Company ยท US
Carbon Medical Technologies, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2002 to 2026. Name variants (Inc, Corp, punctuation) are merged.
18510(k) clearances (1 in 12 months)
2recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 31, 2026 | K253598 | InjecSURE Injection System Carbon Medical Technologies, Inc. | FBK |
| Jul 23, 2025 | K251748 | MammoSTAR Biopsy Site Identifier Carbon Medical Technologies, Inc. | NEU |
| Jun 10, 2021 | K211590 | Fiducial Marker Carbon Medical Technologies, Inc. | IYE |
| Jul 29, 2019 | K191797 | BiomarC Fiducial Marker Carbon Medical Technologies | IYE |
| Aug 23, 2017 | K172227 | Endoscopic Injection Needle Carbon Medical Technologies, Inc. | FBK |
| May 13, 2014 | K133148 | BIOMARC COAXIAL NEEDLE Carbon Medical Technologies, Inc. | FBK |
| Feb 28, 2014 | K132064 | BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc. | IYE |
| Dec 20, 2013 | K132708 | BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc. | NEU |
| Apr 12, 2013 | K130678 | BIOMARC GOLD FIDUCIAL MARKER Carbon Medical Technologies, Inc. | IYE |
| Apr 28, 2011 | K110772 | BIOMARC FIDUCIAL MARKER Carbon Medical Technologies, Inc. | IYE |
| Apr 30, 2010 | K100994 | PRELOADED TISSUE MARKER DEVICE Carbon Medical Technologies, Inc. | NEU |
| Mar 16, 2007 | K070436 | BIOMARC GOLD TISSUE MARKER Carbon Medical Technologies, Inc. | NEU |
| Nov 21, 2006 | K063193 | MODIFICATION TO BIOMARC TISSUE MARKER Carbon Medical Technologies, Inc. | NEU |
| Nov 5, 2004 | K042615 | CARBON MEDICAL TECHNOLOGIES ENDOSCOPIC INJECTION NEEDLE Carbon Medical Technologies, Inc. | FBK |
| Sep 20, 2004 | K042296 | BIOMARC PRELOADED TISSUE MARKER DEVICE Carbon Medical Technologies, Inc. | NEU |
| Aug 21, 2003 | K032347 | BIOMARC TISSUE MARKER Carbon Medical Technologies, Inc. | GDW |
| Apr 30, 2003 | K030451 | CARBON MEDICAL TECHNOLOGIES INJECTION NEEDLE Carbon Medical Technologies, Inc. | FBK |
| Jun 12, 2002 | K021160 | DERMMATRIX SURGICAL MESH Carbon Medical Technologies, Inc. | FTM |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 17, 2024 | Carbon Medical Technologies, Inc. BiomarC EX Fiducial Marker System, Catalog Number 040165 Open, Classified |
IYE | K132064 |
| Jan 30, 2023 | Carbon Medical Technologies, Inc. Mammotome MammoStar Biopsy Site Identified, REF STAR1401 Terminated |
NEU | K100994 |