ClearanceBrief
Panels › General, Plastic Surgery › Product code NEU · Class 2

Marker, Radiographic, Implantable

Regulation 878.4300

4510(k)s in 12 months (110 all time)
3recalls in 12 months (15 all time)
15recalls that name a 510(k)
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Top companies in NEU

Company510(k)sRecalls
Devicor Medical Products, Inc.92
Carbon Medical Technologies, Inc.61
Senorx, Inc.70
Somatex Medical Technologies GmbH61
Biopsy Sciences, LLC60
Bard Peripheral Vascular, Inc.32
Endomagnetics Ltd.,32
Molli Surgical, Inc.50
Elucent Medical, Inc.31
Focal Therapeutics40
Decided510(k)Device and applicantCode
Jan 23, 2026K253761HydroMARK™ Plus Breast Biopsy Site Marker (Dragonfly Shape); HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shap
Devicor Medical Products, Inc.
NEU
Dec 31, 2025K253888MOLLI 2 System
Stryker Endoscopy
NEU
Dec 19, 2025K252892SCOUT MD Surgical Guidance System
Merit Medical Systems, Inc.
NEU
Dec 12, 2025K251989VizMark Preloaded Tissue Marker Device (VM-0001)
Breast-Med, Inc.
NEU
Jul 23, 2025K251748MammoSTAR Biopsy Site Identifier
Carbon Medical Technologies, Inc.
NEU
Mar 24, 2025K243642UltraCor™ Twirl™ Breast Tissue Marker
Bard Peripheral Vascular, Inc.
NEU
Dec 20, 2024K233639SmartClip Secure Soft Tissue Marker
Elucent Medical, Inc.
NEU
Nov 7, 2024K240429Trilogy Tissue Marker
Inrad, Inc.
NEU
Sep 26, 2024K234149MOLLI 2 System
Molli Surgical, Inc., CA
NEU
Sep 25, 2024K240042MOLLI 2 System
Molli Surgical, Inc., CA
NEU
Sep 16, 2024K241762OneMark
View Point Medical
NEU
Jul 10, 2024K240527HydroMARK™ Plus Breast Biopsy Site Marker (Hummingbird Shape) (4010-02-15-T6)
Devicor Medical Products, Inc.
NEU
Jun 28, 2024K232865Magseed Pro Magnetic Marker System
Endomagnetics Ltd.,, GB
NEU
Feb 12, 2024K231468SCOUT MD Surgical Guidance System
Merit Medical System, Inc.
NEU
Jan 23, 2024K230836SchurSign Tissue Marker
Surgmark GmbH, DE
NEU
Jan 12, 2024K232615LumiMARK™ Biopsy Site Marker (LM0215T (Tulip Shape)); LumiMARK™ Biopsy Site Marker (LM0215L (Lotus Shape)); LumiMARK™ Bi
Devicor Medical Products, Inc.
NEU
Oct 26, 2023K231579MOLLI 2
Molli Surgical, Inc., CA
NEU
Jul 13, 2023K221961HydroMARK Plus Breast Biopsy Site Marker
Devicor Medical Products, Inc.
NEU
Jan 21, 2023K222832Sentimag System
Endomagnetics Ltd.,, GB
NEU
Jan 18, 2023K223107MOLLI 2
Molli Surgical, Inc., CA
NEU
Apr 21, 2022K212158HydroMARK Breast Biopsy Site Marker
Devicor Medical Products, Inc.
NEU
Apr 8, 2022K212882SCOUT BX Delivery System
Merit Medical Systems, Inc.
NEU
Apr 16, 2021K210600MOLLI
Molli Surgical, Inc., CA
NEU
Apr 14, 2021K210752HydroMARK Breast Biopsy Site Marker
Devicor Medical Products, Inc.
NEU
Feb 18, 2021K201863Tumark Vision, Tumark Professional, Tumark Q, Tumark Professional Q-Shape
Somatex Medical Technologies GmbH, DE
NEU
Dec 16, 2020K203097HydroMARK Breast Biopsy Site Markers
Devicor Medical Products, Inc.
NEU
Oct 21, 2020K192771C4 Fiducial Marker
C4 Imaging, LLC
NEU
May 6, 2020K193189RFID Localization System
Health Beacons, Inc.
NEU
Oct 17, 2019K183503EasyMark Tissue Marker
Inrad, Inc.
NEU
Sep 26, 2019K192371BioZorb SP Marker
Focal Therapeutics
NEU
Sep 13, 2019K190932RFID Localization System
Health Beacons, Inc.
NEU
Aug 14, 2019K190689SignalMark Breast Marker
View Point Medical, Inc.
NEU
Mar 22, 2019K183400EnVisio Navigation Sytem
Elucent Medical, Inc.
NEU
Oct 31, 2018K182082Tumark for Eviva, Tumark for Brevera
Somatex Medical Technologies GmbH, DE
NEU
Sep 25, 2018K1816925cm Tag Applicator, 7cm Tag Applicator, 10 cm Tag Applicator, 5 cm Tag Applicator (10 pack), 7cm Tag Applicator (10 pac
Health Beacons, Inc.
NEU
Aug 2, 2018K181007Cianna Medical SAVI Scout Reflector and SAVI Scout System
Cianna Medical, Inc.
NEU
Jun 6, 2018K180621EchoMark, EchoMark LP
Sonavex, Inc.
NEU
Jun 4, 2018K180640SmartClip Soft Tissue Marker
Elucent Medical, Inc.
NEU
Mar 22, 2018K180443Tumark Vision
Somatex Medical Technologies GmbH, DE
NEU
Mar 9, 2018K180061UltraCor Twirl Breast Tissue Marker
Bard Peripheral Vascular, Inc.
NEU
Feb 16, 2018K173587Magseed Magnetic Marker Systtem
Endomagnetics Ltd.,, GB
NEU
Oct 31, 2017K171767Cianna Medical SAVI Scout Reflector and SAVI Scout System
Cianna Medical, Inc.
NEU
Jun 15, 2017K170803HydroMARK Breast Biopsy Site Markers
Devicor Medical Products, Inc.
NEU
Jun 2, 2017K170026Radiopaque Tissue Marker
Viscus Biologics, LLC
NEU
Apr 27, 2017K170905Star Tissue Marker
Scion Medical Technologies, LLC
NEU
May 13, 2016K152510UltraCor Twirl Breast Tissue Marker
Bard Peripheral Vascular, Inc.
NEU
May 5, 2016K161021HydroMARK Breast Biopsy Site Marker
Devicor Medical Products, Inc.
NEU
Dec 30, 2015K152586Beacon Fine Needle Fiducial System
Covidien, LLC
NEU
Dec 17, 2015K153189Beacon Tissue Marker (SE)
Scion Medical Technologies, LLC
NEU
Aug 26, 2015K152070BioZorb LP Marker
Focal Therapeutics
NEU

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