Marker, Radiographic, Implantable
FDA product code NEU · Class II (moderate risk) · 21 CFR 878.4300 · General, Plastic Surgery
110510(k) clearances
0PMA approvals
14recalls
Implantimplanted device
Manufacturers
- Devicor Medical Products, Inc. 9
- Senorx, Inc. 7
- Somatex Medical Technologies GmbH 6
- Carbon Medical Technologies, Inc. 6
- Biopsy Sciences, LLC 6
- Molli Surgical, Inc. 5
- Inrad 4
- Focal Therapeutics 4
- Scion Medical Technologies, LLC 4
- Elucent Medical, Inc. 3
- Cianna Medical, Inc. 3
- Endomagnetics Ltd., 3
- Health Beacons, Inc. 3
- Bard Peripheral Vascular Inc 3
- Medical Device Technologies, Inc. 2
- Kapp Surgical Instrument, Inc. 2
- Walter Lorenz Surgical, Inc. 2
- Suros Surgical Systems, Inc. A Hologic Company 2
- Breast-Med, Inc. 2
- Halifax Biomedical, Inc. 2
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253761 | HydroMARK Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK Plus Breast…NEU · Traditional | Devicor Medical Products, Inc. | 01/23/2026SE |
| K253888 | MOLLI 2 SystemNEU · Special | Stryker Endoscopy | 12/31/2025SE |
| K252892 | SCOUT MD Surgical Guidance SystemNEU · Traditional | Merit Medical Systems, Inc. | 12/19/2025SE |
| K251989 | VizMark Preloaded Tissue Marker Device (VM-0001)NEU · Traditional | Breast-Med, Inc. | 12/12/2025SE |
| K251748 | MammoSTAR Biopsy Site IdentifierNEU · Traditional | Carbon Medical Technologies, Inc. | 07/23/2025SE |
| K243642 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/24/2025SE |
| K233639 | SmartClip Secure Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 12/20/2024SE |
| K240429 | Trilogy Tissue MarkerNEU · Traditional | Inrad, Inc. | 11/07/2024SE |
| K234149 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/26/2024SE |
| K240042 | MOLLI 2 SystemNEU · Traditional | Molli Surgical, Inc. | 09/25/2024SE |
| K241762 | OneMarkNEU · Traditional | View Point Medical | 09/16/2024SE |
| K240527 | HydroMARK Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)NEU · Traditional | Devicor Medical Products, Inc. | 07/10/2024SE |
| K232865 | Magseed Pro Magnetic Marker SystemNEU · Traditional | Endomagnetics Ltd., | 06/28/2024SE |
| K231468 | SCOUT MD Surgical Guidance SystemNEU · Traditional | Merit Medical System, Inc. | 02/12/2024SE |
| K230836 | SchurSign Tissue MarkerNEU · Traditional | Surgmark GmbH | 01/23/2024SE |
| K232615 | LumiMARK Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK Biopsy Site Marker…NEU · Traditional | Devicor Medical Products, Inc. | 01/12/2024SE |
| K231579 | Molli 2NEU · Traditional | Molli Surgical, Inc. | 10/26/2023SE |
| K221961 | HydroMARK Plus Breast Biopsy Site MarkerNEU · Traditional | Devicor Medical Products, Inc. | 07/13/2023SE |
| K222832 | Sentimag SystemNEU · Traditional | Endomagnetics Ltd., | 01/21/2023SE |
| K223107 | Molli 2NEU · Traditional | Molli Surgical, Inc. | 01/18/2023SE |
| K212158 | HydroMARK Breast Biopsy Site MarkerNEU · Traditional | Devicor Medical Products, Inc. | 04/21/2022SE |
| K212882 | SCOUT BX Delivery SystemNEU · Traditional | Merit Medical Systems, Inc. | 04/08/2022SE |
| K210600 | MolliNEU · Traditional | Molli Surgical, Inc. | 04/16/2021SE |
