FDA.reportPublic FDA data

Operating room light

Definition
A device designed to provide a specialized source of light for illumination of a site of medical intervention. It provides a high intensity, high colour rendering field of light that minimizes shadows and the emission of heat. It typically consists of an individual light head with more than one light source which may include halogen bulbs or light-emitting diodes (LEDs), reflectors, mirrors and a mechanism to adjust the focus. This device is usually mounted to the ceiling or wall of an operating room (OR) and the mount may be included. It can be part of an OR light system comprising more than one light head.
GUDID devices
3,836
Last updated
2026-06-04 19:44:10

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00684706007404iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-11-01
00684706007411iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-11-01
00684706007428iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-12-12
00684706007435iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-12-12
00684706007442iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-12-13
00684706007459iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-12-13
00684706007466iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-12-13
00684706007473iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-12-13
00684706007480iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-12-13
00684706007497iCE Surgical LightAmico Clinical Solutions CorpiCE30m2022-12-13
00684706009804iCE Surgical LightAmico Clinical Solutions CorpiCE30m2025-10-09
00684706009835iCE Surgical LightAmico Clinical Solutions CorpiCE30m2026-04-06
00684706009842iCE Surgical LightAmico Clinical Solutions CorpiCE30m2026-04-16
00684706009859iCE Surgical LightAmico Clinical Solutions CorpiCE30m2026-04-16
00724995199425HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199456HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199463HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199487HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199531HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199609HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199708HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199746HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199753HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199760HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199814HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199869HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199890HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199937HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995199975HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200244HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200251HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200305HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200367HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200428HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200435HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200442HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200480HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200527HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200541HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995200756HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995203092HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995203108HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995203184HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995203221HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00724995203245HarmonyAIRSTERIS CORPORATIONA-Series Lighting System2021-04-09
00810114912003SurgiTelSurgitelMicro LED Headlight2022-12-21
00810114912010SurgiTelSurgitelMini HI LED Headlight2023-01-12
00810114912027SurgiTelSurgitelEclipse CS LED Headlight2023-01-12
00810114912034SurgiTelSurgitelWireless LED Headlight2023-01-12
00810114912041SurgiTelSurgitelWireless Air LED Headlight2023-01-12
00810114912058SurgiTelSurgitelSurgical 2.0 LED Headlight2023-01-12
00810114912065SurgiTelSurgitelSurgical Headband 2.0 LED2023-01-12
00816835024322MI-1000CAMMedical Illumination International Inc.061524CAM2024-08-19
00816835024339MI-1000CAMMedical Illumination International Inc.061525CAM2024-08-19
00816835024360Vu160Medical Illumination International Inc.NVSD3D3M1-LCH2025-02-19
00816835024445SYSTEM TWO LEDMedical Illumination International Inc.SD2CD2-4K2026-04-30
00816835024452SYSTEM TWO LEDMedical Illumination International Inc.SD2CD2-LCH-4K2026-04-30
00816835024469SYSTEM TWO LEDMedical Illumination International Inc.SD2CM1-LCH-4K2026-04-30
00816835024476SYSTEM TWO LEDMedical Illumination International Inc.SD3C-CNE-4K2026-04-30
00816835024483SYSTEM TWO LEDMedical Illumination International Inc.SD3CM1-CNE-LCH-4K2026-04-30
00840348502572HerculesAADCO MEDICAL, INC.OSL-3500EPS2022-12-09
00840348502589HerculesAADCO MEDICAL, INC.OSL-3500VRS2022-12-09
00840348502596HerculesAADCO MEDICAL, INC.OSL-35032022-12-09
00840348502602HerculesAADCO MEDICAL, INC.OSL-3503CAM2022-12-09
00840348502619HerculesAADCO MEDICAL, INC.OSL-35052022-12-09
00840348502626HerculesAADCO MEDICAL, INC.OSL-3505CAM2022-12-09
00840348502633HerculesAADCO MEDICAL, INC.OSL-35332022-12-09
00840348502640HerculesAADCO MEDICAL, INC.OSL-35352022-12-09
00840348502657HerculesAADCO MEDICAL, INC.OSL-35552022-12-09
00840348505481AADCOAADCO MEDICAL, INC.OSPL-32022-12-12
00840348505771AADCOAADCO MEDICAL, INC.OSPL-3CAM2022-12-12
00840348505795AADCOAADCO MEDICAL, INC.OSPL-52022-12-12
00840348505801AADCOAADCO MEDICAL, INC.OSPL-5CAM2022-12-12
00840348505818AADCOAADCO MEDICAL, INC.OSPL-7002022-12-12
00860000230711Light JacketPATHY MEDICAL, LLCPM-LJ1002020-06-17
00860013814908IlioLUMENXT LLC007.101.2025-10-15
00885380024798CARDINAL HEALTHCardinal Health 200, LLC30968-1102016-12-29
03700712432423Maquet EzeaMAQUET SASARDEZA209000A2024-01-10
03700712432430Maquet EzeaMAQUET SASARDEZA209001A2024-01-10
03700712432461Maquet EzeaMAQUET SASARDEZA209004A2024-01-10