Artema Medical AB
SwedenFDA applicant, unverified
- Devices
- 5
What Artema Medical AB makes
Artema Medical AB manufactures a range of single-use, disposable irrigation systems designed for surgical procedures, including the ARTEMA AQUA+ series and its variants (e.g., AQUA+I-F, AQUA+ T & TS). These devices are intended for controlled fluid delivery in orthopedic, spinal, and joint surgeries, with features such as flexible tubing and modular attachments for specific surgical needs.
The company’s portfolio is classified under Class I medical devices in the U.S. and is listed in the FDA 510(k) registry, reflecting regulatory compliance with U.S. requirements. The manufacturer is based in the United States.
Catalogue
Artema Aqua+ Ref K912333
Regimes: 510(k) Registry: 510(k)Artema Aqua+ Flex Ref K912336
Regimes: 510(k) Registry: 510(k)Aqua+i-F, I-H, I-Fh, Ii-H, Ii-Fh, Iii-H Ref K945359
Regimes: 510(k) Registry: 510(k)Artema Aqua+ T & Ts Ref K912334
Regimes: 510(k) Registry: 510(k)Artema Aqua+ N Ref K912335
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Artema Medical AB have in the registry?
The registry currently lists 5 devices for Artema Medical AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Artema Medical AB's devices?
Among its 5 most recently registered devices, Artema Medical AB has devices listed in FDA 510(k) (5 devices).
What risk classes do Artema Medical AB's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Artema Medical AB's devices are Class I. Each device page shows its own class and authorisation.
What are the newest devices from Artema Medical AB in the registry?
The most recently registered devices listed for Artema Medical AB include ARTEMA AQUA+, ARTEMA AQUA+ FLEX, AQUA+I-F, I-H, I-FH, II-H, II-FH, III-H and ARTEMA AQUA+ T & TS.