Manufacturer Intelligence · Based on 39,573 FDA 510(k) records · 74 countries

FDA 510(k) Medical Device Manufacturers - South Africa

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

South African 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

South Africa

Country

South Africa FDA 510(k) Overview

Manufacturers

Submissions

100%

Clearance rate

Leading South Africa FDA 510(k) manufacturers include Southern Implants (Pty), Ltd., Southern Medical (Pty) , Ltd., Disa Medinotec and 5 others.

South African medical device manufacturers have submitted 31 FDA 510(k) notifications since 2018, achieving a 100% clearance rate across 8 manufacturers. South Africa's FDA-active medtech sector reflects the country's role as the primary medical device development hub in the African continent, with activity in diagnostics and general hospital devices.

Active in FDA 510(k) submissions since 2018. Many South Africa manufacturers work with FDA regulatory consultants to support U.S. market entry.

FDA 510(k) South Africa Manufacturers

1–8 of 8

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Southern Implants (Pty), Ltd. Irene	16	100%	DE HO	ZA
2	Southern Medical (Pty) , Ltd. Irene	6	100%	DE OR	ZA
3	Disa Medinotec Johannesburg	2	100%	CV EN	ZA
4	Ortho-Design (Pty), Ltd. Pretoria	2	100%	OR	ZA
5	Hearx SA (Pty) , Ltd. Pretoria	2	100%	EN	ZA
6	Xavant Technology (Pty), Ltd. Pretoria	1	100%	AN	ZA
7	Sinapi Biomedical (Pty) , Ltd. Stellenbosch	1	100%	OB	ZA
8	Strait Access Technologies Holdings Cape Town	1	100%	CV	ZA

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.