Medical device makers in Mexico: 311 FDA-registered establishments

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

311 establishments in Mexico are registered with the FDA to make medical devices for the US market, listing 1,714 device types. 120 have a 510(k) clearance or PMA approval on file and 6 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
Set, Administration, Intravascular	FPA	36
Tape And Bandage, Adhesive	KGX	24
Electrosurgical, Cutting & Coagulation & Accessories	GEI	22
Laparoscope, General & Plastic Surgery	GCJ	19
Instrument, Manual, Surgical, General Use	MDM	19
Catheter, Intravascular, Diagnostic	DQO	18
Drape, Surgical, Exempt	PUI	18
Bandage, Elastic	FQM	18
Circuit, Breathing (W Connector, Adaptor, Y Piece)	CAI	18
Accessory, Surgical Apparel	LYU	17
Needle, Hypodermic, Single Lumen	FMI	17
Catheter, Irrigation	GBX	17
Humidifier, Respiratory Gas, (Direct Patient Interface)	BTT	17
Orthosis, Limb Brace	IQI	17
Introducer, Catheter	DYB	16
Fiber, Medical, Absorbent	FRL	16
Catheter And Tip, Suction	JOL	16
Filter, Bacterial, Breathing-Circuit	CAH	16
Cannula, Nasal, Oxygen	CAT	16
Syringe, Piston	FMF	15
Kit, Surgical Instrument, Disposable	KDD	15
Tubes, Gastrointestinal (And Accessories)	KNT	15
Nebulizer (Direct Patient Interface)	CAF	15
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase	CCK	15
Continuous Measurement Thermometer	FLL	14
Joint, Knee, External Brace	ITQ	14
General Surgery Tray	LRO	14
Support, Patient Position	CCX	13
Bedding, Disposable, Medical	KME	13
Connector, Airway (Extension)	BZA	13
Drape, Surgical, Antimicrobial	KKX	13
Orthosis, Cervical	IQK	13
Device, Intravascular Catheter Securement	KMK	12
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days	FOZ	12
Pump, Infusion	FRN	12
Mask, Oxygen	BYG	12
System, Thermal Regulating	DWJ	12
Protector, Skin Pressure	FMP	12
Wire, Guide, Catheter	DQX	11
Catheters, Suction, Tracheobronchial	BSY	11
Catheter, Urological	KOD	11
Tubing, Fluid Delivery	FPK	11
Gauze / Sponge,Nonresorbable For External Use	NAB	11
Splint, Hand, And Components	ILH	11
Garment, Protective, For Incontinence	EYQ	11
Tubing, Pressure And Accessories	BYX	11
Accessories, Catheter	KGZ	11
Orthosis, Lumbar	IQE	11
Lens, Spectacle, Non-Custom (Prescription)	HQG	11
Joint, Ankle, External Brace	ITW	11
Catheter, Percutaneous	DQY	10
Needle, Aspiration And Injection, Disposable	GAA	10
Set, I.V. Fluid Transfer	LHI	10
Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)	HOY	10
Bandage, Cast	ITG	10
Dispenser, Liquid Medication	KYX	10
Sling, Arm	ILI	10
Non-Surgical Gown	OEA	10
Tray, Surgical, Instrument	FSM	10
Anesthesia Breathing Circuit Kit (Adult & Pediatric)	OFP	10
Nebulizer, Medicinal, Non-Ventilatory (Atomizer)	CCQ	10
Set, Tubing And Support, Ventilator (W Harness)	BZO	10
Device, Fixation, Tracheal Tube	CBH	10
Monitor, Bed Patient	KMI	10
Gown, Surgical	FYA	10
Container, Specimen, Sterile	FMH	10
Computer, Diagnostic, Programmable	DQK	10
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve	FJK	10
Tube, Tracheal (W/Wo Connector)	BTR	9
Instrument, Surgical, Disposable	KDC	9
Ventilator, Non-Continuous (Respirator)	BZD	9
Ventilator, Continuous, Facility Use	CBK	9
Injector And Syringe, Angiographic	DXT	9
System, Measurement, Blood-Pressure, Non-Invasive	DXN	9
Pad, Menstrual, Unscented	HHD	9
Cover, Limb	IPM	9
Arthroscope	HRX	8
Tubes, Vials, Systems, Serum Separators, Blood Collection	JKA	8
Cap, Surgical	FYF	8
Container, Specimen, Non-Sterile	NNI	8
Ventilator, Emergency, Manual (Resuscitator)	BTM	8
Bag, Reservoir	BTC	8
Tray, Surgical	LRP	8
Apparatus, Suction, Operating-Room, Wall Vacuum Powered	GCX	8
Tubing, Noninvasive	GAZ	8
Cardiovascular Procedure Kit	OEZ	8
Stocking, Medical Support (For General Medical Purposes)	FQL	8
Device, Transfer, Patient, Manual	FMR	8
Aid, Transfer	IKX	8
Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Flutter	OAD	8
