Manufacturer Intelligence · Based on 158,152 FDA 510(k) records · 88 countries

FDA 510(k) Medical Device Manufacturers - Argentina

Argentine medical device manufacturers ranked by FDA 510(k) submission volume. Rankings generated directly from FDA accessdata.gov — no editorial curation, no paid listings.

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  • Identify clearance rates, active panels and years of FDA activity
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Used by regulatory affairs teams and medtech consultants worldwide

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20
Manufacturers
Argentina
Country

Argentina FDA 510(k) Overview

20
Manufacturers
60
Submissions
98%
Clearance rate

Leading Argentina FDA 510(k) manufacturers include Wiener Laboratories Saic, Terragene S.A., Medix I.C.S.A. and 17 others.

Argentine medical device manufacturers have submitted 60 FDA 510(k) notifications since 1989, with a 98.3% clearance rate across 20 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 1989. Many Argentina manufacturers work with FDA regulatory consultants to support U.S. market entry.

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Ranking period: All time Last 5 yrs Last 3 yrs

FDA 510(k) Argentina Manufacturers

1–20 of 20
# Manufacturer Submissions Cleared Active panels Country
1
Wiener Laboratories Saic
Rosario, Santa Fe
24 100%
CH MI
AR
2
Terragene S.A.
Rosario
8 88%
HO
AR
3
Medix I.C.S.A.
San Martin, Buenos Aires
5 100%
HO
AR
4
Odontit S.A.
Buenos Aires
3 100%
DE
AR
5
Mauricio Menconi
Argentina
2 100%
HO
AR
6
Galix Instrumentacion Biomedica
Buenos Aires
2 100%
CV
AR
7
Nuxen S.R.L.
Buenos Aires
2 100%
DE
AR
8
Starbene
Cordoba, Pvcia. Cordoba
2 100%
PM
AR
9
Laboratorio Rodriguez Corswant S.R.L.
Argentina
1 100%
CH
AR
10
Wiener Laboratories
Rosario, Santa Fe
1 100%
CH
AR
11
Silvestrin Fabris S.R.L.
Buenos Aires
1 100%
AN
AR
12
F.P. Rubinstein Y Cia S.R.L.
Cordoba, Cba
1 100%
SU
AR
13
Wiener Laboratorios Saic
Rosario, Santa Fe
1 100%
CH
AR
14
B&W Srl
Buenos Aires
1 100%
DE
AR
15
Visual Medica
Ciudad Autonoma De Buenos Aires
1 100%
RA
AR
16
Oxavita Srl
Buenos Aires
1 100%
AN
AR
17
Megabay S.A.
Ciudad Aut?noma De Buenos Aires
1 100%
SU
AR
18
Tedequim Srl
C?rdoba
1 100%
DE
AR
19
Marzzan Lucas Jorge
Rosario
1 100%
PM
AR
20
Terragene
Alvear
1 100%
HO
AR

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. Rankings reflect real regulatory activity — no paid placements, no self-reported data.

Used by regulatory affairs teams and medtech consultants to benchmark manufacturer activity, identify predicate device candidates, and analyze competitive positioning across FDA review panels.

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