Data / Medical devices / Iceland
Medical device makers in Iceland: 7 FDA-registered establishments
7 establishments in Iceland are registered with the FDA to make medical devices for the US market, listing 42 device types. 4 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.
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- IcelandCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Mesh, Surgical | FTM | 2 |
| Mesh, Surgical, Collagen, Orthopaedics, Reinforcement Of Tendon | OWY | 2 |
| Mesh, Surgical, Collagen, Plastic And Reconstructive Surgery | OXH | 2 |
| Wound Dressing With Animal-Derived Material(S) | KGN | 2 |
| Tape And Bandage, Adhesive | KGX | 1 |
| Splint, Hand, And Components | ILH | 1 |
| Sling, Arm | ILI | 1 |
| Bandage, Elastic | FQM | 1 |
| Cannula, Nasal, Oxygen | CAT | 1 |
| Cable, Electrode | IKD | 1 |
| Orthosis, Lumbar | IQE | 1 |
| Joint, Knee, External Brace | ITQ | 1 |
| Orthosis, Lumbo-Sacral | IPY | 1 |
| Pack, Hot Or Cold, Reusable | IME | 1 |
| Hand, External Limb Component, Mechanical | IRA | 1 |
| Cover, Limb | IPM | 1 |
| Orthosis, Limb Brace | IQI | 1 |
| Shoe, Cast | IPG | 1 |
| Orthosis, Thoracic | IPT | 1 |
| Joint, Ankle, External Brace | ITW | 1 |
| Orthosis, Cervical | IQK | 1 |
| Component, External, Limb, Ankle/Foot | ISH | 1 |
| Support, Arm | IOY | 1 |
| Ventilatory Effort Recorder | MNR | 1 |
| Standard Polysomnograph With Electroencephalograph | OLV | 1 |
| Automatic Event Detection Software For Polysomnograph With Electroencephalograph | OLZ | 1 |
| Full-Montage Standard Electroencephalograph | GWQ | 1 |
| Non-Normalizing Quantitative Electroencephalograph Software | OLT | 1 |
| Device, Biofeedback | HCC | 1 |
| Goniometer, Ac-Powered | KQX | 1 |
| Splint, Extremity, Non-Inflatable, External, Non-Sterile | NOC | 1 |
| Orthosis, Corrective Shoe | KNP | 1 |
| Binder, Abdominal | FSD | 1 |
| Joint, Hip, External Brace | ITS | 1 |
| Hand, External Limb Component, Powered | IQZ | 1 |
| Splint, Clavicle | IQJ | 1 |
| Pack, Hot Or Cold, Water Circulating | ILO | 1 |
| Prosthesis, Thigh Socket, External Component | ISS | 1 |
| Interactive Rehabilitation Exercise Device, Prescription Use | QKC | 1 |
| Joint, Knee, External Limb Component | ISY | 1 |
| Device, Muscle Monitoring | KZM | 1 |
| Computerized Behavioral Therapy Device For Insomnia | QVO | 1 |
Makers in Iceland
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Nox Medical | Reykjavik, Iceland | 8 | 10 | 0 | 1 | api.fda.gov |
| Kerecis Ehf | Isafjordur Vestfiroir, Iceland | 4 | 6 | 0 | 0 | api.fda.gov |
| Kerecis Ehf | Isafjordur Vestfiroir, Iceland | 4 | 6 | 0 | 0 | api.fda.gov |
| Kvikna Medical ehf | Reykjavik, Iceland | 2 | 1 | 0 | 0 | api.fda.gov |
| Kiso Ehf | Reykjavik, Iceland | 1 | 0 | 0 | 0 | api.fda.gov |
| Neckcare | Kopavogur, Iceland | 2 | 0 | 0 | 0 | api.fda.gov |
| Ossur Iceland ehf. | Reykjavik, Iceland | 26 | 0 | 0 | 13 | 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.