Manufacturer Intelligence · Based on 129,480 FDA 510(k) records · 83 countries

FDA 510(k) Medical Device Manufacturers - Mexico

Name: FDA 510(k) Medical Device Manufacturers
Creator: 510k Database

Mexican 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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Manufacturers

Mexico

Country

Mexico FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading Mexico FDA 510(k) manufacturers include Investigacion Farmaceutica S.A. DE C.V., Supertex Industrial, S.A. DE C.V., Clemde SA DE CV and 12 others.

Mexican medical device manufacturers have submitted 41 FDA 510(k) notifications since 1989, achieving a 100% clearance rate across 15 manufacturers. Mexico's medtech sector benefits from geographic proximity to the U.S. market and established manufacturing infrastructure, with activity in Class II medical devices and diagnostic equipment.

Active in FDA 510(k) submissions since 1989. Many Mexico manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) Mexico Manufacturers

1–15 of 15

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Investigacion Farmaceutica S.A. DE C.V. Mexico	24	100%	HE MI	MX
2	Supertex Industrial, S.A. DE C.V. Zapopan, Jalisco	3	100%	HO	MX
3	Clemde SA DE CV Mexico City	2	100%	DE	MX
4	Unomedical Devices S.A DE C.V. Reynosa	1	100%	HO	MX
5	Profilatex, S.A. DE C.V. Chalco	1	100%	OB	MX
6	Radiotecnologia Industrial S.A. DE C.V. Ixtapaluca	1	100%	RA	MX
7	Fixier S.A. DE C.V. Leon	1	100%	OR	MX
8	Renal Care Dialysis Solutions, S.A. DE C.V. El Marques	1	100%	GU	MX
9	Alandra Medical Sapi DE CV Mexico City	1	100%	GU	MX
10	Comercializadora Brever Leon	1	100%	HO	MX
11	Essity Higiene Y Salud Mexico. S.A. DE C.V. Cuidad De Mexico	1	100%	OB	MX
12	Internacional Farmac?utica S.A DE C.V Lerma	1	100%	SU	MX
13	Aleaciones Dentales Zeyco, S.A. DE C.V. Guadalajara	1	100%	DE	MX
14	Mapa Professional Saltillo Coah	1	100%	HO	MX
15	Hindernis DE Mexico, S.A.P.I. DE C.V. Naucalpan De Juarez	1	100%	HO	MX

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.