FDA.reportPublic FDA data

Radiological image marker, implantable

Definition
A device intended to be implanted within the body, either temporarily or permanently, to create identifying marks that can be seen on radiological images. It is typically in the form of a wire, needle, bead, clip, stent-like tube, washer or fluid, and used to locate and delineate a tumour, lesion, or other site of interest. It is made from materials compatible with the imaging system with which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, or nuclear medicine]; it may be intended for use during radiotherapy procedures. It is not an electromagnetic or optical spatial marker.
GUDID devices
1,519
Last updated
2026-09-04 23:14:07

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
00628451892014Tantalum Bead SetHalifax Biomedical Incorporated22015-09-22
00801741000331UltraClip® II Breast Tissue MarkerBard Peripheral Vascular, Inc.8610172015-09-25
00801741031847Gel Mark Ultra™ Breast Tissue MarkerSENORX, INC.GMU11T2015-10-01
00801741031854Gel Mark Ultra™ Breast Tissue MarkerSENORX, INC.GMUEC10GSS2015-10-01
00801741031861Gel Mark Ultra™ Breast Tissue MarkerSENORX, INC.GMUEC7GSS2015-10-01
00801741031885Gel Mark Ultra™ Breast Tissue MarkerSENORX, INC.MK20112015-10-01
00801741031892Gel Mark UltraCor® Breast Tissue MarkerSENORX, INC.GMUTC005SS2015-10-01
00801741031908Gel Mark UltraCor® Breast Tissue MarkerSENORX, INC.GMUTC005T2015-10-01
00801741031915SenoMark® Breast Tissue MarkerSENORX, INC.SMEC10GSS2015-10-01
00801741031922SenoMark® Breast Tissue MarkerSENORX, INC.SMEC12GSS2015-10-01
00801741031939SenoMark® Breast Tissue MarkerSENORX, INC.SMEC7GSS2015-10-01
00801741031946SenoMark® Breast Tissue MarkerSENORX, INC.SMRSU12GT2015-10-01
00801741031953SenoMark® Breast Tissue MarkerSENORX, INC.SMRSU9GT2015-10-01
00801741031960SenoMark® Breast Tissue MarkerSENORX, INC.SMSE9GT2015-10-01
00801741031977SenoMark® Breast Tissue MarkerSENORX, INC.SMTEC10G2015-10-01
00801741031984SenoMark® Breast Tissue MarkerSENORX, INC.SMTMT11G2015-10-01
00801741031991SenoMark® Breast Tissue MarkerSENORX, INC.SMTSU9G2015-10-01
00801741032004SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMEC7C2015-10-02
00801741032011SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMEC7R2015-10-02
00801741032028SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMEC10C2015-10-01
00801741032035SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMEC10R2015-10-01
00801741032042SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMEC12C2015-10-01
00801741032059SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMEC12R2015-10-02
00801741032066SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMMA11C2015-10-01
00801741032073SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMMA11R2015-10-01
00801741032080SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMAT9C2015-10-02
00801741032097SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMAT9R2015-10-02
00801741032103SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMAT12C2015-10-01
00801741032110SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMAT12R2015-10-01
00801741032127SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMEV9C2015-10-02
00801741032134SenoMark® Ultra Breast Tissue MarkerBard Peripheral Vascular, Inc.SMEV9R2015-10-02
00801741032141SenoMark UltraCor™ MRI Breast Tissue MarkerSENORX, INC.SMUCMRI14GSS2015-10-02
00801741032158SenoMark UltraCor™ MRI Breast Tissue MarkerSENORX, INC.SMUCMRI14GT2015-10-02
00801741032165StarchMark® Breast Tissue MarkerSENORX, INC.STMKEC10GSS2015-10-02
00801741032172StarchMark® Breast Tissue MarkerSENORX, INC.STMKEC7GSS2015-10-02
00801741032189StarchMark® Breast Tissue MarkerSENORX, INC.STMKMT11GSS2015-10-02
