FDA 510(k) Applications for Medical Device Product Code "NEU"
(Marker, Radiographic, Implantable)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K121964 | AUGMENIX , INC. | MARKIT TISSUE MARKER-1ML MARKIT TISSUE MARKER-3ML MARKIT TISSUE MARKER-10ML | 01/23/2013 |
| K151998 | AUGMENIX, INC. | TraceIT Tissue Marker - 3mL | 08/19/2015 |
| K180061 | Bard Peripheral Vascular, Inc. | UltraCor Twirl Breast Tissue Marker | 03/09/2018 |
| K152510 | BARD PERIPHERAL VASCULAR, INC. | UltraCor Twirl Breast Tissue Marker | 05/13/2016 |
| K012955 | BIOFORM, INC. | COAPTITE TISSUE MARKER AND COAPTITE FN TISSUE MARKER | 10/22/2001 |
| K010348 | BIOMET, INC. | TANTALUM BEADS - RADIOGRAPHIC MARKER | 05/03/2001 |
| K023694 | BIOPSY SCIENCES, LLC | BIO-MARK RESORBABLE BIOPSY SITE MARKER AND BIO-MARK PERMANENT BIOPSY SITE MARKER | 03/17/2003 |
| K090501 | BIOPSY SCIENCES, LLC | BIOPSY SCIENCES HYDROMARK BREAST BIOPSY SITE MARKER, MODELS 4005-02-15-T1, 4005-02-15-S1, 4005-03-15-T1, 4005-03-15-S1 | 03/05/2009 |
| K130537 | BIOPSY SCIENCES, LLC | BIOPSY SCIENCES LLC HYDROMARK BREAST BIOPSY SITE MARKER | 03/29/2013 |
| K121113 | BIOPSY SCIENCES, LLC | BIOPSY SCIENCES, INC. HYDROMARK BREST BIOSY SITE MARKER | 07/12/2012 |
| K083006 | BIOPSY SCIENCES, LLC | BIOPSY SCIENCES, INC., HYDROMARK BREAST BIOPSY SITE MARKER | 02/09/2009 |
| K060769 | BIOPSY SCIENCES, LLC | HYDROMARK BIOPSY SITE MARKER | 07/25/2006 |
| K133697 | BREAST-MED, INC. | BREAST-MED TISSUE MARKER | 04/10/2015 |
| K123911 | C.R. BARD, INC. | SENOMARK ULTRA BREAST TISSUE MARKER | 01/10/2013 |
| K090547 | C.R. BARD, INC. | ULTRACLIP II US WING AND COIL, MODELS: 862017U, 864017U | 03/18/2009 |
| K192771 | C4 Imaging LLC | C4 Fiducial Marker | 10/21/2020 |
| K132708 | CARBON MEDICAL TECHNOLOGIES, INC. | BIOMARC FIDUCIAL MARKER | 12/20/2013 |
| K070436 | CARBON MEDICAL TECHNOLOGIES, INC. | BIOMARC GOLD TISSUE MARKER | 03/16/2007 |
| K042296 | CARBON MEDICAL TECHNOLOGIES, INC. | BIOMARC PRELOADED TISSUE MARKER DEVICE | 09/20/2004 |
| K063193 | CARBON MEDICAL TECHNOLOGIES, INC. | MODIFICATION TO BIOMARC TISSUE MARKER | 11/21/2006 |
| K100994 | CARBON MEDICAL TECHNOLOGIES, INC. | PRELOADED TISSUE MARKER DEVICE | 04/30/2010 |
| K141722 | CAREFUSION | CAREFUSION GOLD TISSUE MARKER | 01/23/2015 |
| K132463 | CIANNA MEDICAL, INC. | CIANNA MEDICAL PERMANENT TISSUE MARKER AND DELIVERY SYSTEM | 12/03/2013 |
| K171767 | Cianna Medical, Inc. | Cianna Medical SAVI Scout Reflector and SAVI Scout System | 10/31/2017 |
| K181007 | Cianna Medical, Inc. | Cianna Medical SAVI Scout Reflector and SAVI Scout System | 08/02/2018 |
| K102506 | CORTEX MANUFACTURING, INC. | MIXED MEDIA MARKER | 01/12/2011 |
| K152586 | Covidien LLC | Beacon Fine Needle Fiducial System | 12/30/2015 |
| K142198 | Covidien LLC | BNX Fine Needle Aspiration System | 10/08/2014 |
| K072219 | CYTOPHIL INC | CYTOPHIL TISSUE MARKER | 01/18/2008 |