Tray, Catheterization, Sterile Urethral, With Or Without Catheter (Kit)	FCM	8
Mattress, Flotation Therapy, Non-Powered	IKY	8
Restraint, Protective	FMQ	8
Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	MHX	8
Monitor, Breathing Frequency	BZQ	8
Cover, Shoe, Operating-Room	FXP	7
Attachment, Breathing, Positive End Expiratory Pressure	BYE	7
Stents, Drains And Dilators For The Biliary Ducts	FGE	7
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days	LJS	7
Transducer, Ultrasonic, Diagnostic	ITX	7

Makers in Mexico

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

Maker	Location	Device types	510(k) clearances	PMA approvals	Recall events	Source
Arrow Internacional de Chihuahua S.A. de C.V.	Chihuahua, Mexico	113	226	0	0	api.fda.gov
Medtronic Mexico S. de R.L. de CV	Tijuana Baja California, Mexico	59	184	9	0	api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.	Tijuana, B.C. C.P. Baja California, Mexico	58	127	0	0	api.fda.gov
Teleflex Medical de Tecate, S. de R.L de C.V.	TECATE Baja California, Mexico	72	101	1	0	api.fda.gov
Covidien	TIJUANA, B.C. Mexico, Mexico	52	81	0	0	api.fda.gov
GE Medical Systems Information Technologies - Critikon de Mexico S. de R.L. de C.V.	JUAREZ Chihuahua, Mexico	57	78	0	0	api.fda.gov
La Ada de Acuna	CIUDAD DE ACUNA Coahuila, Mexico	26	69	0	0	api.fda.gov
Convertors de Mexico S. de R.L. de C.V	CD.JUAREZ Chihuahua, Mexico	390	64	0	0	api.fda.gov
DJ Orthopedics De Mexico, S.A. De C.V.	TIJUANA Baja California, Mexico	96	59	0	0	api.fda.gov
Cardinal Health (Kenmex Medical Specialties)	TIJUANA Baja California, Mexico	56	55	0	0	api.fda.gov
Cordis de Mexico, SA de CV	JUAREZ Chihuahua, Mexico	12	44	8	1	api.fda.gov
ICU MEDICAL DE MEXICO, S. de R.L. de C.V.	ENSENADA, Baja California, Mexico	24	51	0	1	api.fda.gov
Productos Urologos De Mexico S.A. De C.V.	MEXICALI Baja California, Mexico	75	51	0	0	api.fda.gov
Industrial Vallera de Mexicali, S. A. de C. V.	Mexicali Mexico, Mexico	40	50	0	0	api.fda.gov
Avent S. de R.L. de C.V.	TIJUANA Baja California, Mexico	23	49	0	0	api.fda.gov
Covidien	Ciudad Juarez Chihuahua, Mexico	24	47	0	0	api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.	APODACA Nuevo Leon, Mexico	51	44	0	0	api.fda.gov
STERIS MEXICO, S. de R.L. de C.V.	GUADALUPE Nuevo Leon, Mexico	5	42	0	0	api.fda.gov
Surgical Specialties Mexico S DE RL DE CV	Tijuana Baja California, Mexico	23	39	1	1	api.fda.gov
Bard Reynosa S.A. De C.V.	REYNOSA Tamaulipas, Mexico	48	39	0	0	api.fda.gov
Cordis de Mexico SA de CV	Ciudad Juarez, Chihuahua Mexico, Mexico	8	38	0	0	api.fda.gov
Rci Hudson De Mexico S. De RL. De CV.	Nuevo Laredo Tamaulipas, Mexico	24	38	0	0	api.fda.gov
AVENT S. de R.L. de C.V.	NOGALES Sonora, Mexico	19	37	0	0	api.fda.gov
Intuitive Surgical, S. de R.L. de C.V.	Mexicali Baja California, Mexico	8	34	0	0	api.fda.gov
Salter Labs de Mexico de S.A. de C.V.	Chihuahua Mexico, Mexico	29	34	0	0	api.fda.gov
Tri-State De Mexico, S. De R.L. De C.V.	MEXICALI Baja California, Mexico	146	32	0	0	api.fda.gov
Stryker Tijuana Operations	Tijuana Baja California, Mexico	19	29	0	0	api.fda.gov
Cardinal Health Mexico 244 S de RL de CV	Ciudad Juarez Chihuahua, Mexico	15	24	3	0	api.fda.gov
Erika De Reynosa, S.A. De C.V.	CD, REYNOSA Tamaulipas, Mexico	10	27	0	0	api.fda.gov
Plexus Electronica S. de R.L. de C.V..	Zapopan Jalisco, Mexico	36	27	0	0	api.fda.gov
Erika De Reynosa, S.A. De C.V.	CD, REYNOSA Tamaulipas, Mexico	10	25	0	0	api.fda.gov
Ethicon, Inc.	CIUDAD JUAREZ Chihuahua, Mexico	36	24	1	1	api.fda.gov
Productos Medline S.A. De C.V.	NUEVO LAREDO Tamaulipas, Mexico	110	25	0	0	api.fda.gov
Ge Medical Systems Monterrey Mexico, S.A. De C.V.	APODACA Nuevo Leon, Mexico	18	22	0	0	api.fda.gov
Westmed Javid de Mexico, S.A. de C.V.	NOGALES Sonora, Mexico	33	20	0	0	api.fda.gov
Devicor Medical Products de Mexico S de RL de CV	Tijuana Baja California, Mexico	5	19	0	0	api.fda.gov
