ClearanceBrief
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)
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Top companies in FTD

DateFirm and productCodeLinked 510(k)
Jul 5, 2024Baxter 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
FTDNone listed
Jul 5, 2024Baxter Healthcare Corporation
Trulight 5000/3000 Surgical Light, model numbers: a) 4038210 (Duo Surgical Lights}; b) 4038310 (Trio/Quad Surgical Lights)
Open, Classified
FTDNone listed
Jan 19, 2024Getinge 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
FTDNone listed
Jan 19, 2024Getinge 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
FTDNone listed
Jan 19, 2024Getinge 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
FTDNone listed
Jan 19, 2024Getinge 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
FTDK113679
Jan 19, 2024Getinge 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
FTDK130513
Jan 19, 2024Getinge 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
FTDNone listed
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229037A Model: VST66DF
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229036A Model:VST66SF
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229035A Model:VST60DF
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229034A Model: VST60SF
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229003A Model: VST66DF AIM
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229002A Model: VST66SF AIM
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229001A Model: VST60DF AIM
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARDVST229000A Model: VST60SF AIM
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568812910 Model: VLT400SF STP
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811961 Model: VLT600DF AIM STP
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811911 Model: VLT600SF AIM STP
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811910 Model:VLT600SF STP
Terminated
FTDK130513
Jun 21, 2019Maquet Cardiovascular Us Sales, Llc
Maquet VOLISTA StandOP Surgical Lights- Product Code: ARD568811901 Model: VLT600SF AIM STP
Terminated
FTDK130513
Jun 14, 2018Maquet 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
FTDK130513
Apr 19, 2018Maquet 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
FTDK130513
Dec 12, 2016Steris 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
FTDNone listed
Dec 10, 2010Berchtold Corp.
CHROMOPHARE Surgical Lighting System & CHROMOVIEW Flat Panel Monitor, Mechanical Spring Arms.
Terminated
FTDK922836
Apr 1, 2010Steris 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
FTDK013242
Apr 1, 2010Steris 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
FTDK013242
Apr 1, 2010Steris 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
FTDK013242
Nov 23, 2009Steris 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
FTDK010724
Nov 12, 2009MAQUET 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
FTDK895715
Nov 12, 2009MAQUET 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
FTDK895715
Nov 12, 2009MAQUET 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
FTDK895715
Nov 12, 2009MAQUET 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
FTDK895715
Sep 16, 2009Draeger Medical, Inc.
Drager Surgical Lights Sola 500 and Sola 700.
Terminated
FTDK010724
Apr 12, 2009MAQUET 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
FTDK882613
Apr 12, 2009MAQUET 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
FTDK882613
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Feb 22, 2007Skytron, 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
FTDK915285
Jan 22, 2004Draeger Medical, Inc.
Drager Sola 700 Surgical Lamp and Steris Harmony LL 700 Surgical Lamp
Terminated
FTDK010724
Jan 22, 2004Draeger Medical, Inc.
Drager Sola 500 Surgical Lamp and Steris Harmony LL 500 Surgical Lamp
Terminated
FTDK010724

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