| K203097 | Devicor Medical Products, Inc | HydroMARK Breast Biopsy Site Markers | 12/16/2020 |
| K161021 | DEVICOR MEDICAL PRODUCTS, INC. | HydroMARK Breast Biopsy Site Marker | 05/05/2016 |
| K210752 | Devicor Medical Products, Inc. | HydroMARK Breast Biopsy Site Marker | 04/14/2021 |
| K212158 | Devicor Medical Products, Inc. | HydroMARK Breast Biopsy Site Marker | 04/21/2022 |
| K170803 | Devicor Medical Products, Inc. | HydroMARK Breast Biopsy Site Markers | 06/15/2017 |
| K221961 | Devicor Medical Products, Inc. | HydroMARK Plus Breast Biopsy Site Marker | 07/13/2023 |
| K183400 | Elucent Medical, Inc | EnVisio Navigation Sytem | 03/22/2019 |
| K180640 | Elucent Medical, Inc. | SmartClip Soft Tissue Marker | 06/04/2018 |
| K011856 | ENCORE ORTHOPEDICS, INC. | RADIOGRAPHIC MARKERS | 08/22/2001 |
| K222832 | Endomagnetics Ltd | Sentimag System | 01/21/2023 |
| K173587 | Endomagnetics Ltd. | Magseed Magnetic Marker Systtem | 02/16/2018 |
| K082278 | ETHICON ENDO-SUGERY, LLC | MAMMOMARK, MAMMOMARK MR AND CORMARK BIOPSY SITE IDENTIFIERS | 12/16/2008 |
| K020276 | ETHICON ENDO-SURGERY, INC. | 8 GAUGE MICROMARK II TISSUE MARKER, MODELS C1540 & C1535 | 04/12/2002 |
| K013413 | ETHICON ENDO-SURGERY, INC. | MICROMARK II TISSUE MARKER,MODEL C1535 | 12/03/2001 |
| K152070 | FOCAL THERAPEUTICS | BioZorb LP Marker | 08/26/2015 |
| K143484 | FOCAL THERAPEUTICS | BioZorb Marker | 06/29/2015 |
| K192371 | Focal Therapeutics | BioZorb SP Marker | 09/26/2019 |
| K113202 | FOCAL THERAPEUTICS | TISSUE MARKER | 02/28/2012 |
| K103417 | HALIFAX BIOMEDICAL, INC. | HALIFAX BIOMEDICAL TANATLUM BEAD SET | 06/28/2011 |
| K090581 | HALIFAX BIOMEDICAL, INC. | TANTALUM BEAD SET, MODEL P003175 | 08/21/2009 |
| K181692 | Health Beacons, Inc. | 5cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pack), 10cm Tag Applicator (10 pack), LOCalizer Surgical Probe, LOCalizer Surgical Probe (5 pack) | 09/25/2018 |
| K190932 | Health Beacons, Inc. | RFID Localization System | 09/13/2019 |
| K193189 | Health Beacons, Inc. | RFID Localization System | 05/06/2020 |
| K102768 | HOLOGIC, INC. | SECRMARK BIOPSY SITE MARKING SYSTEM | 12/02/2010 |
| K042341 | INRAD | ULTRACLIP II US | 09/20/2004 |
| K063238 | INRAD | ULTRACLIP II WING AND ULTRACLIP II COIL | 01/30/2007 |
| K183503 | INRAD Inc. | EasyMark Tissue Marker | 10/17/2019 |
| K072216 | KAPP SURGICAL INSTRUMENT, INC. | KAPP BARI-RING ENDOSCOPIC MARKER, MODEL K-9536 | 11/09/2007 |
| K050384 | KAPP SURGICAL INSTRUMENT, INC. | KAPP BARI-RING, MODEL KS-BR-2005 | 01/13/2006 |
| K093473 | KENT MEDICAL DEVICES, INC. | KMD-MARK1 TISSUE MARKER | 07/02/2010 |
| K051421 | MEDICAL DEVICE TECHNOLOGIES, INC. | INTER V BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | 08/30/2005 |
| K053518 | MEDICAL DEVICE TECHNOLOGIES, INC. | INTERV BRAND V-MARK BREAST BIOPSY SITE MARKER WITH TITANIUM ANCHOR | 01/26/2006 |
| K212882 | Merit Medical Systems, Inc. | SCOUT BX Delivery System | 04/08/2022 |