WESTMED de Mexico, S.A de C.V.	Tecate Baja California, Mexico	22	17	0	0	api.fda.gov
Consolidated Medical Equipment Company	Chihuahua, Mexico	62	16	0	0	api.fda.gov
Tecnologias Medicas Innovadoras S De RL	H. MATAMOROS Tamaulipas, Mexico	6	16	0	0	api.fda.gov
BECTON DICKINSON INFUSION THERAPY SYSTEMS INC. S.A. de C.V.	NOGALES Sonora, Mexico	13	15	0	0	api.fda.gov
Oculus Technologies of Mexico, S.A de C.V.	Zapopan Jalisco, Mexico	3	15	0	1	api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, Mexico	14	14	0	0	api.fda.gov
Aligntech de Mexico S, de R. L. de C. V.	Cd. Juarez Chihuahua, Mexico	14	13	0	0	api.fda.gov
Medline Industries, LP - Mexicali (MXC)	Mexicali Baja California, Mexico	200	13	0	0	api.fda.gov
Flextronics Manufacturing Juarez S. DE R.L. DE C.V.	Juarez Chihuahua, Mexico	32	12	0	0	api.fda.gov
Industrial Vallera de Mexicali, S.A. de C.V. (Terra)	Mexicali Baja California, Mexico	23	12	0	0	api.fda.gov
Internacional Farmaceutica, S.A. De C.V.	LERMA Mexico, Mexico	8	11	0	0	api.fda.gov
QUIROPRODUCTOS DE CUAUHTEMOC S. de R.L. de C.V.	CUAUHTEMOC, CHIHUAHUA Mexico, Mexico	7	11	0	0	api.fda.gov
Quiroproductos de Cuauhtemoc S. De R.L. de C.V.	Cuauhtemoc Chihuahua, Mexico	21	11	0	0	api.fda.gov
Internacional Farmaceutica, S.A. De C.V.	Mexico City, Mexico	8	10	0	0	api.fda.gov
Nordson MEDICAL Mexico	Guaymas Sonora, Mexico	7	10	0	0	api.fda.gov
ASO AMERICAS, S. de R. L. de C. V.	JUAREZ Chihuahua, Mexico	23	9	0	0	api.fda.gov
Productos Para El Cuidado De La Salud	NOGALES Sonora, Mexico	61	9	0	0	api.fda.gov
RR Donnelley Global Turnkey Solutions	Juarez Chihuahua, Mexico	23	9	0	0	api.fda.gov
Baja Fur S.A. de C.V.	Tijuana BC. Baja California, Mexico	3	8	0	0	api.fda.gov
Cirpro de Delicias S. de R.L. de C.V.	DELICIAS Chihuahua, Mexico	5	8	0	0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	450	8	0	0	api.fda.gov
Baja Fur S.A. de C.V.	Tijuana Baja California, Mexico	3	7	0	0	api.fda.gov
Conamco SA de CV Medental Inc	C.P. 06880 Ciudad de Mexico, Mexico	7	7	0	0	api.fda.gov
Baxter S.A. De C.V.	Civac, Jiutepec, Morelos, Mexico	6	6	0	0	api.fda.gov
Beaver-Visitec International, Inc.	Ciudad Juarez Chihuahua, Mexico	36	6	0	0	api.fda.gov
Bemis De Mexico, S.A. DE C.V.	Cienega De Flores Nuevo Leon, Mexico	3	6	0	0	api.fda.gov
Haemonetics Mexico Manufacturing S. de R.L. de C.V.	TIJUANA, B.C. Mexico, Mexico	7	6	0	0	api.fda.gov
Invamex S.de R.L. De C.V.	REYNOSA Tamaulipas, Mexico	18	6	0	0	api.fda.gov
La Ada De Acuna, S. de. R. L. de C. V.	COL.EDUCATIVA,NOGALES Sonora, Mexico	8	6	0	0	api.fda.gov
Anza Packaging & Displays De Mexico S. De R.L. De C.V.	TIJUANA Baja California, Mexico	11	5	0	0	api.fda.gov
Baja Fur S.A. de C.V.	Tijuana Baja California, Mexico	4	5	0	0	api.fda.gov
Manufacturas Ke	Nogales Sonora, Mexico	7	5	0	0	api.fda.gov
S & Mohr America, S.A. DE C.V.	ESTADO DE MEXICO Ciudad de Mexico, Mexico	18	5	0	1	api.fda.gov
SOLVENTUM US LLC (Apodaca)	Apodaca Nuevo Leon, Mexico	17	5	0	0	api.fda.gov
Tutamen De Mexico, LLC	Tijuana Baja California, Mexico	19	5	0	0	api.fda.gov
Becton Dickinson De Mexico	CUAUTITLAN, IZCALLI Queretaro, Mexico	4	4	0	0	api.fda.gov
Breg Mexico, S. De R.L. De C.V. (4)	Mexicali Baja California, Mexico	32	4	0	0	api.fda.gov
Compania Mexicana De Radiologia CGR, S.A. De C.V.	Queretaro, Mexico	6	4	0	0	api.fda.gov
Convertors de Mexico S. de R.L. de C.V	Ciudad Juarez Chihuahua, Mexico	13	4	0	0	api.fda.gov
Erika de Reynosa, S.A. de C.V.	CD, Reynosa Tamaulipas, Mexico	2	4	0	0	api.fda.gov
Maq-Ops, S. De R.L.	Tijuana Baja California, Mexico	7	4	0	0	api.fda.gov
Biomerica De Mexico, S.A. De C.V.	MEXICALI Baja California, Mexico	10	3	0	0	api.fda.gov
Gambro Renal Products S.A. De C.V.	TIJUANA Baja California, Mexico	2	3	0	0	api.fda.gov
GVS Filter Technology De Mexico	Apodaca N.L Nuevo Leon, Mexico	2	3	0	0	api.fda.gov
Hill-Rom De Mexico S De RL De CV	APODACA Nuevo Leon, Mexico	19	3	0	0	api.fda.gov
