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Data / Medical devices / El Salvador

Medical device makers in El Salvador: 4 FDA-registered establishments

4 establishments in El Salvador are registered with the FDA to make medical devices for the US market, listing 25 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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  • El SalvadorCountry

Device types made here

Device types with the most registered makers in this country.

DeviceProduct codeMakers
Drape, Surgical, ExemptPUI2
Wrap, SterilizationFRG2
Cap, SurgicalFYF2
Cover, Mattress (Medical Purposes)FMW2
Non-Surgical GownOEA2
Gown, ExaminationFME2
Garment, Protective, For IncontinenceEYQ2
Fiber, Medical, AbsorbentFRL2
Gown, SurgicalFYA2
Drape, Surgical, AntimicrobialKKX2
Instrument, Manual, Surgical, General UseMDM1
Dressing, Wound, DrugFRO1
Accessory, Surgical ApparelLYU1
Dress, SurgicalFYE1
Container, Liquid Medication, GraduatedKYW1
Container, Specimen, Non-SterileNNI1
BedpanFOB1
Humidifier, Respiratory Gas, (Direct Patient Interface)BTT1
Binder, Medical, TherapeuticMDR1
Table And Attachments, Operating-RoomBWN1
Device, Transfer, Patient, ManualFMR1
Suit, SurgicalFXO1
Bath, Sitz, NonpoweredKTC1
Lift, Patient, Non-Ac-PoweredFSA1
Binder, BreastHEF1

Makers in El Salvador

Best documented first: most 510(k) clearances and PMA approvals.

MakerLocationDevice types510(k) clearancesPMA approvalsRecall eventsSource
Laboratorios Biogalenic, S.A. de C.V.Soyapango San Salvador, El Salvador2400api.fda.gov
Icat S.A. De C.V.San Salvador, El Salvador19300api.fda.gov
Salvaplastic Internacional S.A. De C.V.Plan de La laguna La Libertad, El Salvador4000api.fda.gov
Vidales Larranaga SA de CVAhuachapan, El Salvador10000api.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.