Maquet S.A.S.
Country not established FDA
- Devices
- 2
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA establishment
What Maquet S.A.S. makes
Maquet S.A.S. manufactures the VOLISTA 400 and VOLISTA 600, which are likely extracorporeal circulation systems used during cardiac surgeries, and the LUCEA LED Surgical Light System, a high-intensity LED-based illumination device for operating rooms.
These devices are classified as Class II under FDA regulations and are listed in the FDA’s 510(k) clearance registry. The company is based in the United States.
Catalogue
Volista 400; Volista 600 Ref K130513
510(k) 510(k)Lucea Led Surgical Light System Ref K113679
510(k) 510(k)
FDA establishments
- Maquet S.A.S. ARDON, ORLEANS CEDEX 2 Loiret · FR FEI 3002465150
Frequently asked questions
How many devices does Maquet S.A.S. have in the registry?
The registry currently lists 2 devices for Maquet S.A.S.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Maquet S.A.S.'s devices?
Among its 2 most recently registered devices, Maquet S.A.S. has devices listed in FDA 510(k) (2 devices).
What risk classes do Maquet S.A.S.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Maquet S.A.S.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Maquet S.A.S. in the registry?
The most recently registered devices listed for Maquet S.A.S. include VOLISTA 400; VOLISTA 600 and LUCEA LED SURGICAL LIGHT SYSTEM.
Which FDA establishments are linked to Maquet S.A.S.?
1 FDA establishment is linked to Maquet S.A.S. in the registry; they are listed on the company page.