FDA.reportPublic FDA data

Fixed examination/treatment room light

Definition
A fixed device intended to provide light to illuminate a site of patient examination and/or treatment. It typically consists of one or more light bulb(s) and, depending upon the design, reflectors or mirrors which focus and reflect the light. The device can be fixed to a ceiling, wall, or supported on a mobile mount. It can also be part of an operating light system consisting of more than one light head.
GUDID devices
131
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00724995244286HexaLuxSTERIS CORPORATIONHexaLux Ceiling Mount2025-05-05
00724995244309HexaLuxSTERIS CORPORATIONHexaLux Light Wall Mount2025-05-05
00724995244330HexaLuxSTERIS CORPORATIONHexaLux Ceiling Mount2025-05-05
00724995244347HexaLuxSTERIS CORPORATIONHexaLux Light Mobile2025-05-05
00724995244378HexaLuxSTERIS CORPORATIONHexaLux Light Mobile Stand2025-05-05
00732094147629Welch Allyn, Inc.WELCH ALLYN, INC.9010142023-04-25
00840348501599HerculesAADCO MEDICAL, INC.OS-5112022-12-08
00840348501605HerculesAADCO MEDICAL, INC.OS-511L2022-12-08
00858480006339NOVABurton Medical, LLC60004352026-04-02
00858480006346 NOVABurton Medical, LLC60004342026-04-02
00858480006827 OPLEDBurton Medical, LLC60002632026-04-02
00858480006834 AIM HIBurton Medical, LLC60003582026-04-02
00858480006841 AIM HIBurton Medical, LLC60003622026-04-02
00858480006858 AIM LEDBurton Medical, LLC6000319-12026-04-02
05055449401760KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/L-LED150F2022-12-08
05055449404716KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/CL-LED130F2022-12-08
05055449405393KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/CL-LED150F2022-12-08
05055449405461KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/L-LED130F2022-12-08
10845854044346FLX-LITEConmed Corporation3034A2020-09-24
10845854044353FLX-LITEConmed Corporation3058A2020-09-24
00724995244293HexaLuxSTERIS CORPORATIONHexaLux Light Mobile2025-05-05
00724995244354HexaLuxSTERIS CORPORATIONHexaLux Light Mobile2025-05-05
00724995244361HexaLuxSTERIS CORPORATIONHexaLux Light Mobile2025-05-05
00724995244385HexaLuxSTERIS CORPORATIONHexaLux Light Wall Mount2025-05-05
00724995225070NASTERIS CORPORATIONLED2022024-11-25
00724995225667NASTERIS CORPORATIONLED2022024-11-25
00724995225674NASTERIS CORPORATIONLED2022024-11-25
00724995225087NASTERIS CORPORATIONLED2022024-11-07
00724995225094NASTERIS CORPORATIONLED2022024-11-07
03700712434373LUCEA LED®MAQUET SASARDLCA109004A2024-10-15
03700712434380LUCEA LED®MAQUET SASARDLCA209012A2024-10-15
03700712434397LUCEA LED®MAQUET SASARDLCA209013A2024-10-15
03700712434403LUCEA LED®MAQUET SASARDLCA209015A2024-10-15
08800053060769E100 series(E1-M, E1-C, E1-W)DENTIS CO. ,LTDE1-W2024-01-23
08800053060776E100 series(E1-M, E1-C, E1-W)DENTIS CO. ,LTDE1-WB2024-01-23
08800053060783E100 series(E1-M, E1-C, E1-W)DENTIS CO. ,LTDE1-E2024-01-23
08800053060790E100 series(E1-M, E1-C, E1-W)DENTIS CO. ,LTDE1-EB2024-01-23
08800053060806E100 series(E1-M, E1-C, E1-W)DENTIS CO. ,LTDE1-C2024-01-23
08800053060813E100 series(E1-M, E1-C, E1-W)DENTIS CO. ,LTDE1-CB2024-01-23
08800053060820E100 series(E1-M, E1-C, E1-W)DENTIS CO. ,LTDE1-M2024-01-23
