Data / Medical devices / Argentina
Medical device makers in Argentina: 15 FDA-registered establishments
15 establishments in Argentina are registered with the FDA to make medical devices for the US market, listing 116 device types. 7 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- ArgentinaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Orthosis, Thoracic | IPT | 2 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 1 |
| Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented | HSD | 1 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 1 |
| Cement, Bone, Vertebroplasty | NDN | 1 |
| Prosthesis, Hip, Hemi-, Femoral, Metal | KWL | 1 |
| Prosthesis, Hip, Hemi-, Femoral, Metal/Polymer, Cemented Or Uncemented | KWY | 1 |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 1 |
| Acid, Uric, Uricase (Colorimetric) | KNK | 1 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 1 |
| Bromcresol Green Dye-Binding, Albumin | CIX | 1 |
| Kinetic Method, Gamma-Glutamyl Transpeptidase | JQB | 1 |
| Lipase-Esterase, Enzymatic, Photometric, Lipase | CHI | 1 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 |
| Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | CJE | 1 |
| Enzymatic Method, Creatinine | JFY | 1 |
| Diazo Colorimetry, Bilirubin | CIG | 1 |
| Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | CFJ | 1 |
| Urease And Glutamic Dehydrogenase, Urea Nitrogen | CDQ | 1 |
| U.V. Method, Cpk Isoenzymes | JHW | 1 |
| Calibrator, Multi-Analyte Mixture | JIX | 1 |
| Phosphomolybdate (Colorimetric), Inorganic Phosphorus | CEO | 1 |
| Glucose Oxidase, Glucose | CGA | 1 |
| Photometric Method, Iron (Non-Heme) | JIY | 1 |
| Ferrozine (Colorimetric) Iron Binding Capacity | JMO | 1 |
| Photometric Method, Magnesium | JGJ | 1 |
| Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | LBS | 1 |
| Nadh Oxidation/Nad Reduction, Alt/Sgpt | CKA | 1 |
| Nadh Oxidation/Nad Reduction, Ast/Sgot | CIT | 1 |
| Nitroprusside, Ketones (Urinary, Non-Quant.) | JIN | 1 |
| Cresolphthalein Complexone, Calcium | CIC | 1 |
| Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | CGS | 1 |
| Antistreptolysin - Titer/Streptolysin O Reagent | GTQ | 1 |
| Biuret (Colorimetric), Total Protein | CEK | 1 |
| Lowry (Colorimetric), Total Protein | JGP | 1 |
| Prealbumin, Antigen, Antiserum, Control | JZJ | 1 |
| Colorimetric Method, Triglycerides | JGY | 1 |
| Azo-Dyes, Colorimetric, Bilirubin & Its Conjugates (Urinary, Non-Quant.) | JJB | 1 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 |
| Implant, Endosseous, Root-Form | DZE | 1 |
| Tape And Bandage, Adhesive | KGX | 1 |
| Template | HWT | 1 |
| Bone Grafting Material, Animal Source | NPM | 1 |
| Indicator, Physical/Chemical Sterilization Process | JOJ | 1 |
| Splint, Hand, And Components | ILH | 1 |
| Sling, Arm | ILI | 1 |
| Bandage, Elastic | FQM | 1 |
| Laryngoscope, Rigid | CCW | 1 |
| System, Image Processing, Radiological | LLZ | 1 |
| Ventilator, Continuous, Facility Use | CBK | 1 |
| Circuit, Breathing (W Connector, Adaptor, Y Piece) | CAI | 1 |
| Orthosis, Abdominal | KTD | 1 |
| Applicator, Ent | KCJ | 1 |
| Diazonium Colorimetry, Urobilinogen (Urinary, Non-Quant.) | CDM | 1 |
| Light, Examination, Medical, Battery Powered | KYT | 1 |
| System, Pressure Measurement, Intermittent | JFC | 1 |
| Microscope, Operating & Accessories, Ac-Powered, Ophthalmic | HRM | 1 |
