Data / Medical devices / Dominican Republic

Medical device makers in the Dominican Republic: 41 FDA-registered establishments

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

41 establishments in the Dominican Republic are registered with the FDA to make medical devices for the US market, listing 313 device types. 17 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Country: Dominican Republic

Device types made here

Device types with the most registered makers in this country.

Device	Product code	Makers
Drape, Surgical, Exempt	PUI	6
Bedding, Disposable, Medical	KME	6
Set, Administration, Intravascular	FPA	5
Bandage, Elastic	FQM	5
General Surgery Tray	LRO	5
Needle, Aspiration And Injection, Disposable	GAA	4
Light, Surgical, Accessories	FTA	4
Electrosurgical, Cutting & Coagulation & Accessories	GEI	3
Arthroscope	HRX	3
Instrument, Manual, Surgical, General Use	MDM	3
Needle, Hypodermic, Single Lumen	FMI	3
Hemostatic Wound Dressing Without Thrombin Or Other Biologics	QSY	3
Catheter, Intravascular, Diagnostic	DQO	3
Gauze/Sponge, Internal, X-Ray Detectable	GDY	3
Tourniquet, Nonpneumatic	GAX	3
Gauze / Sponge,Nonresorbable For External Use	NAB	3
Set, I.V. Fluid Transfer	LHI	3
Sling, Arm	ILI	3
Floss, Dental	JES	3
Joint, Knee, External Brace	ITQ	3
Orthosis, Lumbo-Sacral	IPY	3
Device, Transfer, Patient, Manual	FMR	3
Joint, Ankle, External Brace	ITW	3
Binder, Abdominal	FSD	3
Pack, Hot Or Cold, Water Circulating	ILO	3
Drape, Urological, Disposable	EYY	3
Laparoscope, General & Plastic Surgery	GCJ	2
Accessory, Surgical Apparel	LYU	2
Nasopharyngoscope (Flexible Or Rigid)	EOB	2
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece	ERL	2
Introducer, Catheter	DYB	2
Wire, Guide, Catheter	DQX	2
Device, Intravascular Catheter Securement	KMK	2
Shunt, Central Nervous System And Components	JXG	2
Catheter, Continuous Flush	KRA	2
Sponge, Ophthalmic	HOZ	2
Pump, Infusion	FRN	2
Transducer, Ultrasonic, Diagnostic	ITX	2
Stopcock, I.V. Set	FMG	2
Neurosurgical Paddie	HBA	2
Splint, Intranasal Septal	LYA	2
Instruments, Surgical, Cardiovascular	DWS	2
Tubes, Gastrointestinal (And Accessories)	KNT	2
Balloon, Epistaxis	EMX	2
Tape And Bandage, Adhesive	KGX	2
System, Imaging, Pulsed Echo, Ultrasonic	IYO	2
Accessories, Cleaning Brushes, For Endoscope	MNL	2
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	2
Sleeve, Limb, Compressible	JOW	2
Splint, Hand, And Components	ILH	2
Dispenser, Liquid Medication	KYX	2
Cotton, Roll	EFN	2
Dissector, Surgical, General & Plastic Surgery	GDI	2
Device, Irrigation, Ocular Surgery	KYG	2
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass	DTL	2
Accessories, Catheter	KGZ	2
Injector And Syringe, Angiographic	DXT	2
Bag, Bile Collecting	EXF	2
Device, Occlusion, Umbilical	FOD	2
Pack, Hot Or Cold, Reusable	IME	2
Apparatus, Autotransfusion	CAC	2
Anti Fog Solution And Accessories, Endoscopy	OCT	2
Ear, Nose, And Throat Surgical Tray	OGR	2
System, Irrigation, Urological	LJH	2
Computer, Diagnostic, Programmable	DQK	2
Orthosis, Limb Brace	IQI	2
Bur, Ear, Nose And Throat	EQJ	2
Instrument, Ultrasonic Surgical	LFL	2
Aid, Transfer	IKX	2
Orthosis, Thoracic	IPT	2
Bed, Flotation Therapy, Powered	IOQ	2
Container, I.V.	KPE	2
Orthosis, Cervical	IQK	2
Drape, Patient, Ophthalmic	HMT	2
Set, Blood Transfusion	BRZ	2
Container, Empty, For Collection & Processing Of Blood & Blood Components	KSR	2
Lift, Patient, Non-Ac-Powered	FSA	2
System, Surgical, Computer Controlled Instrument	NAY	2
Modular Electromechanical Surgical System	SCV	2
System, Hemodialysis, Remote Accessories	MON	2
Suture, Nonabsorbable, Synthetic, Polyethylene	GAT	1
Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment	HWE	1
Syringe, Piston	FMF	1
System, X-Ray, Angiographic	IZI	1
Accessories, Arthroscopic	NBH	1
Dressing, Wound, Drug	FRO	1
Suture, Nonabsorbable, Steel, Monofilament And Multifilament, Sterile	GAQ	1
Stimulator, Nerve	ETN	1
Suture, Absorbable, Synthetic, Polyglycolic Acid	GAM	1
Plate, Cranioplasty, Preformed, Non-Alterable	GXN	1
Drills, Burrs, Trephines & Accessories (Simple, Powered)	HBE	1
Cover, Shoe, Operating-Room	FXP	1
Cover, Burr Hole	GXR	1
Clamp, Vascular	DXC	1
Dressing Change Tray	OXQ	1
Instrument, Biopsy	KNW	1
Dilator, Esophageal	KNQ	1
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	1
Filter, Infusion Line	FPB	1
Device, Monitoring, Intracranial Pressure	GWM	1

