Data / Medical devices / Peru
Medical device makers in Peru: 4 FDA-registered establishments
4 establishments in Peru are registered with the FDA to make medical devices for the US market, listing 23 device types. 3 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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- PeruCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Suture, Absorbable, Synthetic, Polyglycolic Acid | GAM | 1 |
| Accessory, Surgical Apparel | LYU | 1 |
| Cover, Shoe, Operating-Room | FXP | 1 |
| Suture, Surgical, Absorbable, Polydioxanone | NEW | 1 |
| Dress, Surgical | FYE | 1 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 1 |
| Mask, Surgical | FXX | 1 |
| Shield, Protective, Personnel | KPY | 1 |
| Cap, Surgical | FYF | 1 |
| Non-Surgical Gown | OEA | 1 |
| Gown, Examination | FME | 1 |
| Garment, Protective, For Incontinence | EYQ | 1 |
| Mask, Oxygen | BYG | 1 |
| Mask, Oxygen, Low Concentration, Venturi | BYF | 1 |
| Device, Rebreathing | BYW | 1 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 1 |
| Suit, Surgical | FXO | 1 |
| Suture, Nonabsorbable, Synthetic, Polypropylene | GAW | 1 |
| Suture, Nonabsorbable, Silk | GAP | 1 |
| Suture, Absorbable, Synthetic | GAN | 1 |
| Drape, Surgical, Ent | ERY | 1 |
| Helmet, Surgical | FXZ | 1 |
| Chamber, Hyperbaric | CBF | 1 |
Makers in Peru
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Unilene, Sac | Lima Lima(Region), Peru | 11 | 2 | 0 | 0 | api.fda.gov |
| Hyperbaric S.A.C. | Lima Lima(Region), Peru | 1 | 1 | 0 | 0 | api.fda.gov |
| R & G Seguridad E Higiene Industrial S.A.C. | VENTANILLA Lima(Province), Peru | 9 | 1 | 0 | 0 | api.fda.gov |
| KIMBERLY-CLARK PERU S.R.L. - Santa Clara Mill | Lima Lima(Region), Peru | 2 | 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.