Data / Medical devices / South Africa
Medical device makers in South Africa: 18 FDA-registered establishments
18 establishments in South Africa are registered with the FDA to make medical devices for the US market, listing 80 device types. 11 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- South AfricaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Appliance, Fixation, Spinal Intervertebral Body | KWQ | 3 |
| Instrument, Manual, Surgical, General Use | MDM | 2 |
| Orthosis, Spondylolisthesis Spinal Fixation | MNH | 2 |
| Orthosis, Spinal Pedicle Fixation | MNI | 2 |
| Intervertebral Fusion Device With Bone Graft, Lumbar | MAX | 2 |
| Intervertebral Fusion Device With Bone Graft, Cervical | ODP | 2 |
| Intervertebral Fusion Device With Integrated Fixation, Cervical | OVE | 2 |
| Dressing, Wound, Hydrophilic | NAC | 2 |
| Blade, Scalpel | GES | 2 |
| Tray, Surgical, Instrument | FSM | 2 |
| Handle, Scalpel | GDZ | 2 |
| Fastener, Fixation, Nondegradable, Soft Tissue | MBI | 1 |
| Accessories, Arthroscopic | NBH | 1 |
| Bit, Drill | HTW | 1 |
| Orthopedic Manual Surgical Instrument | LXH | 1 |
| Medical Device Data System | OUG | 1 |
| Appliance, Fixation, Spinal Interlaminal | KWP | 1 |
| Plate, Bone | JEY | 1 |
| Thoracolumbosacral Pedicle Screw System | NKB | 1 |
| Screw, Fixation, Intraosseous | DZL | 1 |
| Intervertebral Fusion Device With Integrated Fixation, Lumbar | OVD | 1 |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 1 |
| Clamp, Vascular | DXC | 1 |
| Implant, Endosseous, Root-Form | DZE | 1 |
| Abutment, Implant, Dental, Endosseous | NHA | 1 |
| Bottle, Collection, Vacuum | KDQ | 1 |
| Knife, Surgical | EMF | 1 |
| Bronchoscope Accessory | KTI | 1 |
| Catheter, Percutaneous | DQY | 1 |
| Accessories, Implant, Dental, Endosseous | NDP | 1 |
| Hook, Surgical, General & Plastic Surgery | GDG | 1 |
| Instrument, Surgical, Disposable | KDC | 1 |
| Kit, Surgical Instrument, Disposable | KDD | 1 |
| Stylet, Surgical, General & Plastic Surgery | GAH | 1 |
| Retractor | GAD | 1 |
| Instruments, Surgical, Cardiovascular | DWS | 1 |
| Tape, Measuring, Rulers And Calipers | FTY | 1 |
| Template | HWT | 1 |
| Needle, Suturing, Disposable | GAB | 1 |
| Curette, Surgical, General Use | FZS | 1 |
| Instrument, Microsurgical | GZX | 1 |
| Scissors, General, Surgical | LRW | 1 |
| Knife, Ophthalmic | HNN | 1 |
| Razor, Surgical | LWK | 1 |
| Forceps | HTD | 1 |
| Lamp, Infrared, Therapeutic Heating | ILY | 1 |
| Holder, Needle, Gastroenterologic | FHQ | 1 |
| Caliper | KTZ | 1 |
| Elevator, Surgical, General & Plastic Surgery | GEG | 1 |
| Tap, Bone | HWX | 1 |
| Dilator, Lachrymal | HNW | 1 |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 |
| Forceps, Ophthalmic | HNR | 1 |
| Hook, Ophthalmic | HNQ | 1 |
| Scissors, Ophthalmic | HNF | 1 |
| Spatula, Ophthalmic | HND | 1 |
| Specula, Ophthalmic | HNC | 1 |