| K210752 | HydroMARK Breast Biopsy Site MarkerNEU · Special | Devicor Medical Products, Inc. | 04/14/2021SE |
| K201863 | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-ShapeNEU · Traditional | Somatex Medical Technologies GmbH | 02/18/2021SE |
| K203097 | HydroMARK Breast Biopsy Site MarkersNEU · Traditional | Devicor Medical Products, Inc. | 12/16/2020SE |
| K192771 | C4 Fiducial MarkerNEU · Traditional | C4 Imaging, LLC | 10/21/2020SE |
| K193189 | RFID Localization SystemNEU · Traditional | Health Beacons, Inc. | 05/06/2020SE |
| K183503 | EasyMark Tissue MarkerNEU · Traditional | Inrad, Inc. | 10/17/2019SE |
| K192371 | BioZorb SP MarkerNEU · Special | Focal Therapeutics | 09/26/2019SE |
| K190932 | RFID Localization SystemNEU · Traditional | Health Beacons, Inc. | 09/13/2019SE |
| K190689 | SignalMark Breast MarkerNEU · Traditional | View Point Medical, Inc. | 08/14/2019SE |
| K183400 | EnVisio Navigation SytemNEU · Traditional | Elucent Medical, Inc. | 03/22/2019SE |
| K182082 | Tumark for Eviva, Tumark for BreveraNEU · Traditional | Somatex Medical Technologies GmbH | 10/31/2018SE |
| K181692 | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10…NEU · Traditional | Health Beacons, Inc. | 09/25/2018SE |
| K181007 | Cianna Medical SAVI Scout Reflector and SAVI Scout SystemNEU · Traditional | Cianna Medical, Inc. | 08/02/2018SE |
| K180621 | EchoMark, EchoMark LPNEU · Traditional | Sonavex, Inc. | 06/06/2018SE |
| K180640 | SmartClip Soft Tissue MarkerNEU · Traditional | Elucent Medical, Inc. | 06/04/2018SE |
| K180443 | Tumark VisionNEU · Special | Somatex Medical Technologies GmbH | 03/22/2018SE |
| K180061 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 03/09/2018SE |
| K173587 | Magseed Magnetic Marker SysttemNEU · Traditional | Endomagnetics Ltd., | 02/16/2018SE |
| K171767 | Cianna Medical SAVI Scout Reflector and SAVI Scout SystemNEU · Traditional | Cianna Medical, Inc. | 10/31/2017SE |
| K170803 | HydroMARK Breast Biopsy Site MarkersNEU · Traditional | Devicor Medical Products, Inc. | 06/15/2017SE |
| K170026 | Radiopaque Tissue MarkerNEU · Traditional | Viscus Biologics, LLC | 06/02/2017SE |
| K170905 | Star Tissue MarkerNEU · Special | Scion Medical Technologies, LLC | 04/27/2017SE |
| K152510 | UltraCor Twirl Breast Tissue MarkerNEU · Traditional | Bard Peripheral Vascular, Inc. | 05/13/2016SE |
| K161021 | HydroMARK Breast Biopsy Site MarkerNEU · Special | Devicor Medical Products, Inc. | 05/05/2016SE |
| K152586 | Beacon Fine Needle Fiducial SystemNEU · Traditional | Covidien, LLC | 12/30/2015SE |
| K153189 | Beacon Tissue Marker (SE)NEU · Special | Scion Medical Technologies, LLC | 12/17/2015SE |
| K152070 | BioZorb LP MarkerNEU · Special | Focal Therapeutics | 08/26/2015SE |
| K151998 | TraceIT Tissue Marker - 3mLNEU · Special | Augmenix, Inc. | 08/19/2015SE |
| K143484 | BioZorb MarkerNEU · Traditional | Focal Therapeutics | 06/29/2015SE |
| K133697 | Breast-Med Tissue MarkerNEU · Traditional | Breast-Med, Inc. | 04/10/2015SE |
| K141722 | Carefusion Gold Tissue MarkerNEU · Traditional | Care Fusion | 01/23/2015SE |
| K142198 | BNX Fine Needle Aspiration SystemNEU · Traditional | Covidien, LLC | 10/08/2014SE |
