Manufacturer Intelligence · Based on 108,970 FDA 510(k) records · 76 countries

FDA 510(k) Medical Device Manufacturers - Argentina

Argentine 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
  • Filter by country or FDA review panel specialty
7
Manufacturers
Argentina
Country

Argentina FDA 510(k) Overview

7
Manufacturers
36
Submissions
97%
Clearance rate

Leading Argentina FDA 510(k) manufacturers include Wiener Laboratories Saic, Terragene S.A., Oxavita Srl and 4 others.

Argentine medical device manufacturers have submitted 36 FDA 510(k) notifications since 2001, with a 97.2% clearance rate across 7 manufacturers. Argentina's FDA-active medtech sector reflects the country's established medical device manufacturing tradition, with activity in dental devices, diagnostic equipment and general hospital products.

Active in FDA 510(k) submissions since 2001. Many Argentina 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.