Data / Medical devices / Norway
Medical device makers in Norway: 22 FDA-registered establishments
22 establishments in Norway are registered with the FDA to make medical devices for the US market, listing 48 device types. 13 have a 510(k) clearance or PMA approval on file and 5 have 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.
- NorwayCountry
Device types made here
Device types with the most registered makers in this country.
| Device | Product code | Makers |
|---|---|---|
| Transducer, Ultrasonic, Diagnostic | ITX | 5 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | 5 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | 5 |
| System, Image Processing, Radiological | LLZ | 4 |
| Automated Radiological Image Processing Software | QIH | 3 |
| Catheter, Ultrasound, Intravascular | OBJ | 3 |
| Multi-Analyte Controls, All Kinds (Assayed) | JJY | 2 |
| Flowmeter, Blood, Cardiovascular | DPW | 2 |
| Computer, Blood-Pressure | DSK | 2 |
| Probe, Blood-Flow, Extravascular | DPT | 2 |
| Aid, Cardiopulmonary Resuscitation | LIX | 2 |
| Ldl & Vldl Precipitation, Hdl | LBR | 1 |
| Enzymatic Esterase--Oxidase, Cholesterol | CHH | 1 |
| Enzymatic Method, Creatinine | JFY | 1 |
| C-Reactive Protein, Antigen, Antiserum, And Control | DCK | 1 |
| Assay, Glycosylated Hemoglobin | LCP | 1 |
| Test, Cystatin C | NDY | 1 |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 |
| Drug Mixture Control Materials | DIF | 1 |
| Agent, Clearing | KEM | 1 |
| Colorimetric Method, Triglycerides | JGY | 1 |
| Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica | JQT | 1 |
| Indicator Method, Protein Or Albumin (Urinary, Non-Quant.) | JIR | 1 |
| Attachment, Breathing, Positive End Expiratory Pressure | BYE | 1 |
| Accessories, Retractor, Dental | EIF | 1 |
| Dressing, Wound, Hydrogel Without Drug And/Or Biologic | NAE | 1 |
| Lamp, Infrared, Therapeutic Heating | ILY | 1 |
| Apparatus, Suction, Ward Use, Portable, Ac-Powered | JCX | 1 |
| Ventilator, Emergency, Manual (Resuscitator) | BTM | 1 |
| Mask, Oxygen | BYG | 1 |
| Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | CAP | 1 |
| Transducer, Blood-Pressure, Extravascular | DRS | 1 |
| Material, Impression Tray, Resin | EBH | 1 |
| Pump, Portable, Aspiration (Manual Or Powered) | BTA | 1 |
| Stretcher, Hand-Carried | FPP | 1 |
| Hemoglobin A1c Test System | PDJ | 1 |
| System, Nuclear Magnetic Resonance Imaging | LNH | 1 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | 1 |
| Exerciser, Powered | BXB | 1 |
| Orthosis, Truncal/Orthosis, Limb | MRI | 1 |
| Device, Prosthesis Alignment | IQO | 1 |
| Aligner, Bracket, Orthodontic | ECQ | 1 |
| Device, Galvanic Skin Response Measurement | GZO | 1 |
| Camera, Ophthalmic, General-Use | PJZ | 1 |
| Heavy Metals Control Materials | DIE | 1 |
| Twister, Brace Setting | ITO | 1 |
| System, Communication, Powered | ILQ | 1 |
| Automatic Event Detection Software For Full-Montage Electroencephalograph | OMB | 1 |
Makers in Norway
Best documented first: most 510(k) clearances and PMA approvals.
| Maker | Location | Device types | 510(k) clearances | PMA approvals | Recall events | Source |
|---|---|---|---|---|---|---|
| Ge Vingmed Ultrasound A/S | HORTEN Vestfold, Norway | 7 | 81 | 0 | 2 | api.fda.gov |
| GE Vingmed Ultrasound AS | Trondheim Trondelag, Norway | 6 | 28 | 0 | 0 | api.fda.gov |
| GE Vingmed Ultrasound AS | Oslo, Norway | 6 | 28 | 0 | 0 | api.fda.gov |
| Abbott Diagnostics Technologies AS | Oslo, Norway | 11 | 7 | 0 | 2 | api.fda.gov |
| Laerdal Medical A/S | STAVANGER Rogaland, Norway | 9 | 7 | 0 | 0 | api.fda.gov |
| Nordicneurolab AS | BERGEN Hordaland, Norway | 2 | 6 | 0 | 8 | api.fda.gov |
| Laerdal Medical AS, Stavanger Manufacturing | Sandnes Rogaland, Norway | 3 | 3 | 0 | 0 | api.fda.gov |
| Medistim Asa | Oslo, Norway | 6 | 3 | 0 | 2 | api.fda.gov |
| Medistim Asa | HORTEN Vestfold, Norway | 6 | 3 | 0 | 0 | api.fda.gov |
| Gentian AS | Moss Ostfold, Norway | 1 | 2 | 0 | 1 | api.fda.gov |
| Holberg Eeg AS | Bergen Hordaland, Norway | 1 | 2 | 0 | 0 | api.fda.gov |
| Excitus Medical AS | Tromso, Norway | 1 | 1 | 0 | 0 | api.fda.gov |
| Memscap AS | SKOPPUM Vestfold, Norway | 1 | 1 | 0 | 0 | api.fda.gov |
| Curida | Elverum, Norway | 1 | 0 | 0 | 0 | api.fda.gov |
| Grasp AS | OS Hordaland, Norway | 1 | 0 | 0 | 0 | api.fda.gov |
| Made For Movement Group AS | Skien Telemark, Norway | 1 | 0 | 0 | 0 | api.fda.gov |
| Med Storm Innovation AS | Oslo, Norway | 1 | 0 | 0 | 0 | api.fda.gov |
| Oivi AS | Oslo, Norway | 1 | 0 | 0 | 0 | api.fda.gov |
| Pretect AS | Klokkarstua Akershus, Norway | 1 | 0 | 0 | 0 | api.fda.gov |
| Recharge Health AS | Oslo, Norway | 1 | 0 | 0 | 0 | api.fda.gov |
| Sero AS | Billingstad Oslo, Norway | 3 | 0 | 0 | 0 | api.fda.gov |
| Saga Dental Supply AS | Kongsvinger Hedmark, Norway | 9 | 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.