| K141356 | Echo Tip Ultra Fiducial NeedleNEU · Special | Wilson-Cook Medical, Inc. | 06/20/2014SE |
| K140835 | General and Plastic SurgeryNEU · Special | Scion Medical Technologies, LLC | 05/20/2014SE |
| K132708 | Biomarc Fiducial MarkerNEU · Traditional | Carbon Medical Technologies, Inc. | 12/20/2013SE |
| K132463 | Cianna Medical Permanent Tissue Marker and Delivery SystemNEU · Traditional | Cianna Medical, Inc. | 12/03/2013SE |
| K131654 | Starchmark Breast Tissue Marker; Starchmark Ultracor Breast Tissue MarkerNEU · Special | Senorx, Inc. | 06/27/2013SE |
| K130763 | Beacon Tissue MarkerNEU · Special | Scion Medical Technologies, LLC | 05/08/2013SE |
| K130537 | Biopsy Sciences LLC Hydromark Breast Biopsy Site MarkerNEU · Special | Biopsy Sciences, LLC | 03/29/2013SE |
| K121964 | Markit Tissue MARKER-1ML Markit Tissue MARKER-3ML Markit Tissue MARKER-10MLNEU · Traditional | Augmenix, Inc. | 01/23/2013SE |
| K123911 | Senomark Ultra Breast Tissue MarkerNEU · Special | C.R. Bard, Inc. | 01/10/2013SE |
| K121113 | Biopsy Sciences, Inc. Hydromark Brest Biosy Site MarkerNEU · Traditional | Biopsy Sciences, LLC | 07/12/2012SE |
| K111895 | Echotip(R) Ultra Fiducial NeedleNEU · Traditional | Wilson-Cook Medical Inc./Cook Endoscopy | 04/27/2012SE |
| K113202 | Tissue MarkerNEU · Traditional | Focal Therapeutics | 02/28/2012SE |
| K111692 | Tumark Flex for Mammotome,Tumark Flex for AtecNEU · Special | Somatex Medical Technologies GmbH | 11/08/2011SE |
| K103417 | Halifax Biomedical Tanatlum Bead SetNEU · Special | Halifax Biomedical, Inc. | 06/28/2011SE |
| K102506 | Mixed Media MarkerNEU · Traditional | Cortex Manufacturing, Inc. | 01/12/2011SE |
| K102768 | Secrmark Biopsy Site Marking SystemNEU · Special | Hologic, Inc. | 12/02/2010SE |
| K102608 | Securmark Biopsy Site Marking SystemNEU · Special | Suros Surgical Systems, Inc. A Hologic Company | 10/08/2010SE |
| K093473 | KMD-MARK1 Tissue MarkerNEU · Traditional | Kent Medical Devices, Inc. | 07/02/2010SE |
| K100994 | Preloaded Tissue Marker DeviceNEU · Special | Carbon Medical Technologies, Inc. | 04/30/2010SE |
| K093064 | Tumark Professional, Model 271560, Mr-Tumark Professional, Model 601560NEU · Traditional | Somatex Medical Technologies GmbH | 02/17/2010SE |
| K090581 | Tantalum Bead Set, Model P003175NEU · Traditional | Halifax Biomedical, Inc. | 08/21/2009SE |
| K090547 | Ultraclip II US Wing and Coil, Models: 862017U, 864017UNEU · Special | C.R. Bard, Inc. | 03/18/2009SE |
| K090501 | Biopsy Sciences Hydromark Breast Biopsy Site Marker, Models 4005-02-15-T1…NEU · Special | Biopsy Sciences, LLC | 03/05/2009SE |
| K083006 | Biopsy Sciences, Inc., Hydromark Breast Biopsy Site MarkerNEU · Special | Biopsy Sciences, LLC | 02/09/2009SE |
| K082278 | Mammomark, Mammomark MR and Cormark Biopsy Site IdentifiersNEU · Traditional | Ethicon Endo-Sugery, LLC | 12/16/2008SE |
| K081085 | Starchmark Biopsy Site Marker, Model STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GSNEU · Traditional | Senorx, Inc. | 08/01/2008SE |
| K081170 | Prostate Tissue MarkerNEU · Traditional | Senorx, Inc. | 05/28/2008SE |