Martech Medical Products S. De RL. De CV.	MEXICALI Baja California, Mexico	54	3	0	0	api.fda.gov
Wear Tex S. De R.L. De C.V.	Torreon Coahuila, Mexico	24	3	0	0	api.fda.gov
AMETEK Lamb Motores de Mexico, S. de R.L. de C.V.	Reynosa Tamaulipas, Mexico	2	2	0	0	api.fda.gov
Abbott Medical Mexico, S. de R.L. de C.V.	Santa Rosa Jauregui Queretaro, Mexico	4	2	0	0	api.fda.gov
BSN Medical S.A. de C.V.	Reynosa Tamaulipas, Mexico	26	2	0	0	api.fda.gov
Border Assembly S de RL de CV	TIJUANA Baja California, Mexico	7	2	0	0	api.fda.gov
Border Assembly S. de R.L de C.V.	Tijuana Baja California, Mexico	5	2	0	0	api.fda.gov
Fisher & Paykel Healthcare S.a.de C.V.	Tijuana, Baja California, Mexico	8	2	0	0	api.fda.gov
Fresenius Medical Care de Mexico	Zapopan Jalisco, Mexico	1	2	0	0	api.fda.gov
Intuitive Surgical, S. de R.L. de C.V.	Mexicali Baja California, Mexico	1	2	0	0	api.fda.gov
K-C AFC Manufacturing, S. de R.L. de C.V	Nogales, Sonora Mexico, Mexico	4	2	0	0	api.fda.gov
Laboratorios Scantibodies S.A. De C.V.	TECATE Baja California, Mexico	24	2	0	0	api.fda.gov
Manufacturera Dental Continental	ZAPOPAN Jalisco, Mexico	17	2	0	0	api.fda.gov
Medtronic Mexico Eg	EMPALME Sonora, Mexico	1	0	2	0	api.fda.gov
Medline Soluciones Medicas	Nuevo Laredo Tamaulipas, Mexico	77	2	0	0	api.fda.gov
Ortotec De BC MX SA De CV	Tecate Baja California, Mexico	6	2	0	0	api.fda.gov
Ormex S. de R.L. de C.V.	Yucatan Uman, Mexico	10	2	0	0	api.fda.gov
Starkey De Mexico, S.A. De C.V.	Colonia Ciudad Industrial, H.MATAMOROS Tamaulipas, Mexico	3	2	0	0	api.fda.gov
TE Sensores S. de R.L. de C.V	Hermosillo Mexico, Mexico	4	2	0	0	api.fda.gov
3M Edumex, S.A De C.V	CD. JUAREZ Chihuahua, Mexico	28	1	0	0	api.fda.gov
Advanced Bionics North American Operations Center S.A. de C.V.	Mexicali Baja California, Mexico	1	0	1	0	api.fda.gov
Breg Mexico, S. De R.L. De C.V. (3)	Mexicali Baja California, Mexico	17	1	0	0	api.fda.gov
Clemde S.A. De C.V.	MEXICO, DF Ciudad de Mexico, Mexico	4	1	0	0	api.fda.gov
Cardiva Medical, Inc.	Guaymas Sonora, Mexico	3	0	1	0	api.fda.gov
Demant Operations, S.a. De C.v.	Tijuana Baja California, Mexico	4	1	0	0	api.fda.gov
Fixier S.A. De C.V.	Doctor Mora Guanajuato, Mexico	2	1	0	0	api.fda.gov
Iimed Medical Mexicana S. De R.L. De C.V.	Reynosa Tamaulipas, Mexico	61	1	0	0	api.fda.gov
IVEMSA S.A. de C.V DIVISION AG INDUSTRIES	Tijuana Baja California, Mexico	10	1	0	0	api.fda.gov
Life Outcomes Javid de Mexico	Nogales Sonora, Mexico	4	1	0	0	api.fda.gov
Merit Maquiladora Mexico, S. DE R.L. DE C.V.	Tijuana Baja California, Mexico	55	1	0	0	api.fda.gov
Ortosim, S.A. De C.V.	TLALNEPANTLA Mexico, Mexico	1	1	0	0	api.fda.gov
Posey S. de R.L. de C.V.	Tijuana, Baja California Mexico, Mexico	5	1	0	0	api.fda.gov
Procter & Gamble Manufacturing Mexico S. de R.L. de C.V.	Estado de Mexico, C.P., Mexico	4	1	0	0	api.fda.gov
Renal Care Dialysis Solutions, S.A. De C.V.	El Marques Queretaro, Mexico	1	1	0	0	api.fda.gov
Sofi De Chihuahua	10 Y 11, Chihuahua, Chib, Mexico	4	1	0	0	api.fda.gov
Sunrise Medical Tecnologias, S.A. de CV	Tijuana Baja California, Mexico	18	1	0	0	api.fda.gov
Welch Allyn De Mexico, S. De R.L. De C.V.	TIJUANA Baja California, Mexico	32	1	0	0	api.fda.gov
WS Audiology Mexico S.A. de C.V.	Tijuana Baja California, Mexico	5	1	0	0	api.fda.gov
Westmed de Mexico, S.A de C.V	NOGALES Sonora, Mexico	19	1	0	0	api.fda.gov
3M Purification, S. de R.L. de C. V.	San Luis Potosi Mexico, Mexico	1	0	0	0	api.fda.gov
Ametek Lamb Motores De Mexico S. De R.L. De C.V.	Nuevo Laredo Tamaulipas, Mexico	1	0	0	0	api.fda.gov
Ammar Apparel Ii S. De R.L De C.V.	CALKINI Campeche, Mexico	11	0	0	0	api.fda.gov
Amphenol Alden Products Company	Hermosillo Sonora, Mexico	23	0	0	0	api.fda.gov
Amphenol DC Electronics	Nogales Sonora, Mexico	1	0	0	0	api.fda.gov
AP Services de Mexico, S. De R.L. De C.V.	Tijuana Baja California, Mexico	2	0	0	0	api.fda.gov
Articulos Mexicanos De Curacion S.A. De C.V.	Mexico Ciudad de Mexico, Mexico	1	0	0	0	api.fda.gov