| Led Light Source | NTN | 1 |
| Needle, Biopsy, Cardiovascular | DWO | 1 |
| Apparatus, Suction, Single Patient Use, Portable, Nonpowered | GCY | 1 |
| Joint, Knee, External Brace | ITQ | 1 |
| Crutch | IPR | 1 |
| Dye-Indicator, Ph (Urinary, Non-Quantitative) | CEN | 1 |
| Bag, Ice | KYR | 1 |
| Orthosis, Lumbo-Sacral | IPY | 1 |
| Pack, Hot Or Cold, Reusable | IME | 1 |
| Camera, Television, Endoscopic, Without Audio | FWF | 1 |
| Sunglasses (Non-Prescription Including Photosensitive) | HQY | 1 |
| Otoscope | ERA | 1 |
| Implant, Endosseous, Orthodontic | OAT | 1 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 |
| Indicator, Biological Sterilization Process | FRC | 1 |
| Enzyme Linked Immunosorbent Assay, T. Cruzi | MIU | 1 |
| Orthosis, Limb Brace | IQI | 1 |
| Shoe, Cast | IPG | 1 |
| Source, Carrier, Fiberoptic Light | EQH | 1 |
| System, Digital Image Communications, Radiological | LMD | 1 |
| Joint, Ankle, External Brace | ITW | 1 |
| Turbidimetric Method, Lipoproteins | JHN | 1 |
| Blood, Occult, Colorimetric, In Urine | JIO | 1 |
| Diazo (Colorimetric), Nitrite (Urinary, Non-Quant) | JMT | 1 |
| Refractometer For Clinical Use | JRE | 1 |
| Test, Urine Leukocyte | LJX | 1 |
| Method, Enzymatic, Glucose (Urinary, Non-Quantitative) | JIL | 1 |
| Catalytic Methods, Amylase | JFJ | 1 |
| Azo Dye, Calcium | CJY | 1 |
| Colorimetry, Cholinesterase | DIH | 1 |
| Apolipoproteins | MSJ | 1 |
| Albumin, Antigen, Antiserum, Control | DCF | 1 |
| Walker, Mechanical | ITJ | 1 |
| Brush, Dermabrasion, Powered | GFE | 1 |
| Orthosis, Cervical | IQK | 1 |
| Laryngoscope, Non-Rigid | CAL | 1 |
| Flowmeter, Calibration, Gas | BXY | 1 |
| Cane | IPS | 1 |
| Headlight, Fiberoptic Focusing | FCT | 1 |
| Camera, Television, Microsurgical, Without Audio | FWD | 1 |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 |
| Colposcope (And Colpomicroscope) | HEX | 1 |
| Microscope, Surgical | EPT | 1 |
Makers in Argentina
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Wiener Laboratorios S.A.I.C. | ROSARIO Santa Fe, Argentina | 50 | 26 | 0 | 0 | api.fda.gov |
| Terragene SA | Alvear Santa Fe, Argentina | 4 | 8 | 0 | 2 | api.fda.gov |
| Odontit SA | BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina | 4 | 4 | 0 | 0 | api.fda.gov |
| Ecleris SRL | Villa Martelli Buenos Aires, Argentina | 18 | 3 | 0 | 0 | api.fda.gov |
| Tecme SA | Cordoba, Argentina | 2 | 2 | 0 | 0 | api.fda.gov |
| Marzzan Lucas Jorge | Rosario Santa Fe, Argentina | 3 | 1 | 0 | 0 | api.fda.gov |
| Visual Medica | Ciudad Autonoma Buenos Aires Buenos Aires, Ciudad Autonoma de, Argentina | 2 | 1 | 0 | 0 | api.fda.gov |
| Assistance SRL | Caba Buenos Aires, Argentina | 1 | 0 | 0 | 0 | api.fda.gov |
| Histo S.A. | VILLA RAFFO Buenos Aires, Argentina | 1 | 0 | 0 | 0 | api.fda.gov |
| Laboratorio Pablo Cassara | Caba Buenos Aires, Argentina | 1 | 0 | 0 | 0 | api.fda.gov |
| Laboratorios SL SA | Malvinas Argentinas Buenos Aires, Argentina | 7 | 0 | 0 | 0 | api.fda.gov |
| Oxavita S.R.L. | Buenos Aires, Argentina | 1 | 0 | 0 | 0 | api.fda.gov |
| Pampamed SRL | Buenos Aires, Argentina | 2 | 0 | 0 | 0 | api.fda.gov |
| Pantymed S.A. | BUENOS AIRES Buenos Aires, Ciudad Autonoma de, Argentina | 20 | 0 | 0 | 0 | api.fda.gov |
| Plenorius S.A. | Haedo Buenos Aires, Argentina | 1 | 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.