa Rica	5	0	0	0	api.fda.gov
Cirtec Medical	Coyol Alajuela, Costa Rica	2	0	0	0	api.fda.gov
Creganna Medical S. R. L	San Rafael Heredia, Costa Rica	5	0	0	0	api.fda.gov
DDS Lab Costa Rica Sociedad Amonima	Grecia Alajuela, Costa Rica	4	0	0	0	api.fda.gov
EH Dental Services Costa Rica Sociedad de Responsabilidad Limitada	Escazu, San Rafael San Jose, Costa Rica	1	0	0	0	api.fda.gov
Freudenberg Medical, SRL	La Garita Alajuela, Costa Rica	4	0	0	0	api.fda.gov
Hype Align Clear Orthodontics, Limitada	Santa Ana San Jose, Costa Rica	2	0	0	0	api.fda.gov
Heraeus Medical Components, SRL	Guadalupe Cartago, Costa Rica	9	0	0	0	api.fda.gov
International BMC Medical Costa Rica S.R.L.	Coyol Alajuela, Costa Rica	1	0	0	0	api.fda.gov
International Precision Molds	COYOL Alajuela, Costa Rica	2	0	0	0	api.fda.gov
Itek	Cartago, Costa Rica	6	0	0	0	api.fda.gov
KIMBERLY-CLARK COSTA RICA, Ltda	Cartago, Costa Rica	2	0	0	0	api.fda.gov
MicroVention Costa Rica S.R.L.	. Alajuela, Costa Rica	13	0	0	0	api.fda.gov
Moog Costa Rica, SRL	Alajuela San Jose, Costa Rica	3	0	0	0	api.fda.gov
Nextern Costa Rica Ltd.	Cartago, Costa Rica	5	0	0	0	api.fda.gov
Nitinol Devices & Components Costa Rica, S. R. L.	El Coyol Alajuela, Costa Rica	18	0	0	0	api.fda.gov
Orthomed Del Sol, S.A.	Piedades de Santa Ana San Jose, Costa Rica	1	0	0	0	api.fda.gov
Oral Arts Dental Laboratories de Costa Rica Limitada	Curridabat San Jose, Costa Rica	6	0	0	0	api.fda.gov
Preferred Oral Design Limitada	Alajuela, San Rafael, Costa Rica	9	0	0	0	api.fda.gov
Rhythmlink Costa Rica Sociedad Anonima	Alajuela, Costa Rica	2	0	0	0	api.fda.gov
SACO Internacional S.A.	Bagaces Guanacaste, Costa Rica	1	0	0	0	api.fda.gov
SMC Costa Rica Division S.R.L.	El Coyol Alajuela, Costa Rica	6	0	0	0	api.fda.gov
Synergy Health AST, SRL	Alajuela, Costa Rica	153	0	0	0	api.fda.gov
Tegra Medical Costa Rica S.A.	La Aurora Heredia, Costa Rica	3	0	0	0	api.fda.gov
TFB Manufacturing SRL	La Lima, Guadalupe Cartago, Costa Rica	2	0	0	0	api.fda.gov
Utitec Medical S.A.	El Coyol Alajuela, Costa Rica	2	0	0	0	api.fda.gov
Viant Costa Rica, S.A.	Barreal De Heredia, Costa Rica	7	0	0	0	api.fda.gov
Zollner Electronics Costa Rica Limitada	Cartago, Costa Rica	1	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.