Medical Vision AB
Country not established
- Devices
- 1
- FDA recalls
- 1
At a glance
Market reach
- United States
- FDA recalls
What Medical Vision AB makes
Medical Vision AB manufactures the PowerPump Arthroscopy System, a device designed for fluid management during arthroscopic surgical procedures. It controls irrigation flow and suction to enhance visibility and efficiency in joint surgeries.
The PowerPump Arthroscopy System is classified as a Class II medical device under FDA regulations and is listed via the 510(k) clearance process. The company is based in the United States.
Catalogue
Powerpump Arthroscopy System Ref K093409
Regimes: 510(k) Registry: 510(k)
FDA recalls
FDA recall records list 1 recall initiated by Medical Vision AB, initiated on 2016-05-10. By recorded status: 1 terminated. The reasons filed fall into these groups: sterility or contamination, packaging and mechanical integrity. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
2016
- 10 May 2016 Z-2705-2016 Class II Terminated Sterility of device may be compromised due to sterile package breakage.
Full distribution text
- 10 May 2016 Z-2705-2016 Class II Terminated Sterility of device may be compromised due to sterile package breakage.
Frequently asked questions
How many devices does Medical Vision AB have in the registry?
The registry currently lists 1 device for Medical Vision AB. Devices recorded under merged duplicate company entries are counted once.
Which registries list Medical Vision AB's devices?
Among its 1 most recently registered device, Medical Vision AB has devices listed in FDA 510(k) (1 device).
What risk classes do Medical Vision AB's devices fall under?
Among its 1 most recently registered device, the classes recorded for Medical Vision AB's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Medical Vision AB?
FDA recall records list 1 recall initiated by Medical Vision AB, the most recent initiated on 10 May 2016. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Medical Vision AB in the registry?
The most recently registered devices listed for Medical Vision AB include POWERPUMP ARTHROSCOPY SYSTEM.