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 radiographic film or digital 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.
GUDID devices
60
Last updated
2026-03-19 21:56:43

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
10840277411812Gold MarkerRIVERPOINT MEDICAL, LLCGM0453-20202026-03-11
10841911102936HydroMARK PlusDEVICOR MEDICAL PRODUCTS, INC.4010-MR-15-T52026-03-05
00851674008577SmartClipElucent Medical, Inc.SMARTCLIPLT-VLT-5 2026-02-16
00851674008584SmartClipElucent Medical, Inc.SMARTCLIPLT-VLT-7.52026-02-16
00851674008591SmartClipElucent Medical, Inc.SMARTCLIPLT-VLT-10 2026-02-16
00851674008607SmartClip SecureElucent Medical, Inc.SMARTCLIP-SEC-VLT2026-02-16
10841911103551HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-10-T12025-11-18
10841911103568HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-10-T32025-11-18
10841911103575HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-10-T42025-11-18
10841911103520HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-08-T12025-11-11
10841911103544HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-08-T42025-11-11
14250195612165Tumark EyeSOMATEX Medical Technologies GmbH3512902025-07-15
14250195612172Tumark EyeSOMATEX Medical Technologies GmbH3512922025-07-15
10801741226332UltraCor™ Twirl™Bard Peripheral Vascular, Inc.UCLS172025-04-01
10801741226349UltraCor™ Twirl™Bard Peripheral Vascular, Inc.UCVR172025-04-01
08719992742509Sirius PintuitionSirius Medical Systems B.V.Sirius Pintuition Bracket Packet 14G x 12cm2024-11-22
10841911103643HydromarkDEVICOR MEDICAL PRODUCTS, INC.4010-05-08-T42024-08-29
10841911103667HydromarkDEVICOR MEDICAL PRODUCTS, INC.4010-05-10-T12024-08-29
10841911103674HydromarkDEVICOR MEDICAL PRODUCTS, INC.4010-05-10-T32024-08-29
15060391210428Magseed ProENDOMAGNETICS LTDMS2-17-1-072024-08-15
15060391210435Magseed ProENDOMAGNETICS LTDMS2-17-1-122024-08-15
10850002461340BiomarC®Carbon Medical Technologies, Inc.0401672024-07-23
10850002461357Carbon Bright ®Carbon Medical Technologies, Inc.0401662024-07-23
G6352120052MAMAWIREHISTO S.A. 20 Ga x 5 cm2024-05-17
G6352120072MAMAWIREHISTO S.A. 20 Ga x 7 cm2024-05-17
G6352120102MAMAWIREHISTO S.A. 20 Ga x 10 cm2024-05-17
G6352120122MAMAWIREHISTO S.A. 20 Ga x 12 cm2024-05-17
G6352120132MAMAWIREHISTO S.A. 20 Ga x 13 cm2024-05-17
G6352120152MAMAWIREHISTO S.A. 20 Ga x 15 cm2024-05-17
G6353120052MAMAWIRE PLUSHISTO S.A. 20 Ga x 5 cm2024-05-17
G6353120072MAMAWIRE PLUSHISTO S.A. 20 Ga x 7 cm2024-05-17
G6353120102MAMAWIRE PLUSHISTO S.A. 20 Ga x 10 cm2024-05-17
G6353120122MAMAWIRE PLUSHISTO S.A. 20 Ga x 12 cm2024-05-17
G6353120132MAMAWIRE PLUSHISTO S.A. 20 Ga x 13 cm2024-05-17
G6353120152MAMAWIRE PLUSHISTO S.A. 20 Ga x 15 cm2024-05-17
G6359118102MAMAWIRE FIXHISTO S.A. 18 Ga x 10 cm2024-05-17
G635911810B2MAMAWIRE FIXHISTO S.A. 18 Ga x 10 cm2024-05-17
G635911810D2MAMAWIRE FIXHISTO S.A. 18 Ga x 10 cm2024-05-17
G635911810DB2MAMAWIRE FIXHISTO S.A. 18 Ga x 10 cm2024-05-17
G635911810DY2MAMAWIRE FIXHISTO S.A. 18 Ga x 10 cm2024-05-17
05744002210016BioXmarkNanovi A/S112105902024-05-08
10841911102981LumiMARK Breast Biopsy Site MarkerDEVICOR MEDICAL PRODUCTS, INC.LM0215T2024-03-11
10841911102998LumiMARK Breast Biopsy Site Marker DEVICOR MEDICAL PRODUCTS, INC.LM0215L2024-03-11
10841911103001LumiMARK Breast Biopsy Site MarkerDEVICOR MEDICAL PRODUCTS, INC.LM0215R2024-03-11
00850016008183VeraFormViscus Biologics LLC600232024-01-16
07340145700438Gold AnchorNaslund Medical ABGA150X-102023-01-23
07340145700452Gold AnchorNaslund Medical ABGA150X-202023-01-23
07340145700513Gold AnchorNaslund Medical ABGA250-102023-01-23
07340145700599Gold AnchorNaslund Medical ABGA350-102023-01-23
07340145700650Gold AnchorNaslund Medical ABGA350-20-B2023-01-23
07340145700674Gold AnchorNaslund Medical ABGA80-102023-01-23
07340145701077Gold AnchorNaslund Medical AB2225-102023-01-23
07340145701091Gold AnchorNaslund Medical ABGATD-102023-01-23
07340145701114Gold AnchorNaslund Medical ABGATD-202023-01-23
07340145701138Gold AnchorNaslund Medical AB2215-102023-01-23
07340145701152Gold AnchorNaslund Medical AB2208-102023-01-23
07340145701176Gold AnchorNaslund Medical AB2010-10-B2023-01-23
07340145701190Gold AnchorNaslund Medical AB2010-20-B2023-01-23
07340145701213Gold AnchorNaslund Medical ABGA100-10-B2023-01-23
07340145701237Gold AnchorNaslund Medical ABGA100-20-B2023-01-23