Data / Medical devices / Saudi Arabia
Medical device makers in Saudi Arabia: 2 FDA-registered establishments
2 establishments in Saudi Arabia are registered with the FDA to make medical devices for the US market, listing 8 device types. 2 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 2, 2026.
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- Saudi ArabiaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Suture, Nonabsorbable, Synthetic, Polyethylene | GAT | 1 |
| Syringe, Piston | FMF | 1 |
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 1 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 1 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 1 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 1 |
| Suture, Nonabsorbable, Silk | GAP | 1 |
| Suture, Absorbable, Natural | GAL | 1 |
Makers in Saudi Arabia
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| United Medical Industries Co. Ltd. | RIYADH Ar Riyad, Saudi Arabia | 7 | 10 | 0 | 0 | api.fda.gov |
| Alshifa Medical Products Co. (CJS) | Damman, Eastern Province Ash Sharqiyah, Saudi Arabia | 1 | 2 | 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.