Data / Medical devices / Colombia
Medical device makers in Colombia: 28 FDA-registered establishments
28 establishments in Colombia are registered with the FDA to make medical devices for the US market, listing 121 device types. 5 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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- ColombiaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Pad, Menstrual, Unscented | HHD | 4 |
| Binder, Medical, Therapeutic | MDR | 3 |
| Denture, Plastic, Teeth | ELM | 3 |
| Needle, Aspiration And Injection, Disposable | GAA | 2 |
| Sling, Arm | ILI | 2 |
| Stand, Infusion | FOX | 2 |
| Floss, Dental | JES | 2 |
| Garment, Protective, For Incontinence | EYQ | 2 |
| Tray, Surgical, Instrument | FSM | 2 |
| Table, Operating-Room, Electrical | GDC | 2 |
| Bed, Ac-Powered Adjustable Hospital | FNL | 2 |
| Bed, Manual | FNJ | 2 |
| Pad, Menstrual, Scented, Scented-Deodorized Made Of Common Cellulosic & Synthetic Material W/Established Safety Profile | NRC | 2 |
| Wax, Dental, Intraoral | EGD | 2 |
| Stretcher, Wheeled | FPO | 2 |
| Dental Hygiene Kit | NXZ | 2 |
| Screw, Fixation, Bone | HWC | 1 |
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 1 |
| Bit, Drill | HTW | 1 |
| Orthopedic Manual Surgical Instrument | LXH | 1 |
| Plate, Fixation, Bone | HRS | 1 |
| Plate, Bone | JEY | 1 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer/Metal/Polymer | JWH | 1 |
| Knee Arthroplasty Implantation System | OOG | 1 |
| Shoulder Prosthesis, Reverse Configuration | PHX | 1 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer | MBH | 1 |
| Driver, Wire, And Bone Drill, Manual | DZJ | 1 |
| Prosthesis, Knee, Patellofemorotibial, Semi-Constrained, Cemented, Polymer + Additive/Metal/Polymer + Additive | OIY | 1 |
| Neurological Stereotaxic Instrument | HAW | 1 |
| Set, Administration, Intravascular | FPA | 1 |
| Filter, Infusion Line | FPB | 1 |
| Bottle, Collection, Vacuum | KDQ | 1 |
| Tube, Tracheal (W/Wo Connector) | BTR | 1 |
| Catheters, Suction, Tracheobronchial | BSY | 1 |
| Holder, Needle; Orthopedic | HXK | 1 |
| Accessories, Implant, Dental, Endosseous | NDP | 1 |
| Tubing, Fluid Delivery | FPK | 1 |
| Gauze / Sponge,Nonresorbable For External Use | NAB | 1 |
| Tube, Feeding | FPD | 1 |
| Tape And Bandage, Adhesive | KGX | 1 |
| Template | HWT | 1 |
| Pad, Eye | HMP | 1 |
| Splint, Hand, And Components | ILH | 1 |
| Bandage, Cast | ITG | 1 |
| Absorber, Saliva, Paper | KHR | 1 |
| Cotton, Roll | EFN | 1 |
| Bedding, Disposable, Medical | KME | 1 |
| Cover, Mattress (Medical Purposes) | FMW | 1 |
| Forceps | HTD | 1 |
| Non-Surgical Gown | OEA | 1 |
| Toothbrush, Manual | EFW | 1 |
| Dressing, Wound, Occlusive | NAD | 1 |
| Handle, Scalpel | GDZ | 1 |
| Clamp | HXD | 1 |
| Bar, Preformed | EHO | 1 |
| Mallet | HXL | 1 |
| Screwdriver | HXX | 1 |
| Impactor | HWA | 1 |
| Instrument, Bending Or Contouring | HXP | 1 |
| Wrench | HXC | 1 |
| Instrument, Compression | HWN | 1 |
| System, Image Processing, Radiological | LLZ | 1 |
| Gauge, Depth | HTJ | 1 |
| Guide, Surgical, Instrument | FZX | 1 |
| Elevator | HTE | 1 |
| Tap, Bone | HWX | 1 |
| Cannula, Nasal, Oxygen | CAT | 1 |
| Mouthpiece, Breathing | BYP | 1 |
| Cranial Surgical Planning And Instrument Guides | PPT | 1 |
| Dissector, Surgical, General & Plastic Surgery | GDI | 1 |
| Passer, Wire, Orthopedic | HXI | 1 |
| Table, Operating-Room, Manual | FSE | 1 |
| Clamp, Penile | FHA | 1 |
| Table And Attachments, Operating-Room | BWN | 1 |
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | 1 |
| Orthosis, Lumbar | IQE | 1 |
| Joint, Knee, External Brace | ITQ | 1 |
| Brush, Scrub, Operating-Room | GEC | 1 |
