Manufacturer Intelligence · Based on 22,055 FDA 510(k) records · 72 countries

FDA 510(k) Medical Device Manufacturers - Mexico

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.

  • Compare manufacturers by FDA 510(k) submission activity
  • Identify clearance rates, active panels and years of FDA activity
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8
Manufacturers
Mexico
Country

Mexico FDA 510(k) Overview

7
Manufacturers
8
Submissions
100%
Clearance rate

Leading Mexico FDA 510(k) manufacturers include Clemde SA DE CV, Fixier S.A. DE C.V., Renal Care Dialysis Solutions, S.A. DE C.V. and 5 others.

Mexican medical device manufacturers have submitted 8 FDA 510(k) notifications since 2022, achieving a 100% clearance rate across 7 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 2022. Many Mexico manufacturers work with FDA regulatory consultants to support U.S. market entry.

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.