08800053060837E100 series(E1-M, E1-C, E1-W)DENTIS CO. ,LTDE1-MB2024-01-23
08800053081061S200 Series (Mobile, Ceiling, Dual Ceiling, Wall)DENTIS CO. ,LTDS200 CEILING2024-01-23
08800053081078S200 Series (Mobile, Ceiling, Dual Ceiling, Wall)DENTIS CO. ,LTDS200 MOBILE2024-01-23
08800053081085S200 Series (Mobile, Ceiling, Dual Ceiling, Wall)DENTIS CO. ,LTDS200 DUAL CEILING2024-01-23
08800053083034S200 Series (Mobile, Ceiling, Dual Ceiling, Wall)DENTIS CO. ,LTDS200 WALL2024-01-23
08800053084116L2S20-00210 (S200 Chair, S200 Dual Connection)DENTIS CO. ,LTDS200 DUAL CONNECTION2024-01-23
D104SAF30201Dental Operating LightSafari Dentaire IncSAF-302-012023-10-02
00732094072709Welch Allyn, Inc.WELCH ALLYN, INC.9010672023-08-16
00732094073362Welch Allyn, Inc.WELCH ALLYN, INC.9010672023-08-16
00732094073621Welch Allyn, Inc.WELCH ALLYN, INC.9010672023-08-16
00732094073683Welch Allyn, Inc.WELCH ALLYN, INC.9010672023-08-16
00732094073898Welch Allyn, Inc.WELCH ALLYN, INC.9010672023-08-16
00732094074109Welch Allyn, Inc.WELCH ALLYN, INC.9010672023-08-16
00886799001806Terumo® Advanced Perfusion System 1Terumo Cardiovascular Systems Corporation8934792023-08-01
07613327616545SircaBerchtold Holding GmbHCE38630752023-07-14
07613327616620SircaBerchtold Holding GmbHCG39132752023-07-14
07613327616644SircaBerchtold Holding GmbHCG39131752023-07-14
05055449403092KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/WL-LED130F2023-07-12
05055449403108KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/WL-LED150F2023-07-12
05055449403788KENEXKENEX (ELECTRO-MEDICAL) LIMITED150/430/31302023-07-11
05055449410397KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/L-LED150FP2023-01-16
05055449410731KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/CL-LED150FP2023-01-16
05055449410748KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/WL-LED150FP2023-01-16
05055449410779KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/L-LED150MC2023-01-16
05055449410786KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/CL-LED150MC2023-01-16
05055449410793KENEXKENEX (ELECTRO-MEDICAL) LIMITED300/WL-LED150MC2023-01-16
00732094144086Welch Allyn, Inc.WELCH ALLYN, INC.9010142023-04-25
10841736123482DoVera DE12 Examination Light SeriesSKYTRON LLCDE12C2023-04-13
10841736123499DoVera DE12 Examination Light SeriesSKYTRON LLCDE1212C2023-04-13
10841736123505DoVera DE12 Examination Light SeriesSKYTRON LLCDE12W2023-04-13
06975899060074EPSIMEDEPSIMED LLCOL-1002023-04-04
07613327622706SircaBerchtold Holding GmbHCE38530752023-03-02
00887761968332TL 1000 - Examination LightBaxter Medical Systems GmbH + Co. KG40581402022-12-15
00887761968349TL 1000 - Examination LightBaxter Medical Systems GmbH + Co. KG40581302022-12-15
00887761968356TL 1000 - Examination LightBaxter Medical Systems GmbH + Co. KG40581202022-12-15
00887761968363TL 1000 - Examination LightBaxter Medical Systems GmbH + Co. KG40581102022-12-15
00887761986091Hillrom™Baxter Medical Systems GmbH + Co. KG40581202022-01-05
04048675061328Sterilizable handle set (2pcs)Drägerwerk AG & Co. KGaAG920992022-06-28
00732094004564Welch Allyn, Inc.WELCH ALLYN, INC.9010672022-05-19
00732094004571Welch Allyn, Inc.WELCH ALLYN, INC.9010672022-05-19