Augen Opticos S.A.	ENSENADA (EL SAUZAL) Baja California, Mexico	1	0	0	0	api.fda.gov
Abbott Laboratories de Mexico	Cuautitlan Izcalli Mexico, Mexico	6	0	0	0	api.fda.gov
Ambu Mexico Operations S.A. DE C.V.	Ciudad Juarez Chihuahua, Mexico	7	0	0	0	api.fda.gov
Ametek EMC	Reynosa Tamaulipas, Mexico	3	0	0	0	api.fda.gov
Amex de Mexico, S.A./Anderson Desk - Mexico	Tijuana Baja California, Mexico	1	0	0	0	api.fda.gov
Ansell Perry de Mexico S.A. de C.V.	Cd. Juarez Chihuahua, Mexico	3	0	0	0	api.fda.gov
Articulos Higienicos S.A.	Cuautitlan Izcalli Mexico, Mexico	3	0	0	0	api.fda.gov
AvailMed S.A.De C.V.	Tijuana Baja California, Mexico	50	0	0	0	api.fda.gov
Avances Cientificos de Mexico	H. Matamoros Tamaulipas, Mexico	5	0	0	0	api.fda.gov
BENCHMARK ELECTRONICS San Jorge	Tlajomulco de Zuniga Jalisco, Mexico	8	0	0	0	api.fda.gov
Benteng Science & Technology Mexico SA De CV	Pesqueria Nuevo Leon, Mexico	1	0	0	0	api.fda.gov
Bioana	Monterrey Nuevo Leon, Mexico	4	0	0	0	api.fda.gov
BMC Medical Manufacturing S.A. De C.V.	Apodaca Nuevo Leon, Mexico	1	0	0	0	api.fda.gov
Boyd Corporation	Juarez Chihuahua, Mexico	5	0	0	0	api.fda.gov
Border Assembly S. de R.L de C.V.	Tijuana B.C. Baja California, Mexico	2	0	0	0	api.fda.gov
Border Assembly, S. de R.L. de C.V.	Tijuana B.C. Baja California, Mexico	4	0	0	0	api.fda.gov
Boss Laboratories	Leon Guanajuato, Mexico	1	0	0	0	api.fda.gov
Brady Mexico, S. de R.L. de C.V.	Tijuana Baja California, Mexico	4	0	0	0	api.fda.gov
C&S Manufacturing International SRL de CV	Torreon Coahuila, Mexico	2	0	0	0	api.fda.gov
Calibaja Manufacturing, S.A. De C.V.	MEXICALI Baja California, Mexico	10	0	0	0	api.fda.gov
Cardio Technics S.A. De C.V.	SAN ANDRES CHOLULA Puebla, Mexico	4	0	0	0	api.fda.gov
Carl Zeiss Vision Manufactura De Mexico, S. De R.L	TIJUANA Baja California, Mexico	2	0	0	0	api.fda.gov
CELESTICA de MONTERREY S.A. de C.V.	Apodaca Nuevo Leon, Mexico	40	0	0	0	api.fda.gov
Centerpiece S. De R.L De C.V	Playas de Rosarito Baja California, Mexico	11	0	0	0	api.fda.gov
Centro Integral Optico, SA De CV	Mexico, Mexico	2	0	0	0	api.fda.gov
Coastline de Mexico SA de CV	Tijuana Baja California, Mexico	17	0	0	0	api.fda.gov
Corning Science Mexico	Reynosa Tamaulipas, Mexico	1	0	0	0	api.fda.gov
Costco Optical Laboratory #790	Tepeji del Rio Hidalgo, Mexico	1	0	0	0	api.fda.gov
Davol Surgical Innovations	CD. JUAREZ Chihuahua, Mexico	14	0	0	0	api.fda.gov
Degasa, S.A. De C.V.	Jiutepec Morelos, Mexico	14	0	0	0	api.fda.gov
Dela De Mexico S De RL De CV	TIJUANA Baja California, Mexico	11	0	0	0	api.fda.gov
Dianceht, S.A De C.V.	Tlajomulco de Zuniga Jalisco, Mexico	2	0	0	0	api.fda.gov
DIME-PACK S. De R.L. De C.V.	Tijuana Baja California, Mexico	4	0	0	0	api.fda.gov
Diseno Electronico Mexicano SA De CV	IMURIS Sonora, Mexico	6	0	0	0	api.fda.gov
Domenico Internacional	San Andres Cholula Puebla, Mexico	1	0	0	0	api.fda.gov
Domico Med-Device, LLC	Las palomas Guanajuato, Mexico	4	0	0	0	api.fda.gov
E. Tec SA De C.V.	Tijuana Baja California, Mexico	12	0	0	0	api.fda.gov
Empresas Iai S De RL De C.V.	H. MATAMOROS Tamaulipas, Mexico	1	0	0	0	api.fda.gov
Enrocan Sapi De C.V.	Cuautitlan Izcalli Mexico, Mexico	2	0	0	0	api.fda.gov
Especialistas En Esterilizacion Y Envase, S. A. De C. V.	Tlalnepantla, Estado de Mexico, Mexico	2	0	0	0	api.fda.gov
Essilor Tijuana Optica, S. De R.L. De C.V.	Chihuahua, Mexico	1	0	0	0	api.fda.gov
Ethicon Endo-Surgery S.A. De C.V. Planta Ii	CIUDAD JUAREZ Chihuahua, Mexico	12	0	0	0	api.fda.gov
Eastek Mexico Holdings LLC	Fresnillo Zacatecas, Mexico	2	0	0	0	api.fda.gov
Eastprint Mexico S. DE R.L. DE C.V.	Juarez Chihuahua, Mexico	2	0	0	0	api.fda.gov
Essilor Tijuana Optica	Tijuana Baja California, Mexico	1	0	0	0	api.fda.gov
EssilorLuxottica Mexico S. de R.L de C.V	Tijuana Baja California, Mexico	5	0	0	0	api.fda.gov
Essity Hygiene Y Salud Mexico, S.A. DE C.V.	Ecatepec, Mexico, Mexico	4	0	0	0	api.fda.gov
