Data / Medical devices / France / Maquet S.A.S.
Maquet S.A.S.: FDA-registered device maker in ARDON, ORLEANS CEDEX 2 Loiret, France, 2 510(k) clearances
Maquet S.A.S. is registered with the FDA (registration 9710055) in ARDON, ORLEANS CEDEX 2 Loiret, France. It lists 8 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 8, 2013. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9710055
- FEI number
- 3002465150
- Address
- Parc De Limere Avenue De La Pomme De Pin, ARDON, ORLEANS CEDEX 2 Loiret, France, 45074
- Owner or operator
- MAQUET SAS (9059038)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- July 10, 2002
- Registered through
- 2026
- Brand names listed
- LUCEA 10, LUCEA 40, LUCEA 50, LUCEA LED, MAQUET EQUIPMENT, MAQUET STERIGRIP, Maquet EZEA, Maquet Orchide and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | 1 | Manufacturer | accessdata.fda.gov |
| Device, Medical Examination, Ac Powered | KZF | 1 | Manufacturer | accessdata.fda.gov |
| Holder, Camera, Surgical | FXR | 1 | Manufacturer | accessdata.fda.gov |
| Lamp, Surgical | FTD | 2 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Accessories | FTA | 2 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Ceiling Mounted | FSY | 2 | Manufacturer | accessdata.fda.gov |
| Light, Surgical, Floor Standing | FSS | 2 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Contract manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 8, 2013 | K130513 | VOLISTA 400; VOLISTA 600 | FTD | Substantially Equivalent | Maquet S.A.S. | accessdata.fda.gov |
| March 16, 2007 | K070442 | POWERLED SURGICAL LIGHT SYSTEM | FSY | Substantially Equivalent | Maquet S.A. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 7, 2026 | 99696 | Class II | Ongoing | PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm) Model Numbers: 1. ARD568474114A, 2. ARD567501286 | The potential for the device to detach at the junction between the spring arm and suspension arm and fall causing potential injury. | accessdata.fda.gov |
| June 14, 2018 | 80452 | Class II | Terminated | VOLISTA StandOP Surgical Light, ARD568811961 VLT600DF AIM STP; ARD568821961 VLT600DF AIM STP QL; ARD568811911 VLT600SF AIM STP; ARD568821911 VLT600SF AIM STP QL; ARD568821910 VLT600SF STP QL; ARD568811901 VLT600SF AIM ST | Certain VOLISTA StandOP Surgical Lights have been identified as having a potential light head detachment issue. Improper assembly of the bracket that connects the light head to the axle fork could result in the light head bracket breaking, causing the light head to detach from the arm and become suspended only from the cabling inside the arm. Use of an affec | accessdata.fda.gov |
| April 19, 2018 | 79898 | Class II | Terminated | VOLISTA StandOP (model 600) surgical lights shipped from October 2012 until June 2017 equipped with keypads with Ref. ARD568801560; Part numbers: 568811901, VLT600SF AIM STP; 568811911, VLT600SF AIM STP; 568811961, VLT60 | Potential keypad failure on VOLISTA StandOP Surgical Lights. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Surgical
- All makers of Light, Surgical, Ceiling Mounted
- All makers of Light, Surgical, Accessories
- All makers of Camera, Surgical And Accessories
- All makers of Light, Surgical, Floor Standing
- All makers of Device, Medical Examination, Ac Powered
Updated September 18, 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.