00801741032196StarchMark® UltraCor™ Breast Tissue MarkerSENORX, INC.STMK14GSS2015-10-02
00801741032202UltraCor® Breast Tissue MarkerSENORX, INC.UCTC17GSS2015-10-02
00801741032219UltraClip® Dual Trigger Breast Tissue MarkerBard Peripheral Vascular, Inc.862017D2015-09-25
00801741032226UltraClip® Dual Trigger Breast Tissue MarkerBard Peripheral Vascular, Inc.862017DL2015-09-25
00801741032233UltraClip® Dual Trigger Breast Tissue MarkerBard Peripheral Vascular, Inc.863017D2015-09-25
00801741032240UltraClip® Dual Trigger Breast Tissue MarkerBard Peripheral Vascular, Inc.863017DL2015-09-25
00801741032257UltraClip® Dual Trigger Breast Tissue MarkerBard Peripheral Vascular, Inc.864017D2015-09-25
00801741032264UltraClip® Dual Trigger Breast Tissue MarkerBard Peripheral Vascular, Inc.864017DL2015-09-25
00801741032271UltraClip® II Breast Tissue MarkerBard Peripheral Vascular, Inc.8612172015-09-25
00801741032288UltraClip® II Breast Tissue MarkerBard Peripheral Vascular, Inc.8620172015-09-25
00801741032295UltraClip® II Breast Tissue MarkerBard Peripheral Vascular, Inc.8630172015-09-25
00801741032301UltraClip® II Breast Tissue MarkerBard Peripheral Vascular, Inc.8640172015-09-25
00801741032318UltraClip® II Breast Tissue MarkerBard Peripheral Vascular, Inc.8650172015-09-25
00801741032325UltraClip® II Breast Tissue MarkerBard Peripheral Vascular, Inc.8655172015-09-25
00801741032332SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.SMUC13R2015-09-25
00801741032349SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.SMUC13C2015-09-25
00801741032356SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.SMUC13H2015-09-25
00801741032363SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.SMUC13V2015-09-25
00801741032370SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.SMUC10R2015-09-25
00801741032387SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.SMUC10C2015-09-25
00801741032394SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.SMUC10H2015-09-25
00801741032400SenoMark® UltraCor® Breast Tissue MarkerBard Peripheral Vascular, Inc.SMUC10V2015-09-25
00801741032417UltraClip® Dual Trigger Breast Tissue MarkerBard Peripheral Vascular, Inc.866017D2015-09-25
00801741032424UltraClip® Dual Trigger Breast Tissue MarkerBard Peripheral Vascular, Inc.867017D2015-09-25
00801741079726DuaLok™Bard Peripheral Vascular, Inc.LW00372016-09-13
00801741079733DuaLok™Bard Peripheral Vascular, Inc.LW00572016-09-13
00801741079740DuaLok™Bard Peripheral Vascular, Inc.LW00772016-09-13
00801741079757DuaLok™Bard Peripheral Vascular, Inc.LW01072016-09-13
00801741079764DuaLok™Bard Peripheral Vascular, Inc.LW01372016-09-13
00801741079771GHIATAS®Bard Peripheral Vascular, Inc.470202016-09-16
00801741079788GHIATAS®Bard Peripheral Vascular, Inc.473202016-09-16
00801741079795GHIATAS®Bard Peripheral Vascular, Inc.475192016-09-16
00801741079801GHIATAS®Bard Peripheral Vascular, Inc.475202016-09-16
00801741079818GHIATAS®Bard Peripheral Vascular, Inc.477202016-09-16
00801741079825GHIATAS®Bard Peripheral Vascular, Inc.479192016-09-16
00801741079832GHIATAS®Bard Peripheral Vascular, Inc.479202016-09-16
00801741079870GHIATAS®Bard Peripheral Vascular, Inc.495202016-09-16
00801741079887GHIATAS®Bard Peripheral Vascular, Inc.497202016-09-16
00801741079894GHIATAS®Bard Peripheral Vascular, Inc.499202016-09-16
00801741079900GHIATAS®Bard Peripheral Vascular, Inc.4702012016-09-16
00801741079917GHIATAS®Bard Peripheral Vascular, Inc.4752012016-09-16
00801741079924GHIATAS®Bard Peripheral Vascular, Inc.4772012016-09-16
00801741079931GHIATAS®Bard Peripheral Vascular, Inc.4792012016-09-16
00801741079948CHESBROUGH®Bard Peripheral Vascular, Inc.4605192016-09-15