Panels › General, Plastic Surgery › Product code FTD · Class 2
Lamp, Surgical
Regulation 878.4580
0510(k)s in 12 months (29 all time)
0recalls in 12 months (49 all time)
42recalls that name a 510(k)
Top companies in FTD
| Company | 510(k)s | Recalls |
|---|---|---|
| Maquet Cardiovascular Us Sales, Llc | 0 | 13 |
| Skytron, Div. The KMW Group, Inc | 0 | 11 |
| MAQUET Inc. | 0 | 8 |
| Getinge Usa Sales Inc | 0 | 6 |
| STERIS Corporation | 1 | 5 |
| Draeger Medical, Inc. | 0 | 3 |
| AtriCure, Inc. | 2 | 0 |
| Baxter Healthcare Corporation | 0 | 2 |
| Burton Medical Products Corp. | 2 | 0 |
| Engineered Medical Solutions Co., LLC | 2 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 5, 2024 | Baxter Healthcare Corporation iLED 7 surgical lights, Model Numbers:
a) 4068110 (Ceiling Single Surgical Light);
b) 4068120 (Mobile Surgical Light);
c) 4068140 (Pendant Surgical Light);
d) 4068210 (Ceiling Duo Surgical Ligh Open, Classified |
FTD | None listed |
| Jul 5, 2024 | Baxter Healthcare Corporation Trulight 5000/3000 Surgical Light, model numbers:
a) 4038210 (Duo Surgical Lights};
b) 4038310 (Trio/Quad Surgical Lights) Open, Classified |
FTD | None listed |
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Orchide OR Light Systems, Model Numbers and Catalog Numbers OHDII FHD QL VP01 - ARD568803935, OHDII FHD QL AIR03 U - ARD568803952, OHDII FHD QL AIR03 E - ARD568803967, OHDII FHD QL AIR04 E/U - Open, Classified |
FTD | None listed |
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Equipment OR Light Systems, Model Numbers and Catalog Numbers BRAINLAB CAMERA - ARDEQT269000A, BRAINLAB CAMERA - ARDEQT269000C, BRAINLAB CAMERA - ARDEQT269001A, BRAINLAB CAMERA - ARDEQT269001C, Open, Classified |
FTD | None listed |
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Rolite OR Light Systems, Model Numbers and Catalog Numbers ROL PWDII50SF - ARDPWT309001A, ROL PWDII50SF - ARDPWT309002A, ROL PWDII50SF - ARDPWT309009A, ROL PWDII50SF - ARDPWT309010A, ROL PWDII7 Open, Classified |
FTD | None listed |
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet Lucea - Lucea10/40, Lucea50/100 OR Light Systems, Model Numbers and Catalog Numbers LCA 10 - ARD2LCA00040C, LCA 10 - ARDLCA109000C, LCA 10 - ARDLCA109002C, LCA 10 - ARDLCA109006C, LCA 10 - ARDL Open, Classified |
FTD | K113679 |
| 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 | K130513 |
| Jan 19, 2024 | Getinge Usa Sales Inc Maquet PowerLEDII OR Light System, Model Names and Catalog Numbers PWDII77SF - ARDPWT629100A, PWDII555DF - ARDPWT629101A, PWDII555SF - ARDPWT629102A, PWDII755DF - ARDPWT629103A, PWDII755SF - ARDPWT629 Open, Classified |
FTD | None listed |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229037A
Model: VST66DF Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229036A
Model:VST66SF Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229035A
Model:VST60DF Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229034A
Model: VST60SF Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229003A
Model: VST66DF AIM Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229002A
Model: VST66SF AIM Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229001A
Model: VST60DF AIM Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARDVST229000A
Model: VST60SF AIM Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568812910
Model: VLT400SF STP Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811961 Model: VLT600DF AIM STP Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811911
Model: VLT600SF AIM STP Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811910
Model:VLT600SF STP Terminated |
FTD | K130513 |
| Jun 21, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet VOLISTA StandOP Surgical Lights-
Product Code: ARD568811901
Model: VLT600SF AIM STP Terminated |
FTD | K130513 |
| 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 | K130513 |
| 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 | K130513 |
| Dec 12, 2016 | Steris Corporation Harmony Insight Diagnostic Monitor Support System - 100 Spring Arm (EMS)
The system is intended for use in surgical operating rooms (OR) or intraoperative surgical/imaging rooms where simultaneous mul Terminated |
FTD | None listed |
| Dec 10, 2010 | Berchtold Corp. CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms. Terminated |
FTD | K922836 |
| Apr 1, 2010 | Steris Corporation Harmony Lux Classic, Surgical Lighting System, also known as the Harmony LC 500, B129388085 and B12988086.
