FDA.reportPublic FDA data

Imaging lesion localization marker, external, single-use

Definition
A device placed on the surface of a patient's body during a surgical procedure to create identifying marks that can be seen on radiographic film or digital images for the localization and delineation of areas of interest (e.g., a tumour or lesion), or attached to navigated instruments used to assist in computer-assisted surgery. It is made from materials compatible with the imaging system in which it is intended to be used [e.g., magnetic resonance imaging (MRI), x-ray, nuclear medicine], or as reflective markers detected by the cameras/computer software of an image guided surgery/patient positioning system (PPS). This is a single-use device.
GUDID devices
125
Last updated
2026-06-11 06:05:22

Representative GUDID Devices#

Primary DI, Brand, Company table
Primary DIBrandCompanyModelPublished
08052286425857MEDWIREMEDAX SRL UNIPERSONALEXW20060-0O2020-12-28
08052286425864MEDWIREMEDAX SRL UNIPERSONALEXW20090-0O2020-12-28
08052286425871MEDWIREMEDAX SRL UNIPERSONALEXW20120-0O2020-12-28
08052286425888MEDWIREMEDAX SRL UNIPERSONALEXW20030-0J2020-12-28
08052286425895MEDWIREMEDAX SRL UNIPERSONALEXW20050-0J2020-12-28
08052286425901MEDWIREMEDAX SRL UNIPERSONALEXW20070-0J2020-12-28
08052286428278MEDWIREMEDAX SRL UNIPERSONALEXW20100-0J2021-02-26
08053329377089MEDWIREMEDAX SRL UNIPERSONALEMW20060-202018-04-13
08053839012449SINUREPMEDAX SRL UNIPERSONALESR20120-022018-05-26
08054301667273MEDWIREMEDAX SRL UNIPERSONALEMW20030-112018-10-29
08054301667280MEDWIREMEDAX SRL UNIPERSONALEMW20050-112018-10-29
08054301667297MEDWIREMEDAX SRL UNIPERSONALEMW20070-112018-10-29
08054301667303MEDWIREMEDAX SRL UNIPERSONALEMW20100-112018-10-29
08055002909556SINUREPMEDAX SRL UNIPERSONALESR20080-032018-04-10
08055002909587SINUREPMEDAX SRL UNIPERSONALESR20120-032018-04-10
08056515887799SINUREPMEDAX SRL UNIPERSONALESR20100-032018-03-08
08056515888093SINUREPMEDAX SRL UNIPERSONALESR20100-002018-03-08
08056515888178SINUREPMEDAX SRL UNIPERSONALESR20100-022018-05-26
08056772670448SINUREPMEDAX SRL UNIPERSONALESR20120-002018-04-10
08056772672527SINUREPMEDAX SRL UNIPERSONALESR20080-002018-04-10
08056772674910MEDWIREMEDAX SRL UNIPERSONALEMW20120-202018-03-08
08056772677324MEDWIREMEDAX SRL UNIPERSONALEMW20090-202018-03-08
08056772679946SINUREPMEDAX SRL UNIPERSONALESR20080-022018-05-26
08059174746964MEDWIREMEDAX SRL UNIPERSONALEXW20060-1S2023-01-03
08059174746971MEDWIREMEDAX SRL UNIPERSONALEXW20080-1S2022-12-20
08059174746988MEDWIREMEDAX SRL UNIPERSONALEXW20100-1S2022-07-15
08059174747008MEDWIREMEDAX SRL UNIPERSONALEXW20120-1S2022-12-20
08059174747084MEDWIREMEDAX SRL UNIPERSONALEXW20060-2S2023-01-03
08059174747091MEDWIREMEDAX SRL UNIPERSONALEXW20080-2S2022-12-20
08059174747107MEDWIREMEDAX SRL UNIPERSONALEXW20100-2S2022-12-20
08059174747121MEDWIREMEDAX SRL UNIPERSONALEXW20120-2S2022-12-20
00386120008578RELIMYCO MEDICAL SUPPLIES INC.R-MRN21062018-09-11
00386120008585RELIMYCO MEDICAL SUPPLIES INC.R-MRN21092018-09-11
00386120008592RELIMYCO MEDICAL SUPPLIES INC.R-MRN21112018-09-11
00386120008608RELIMYCO MEDICAL SUPPLIES INC.R-MRN21152018-09-11
