Data / Medical devices / Malta
Medical device makers in Malta: 6 FDA-registered establishments
6 establishments in Malta are registered with the FDA to make medical devices for the US market, listing 22 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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- MaltaCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Syringe, Piston | FMF | 1 |
| Laparoscope, General & Plastic Surgery | GCJ | 1 |
| Arthroscope | HRX | 1 |
| Set, Administration, Intravascular | FPA | 1 |
| Filter, Infusion Line | FPB | 1 |
| Stopcock, I.V. Set | FMG | 1 |
| Splint, Intranasal Septal | LYA | 1 |
| Set, I.V. Fluid Transfer | LHI | 1 |
| Drape, Surgical, Exempt | PUI | 1 |
| Dispenser, Liquid Medication | KYX | 1 |
| Garment, Protective, For Incontinence | EYQ | 1 |
| Dressing, Wound, Occlusive | NAD | 1 |
| Apparatus, Suction, Operating-Room, Wall Vacuum Powered | GCX | 1 |
| Tubing, Noninvasive | GAZ | 1 |
| Adaptor, Ureteral Catheter | EYI | 1 |
| System, Irrigation, Urological | LJH | 1 |
| Lubricant, Personal | NUC | 1 |
| Cover, Barrier, Protective | MMP | 1 |
| Set, Blood Transfusion | BRZ | 1 |
| System, Hemodialysis, Remote Accessories | MON | 1 |
| System, Processing For Frozen Blood | KSW | 1 |
| Lubricant, Personal, Gamete, Fertilization, And Embryo Compatible | PEB | 1 |
Makers in Malta
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Baxter Limited | Marsa, Malta | 12 | 40 | 0 | 0 | api.fda.gov |
| Sasmar Pharma Ltd | Ta' Xbiex, Malta | 2 | 2 | 0 | 0 | api.fda.gov |
| Microtek Medical Malta Limited | Mosta, Malta | 4 | 1 | 0 | 0 | api.fda.gov |
| Cardinal Health Malta 212 Ltd | Marsa, Malta | 2 | 0 | 0 | 0 | api.fda.gov |
| Equimedical | Floriana, Malta | 2 | 0 | 0 | 0 | api.fda.gov |
| Velocity Vector Ltd | Birkirkara CBD, Malta | 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.