510(k) K040735 ยท FSY Light, Surgical, Ceiling Mounted
ALM X'TEN (X10) SURGICAL LIGHT SYSTEM
| Applicant | Alm S.A., Rochester NY, US |
| Decision | Substantially Equivalent, May 21, 2004 |
| Received | Mar 22, 2004 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K040735
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet XTen OR Light Systems, Model Numbers and Catalog Numbers 3001 HMD14 - ARD567732001C, X TEN DUO - ARD568221510C, X TEN DUO - ARD568221561C, X10AXL DF - ARD568211010C, X10AXL SF - ARD568231010C, Open, Classified |
FSY | None listed |
| Mar 5, 2018 | GETINGE US SALES LLC ALM XTEN Surgical Light intended to provide visible illumination for the surgical field or for the examination of the patient. Part Numbers: ARD567801093, ARD567801094 Terminated |
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 |
| Nov 12, 2009 | MAQUET Inc. XTEN DF cupola, P/N: 567800999.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FSY | None listed |
| Nov 12, 2009 | MAQUET Inc. XTEN LED Video DF cupola, P/N: 567801999.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FSY | None listed |
| Nov 12, 2009 | MAQUET Inc. XTEN LED DF cupola, P/N: 567815999.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FSY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.