Fabricantes De Basculas Torrey SA De CV	MONTERREY Nuevo Leon, Mexico	2	0	0	0	api.fda.gov
Foxconn Baja California S.A De C.V.	tijuana Baja California, Mexico	7	0	0	0	api.fda.gov
Fisher & Paykel Healthcare S.A.de C.V.	Tijuana Baja California, Mexico	12	0	0	0	api.fda.gov
Flextronics Manufacturing Aguascalientes, S.A de C.V	Aguascalientes, Mexico	16	0	0	0	api.fda.gov
Galaz Science And Engineering S.S. De C.V.	Hermosillo Sonora, Mexico	1	0	0	0	api.fda.gov
Galia Textil S.A. De C.V.	Xiloxoxtla, Tlaxcala, Mexico	5	0	0	0	api.fda.gov
GPV Americas Mexico	Zapopan Jalisco, Mexico	1	0	0	0	api.fda.gov
Grupo Alyger, S.A. De C.V.	Guadalupe Nuevo Leon, Mexico	5	0	0	0	api.fda.gov
Greatbatch Medical S. de R.L. de C.V.	Tijuana Baja California, Mexico	9	0	0	0	api.fda.gov
Greatbatch Medical, S. de R.L. de C.V.	Tijuana Baja California, Mexico	4	0	0	0	api.fda.gov
Grupo American Industries, S.A. De C.V	Ciudad Juarez Chihuahua, Mexico	2	0	0	0	api.fda.gov
Haemotronic De Mexico S De RL	REYNOSA Tamaulipas, Mexico	11	0	0	0	api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de C.V.	Tijuana Baja California, Mexico	14	0	0	0	api.fda.gov
HARMAC MEDICAL PRODUCTS, INC./H3 de Tijuana, S. de RL de CV	Tijuana Baja California, Mexico	6	0	0	0	api.fda.gov
Hi-Tech Products De Mexico S.A. De C.V.	La Mesa, Tijuana Baja California, Mexico	21	0	0	0	api.fda.gov
Hindernis De Mexico S.A.P.I. De C.V.	Naucalpan de Juarez Mexico, Mexico	1	0	0	0	api.fda.gov
Industrias Grayling De Mexico, SA De C	Juarez Chihuahua, Mexico	1	0	0	0	api.fda.gov
Industrias Plasticas Medicas, S.A. De C.V.	Ayala Morelos, Mexico	14	0	0	0	api.fda.gov
Insumos Desechables Para La Salud S.A. De CV.	Tecoh Yucatan, Mexico	6	0	0	0	api.fda.gov
IOTP-OB (Administradores de Maquila S de RL de CV)	Municipio de Cajeme Sonora, Mexico	1	0	0	0	api.fda.gov
Industrias Plasticas Martins S.A.de C.V.	Ecatepec Mexico, Mexico	3	0	0	0	api.fda.gov
Integra Biotechnical, SA de CV	Tijuana Baja California, Mexico	77	0	0	0	api.fda.gov
InterMetro de Acuna	Acuna Coahuila, Mexico	4	0	0	0	api.fda.gov
International Manufacturing Solutions Operaciones	Cd. Juarez Chihuahua, Mexico	10	0	0	0	api.fda.gov
Jabil Circuit de Chihuahua, S. De R.L. de C.V.	Chihuahua, Mexico	4	0	0	0	api.fda.gov
Javid de Mexico S. De R.L. De C.V. (resplabs)	Nogales Sonora, Mexico	7	0	0	0	api.fda.gov
Joerns Healthcare Matamoros	H. Matamoros, Tamaulipas Mexico, Mexico	7	0	0	0	api.fda.gov
Ke-Nal Hosiery Sa De Cv	Chapa de Mota Mexico, Mexico	1	0	0	0	api.fda.gov
Key Tronic Corporation	Juarez Chihuahua, Mexico	1	0	0	0	api.fda.gov
Key Tronic Juarez, S.A de C.V.	Juarez Chihuahua, Mexico	4	0	0	0	api.fda.gov
Kimball Electronics - Mexico SA de CV	Reynosa Tamaulipas, Mexico	1	0	0	0	api.fda.gov
Kimberly-Clark de Mexico	CUAUTITLAN Mexico, Mexico	3	0	0	0	api.fda.gov
Labomex MBP	TIJUANA Baja California, Mexico	1	0	0	0	api.fda.gov
Laboratorio Optimex SA De CV	Zapopan Jalisco, Mexico	3	0	0	0	api.fda.gov
Laboratorios Clinic, S.A. De C.V.	Queretaro, Qro., Mexico	1	0	0	0	api.fda.gov
Laboratorios Jaloma, S.A. De C.V.	GUADALAJARA Jalisco, Mexico	3	0	0	0	api.fda.gov
Laboratorios Le Roy, S.A. De C.V.	YECAPIXTLA Morelos, Mexico	7	0	0	0	api.fda.gov
Lambi, S.A. De C.V.	Escobedo Nuevo Leon, Mexico	3	0	0	0	api.fda.gov
Lyssette, S.A. De C.V.	Mexico City, Mexico	2	0	0	0	api.fda.gov
Laboratorios PISA S.A. de C.V.	GUADALAJARA Jalisco, Mexico	4	0	0	0	api.fda.gov
Laboratorios PiSA, S. A. de C.V.	Tlajomulco de Zuniga Jalisco, Mexico	8	0	0	0	api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.	Tijuana Baja California, Mexico	22	0	0	0	api.fda.gov
Laboratorios Scantibodies, S.A. de C.V.	Tijuana Baja California, Mexico	6	0	0	0	api.fda.gov
Lumitex, Celaya	Celaya Guanajuato, Mexico	1	0	0	0	api.fda.gov
M&C Specialties and IVEMSA	Mexicali Baja California, Mexico	2	0	0	0	api.fda.gov
Manufactura Integrada Del Pacifico	Tijuana Baja California, Mexico	3	0	0	0	api.fda.gov
