Radi Medical Systems AB
SwedenFDA 510(k) applicant, unverified
- Devices
- 24
What Radi Medical Systems AB makes
Radi Medical Systems AB manufactures diagnostic and interventional devices for cardiovascular assessment and haemorrhage control, including pressure wire sensors for coronary physiology, a femoral compression system for post-procedure bleeding management, and software for analysing haemodynamic measurements. Their portfolio also includes a quantitative measurement system for coronary artery evaluation and a CT guidance tool for procedural navigation.
The company’s devices are classified under FDA categories Class I, Class II, and Unclassified (U), with most submissions recorded in the FDA’s 510(k) premarket notification registry. Products are listed under these regulatory pathways, and the company operates from the United States.
Catalogue
Search and filter all 24 devicesFrequently asked questions
How many devices does Radi Medical Systems AB have in the registry?
The registry currently lists 24 devices for Radi Medical Systems AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radi Medical Systems AB's devices?
Among its 24 most recently registered devices, Radi Medical Systems AB has devices listed in FDA 510(k) (24 devices).
What risk classes do Radi Medical Systems AB's devices fall under?
Among its 24 most recently registered devices, the classes recorded for Radi Medical Systems AB's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Radi Medical Systems AB in the registry?
The most recently registered devices listed for Radi Medical Systems AB include RADIANALYZER, MODEL 12710, FEMOSTOP, FEMOSTOP PUMP, RADIANALYZER, MODEL 12710, RADIVIEW (PC-SOFTWARE ACCESSORY), MODEL 12720 and FEMOSTOP FEMORAL COMPRESSION SYSTEM.