| K080698 | Gel Mark Ultracor Biopsy Site Marker, Model: GMUC-17GGPNEU · Special | Senorx, Inc. | 03/31/2008SE |
| K073095 | Tumark Professional, Model 271560; Mr- Tumark Professional, Model 601560NEU · Traditional | Somatex Medical Technologies GmbH | 03/19/2008SE |
| K072219 | Cytophil Tissue MarkerNEU · Traditional | Cytophil, Inc. | 01/18/2008SE |
| K072913 | Securmark Biopsy Site Identification SystemNEU · Special | Suros Surgical Systems, Inc. A Hologic Company | 01/04/2008SE |
| K072216 | Kapp Bari-Ring Endoscopic Marker, Model K-9536NEU · Special | Kapp Surgical Instrument, Inc. | 11/09/2007SE |
| K070436 | Biomarc Gold Tissue MarkerNEU · Special | Carbon Medical Technologies, Inc. | 03/16/2007SE |
| K063238 | Ultraclip II Wing and Ultraclip II CoilNEU · Traditional | Inrad | 01/30/2007SE |
| K062528 | Tissue Site Marking SystemNEU · Traditional | Suros Surgical Systems, Inc. | 01/26/2007SE |
| K063193 | Modification to Biomarc Tissue MarkerNEU · Special | Carbon Medical Technologies, Inc. | 11/21/2006SE |
| K060769 | Hydromark Biopsy Site MarkerNEU · Traditional | Biopsy Sciences, LLC | 07/25/2006SE |
| K053518 | Interv Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Special | Medical Device Technologies, Inc. | 01/26/2006SE |
| K050384 | Kapp Bari-Ring, Model KS-BR-2005NEU · Traditional | Kapp Surgical Instrument, Inc. | 01/13/2006SE |
| K051421 | Inter V Brand V-Mark Breast Biopsy Site Marker with Titanium AnchorNEU · Traditional | Medical Device Technologies, Inc. | 08/30/2005SE |
| K050090 | Gel Mark VNEU · Special | Senorx, Inc. | 02/07/2005SE |
| K042341 | Ultraclip II USNEU · Special | Inrad | 09/20/2004SE |
| K042296 | Biomarc Preloaded Tissue Marker DeviceNEU · Traditional | Carbon Medical Technologies, Inc. | 09/20/2004SE |
| K040990 | Modification to Self-Drilling Radiographic MarkersNEU · Special | Walter Lorenz Surgical, Inc. | 05/13/2004SE |
| K040706 | Gel Mark IVNEU · Special | Senorx, Inc. | 04/08/2004SE |
| K033447 | Cliploc Soft Tissue Marker 18G/100MM (4), /130MM (5 1/8), /150MM (6), Models 12370…NEU · Traditional | Mri Devices Corp. | 01/28/2004SE |
| K031938 | Gel Mark III Biopsy Site MarkerNEU · Traditional | Senorx, Inc. | 09/05/2003SE |
| K023694 | Bio-Mark Resorbable Biopsy Site Marker and Bio-Mark Permanent Biopsy Site MarkerNEU · Traditional | Biopsy Sciences, LLC | 03/17/2003SE |
| K023450 | Biopsy Site Tissue Marker DeviceNEU · Traditional | Promex, Inc. | 12/19/2002SE |
| K020276 | 8 Gauge Micromark II Tissue Marker, Models C1540 & C1535NEU · Traditional | Ethicon Endo-Surgery, Inc. | 04/12/2002SE |
| K014148 | Self-Drilling Radiographic MarkerNEU · Special | Walter Lorenz Surgical, Inc. | 01/17/2002SE |
| K013413 | Micromark II Tissue Marker,Model C1535NEU · Traditional | Ethicon Endo-Surgery, Inc. | 12/03/2001SE |
| K012955 | Coaptite Tissue Marker and Coaptite FN Tissue MarkerNEU · Traditional | Bioform, Inc. | 10/22/2001SE |
| K011856 | Radiographic MarkersNEU · Traditional | Encore Orthopedics, Inc. | 08/22/2001SE |
