Light, Surgical, Fiberoptic

Product Code: FST

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 FST

5516Light, Surgical, FiberopticSurgical Lamp.

Total Product Life Cycle (TPLC) Devices

5516Light, Surgical, FiberopticSurgical Lamp.

Pre-market Notifications for FST

K200874TruView Light Cable, TruView Lateral Retractor Light Cable, Bifurcated Light Cable With Universal EndInnovasis, Inc.
K141330ENDO-CORDENROXTECH, INC.
K122637LITE DECOMPRESSION SYSTEM- LIGHT CABLE MODEL 48089999STRYKER SPINE
K113697EIGR SURGICAL ILLUMINATION SYSTEMINVUITY, INC.
K113330CABLECAPSENSORMED
K102266ISOLED AC-POWERED LED HEADLIGHT SYSTEMISOLUX LLC
K101496CABLECAP MODEL: WLF, STZ, ACMSENSORMED
K10038821ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMSMEDICAL ILLUMINATION INTERNATIONAL, INC.
K100395HARMONY VLED SURGICAL LIGHTNING SYSTEMSTERIS Corporation
K093386CHROMALUME TURBO LIGHT SOURCE WITH XTREMEBEAM FIBER OPTIC HEADLAMPFST MODEL FSTBFW, INC
K090070INVUITY BRITEFIELD MCCULLOCH RETRACTOR SYSTEMINVUITY, INC.
K083710RETRACTOR LITETHOMAS SURGICAL INSTRUMENTS, INC.
K082992AXXION LIGHT GUIDESPINAL ELEMENTS, INC.
K080367ZIMMER MIS LIGHTZIMMER SPINE, INC.
K071218PROXENON 350, MODEL 902XXWELCH ALLYN, INC.

Global Unique Device Identification Database

00724995151478LIGHT, SURGICAL, FIBEROPTIC
00812231030356Light, Surgical, Fiberoptic
00812231030349Light, Surgical, Fiberoptic
00816835021994Light, Surgical, Fiberoptic
00816835021987Light, Surgical, Fiberoptic
00816835021970Light, Surgical, Fiberoptic
00816835021963Light, Surgical, Fiberoptic
00816835021956Light, Surgical, Fiberoptic
00816835021949Light, Surgical, Fiberoptic
00816835021932Light, Surgical, Fiberoptic
00816835021925Light, Surgical, Fiberoptic
00816835021918Light, Surgical, Fiberoptic
00816835021901Light, Surgical, Fiberoptic
00816835021895Light, Surgical, Fiberoptic
00816835021888Light, Surgical, Fiberoptic

Maude Adverse Events

SNOWDEN-PENCERCAREFUSION 2200, INC2020-03-19
HARMONYSTERIS CORPORATION2020-03-06
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2020-02-19
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2020-01-15
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2020-01-02
ASSY, CABLE ULTRALITE 2 BIFURCINTEGRA YORK, PA INC.2019-09-16
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2019-08-29
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2019-08-29
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2019-08-28
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2019-07-22
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2019-07-12
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2019-07-09
HARMONY VLED SURGICAL LIGHTSTERIS CORPORATION - MONTGOMERY2019-06-12
MI-1000MEDICAL ILLUMINATION INTRNATION INC.2019-05-31
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2019-05-16
MI-1000MEDICAL ILLUMINATION INTRNATION INC.2019-05-15
MI-1000MEDICAL ILLUMINATION INTRNATION INC.2019-05-15
MI-1000MEDICAL ILLUMINATION INTRNATION INC.2019-05-14
MI-1000 DUAL CEILINGMEDICAL ILLUMINATION INTRNATION INC.2019-05-14
MI-1000MEDICAL ILLUMINATION INTRNATION INC.2019-05-14
MI-1000MEDICAL ILLUMINATION INTERNATIONAL INC.2019-05-14
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2019-04-11
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2019-04-11
ASSY, CABLE ULTRALITE 2 BIFURCINTEGRA YORK, PA INC.2019-03-19
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2019-03-11
ANCILLARY, SWEATBAND UL PLUS BINTEGRA YORK, PA INC.2019-03-06
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2019-02-26
ANCILLARY, HEADBAND UL PLUS BIINTEGRA YORK, PA INC.2019-01-23
FIBER OPTIC ILLUMINATORALCON RESEARCH, LLC - HOUSTON2019-01-16
ASSY, CABLE ULTRALITE 2 BIFURCINTEGRA YORK, PA INC.2019-01-02
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2018-12-21
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2018-12-19
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2018-12-18
FIBER-OPTIC LIGHT CABLE 3.5MMX7.5FT A/ACAREFUSION, INC2018-12-06
FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')ARTHREX, INC.2018-11-19
FUSED LIGHT CABLE, 5.0 MM X 274CM (9.0')ARTHREX, INC.2018-11-19
WELCH ALLYN PROXENON LIGHT SOURCEWELCHALLYN2018-11-02
DEEPSITE LIGHT CONNECTED TO HARMONY LA500 LIGHTING SYSTEMSTERIS CORPORATION - MONTGOMERY2018-10-04
FIBER OPTIC ILLUMINATORALCON RESEARCH, LTD. - HOUSTON2018-08-20
SINGLE FIBER OPTIC CABLE, 10FT, PINKINVUITY, INC2018-08-15
SINGLE FIBER OPTIC CABLE, 10FT, PINKINVUITY, INC2018-08-06
LUXTEC HEADLIGHT SYSTEMINTEGRA LIFESCIENCES CORPORATION2018-04-05
FIBER OPTIC ILLUMINATORALCON RESEARCH, LTD. - HOUSTON2018-02-13
HARMONY VLED SURIGICAL LIGHTING SYSTEMSTERIS CORPORATION - MONTGOMERY2018-01-25
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2017-12-11
UL PRO FUSED HEADLIGHT CABLE 9FT, 275CMINTEGRA YORK, PA INC.2017-12-10
FIBER OPTIC ILLUMINATORALCON RESEARCH, LTD. - HOUSTON2017-11-10
FUSED UNI LIGHT CABLE,3.5MMX 274CM,GRARTHREX INC.2017-10-27
FUSED UNI LIGHT CABLE,3.5MMX 274CM,GRARTHREX INC.2017-10-27
FIBER OPTIC ILLUMINATORALCON RESEARCH, LTD. - HOUSTON2017-10-26
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