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
DateFirm and productCodeLinked 510(k)
Oct 15, 2026Merit Medical Systems, Inc.
Scout MD, REF MDS05A-01, MDS05C-01, MDS10C-01 Contents: (1) Scout MD Delivery System, Standard for use with the SCOUT MD Surgical Guidance System, Rx Only, Sterile-EO
Open, Classified		 NEUK252892
May 27, 2026Devicor Medical Products Inc
HydroMARK Breast Biopsy Site Marker, Model Number: 4010-02-15-T3
Open, Classified		 NEUK212158
Feb 17, 2026Stryker Corporation
MOLLI 2 System System includes: MM1000 (Pack of 10) - MOLLI Introducer (8cm, 14G) and MOLLI Marker UDI (GTIN): 00850024195028 MS-00009 (Pack of 10) - MOLLI Introducer (12cm, 14G) and MOLLI Marker UDI
Open, Classified		 NEUK231579
K253888
Oct 24, 2025ENDOMAGNETICS LTD
Magseed Pro 12 cm soft tissue marker. Model Number: MS2-17-1-12. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in
Open, Classified		 NEUK232865
Oct 24, 2025ENDOMAGNETICS LTD
Magseed Pro 7 cm soft tissue marker. Model Number: MS2-17-1-07. Product Description: The Endomag Magseed Pro Magnetic Marker System is a sterile, single use device composed of a marker preloaded in a
Open, Classified		 NEUK232865
Jan 6, 2025Elucent Medical Inc
EnVisio Patient Pad Transition Cushion, Model/Catalog Number: ENVISIO-SYS Product Description: The EnVisio Patient Pad Transition Cushion is a component of the EnVisio Navigation System which is a med
Open, Classified		 NEUK183400
Nov 26, 2024Hologic, Inc
BioZorb Marker. Radiographic soft tissue marker.
Open, Classified		 NEUK143484
K152070
May 3, 2024Hologic, Inc
BioZorb Marker-BioZorb 3D Bioabsorbable Marker-Intended Use radiographic marking of sites in soft tissue. 1) F0405 BioZorb Marker 4cm x 5cm 2) F0404 BioZorb Marker 4cm x 4cm 3) F0331 BioZorb Marker 1c
Open, Classified		 NEUK152070
Jan 30, 2023Carbon Medical Technologies, Inc.
Mammotome MammoStar Biopsy Site Identified, REF STAR1401
Terminated		 NEUK100994
Sep 30, 2022Hologic, Inc
The BioZorb LP Marker is an implantable radiopaque marker used to facilitate visualization of a soft tissue site. The BioZorb LP Marker is comprised of a bioabsorbable PLA (polylactic acid) component
Open, Classified		 NEUK152070
Mar 30, 2022Devicor Medical Products Inc
HydroMARK Breast Biopsy Marker, Model No. 4010-05-08-T4
Terminated		 NEUK210752
May 22, 2017Somatex Medical Technologies GmbH
TUMARK Q, Length 12 cm, Diameter 18G, GTIN 04250195603081, REF 271500, STERILE
Terminated		 NEUK073095
Jun 10, 2013Bard Peripheral Vascular Inc
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Ribbon Marker 5 Pack, Sterile, Single Use, N
Terminated		 NEUK090547
Jun 10, 2013Bard Peripheral Vascular Inc
BARD Biopsy Systems (A Business Unit of Bard Peripheral Vascular, Inc.), UltraClip Dual Trigger Breast Tissue Marker 17g X 10cm needle, Ultrasound Enhanced Coil Marker 5 Pack; Sterilize, Non-pyrogenic
Terminated		 NEUK090547
Jul 7, 2011Kapp Surgical Instrument Inc
Bariatric Target Ring (Nitinol) (a thin, circular nitinol ring) Model # K-9536-N, Lot #08-001, Lot #08-002 & Lot #08-003. One ring per plastic pouch, three rings are then placed into a plastic box wi
Terminated		 NEUK072216

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