Manufacturas Y Servicios Internacionales, S. De R.L.	Cd Juarez Chihuahua, Mexico	8	0	0	0	api.fda.gov
MAQ-OPS S. de R.L.	Tijuana Baja California, Mexico	3	0	0	0	api.fda.gov
Maquiladora De Coahuila S De RL De CV	CUIDAD ACUNA Coahuila, Mexico	16	0	0	0	api.fda.gov
Maquilas Teta Kawi S.A. De C.V.	NOGALES KM2 EMPALME Sonora, Mexico	2	0	0	0	api.fda.gov
MCR Internacional SA De CV	REYNOSA Tamaulipas, Mexico	10	0	0	0	api.fda.gov
Medimexico, S. De R.L. De C.V.	TIJUANA Baja California, Mexico	8	0	0	0	api.fda.gov
Medtech Acuna S.A. De C.V.	Acuna Coahuila, Mexico	19	0	0	0	api.fda.gov
Medtech Mexico Health, S. De R.L. De C.V	SALINAS VICTORIA Nuevo Leon, Mexico	1	0	0	0	api.fda.gov
Menshen Mexicana S. De R.L. De C.V.	Toluca Mexico, Mexico	1	0	0	0	api.fda.gov
MFG Amp	Tijuana Baja California, Mexico	6	0	0	0	api.fda.gov
Miwo Technologies Mexico S De R.L. De C.V.	Tepeji Hidalgo, Mexico	2	0	0	0	api.fda.gov
Molex S.A. De C.V.	Nogales Sonora, Mexico	4	0	0	0	api.fda.gov
Moosni Internacional SA De CV	HERMOSILLO Sonora, Mexico	1	0	0	0	api.fda.gov
Medical Molding & Manufacturing de Mexico S. de R.L. de C.V.	Reynosa Tamaulipas, Mexico	2	0	0	0	api.fda.gov
Novem Medical S. De R.L. De C.V.	TIJUANA Baja California, Mexico	27	0	0	0	api.fda.gov
NPA de Mexico S.de R.L. de C.V.	Tijuana Baja California, Mexico	17	0	0	0	api.fda.gov
NPA de México S. de R.L. de C.V.	TIJUANA Baja California, Mexico	27	0	0	0	api.fda.gov
NextPhase Medical Devices Mexico LLC	TIJUANA Baja California, Mexico	15	0	0	0	api.fda.gov
North Safety de Mexicali, S. DE R.I. DE C.V.	MEXICALI Baja California, Mexico	1	0	0	0	api.fda.gov
Nova Pack, S. A. de C. V.	Jiutepec Morelos, Mexico	1	0	0	0	api.fda.gov
Nypro Healthcare Baja Inc. (Torres)	Ciudad Juarez Chihuahua, Mexico	6	0	0	0	api.fda.gov
O And P De Mexico S.A. De C.V.	Guadalajara Jalisco, Mexico	4	0	0	0	api.fda.gov
Ocp De Mexico De Mexico S.A. De C.V.	Tijuana Baja California, Mexico	1	0	0	0	api.fda.gov
Oechsler Mexico S.A. De C.V.	Santiago de Queretaro, Mexico	1	0	0	0	api.fda.gov
Omni Manufacturing Services S. A. De C. V.	Queretaro, Mexico	2	0	0	0	api.fda.gov
Ontex Mexico Operations SA De CV	Tijuana Baja California, Mexico	2	0	0	0	api.fda.gov
Ortompl SA De CV	Tecate Baja California, Mexico	4	0	0	0	api.fda.gov
Orthodental S.A. de C.V.	Mexicali Baja California, Mexico	3	0	0	0	api.fda.gov
Ossur Mexico	Tijuana Baja California, Mexico	13	0	0	0	api.fda.gov
Plasticos Y Materias Primas, S.A. De C.V.	GUADALAJARA Jalisco, Mexico	2	0	0	0	api.fda.gov
Plasticoscrt, S.A. De C.V.	Santa Catarina Nuevo Leon, Mexico	1	0	0	0	api.fda.gov
Poliuretanos, S.A. De C.V.	Toluca Mexico, Mexico	5	0	0	0	api.fda.gov
POSEY, S. de R.L. de C.V.	TIJUANA Baja California, Mexico	4	0	0	0	api.fda.gov
Procter & Gamble Manufacturing Mexico S. De R.L. De C.V.	MUNIC. TEPEJI D. RIO Hidalgo, Mexico	2	0	0	0	api.fda.gov
Productos Mexicanos De Resinas SA De CV	ESCOBEDO Nuevo Leon, Mexico	1	0	0	0	api.fda.gov
Profilatex, S.A. De C.V.	Mexico, Mexico	1	0	0	0	api.fda.gov
Parker Industrial S de RL de CV	Tijuana Baja California, Mexico	7	0	0	0	api.fda.gov
Pharmapack S.A. de C.V. / Pharmapack GDL	Zapopan Jalisco, Mexico	1	0	0	0	api.fda.gov
Polimeros Formula de Tecate S.A de C.V	Tecate Baja California, Mexico	20	0	0	0	api.fda.gov
Posey, S. De R.L. De C.V.	Tijuana Baja California, Mexico	4	0	0	0	api.fda.gov
Posey, S. de R.L. de C.V.	Tijuana Baja California, Mexico	19	0	0	0	api.fda.gov
Productos Internacionales MABE SA DE CV	Puebla, Mexico	2	0	0	0	api.fda.gov
Quasar Medical Tecate, S.A. de C.V	Tecate Baja California, Mexico	6	0	0	0	api.fda.gov
Rasmussen De Tecate S.A. De C.V.	Tecate Baja California, Mexico	1	0	0	0	api.fda.gov
RM Healthcare Products SA de CV	JUAREZ Chihuahua, Mexico	13	0	0	0	api.fda.gov
Rogers Foam Juarez S de RL de CV	Juarez Chihuahua, Mexico	1	0	0	0	api.fda.gov
Rogers Foam Tijuana S. de R.L. de C.V.	Tijuana Baja California, Mexico	11	0	0	0	api.fda.gov
