Illuminator, Fiberoptic, Surgical Field

Product Code: HBI

General & Plastic Surgery General Optical Products / Medical

Definition: Radiation Emitting Electronic Product Codes // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Co

Applicable Standards: No Standard Applicable. General Radiological Health Requirements Apply. [1000-1005]

Code of Federal Regulations: 878.4580


Radiation TypeOptical
Radition SafetyNone
Annual ReportsNo

Products Classified as HBI

5667Illuminator, Fiberoptic, Surgical FieldSurgical Lamp.

Total Product Life Cycle (TPLC) Devices

5667Illuminator, Fiberoptic, Surgical FieldSurgical Lamp.

Pre-market Notifications for HBI

K163185OptiLux LED IlluminatorISOLUX LLC
K141781KOGENT SPETZLER LIGHTED SUCTION TUBESKATALYST SURGICAL, LLC
K111342LIGHT GUIDE CABLESCHOTT NORTH AMERICA
K0529791125 XSB XENON FIBER-OPTIC LIGHT SOURCEISOLUX LLC
K021931ENDOSCOPIC FIBEROPTIC CABLEGULF MEDICAL FIBEROPTICS
K991208ENDOSCOPIC FIBEROPTIC CABLEISOLUX AMERICA
K983277LIGHTSOURCE OR ILLUMINATOR MODEL I-100CUDA PRODUCTS CO.
K933593LUMINOUS 150 FIBEROPTIC ILLUMINATORPROGRESSIVE DYNAMICS, INC.
K922837S1500 XENON LIGHT SOURCEENDOMEDIX
K922462NEXTEC FIBEROPTIC CABLESNEXTEC CORP.
K921866LUMINOUS 250 FIBEROPTIC ILLUMINATORPROGRESSIVE DYNAMICS, INC.
K920167NEXTEC FIBEROPTIC ILLUMINAT 150 WATT/HALO/3500 KELNEXTEC CORP.
K904681VLS 5300 300W XENON LIGHT SOURCEVISTEK CORP.
K904616STORZ ULTRA-SOURCE HIGH OUTPUT ILLUMINATORSTORZ INSTRUMENT CO.
K904609XENON LIGHT SOURCEMEDICAL DYNAMICS, INC.

Global Unique Device Identification Database

00857580006706Illuminator, Fiberoptic, Surgical Field
00857580006690Illuminator, Fiberoptic, Surgical Field
00857580006676Illuminator, Fiberoptic, Surgical Field
00857580006652Illuminator, Fiberoptic, Surgical Field
00852350007020Illuminator, Fiberoptic, Surgical Field
20884521176109ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
20884521176116ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
20884521176093ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
20884521176086ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
20884521176079ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
10856312006097Illuminator, Fiberoptic, Surgical Field
10856312006073Illuminator, Fiberoptic, Surgical Field
00857580006768Illuminator, Fiberoptic, Surgical Field
10884521042520ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD
10884521042490ILLUMINATOR, FIBEROPTIC, SURGICAL FIELD

Maude Adverse Events

LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEOLYMPUS WINTER & IBE GMBH2020-01-10
LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEOLYMPUS WINTER & IBE GMBH2020-01-10
LIGHT-GUIDE CABLE, 2.8 MM, 3 M, CF TYPEOLYMPUS WINTER & IBE GMBH2019-06-17
VITAL VUENELLCOR PURITAN BENNETT MEXICO SA2019-04-17
LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPEOLYMPUS WINTER & IBE GMBH2019-02-27
VITAL VUEPLEXUS CORP2018-09-06
LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPEOLYMPUS WINTER & IBE GMBH2018-08-13
VITAL VUECOVIDIEN LP LLC NORTH HAVEN2018-07-02
VITAL VUECOVIDIEN LP2017-12-01
GEMINI UNIVERSAL 5 MM FIBER OPTIC LIGHT CABLE 5.0 MM X 10 FTSMITH & NEPHEW PLC2017-09-06
LIGHT-GUIDE CABLE, 4.25 MM, 3 M, CF TYPEOLYMPUS WINTER & IBE GMBH2017-06-15
VITAL VUE* LIGHT POWER SOURCE (110V)COVIDIEN, FORMERLY NELLCOR PURITAN BENNE2015-07-09
VITAL VUE EXT YANK W/EXT 12FR METAL SUCTCOVIDIEN, FORMERLY NELLCOR PURITAN BENNETT MEXICO, S.A. DE C2014-07-21
STORZ BFW ILLUMINATORBAUSCH & LOMB, INC.2014-04-23
VITAL VUE EXT YANKAUER SUCTION W/ BULB TPCOVIDIEN, FORMERLY NELLCOR2013-03-04
VITAL VUECOVIDIEN UNITED STATES SURGICAL CORP2012-12-24
VITAL*VUECOVIDIEN, FORMERLY US SURGICAL A DIVISON OF TYCO HEALTHCARE2012-12-04
VITAL-VUECARDINAL HEALTH2011-06-14
VITAL VUE LIGHT POWER SOURCE (110V)NELLCOR PURITAN BENNETT2011-03-02
VITAL VUECOVIDIEN2011-02-21
VITAL VUE EXT YANKAUER SUCTION W/BULB TPTIJUANA - USS2009-04-03
LIGHT SOURCE2008-12-19
XENON SERIES 900LUXTEC2008-11-03
*TRANSILLUMINATORUNK2005-01-04
ENDOLUMINA II TRANSILLUMINATION SYSTEMBIOENTERICS CORPORATION2001-10-16
PILLING WECKPILLING WECK SURGICAL2000-04-05
PILLING WECK SURGICAL2000-04-05
STORZ LIGHT PIPE, 20 GAUGE, 6/BOXBAUSCH & LOMB SURGICAL1998-11-05
STORZ 20 GAUGE LIGHT PIPESSTORZ INSTRUMENT CO.1997-03-21
STORZ LIGHT PIPE 20 GAUGESTORZ INSTRUMENT COMPANY1997-01-17
STORZ LIGHT PIPE 20 GAUGESTORZ INSTRUMENT COMPANY1997-01-17
STORZ LIGHT PIPE 20 GAUGESTORZ INSTRUMENT CO.1997-01-17
VITAL VUE PROBESHERWOOD DAVIS AND GECK1996-11-21
STORZ FIBEROPTIC LIGHT PIPESTORZ INSTRUMENT CO1996-10-23
STORZ FIBEROPTIC LIGHT PIPESTORZ INSTRUMENT CO1996-10-23
STORZ FIBEROPTIC LIGHT PIPESTORZ INSTRUMENT CO1996-10-23
STORZ FIBEROPTIC LIGHT PIPESTORZ INSTRUMENT CO1996-10-23
N/AFIBEROPTIC TRANSILUMINATORWELCHALLYN1992-01-31
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