| Clamp, Surgical, General & Plastic Surgery | GDJ | 1 |
| Rongeur | HTX | 1 |
| Retractor, Ophthalmic | HNI | 1 |
| Caliper, Ophthalmic | HOE | 1 |
| Marker, Ocular | HMR | 1 |
| Punch, Corneo-Scleral | HNJ | 1 |
| Spud, Ophthalmic | HNA | 1 |
| Table, Operating-Room, Electrical | GDC | 1 |
| Starter, Bone Screw | HWD | 1 |
| Retractor, Non-Self-Retaining | FGN | 1 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 1 |
| Bur, Ear, Nose And Throat | EQJ | 1 |
| Dental Abutment Design Software For Dental Laboratory | PNP | 1 |
| Prosthesis, Nose, Internal | FZE | 1 |
| Device, Urine Flow Rate Measuring, Non-Electrical, Disposable | FFG | 1 |
| Balloon Aortic Valvuloplasty | OZT | 1 |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 1 |
| Cushion, Wheelchair | IMP | 1 |
| Trap, Sterile Specimen | BYZ | 1 |
| Stimulator, Nerve, Battery-Powered | BXN | 1 |
| System, X-Ray, Tomography, Computed | JAK | 1 |
| Material, External Aesthetic Restoration, No Adhesive | NOK | 1 |
| Device, External Penile Rigidity | LKY | 1 |
Makers in South Africa
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Southern Implants (pty) Ltd | IRENE Gauteng, South Africa | 7 | 29 | 0 | 1 | api.fda.gov |
| Southern Medical (pty) Ltd | IRENE Gauteng, South Africa | 11 | 6 | 0 | 0 | api.fda.gov |
| Elite Surgical Supplies (pty) Ltd | Pretoria Gauteng, South Africa | 13 | 4 | 0 | 0 | api.fda.gov |
| Xavant Technology (pty) Ltd | Pretoria Gauteng, South Africa | 2 | 4 | 0 | 0 | api.fda.gov |
| Disa Medinotec (pty) Ltd | Northriding, Johannesburg Gauteng, South Africa | 2 | 2 | 0 | 0 | api.fda.gov |
| Ortho-Design | Pretoria Gauteng, South Africa | 6 | 2 | 0 | 0 | api.fda.gov |
| Ad Systems And Consulting | Silver Lakes, Pretoria Gauteng, South Africa | 2 | 1 | 0 | 0 | api.fda.gov |
| Glycar SA Pty., Ltd. | IRENE Gauteng, South Africa | 1 | 1 | 0 | 1 | api.fda.gov |
| Lodox Systems (pty) Ltd. | SANDTON Gauteng, South Africa | 1 | 1 | 0 | 0 | api.fda.gov |
| Strait Access Technologies Holdings (pty) Ltd | Cape Town Western Cape, South Africa | 1 | 1 | 0 | 0 | api.fda.gov |
| Titamed | Cape Town Western Cape, South Africa | 4 | 1 | 0 | 0 | api.fda.gov |
| Beier Drawtex Healthcare (pty) Ltd | Durban KwaZulu-Natal, South Africa | 1 | 0 | 0 | 0 | api.fda.gov |
| Bon Roux (pty) Ltd | PRETORIA Gauteng, South Africa | 1 | 0 | 0 | 0 | api.fda.gov |
| Coba Biomedical Pty (ltd) | Bloemfontein Free State, South Africa | 32 | 0 | 0 | 0 | api.fda.gov |
| Medi-Safe Surgicals (pty) Ltd. | Paardevlei Western Cape, South Africa | 1 | 0 | 0 | 0 | api.fda.gov |
| Photon Therapy Systems (pty) Ltd | Pretoria Gauteng, South Africa | 1 | 0 | 0 | 0 | api.fda.gov |
| Shonaquip Social Enterprise | Cape Town Western Cape, South Africa | 1 | 0 | 0 | 0 | api.fda.gov |
| Sinapi Biomedical (pty) Ltd | Stellenbosch Western Cape, South Africa | 5 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.