Savaria Mexico S.A. De C.V.	Santiago de Queretero Queretaro, Mexico	1	0	0	0	api.fda.gov
SCHOTT Technologies Mexico, S.A. de C.V.	Amatlan de los Reyes Veracruz, Mexico	3	0	0	0	api.fda.gov
SDS de Mexico S. de R.L. de C.V.	MEXICALI, B.C. C.P. Baja California, Mexico	48	0	0	0	api.fda.gov
Seacomp Displays	Tijuana Baja California, Mexico	7	0	0	0	api.fda.gov
Seamless Global Solutions SA De CV	Huejotzingo Puebla, Mexico	1	0	0	0	api.fda.gov
SEI Medical S.A. de C.V.	Juarez Chihuahua, Mexico	66	0	0	0	api.fda.gov
SISTEMAS MEDICOS ALARIS, S.A De C.V.	TIJUANA Baja California, Mexico	5	0	0	0	api.fda.gov
Solomed S.A. De C.V.	Zapopan Jalisco, Mexico	7	0	0	0	api.fda.gov
Suministros Y Desechables Skkyd S.A. De C.V.	Naucalpan Estado de Mexico, Mexico	9	0	0	0	api.fda.gov
SYNTECH DE BAJA CALIFORNIA, S De RL DE CV	Col. San Antonio Oeste Mexico, Mexico	1	0	0	0	api.fda.gov
Sanmina-SCI Systems de Mexico SA de CV	Carr. Chapala-Guadalajara Jalisco, Mexico	3	0	0	0	api.fda.gov
Sharp Detail Orthodontic Laboratory S DE EL DE CV	Tijuana Baja California, Mexico	10	0	0	0	api.fda.gov
Sion Biotext Mexico, S.A.P.I. De C.V.	Civac Mexico, Mexico	11	0	0	0	api.fda.gov
Sion Biotext Mexico, S.A.P.I. de C.V	Jiutepec Morelos, Mexico	10	0	0	0	api.fda.gov
Sistemas Medicos Alaris S.A de C.V.	Tijuana Baja California, Mexico	5	0	0	0	api.fda.gov
Smiths Interconnect Mexico	Tijuana Baja California, Mexico	1	0	0	0	api.fda.gov
Sofi de Chihuahua SA de CV	Chihuahua, Mexico	1	0	0	0	api.fda.gov
Sonova North American Operations Center S.A.de C.V	Mexicali Baja California, Mexico	3	0	0	0	api.fda.gov
Spellman de Mexico Plant 3	Matamoros Tamaulipas, Mexico	2	0	0	0	api.fda.gov
Sperian Hearing Protection de Mexico S.A. de C.V.	Tijuana B.C. Mexico, Mexico	2	0	0	0	api.fda.gov
Tech Creations Torreon	Torreon Coahuila, Mexico	1	0	0	0	api.fda.gov
Tecma Operaciones S. De R.L. De C.V.	Juarez Chihuahua, Mexico	3	0	0	0	api.fda.gov
Tecma Operaciones S. De R.L. De C.V.	Juarez Chihuahua, Mexico	8	0	0	0	api.fda.gov
Teleflex Medical de Mexico, S. de R.L. de C.V.	NUEVO LAREDO Tamaulipas, Mexico	44	0	0	0	api.fda.gov
Thermo Fisher Scientific (Monterrey)	Apodaca Nuevo Leon, Mexico	4	0	0	0	api.fda.gov
Thermometrics Mexico, S.A. de C.V	Tijuana Baja California, Mexico	4	0	0	0	api.fda.gov
Ureblock	Cienega de Flores Nuevo Leon, Mexico	1	0	0	0	api.fda.gov
Unileben S.A. de C.V	Mexico City Ciudad de Mexico, Mexico	2	0	0	0	api.fda.gov
Unomedical Devices S.A de C.V	Reynosa Tamaulipas, Mexico	3	0	0	0	api.fda.gov
Vago International Manufacturing SA De CV	Monterrey Nuevo Leon, Mexico	6	0	0	0	api.fda.gov
Velcromex, S.A. De C.V.	AGUA PRIETA Sonora, Mexico	32	0	0	0	api.fda.gov
Veteran Promotions S. De R.L. De C.V.	Tijuana Baja California, Mexico	3	0	0	0	api.fda.gov
Via Systems Manufacturas	Tijuana Baja California, Mexico	5	0	0	0	api.fda.gov
Viotin Trading Limited, S.A. De C.V.	Mexico City Ciudad de Mexico, Mexico	3	0	0	0	api.fda.gov
Volex De Mexico	TIJUANA Baja California, Mexico	2	0	0	0	api.fda.gov
Venusa de Mexico S. de R.L de C.V	CIUDAD JUAREZ Chihuahua, Mexico	20	0	0	0	api.fda.gov
Viant Mexicana de Servicios, S. de R.L. de C.V.	TIJUANA Baja California, Mexico	12	0	0	0	api.fda.gov
Weidmann Tecnologia Electrica De Mexico S.A. De C.V.	Arteaga Coahuila, Mexico	1	0	0	0	api.fda.gov
Westmed de Mexico, S.A de C.V	MAGDALENA Sonora, Mexico	7	0	0	0	api.fda.gov
Xcaliber Sciences, S. de R.L. de C.V.	TIJUANA Baja California, Mexico	3	0	0	0	api.fda.gov
Yamada Vistamex S.A. De C.V.	Apaseo el Grande Guanajuato, Mexico	2	0	0	0	api.fda.gov
Ymex (maquilas Teta Kawi, S.A. De C.V.)	EMPALME Sonora, Mexico	1	0	0	0	api.fda.gov
YMEX-OB (Administradores de Maquila S de RL de CV)	Tramo Obregon-Navojoa Sonora, Mexico	2	0	0	0	api.fda.gov
Zeffer Research & Assoc. S. A. de C. V.	Ensenada Baja California, Mexico	18	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.