510(k) K070442 ยท FSY Light, Surgical, Ceiling Mounted
POWERLED SURGICAL LIGHT SYSTEM
| Applicant | Maquet S.A., Rochester NY, US |
| Decision | Substantially Equivalent, Mar 16, 2007 |
| Received | Feb 15, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070442
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 18, 2026 | Maquet SAS PowerLED 300 Concealed Lighting System (PWD30+SF W K3 SPRING ARM A2 FC3 50-100nm)
Model Numbers: 1. ARD568474114A, 2. ARD567501286; Open, Classified |
FSY | None listed |
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet PowerLED/HLED and PowerLED300 OR Light Systems, Model Numbers and Catalog Numbers EPS MB1 - ARDINT059002A, EPS MB1 - ARDINT059002C, EPS MB1 TR - ARDINT059000A, EPS MB1 TR - ARDINT059000C, EPS M Open, Classified |
FSY | None listed |
| Jul 7, 2015 | Maquet Cardiovascular Us Sales, Llc The PowerLED / X-TEN / VOLISTA Surgical Light Systems are surgical light systems intended to be used to provide visible illumination of the surgical area or the patient. Ceiling surgical light systems Terminated |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.