Makers in the Dominican Republic

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

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Covidien	- Santo Domingo, Dominican Republic	66	79	0	0	api.fda.gov
Baxter Healthcare, S.A.	Haina San Cristobal, Dominican Republic	13	35	0	0	api.fda.gov
CCT Critical Care Technologies, S.R.L. Also Trading As Edwards Lifesciences AG	HAINA San Cristobal, Dominican Republic	23	28	0	2	api.fda.gov
Deroyal Intercontinental, S.R.L.	Santiago, Dominican Republic	95	21	0	0	api.fda.gov
Fenwal International, Inc.	HAINA San Cristobal, Dominican Republic	21	12	0	0	api.fda.gov
Convatec Dominican Republic, Inc.	Haina San Cristobal, Dominican Republic	16	9	0	0	api.fda.gov
Microtek Dominicana, S.A.S.	La Romana, Dominican Republic	31	9	0	0	api.fda.gov
B. Braun Dominican Republic Inc.	SANTO DOMINGO Distrito Nacional, Dominican Republic	24	8	0	0	api.fda.gov
Remington Medical, S.A.	Santo Domingo Este, Dominican Republic	13	5	0	0	api.fda.gov
Microtek Dominicana, S.A.S.	Las Americas Santo Domingo, Dominican Republic	11	4	0	0	api.fda.gov
Das Medical International, SRL	La Romana, Dominican Republic	15	3	0	0	api.fda.gov
Cardinal Health D.R. 203 Ii Ltd	Santo Domingo, Dominican Republic	8	2	0	0	api.fda.gov
Metrix Dominicana S.R.L.	HAINA San Cristobal, Dominican Republic	2	2	0	0	api.fda.gov
Arjo Dominican Republic	Itabo, Haina San Cristobal, Dominican Republic	5	1	0	1	api.fda.gov
Oscor Caribe LLC	SANTO DOMINGO Distrito Nacional, Dominican Republic	5	1	0	0	api.fda.gov
Sorin Group DR S.r.l.	Santo Domingo, Dominican Republic	1	0	1	0	api.fda.gov
T-Scientific International, Inc.	SANTO DOMINGO Distrito Nacional, Dominican Republic	2	1	0	0	api.fda.gov
AJR International S.R.L.	El Ingenio Abajo Santiago, Dominican Republic	2	0	0	0	api.fda.gov
Arriol International Corp.	Santo Domingo, Dominican Republic	1	0	0	0	api.fda.gov
AccuMED Corp.	Haina San Cristobal, Dominican Republic	1	0	0	0	api.fda.gov
AccuMed Corp.	Nigua San Cristobal, Dominican Republic	19	0	0	0	api.fda.gov
Biomerics Dominican Republic	Haina San Cristobal, Dominican Republic	1	0	0	0	api.fda.gov
Caribbean Custom Mold Inc	Santo Domingo, Dominican Republic	5	0	0	0	api.fda.gov
CEA Global Dominicana d.b.a. Nissha Medical Technologies	San Pedro de Macoris, Dominican Republic	13	0	0	0	api.fda.gov
CareFusion D.R. 203 Ltd.	SANTO DOMINGO Distrito Nacional, Dominican Republic	9	0	0	0	api.fda.gov
Corflex Caribe	Santo Domingo Este, Dominican Republic	7	0	0	0	api.fda.gov
DRL Manufacturing S.A.	San Pedro de Macoris, Dominican Republic	1	0	0	0	api.fda.gov
Global Resources International Dominicana Grid S.R.L.	San Pedro de Macoris, Dominican Republic	7	0	0	0	api.fda.gov
Garware Healthcare, SAS	Santiago de los Caballeros, Dominican Republic	3	0	0	0	api.fda.gov
Hayco Dominican Republic Co., S.R.L.	Santo Domingo Este, Dominican Republic	1	0	0	0	api.fda.gov
Joeanne Dominicana Division Of Joeanne Company International	Santiago, Dominican Republic	1	0	0	0	api.fda.gov
LG H&H Usa, Inc	HAINA San Cristobal, Dominican Republic	1	0	0	0	api.fda.gov
Luminlo SRL	San Pedro de Macoris, Dominican Republic	2	0	0	0	api.fda.gov
Med Paper Dominicana Mepadom SRL	Santo Domingo Oeste, Dominican Republic	5	0	0	0	api.fda.gov
Medsorb Dominicana, S.A.	San Pedro De Macoris, Dominican Republic	31	0	0	0	api.fda.gov
NYPRO DR, LLC (Bldg 11)	Haina San Cristobal, Dominican Republic	1	0	0	0	api.fda.gov
NYPRO DR, LLC (Building 52)	Haina San Cristobal, Dominican Republic	5	0	0	0	api.fda.gov
Optec Usa, Inc	San Pedro De Macoris, Dominican Republic	13	0	0	0	api.fda.gov
Qel Dominicana S.A.	ESPERANZA Valverde, Dominican Republic	3	0	0	0	api.fda.gov
Sandcastle Corporation, S.L.C.	Santo Domingo Este., Dominican Republic	1	0	0	0	api.fda.gov
Vexxus Medical Inc.	SANTO DOMINGO Distrito Nacional, Dominican Republic	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.