00805832020048NDI Passive SpheresNorthern Digital Inc88010022016-09-24
00805832030016NDI Passive SpheresNorthern Digital Inc88009652016-09-24
00805832030023NDI Passive SpheresNorthern Digital Inc88009672016-09-24
00805832030030NDI Passive SpheresNorthern Digital Inc88009662016-09-24
00805832030047NDI Passive SpheresNorthern Digital Inc88013202016-09-24
00805832040015NDI Passive SpheresNorthern Digital Inc88007372016-09-24
00805832040022NDI Passive SpheresNorthern Digital Inc88007382016-09-24
00805832040039NDI Passive SpheresNorthern Digital Inc88007392016-09-24
00805832070012NDI Passive SphereNorthern Digital Inc88010712016-09-24
00805832070029NDI Passive SphereNorthern Digital Inc88010742016-09-24
00805832070036NDI Passive SphereNorthern Digital Inc88010752016-09-24
00885556757475REAL INTELLIGENCESmith & Nephew, Inc.ROB100322020-04-03
30815112020218Fast Find Grid: Disposable CT Biopsy GridBracco Diagnostics Inc.6000012016-09-19
00850030914255N/AMicroport Navibot International LLC10035-NB2022-12-08
00850030914323SkyWalkerMicroport Navibot International LLCNB-101472023-06-29
006283415206217D Surgical FLASH Frame7D Surgical ULC11-00482022-10-11
18059174746985MEDWIREMEDAX SRL UNIPERSONALEXW20100-1S2022-07-15
00815212024108DKBL-20-15.0-AIzi Medical Products, LLCG028502021-10-12
00815212024115DKBL-20-5.0-AIzi Medical Products, LLCG025862021-10-12
00815212024122DKBL-20-7.0-AIzi Medical Products, LLCG026012021-10-12
00815212024139DKBL-20-9.0-AIzi Medical Products, LLCG025872021-10-12
00815212024146DKBL-21-15.0-AIzi Medical Products, LLCG029382021-10-12
00815212024153DKBL-21-5.0-AIzi Medical Products, LLCG029002021-10-12
00815212024160DKBL-21-7.0-AIzi Medical Products, LLCG035072021-10-12
00815212024177DKBL-21-9.0-AIzi Medical Products, LLCG025542021-10-12
00815212024184DKBL-20-7.0-A-UIzi Medical Products, LLCG099842021-10-12
00815212024191DKBL-20-5.0-A-UIzi Medical Products, LLCG043432021-10-12
00815212024207DKBL-20-9.0-A-UIzi Medical Products, LLCG042962021-10-12
00815212024214DKBL-21-5.0-A-UIzi Medical Products, LLCG058622021-10-12
00815212024221DKBL-21-7.0-A-UIzi Medical Products, LLCG090422021-10-12
00815212024238DKBL-21-9.0-A-UIzi Medical Products, LLCG073702021-10-12
00815212024245DXRBL-18-5.0Izi Medical Products, LLCG194182021-10-12
00815212024252DXRBL-18-9.0Izi Medical Products, LLCG193802021-10-12
00815212024269DXRBL-19.5-15.0-SIzi Medical Products, LLCG195892021-10-12
00815212024276DXRBL-19.5-5.0-SIzi Medical Products, LLCG196172021-10-12
00815212024283DXRBL-19.5-9.0-SIzi Medical Products, LLCG195332021-10-12
00815212024290IDLC-19.5-9.0-4-U-DMIzi Medical Products, LLCG207822021-10-12
00815212024306DGC-30-5Izi Medical Products, LLCG043032021-10-12
006283415205537D Surgical Registration Frame 7D Surgical ULC11-00662021-07-27
18052286428275MEDWIREMEDAX SRL UNIPERSONALEXW20100-0J2021-02-26
18052286425854MEDWIREMEDAX SRL UNIPERSONALEXW20060-0O2020-12-28
18052286425861MEDWIREMEDAX SRL UNIPERSONALEXW20090-0O2020-12-28
18052286425878MEDWIREMEDAX SRL UNIPERSONALEXW20120-0O2020-12-28
18052286425885MEDWIREMEDAX SRL UNIPERSONALEXW20030-0J2020-12-28
18052286425892MEDWIREMEDAX SRL UNIPERSONALEXW20050-0J2020-12-28