Designed to provide visible immunization of the surgical field or the patient and to provide Terminated |
FTD | K013242 |
| Apr 1, 2010 | Steris Corporation Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 700, B129382393.
Designed to provide visible immunization of the surgical field or the patient and to Terminated |
FTD | K013242 |
| Apr 1, 2010 | Steris Corporation Harmony Lux Advantage LA Surgical Lighting and Visualization System, also known as the Harmony LA 500, B129382391.
Designed to provide visible immunization of the surgical field or the patient and to Terminated |
FTD | K013242 |
| Nov 23, 2009 | Steris Corp STERIS Harmony LL 500/700 Surgical Light, Vertical Spring-Loaded Arm.
Intended for local illumination of the operating and examination area of the patient in treatment rooms. Terminated |
FTD | K010724 |
| Nov 12, 2009 | MAQUET Inc. HANAULUX 2004-2005 TV Spring Arm, P/N: 569002998.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FTD | K895715 |
| Nov 12, 2009 | MAQUET Inc. HANAULUX 2005 IXL cupola, P/N: 56076869.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FTD | K895715 |
| Nov 12, 2009 | MAQUET Inc. HANAULUX 2005 I cupola, P/N: 56076865.
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FTD | K895715 |
| Nov 12, 2009 | MAQUET Inc. HANAULUX 2004 IXL cupola, P/N: 56076868
Intended to provide visible illumination for the surgical field or for the examination of the patient. Terminated |
FTD | K895715 |
| Sep 16, 2009 | Draeger Medical, Inc. Drager Surgical Lights Sola 500 and Sola 700. Terminated |
FTD | K010724 |
| Apr 12, 2009 | MAQUET Inc. Alm Prismatic Surgical Light 5004 SF;
Maquet SA.
ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is des Terminated |
FTD | K882613 |
| Apr 12, 2009 | MAQUET Inc. ALM Prismatic Surgical Light 9551 DF;
Maquet SA.
ALM PRISMATIC (PRC) Surgical Lights are used to provide visible illumination for the surgical field or for the examination of the patient. PRC is des Terminated |
FTD | K882613 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 8 bulbs in 1 - 30' diameter lighthead and 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 5 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF222222-B, IF222222EL a Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in 1 - 22' lighthead and 8 bulbs in 1 - 30' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Model IF3 Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 5 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF2222, IF2222-B, IF2222B/ Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light, 5 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF22, IF22B, IF22LH, IF22LHH-B, IF22M-S, IN22, IN22EL, I Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with triple lightheads, 4 bulbs in each of 3 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF545454 and IF545454EL Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light with dual lightheads, 4 bulbs in each of 2 - 22' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF5454 and IF5454EL. Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series surgical light, 4 bulbs in 1 - 22' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Models IF54, IF54EL, IF54LH and IF54S. Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity Series (also called Astro series) minor surgery light with dual lightheads, 3 bulbs in each of 2 - 19' diameter lightheads, Manufactured by Dai-ichi Shomei Co., Ltd., Made in Japan; Terminated |
FTD | K915285 |
| Feb 22, 2007 | Skytron, Div. The KMW Group, Inc Skytron Infinity series (also called Astro series) minor surgery light, 3 bulbs in 1 - 19' diameter lighthead, Manufactured by Dai-ichi Shomei Co., Ltd., Japan; Models IN19, IN19EL, IN19LH and IN19S. Terminated |
FTD | K915285 |
| Jan 22, 2004 | Draeger Medical, Inc. Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp Terminated |
FTD | K010724 |
| Jan 22, 2004 | Draeger Medical, Inc. Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp Terminated |
FTD | K010724 |
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