| K223107 | MOLLI Surgical, Inc | MOLLI 2 | 01/18/2023 |
| K210600 | MOLLI Surgical, Inc. | MOLLI | 04/16/2021 |
| K033447 | MRI DEVICES CORP. | CLIPLOC SOFT TISSUE MARKER 18G/100MM (4), /130MM (5 1/8), /150MM (6), MODELS 12370, 12372, 12376 | 01/28/2004 |
| K023450 | PROMEX, INC. | BIOPSY SITE TISSUE MARKER DEVICE | 12/19/2002 |
| K130763 | SCION MEDICAL TECHNOLOGIES LLC | BEACON TISSUE MARKER | 05/08/2013 |
| K140835 | SCION MEDICAL TECHNOLOGIES LLC | GENERAL AND PLASTIC SURGERY | 05/20/2014 |
| K153189 | SCION MEDICAL TECHNOLOGIES, LLC | Beacon Tissue Marker (SE) | 12/17/2015 |
| K170905 | Scion Medical Technologies, LLC | Star Tissue Marker | 04/27/2017 |
| K031938 | SENORX, INC. | GEL MARK III BIOPSY SITE MARKER | 09/05/2003 |
| K040706 | SENORX, INC. | GEL MARK IV | 04/08/2004 |
| K080698 | SENORX, INC. | GEL MARK ULTRACOR BIOPSY SITE MARKER, MODEL: GMUC-17GGP | 03/31/2008 |
| K050090 | SENORX, INC. | GEL MARK V | 02/07/2005 |
| K081170 | SENORX, INC. | PROSTATE TISSUE MARKER | 05/28/2008 |
| K081085 | SENORX, INC. | STARCHMARK BIOPSY SITE MARKER, MODEL STMKEC-10GSS, STMKEC-10GTR, STMKMT-11GS | 08/01/2008 |
| K131654 | SENORX, INC. | STARCHMARK BREAST TISSUE MARKER; STARCHMARK ULTRACOR BREAST TISSUE MARKER | 06/27/2013 |
| K111692 | SOMATEX MEDICAL TECHNOLOGIES GMBH | TUMARK FLEX FOR MAMMOTOME,TUMARK FLEX FOR ATEC | 11/08/2011 |
| K182082 | Somatex Medical Technologies GmbH | Tumark for Eviva, Tumark for Brevera | 10/31/2018 |
| K093064 | SOMATEX MEDICAL TECHNOLOGIES GMBH | TUMARK PROFESSIONAL, MODEL 271560, MR-TUMARK PROFESSIONAL, MODEL 601560 | 02/17/2010 |
| K073095 | SOMATEX MEDICAL TECHNOLOGIES GMBH | TUMARK PROFESSIONAL, MODEL 271560; MR- TUMARK PROFESSIONAL, MODEL 601560 | 03/19/2008 |
| K180443 | SOMATEX Medical Technologies GmbH | Tumark Vision | 03/22/2018 |
| K201863 | SOMATEX Medical Technologies GmbH | Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape | 02/18/2021 |
| K180621 | Sonavex, Inc. | EchoMark, EchoMark LP | 06/06/2018 |
| K072913 | SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY | SECURMARK BIOPSY SITE IDENTIFICATION SYSTEM | 01/04/2008 |
| K102608 | SUROS SURGICAL SYSTEMS, INC, A HOLOGIC COMPANY | SECURMARK BIOPSY SITE MARKING SYSTEM | 10/08/2010 |
| K062528 | SUROS SURGICAL SYSTEMS, INC. | TISSUE SITE MARKING SYSTEM | 01/26/2007 |
| K190689 | View Point Medical, Inc. | SignalMark Breast Marker | 08/14/2019 |
| K170026 | Viscus Biologics, LLC | Radiopaque Tissue Marker | 06/02/2017 |
| K040990 | WALTER LORENZ SURGICAL, INC. | MODIFICATION TO SELF-DRILLING RADIOGRAPHIC MARKERS | 05/13/2004 |
| K014148 | WALTER LORENZ SURGICAL, INC. | SELF-DRILLING RADIOGRAPHIC MARKER | 01/17/2002 |
| K141356 | WILSON-COOK MEDICAL INC. | ECHO TIP ULTRA FIDUCIAL NEEDLE | 06/20/2014 |
| K111895 | WILSON-COOK MEDICAL, INC. / COOK ENDOSCOPY | ECHOTIP(R) ULTRA FIDUCIAL NEEDLE | 04/27/2012 |
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