| Pick, Massaging | JET | 1 |
| Crown And Bridge, Temporary, Resin | EBG | 1 |
| Material, Tooth Shade, Resin | EBF | 1 |
| Resin, Denture, Relining, Repairing, Rebasing | EBI | 1 |
| Alloy, Amalgam | EJJ | 1 |
| Material, Impression Tray, Resin | EBH | 1 |
| Protector, Skin Pressure | FMP | 1 |
| Stocking, Medical Support (For General Medical Purposes) | FQL | 1 |
| Dentures, Full | NSL | 1 |
| Restoration, Porcelain | NSP | 1 |
| Orthosis, Limb Brace | IQI | 1 |
| Skid, Bone | HWO | 1 |
| Shoulder Arthroplasty Implantation System | QHE | 1 |
| Device, Transfer, Patient, Manual | FMR | 1 |
| Bed, Hydraulic, Adjustable Hospital | FNK | 1 |
| Stretcher, Patient Restraint | NZD | 1 |
| Table, Operating-Room, Pneumatic | FWW | 1 |
| System, Digital Image Communications, Radiological | LMD | 1 |
| Sheet, Burn | FPY | 1 |
| Tubeless Analysis, Gastric Acidity | JLL | 1 |
| Chair, Adjustable, Mechanical | INN | 1 |
| Mattress, Flotation Therapy, Non-Powered | IKY | 1 |
Makers in Colombia
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Materialise Colombia S.A.S | Medellin Antioquia, Colombia | 13 | 13 | 0 | 0 | api.fda.gov |
| Vygon Colombia S.A. | BARRANQUILLA Atlantico, Colombia | 8 | 6 | 0 | 0 | api.fda.gov |
| New Stetic | GUARNE Antioquia, Colombia | 13 | 5 | 0 | 0 | api.fda.gov |
| Industrias Medicas Sampedro S.A.S | La Estrella Antioquia, Colombia | 21 | 2 | 0 | 0 | api.fda.gov |
| Masterdent, Ltda | Medellin Antioquia, Colombia | 1 | 1 | 0 | 0 | api.fda.gov |
| Abl Dental Solutions S.A.S | Envigado Antioquia, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| Absorbentes De Colombia S.A. | Rionegro Antioquia, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| BSN medical Limitada (COLOMBIA) | CALI Valle del Cauca, Colombia | 5 | 0 | 0 | 0 | api.fda.gov |
| C.I.G & Lingerie S.A.S | Medellin Antioquia, Colombia | 4 | 0 | 0 | 0 | api.fda.gov |
| Caribbean Manufacturing SAS | Cartagena Bolivar, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| Familia Del Pacifico SAS | Guachene Cauca, Colombia | 3 | 0 | 0 | 0 | api.fda.gov |
| Imaging Experts And Healthcare Services S.A.S | Cundinamarca Bogota, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| Industria Colombiana De Dotaciones Metalicas-Dometal S.A.S | Medellin Antioquia, Colombia | 12 | 0 | 0 | 0 | api.fda.gov |
| Industrias Metalicas Los Pinos SA | ITAGUI Antioquia, Colombia | 14 | 0 | 0 | 0 | api.fda.gov |
| Innovative Medical Tech SAS | Baranquilla Atlantico, Colombia | 3 | 0 | 0 | 0 | api.fda.gov |
| Kamex International S.A.S | Cajica Cundinamarca, Colombia | 10 | 0 | 0 | 0 | api.fda.gov |
| Macrolab Asociados S.A.S. | MEDELLIN Antioquia, Colombia | 2 | 0 | 0 | 0 | api.fda.gov |
| Maya Villegas S.A.S. | MEDELLIN Antioquia, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| Medi Varic Products SAS | Bogota, Colombia | 2 | 0 | 0 | 0 | api.fda.gov |
| Nitta S.A. | Bogota, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| Nuvia Smiles SAS | galapa Atlantico, Colombia | 3 | 0 | 0 | 0 | api.fda.gov |
| Pilab S.A.S. | Bogota, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| Placecol S.A | funza Cundinamarca, Colombia | 6 | 0 | 0 | 0 | api.fda.gov |
| Productos Familia Rionegro S.A.S | Medellin Antioquia, Colombia | 3 | 0 | 0 | 0 | api.fda.gov |
| Productos Familia S.A. | Medellin Antioquia, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| Ronexmed S.A.S. | Barranquilla Atlantico, Colombia | 8 | 0 | 0 | 0 | api.fda.gov |
| Vivell SAS | Medellin Antioquia, Colombia | 1 | 0 | 0 | 0 | api.fda.gov |
| Wiesner Healthcare SAS | Medellin Antioquia, Colombia | 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.