Manufacturer Intelligence · Based on 176,079 FDA 510(k) records · 90 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. Rankings generated directly from FDA accessdata.gov — no editorial curation, no paid listings.

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Manufacturers

South Africa

Country

South Africa FDA 510(k) Overview

Manufacturers

Submissions

98%

Clearance rate

Leading South Africa FDA 510(k) manufacturers include Southern Implants (Pty), Ltd., Aurex Precious Metal Industries (Pty)Ltd, Xavant Technology (Pty), Ltd. and 18 others.

South African medical device manufacturers have submitted 82 FDA 510(k) notifications since 1993, achieving a 97.6% clearance rate across 21 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 1993. Many South Africa 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) South Africa Manufacturers

1–21 of 21

#	Manufacturer	Submissions	Cleared	Active panels	Country
1	Southern Implants (Pty), Ltd. Irene	19	100%	DE HO SU	ZA
2	Aurex Precious Metal Industries (Pty)Ltd Edenvale	19	100%	DE	ZA
3	Xavant Technology (Pty), Ltd. Pretoria	7	100%	AN NE	ZA
4	Aurex SA (Pty) , Ltd. Edenvale, Gauteng	6	100%	DE	ZA
5	Southern Medical (Pty) , Ltd. Irene	6	100%	DE OR	ZA
6	Levtrade Intl. (Pty) , Ltd. Petoria, South Africa	4	50%	SU	ZA
7	Save-T-Breath Distributors C.C. South Africa	3	100%	AN HO OB	ZA
8	Disa Medinotec Johannesburg	2	100%	CV EN	ZA
9	Ortho-Design (Pty), Ltd. Pretoria	2	100%	OR	ZA
10	Hearx SA (Pty) , Ltd. Pretoria	2	100%	EN	ZA
11	Emox 911 CC Somerset West	2	100%	AN SU	ZA
12	Sadler Electronics Edgemead	1	100%	NE	ZA
13	Modular X-Ray Devices Roodepoort	1	100%	RA	ZA
14	Suretone International Cape Town, Cape	1	100%	PM	ZA
15	Panag International Johannesburg	1	100%	NE	ZA
16	Iqteq Development Cape Town, Western Cape	1	100%	AN	ZA
17	Ti-Tamed (Pty), Ltd. Cape Town, Western Cape	1	100%	OR	ZA
18	Redline Products (Pty) , Ltd. Strand Industria, Western Cape	1	100%	TX	ZA
19	Sinapi Biomedical (Pty) , Ltd. Stellenbosch	1	100%	OB	ZA
20	Strait Access Technologies Holdings Cape Town	1	100%	CV	ZA
21	Mwr Electronics Industrial Co. Goodwood, Capetown	1	100%	NE	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. 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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