510(k) K130513 ยท FTD Lamp, Surgical
VOLISTA 400; VOLISTA 600
| Applicant | Maquet S.A.S., Wayne NJ, US |
| Decision | Substantially Equivalent, May 8, 2013 |
| Received | Feb 27, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K130513
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Volista, Volista Access, Volista Access II, Volista Standop OR Light System, Model Numbers and Catalog Numbers ROL B FOR VLT400SF STP - ARDROL309001A, ROL B FOR VLT400SF STP - ARDROL309001C, RO Open, Classified |
FTD | None listed |
| Jun 30, 2022 | Getinge Usa Sales Inc VOLISTA StandOP Surgical Light, Product Code/Part Numbers ARD568811901 VLT600SF AIM STP
ARD568811911 VLT600SF AIM STP
ARD568811961 VLT600DF AIM STP
ARDVST229000A VST60SF AIM
ARDVST229001A VST60DF AIM
Open, Classified |
FSY | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811901
Model: VLT600SF AIM STP Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811910
Model:VLT600SF STP Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811911
Model: VLT600SF AIM STP Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811961 Model: VLT600DF AIM STP Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568812910
Model: VLT400SF STP Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229000A
Model: VST60SF AIM Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229001A
Model: VST60DF AIM Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229002A
Model: VST66SF AIM Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229003A
Model: VST66DF AIM Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229034A
Model: VST60SF Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229035A
Model:VST60DF Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229036A
Model:VST66SF Terminated |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229037A
Model: VST66DF Terminated |
FTD | None listed |
| Jun 14, 2018 | Maquet SAS 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;
ARD5688 Terminated |
FTD | None listed |
| Apr 19, 2018 | Maquet SAS 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 S Terminated |
FTD | None listed |
| Apr 10, 2018 | GETINGE US SALES LLC VOLISTA StandOP Surgical Light; Model numbers VLT600 SF AIM STP, VLT600 DF AIM STP, Ref. codes ARD568811901, ARD568811911
ARD568811951, ARD568811961
The device is designed to illuminate the body of a 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 |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.