| K010348 | Tantalum Beads - Radiographic MarkerNEU · Traditional | Biomet, Inc. | 05/03/2001SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2239-2026 Class II | HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3Incorrect inner package labeling. Boxes labeled 4010-02-15-T3 markers may contain individual packages… | Devicor Medical Products Inc | 04/24/2026Open, Classified |
| Z-1427-2026 Class II | MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and…Due to a need to update the product labeling (Instructions for Use IFU) as a result of the magnetized… | Stryker Corporation | 01/21/2026Open, Classified |
| Z-0317-2026 Class II | Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description:…Potential for contamination with cotton fibers. | Endomagnetics Ltd | 10/01/2025Open, Classified |
| Z-0316-2026 Class II | Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The…Potential for contamination with cotton fibers. | Endomagnetics Ltd | 10/01/2025Open, Classified |
| Z-0806-2025 Class II | EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product…There is a potential safety risk caused by physical disassociation of the back section from the bed frame of… | Elucent Medical Inc | 11/18/2024Open, Classified |
| Z-0328-2025 Class I | BioZorb Marker. Radiographic soft tissue marker.Firm received reports of adverse events/complications that include serious injuries, such as pain… | Hologic, Inc | 10/10/2024Open, Classified |
| Z-1733-2024 Class I | BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of…Safety Information: Complaints describe complications/adverse events that include pain, infection, rash… | Hologic, Inc | 03/13/2024Open, Classified |
| Z-1041-2023 Class II | Mammotome MammoStar Biopsy Site Identified, REF STAR1401The label incorrectly identifies the product as STAR1401, a 1x3mm Barbell shaped marker pre-loaded in a 14… | Carbon Medical Technologies, Inc. | 12/16/2022Terminated |
| Z-1858-2022 Class II | The BioZorb LP Marker is an implantable radiopaque marker used to facilitate…Hologic BioZorb LP Marker, (Product number F0221), lot number 22A0RL, contained removable labels with an… | Hologic, Inc | 08/09/2022Open, Classified |
| Z-1124-2022 Class II | HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4Small patient labels do not match the primary device label. The primary device label accurately identifies… | Devicor Medical Products Inc | 03/30/2022Terminated |
| Z-0410-2018 Class II | TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILEThere is a potential risk of puncture to the packaging material which can compromise the devices sterility… | Somatex Medical Technologies GmbH | 05/22/2017Terminated |
| Z-1527-2013 Class II | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual…Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual… | Bard Peripheral Vascular Inc | 01/23/2013Terminated |
| Z-1526-2013 Class II | BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual…Bard Peripheral Vascular (BPV) is initiating this recall because a combination of Bard UltraClip Dual… | Bard Peripheral Vascular Inc | 01/23/2013Terminated |
| Z-2753-2011 | Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot…During an FDA Inspection on 3/21/11 - 3/22/11 at Kapp Surgical an uncontrolled instruction for use was… | Kapp Surgical Instrument Inc | 05/24/2011Terminated |