Data / Medical devices / Ukraine
Medical device makers in Ukraine: 7 FDA-registered establishments
7 establishments in Ukraine are registered with the FDA to make medical devices for the US market, listing 25 device types. 1 has 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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- UkraineCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Prosthesis, Shoulder, Semi-Constrained, Metal/Polymer Cemented | KWS | 1 |
| Medical Device Data System | OUG | 1 |
| Plate, Bone | JEY | 1 |
| Prosthesis, Knee, Femorotibial, Semi-Constrained, Cemented, Metal/Polymer | HRY | 1 |
| Prosthesis, Knee, Femorotibial, Non-Constrained, Cemented, Metal/Polymer | HSX | 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 |
| Tourniquet, Nonpneumatic | GAX | 1 |
| Suture, Nonabsorbable, Synthetic, Polyamide | GAR | 1 |
| Orthopaedic Surgical Planning And Instrument Guides | PBF | 1 |
| System, Image Processing, Radiological | LLZ | 1 |
| Cranial Surgical Planning And Instrument Guides | PPT | 1 |
| Ear, Nose, And Throat Stereotaxic Instrument | PGW | 1 |
| Pad, Menstrual, Unscented | HHD | 1 |
| Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uhmwpe, Pegged, Cemented, Polymer/Metal/Polymer | MBV | 1 |
| Shoulder Arthroplasty Implantation System | QHE | 1 |
| Suture, Surgical, Nonabsorbable, Expanded, Polytetraflouroethylene | NBY | 1 |
| Hand, External Limb Component, Powered | IQZ | 1 |
| Sling, Arm, Overhead Supported | ILE | 1 |
| Oral Airway Assist | PHS | 1 |
| Distometer | HMM | 1 |
Makers in Ukraine
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Materialise Ukraine, Rep. office | Kyiv Kyyiv, Misto, Ukraine | 18 | 47 | 0 | 0 | api.fda.gov |
| E&E Cable Solutions (Ukraine), LLC | Kyiv Kyyiv, Misto, Ukraine | 1 | 0 | 0 | 0 | api.fda.gov |
| Esper LLC. | Kyiv Kyyiv, Misto, Ukraine | 1 | 0 | 0 | 0 | api.fda.gov |
| Golnit Ltd | Kiev Kyyiv, Misto, Ukraine | 2 | 0 | 0 | 0 | api.fda.gov |
| Guldmann-Ukraine Ltd | Lviv L'vivs'ka Oblast', Ukraine | 1 | 0 | 0 | 0 | api.fda.gov |
| Procter And Gamble Ukraine, LLC | BORYSPIL Kyyiv, Misto, Ukraine | 1 | 0 | 0 | 0 | api.fda.gov |
| Sich Ua | Kyiv Kyyivs'ka Oblast', Ukraine | 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.