Carbon Medical Technologies, Inc.
FDA Regulatory Profile
Summary
- Total Recalls
- 2
- 510(k) Clearances
- 17
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3161-2024 | Class III | BiomarC EX Fiducial Marker System, Catalog Number 040165 | July 26, 2024 |
| Z-1041-2023 | Class II | Mammotome MammoStar Biopsy Site Identified, REF STAR1401 | December 16, 2022 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251748 | MammoSTAR Biopsy Site Identifier | July 23, 2025 |
| K211590 | Fiducial Marker | June 10, 2021 |
| K191797 | BiomarC Fiducial Marker | July 29, 2019 |
| K172227 | Endoscopic Injection Needle | August 23, 2017 |
| K133148 | BIOMARC COAXIAL NEEDLE | May 13, 2014 |
| K132064 | BIOMARC FIDUCIAL MARKER | February 28, 2014 |
| K132708 | BIOMARC FIDUCIAL MARKER | December 20, 2013 |
| K130678 | BIOMARC GOLD FIDUCIAL MARKER | April 12, 2013 |
| K110772 | BIOMARC FIDUCIAL MARKER | April 28, 2011 |
| K100994 | PRELOADED TISSUE MARKER DEVICE | April 30, 2010 |
| K070436 | BIOMARC GOLD TISSUE MARKER | March 16, 2007 |
| K063193 | MODIFICATION TO BIOMARC TISSUE MARKER | November 21, 2006 |
| K042615 | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE | November 5, 2004 |
| K042296 | BIOMARC PRELOADED TISSUE MARKER DEVICE | September 20, 2004 |
| K032347 | BIOMARC TISSUE MARKER | August 21, 2003 |
| K030451 | CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE | April 30, 2003 |
| K021160 | DERMMATRIX SURGICAL MESH | June 12, 2002 |