FDA.reportPublic FDA data

Imaging lesion localization marker, implantable

Definition
A sterile 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 formed as a wire, needle, bead, stent-like tube or washer, 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
405
Last updated
2022-05-24 13:01:11

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
14250195611922Tumark ProfessionalSOMATEX Medical Technologies GmbH3512802022-05-16
14250195611939Tumark ProfessionalSOMATEX Medical Technologies GmbH3512822022-05-16
20884521198798superDimensionCovidien LPSDM22016-09-24
10841911102394Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-08-T32022-03-02
10841911102424Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-10-T12022-03-02
10841911102431Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-10-T32022-03-02
10841911102448Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-10-T42022-03-02
10841911102462Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-08-T12022-03-02
10841911102479Mammotome HydroMARKDEVICOR MEDICAL PRODUCTS, INC.4010-05-08-T42022-03-02
10841911102301Mammotome HydromarkDEVICOR MEDICAL PRODUCTS, INC.4010-03-09-T12022-02-08
10841911102318Mammotome HydromarkDEVICOR MEDICAL PRODUCTS, INC.4010-03-09-T32022-02-08
10850002461302BIOMARC ® EXCarbon Medical Technologies, Inc.0401652022-02-07
04250195604583Q-Wire SystemSOMATEX Medical Technologies GmbH2714622021-10-28
04250195604590Q-Wire SystemSOMATEX Medical Technologies GmbH2714632021-10-28
04250195604606Q-Wire SystemSOMATEX Medical Technologies GmbH2714642021-10-28
04250195604705TulocSOMATEX Medical Technologies GmbH2716602021-10-28
04250195604712TulocSOMATEX Medical Technologies GmbH2716612021-10-28
04250195604729TulocSOMATEX Medical Technologies GmbH2716632021-10-28
04250195604767Tuloc PremiumSOMATEX Medical Technologies GmbH2718802021-10-28
04250195604774Tuloc PremiumSOMATEX Medical Technologies GmbH2718812021-10-28
04250195604781Tuloc PremiumSOMATEX Medical Technologies GmbH2718832021-10-28
04250195604798Lung Marker SystemSOMATEX Medical Technologies GmbH2720122021-10-28
04250195604804Lung Marker SystemSOMATEX Medical Technologies GmbH2720152021-10-28
04250195605825MRI TulocSOMATEX Medical Technologies GmbH6016492021-10-28
04250195605832MRI TulocSOMATEX Medical Technologies GmbH6016512021-10-28
14250195611809Tumark SpheraSOMATEX Medical Technologies GmbH3512702021-10-08
14250195611816Tumark SpheraSOMATEX Medical Technologies GmbH3512722021-10-08
48033003340071ALM SETH.S. HOSPITAL SERVICE SPAALM SET V TYPE2021-10-04
14250195611823Tumark ConicSOMATEX Medical Technologies GmbH3512602021-10-01
14250195611830Tumark ConicSOMATEX Medical Technologies GmbH3512622021-10-01
B887GF1001VISICOIL MRRADIOMED CORPGF10042021-09-17
B887GF1321VISICOIL MRRADIOMED CORPGF13232021-09-17
B887GF1501Gold FiducialRADIOMED CORPGF15032021-09-17
00850024195035MOLLI Molli Surgical IncMM10002021-08-27
04250195611727Tumark SpheraSOMATEX Medical Technologies GmbH2715322021-07-30
20884521762685SuperLockCovidien LPSDGN4472021-07-05
00850016008046VeraFormVISCUS BIOLOGICS LLC012021-06-23
18056138586243MarkMDL SRLPN20152021-05-17
18056138586250AutoMarkMDL SRLPNA20052021-05-17
18056138586267AutoMarkMDL SRLPNA20102021-05-17
18056138586274AutoMarkMDL SRLPNA20152021-05-17
18056138586304MarkSlimMDL SRLPNS20102021-05-17
18056138586311MarkslimMDL SRLPNS20152021-05-17
18056138586366RepoMarkMDL SRLPR20072021-05-17
18056138586373RepoMarkMDL SRLPR20102021-05-17
18056138586380RepoMarkMDL SRLPR20152021-05-17
18056138586229MarkMDL SRLPN20102021-05-14
18056138586236MarkMDL SRLPN20122021-05-14
20884521539706SuperLockCovidien LPSDGN4472016-09-24
07340145700759Gold AnchorNaslund Medical AB2020-10-B2020-12-15
07340145700773Gold AnchorNaslund Medical AB2020-20-B2020-12-15
07340145700797Gold AnchorNaslund Medical AB2035-10-B2020-12-15
07340145700810Gold AnchorNaslund Medical AB2208-10-B2020-12-15
07340145700834Gold AnchorNaslund Medical AB2208-20-B2020-12-15
07340145700858Gold AnchorNaslund Medical AB2215-10-B2020-12-15
07340145700872Gold AnchorNaslund Medical AB2215-20-B2020-12-15
07340145700896Gold AnchorNaslund Medical AB2220-102020-12-15
07340145700919Gold AnchorNaslund Medical AB2220-202020-12-15
07340145700933Gold AnchorNaslund Medical AB2220-10-B2020-12-15
07340145700957Gold AnchorNaslund Medical AB2220-20-B2020-12-15
07340145700971Gold AnchorNaslund Medical AB2225-10-B2020-12-15
07340145700995Gold AnchorNaslund Medical AB2225-20-B2020-12-15
07340145701015Gold AnchorNaslund Medical AB2515-102020-12-15
07340145701039Gold AnchorNaslund Medical AB2515-202020-12-15
07340145701053Gold AnchorNaslund Medical AB2020-102020-12-15
10813079020360Breast Needle LocatorREMINGTON MEDICAL, INC.BNL-20032020-09-24
20813079020374Breast Needle LocatorREMINGTON MEDICAL, INC.BNL-20052020-09-24
10813079020384Breast Needle LocatorREMINGTON MEDICAL, INC.BNL-20072020-09-24
10813079020391Breast Needle LocatorREMINGTON MEDICAL, INC.BNL-20102020-09-24
04250195611567TuflexSOMATEX Medical Technologies GmbH2716402020-08-31
04250195611581TuflexSOMATEX Medical Technologies GmbH2716412020-08-31
04250195611604TuflexSOMATEX Medical Technologies GmbH2716422020-08-31
04250195611628TuflexSOMATEX Medical Technologies GmbH2716432020-08-31
04250195611642Tuflex PremiumSOMATEX Medical Technologies GmbH2716502020-08-31
04250195611666Tuflex PremiumSOMATEX Medical Technologies GmbH2716512020-08-31
04250195611680Tuflex PremiumSOMATEX Medical Technologies GmbH2716522020-08-31
B8872150040X-SeedRADIOMED CORP2150042020-04-30
B8872850030X-SeedRADIOMED CORP2850032020-04-30
B8872850040X-SeedRADIOMED CORP2850042020-04-30
10855436007126LOCalizerHEALTH BEACONS INCHB300-102020-02-23